Expressive writing treatments to reduce PTSD symptom severity and negative alcohol-related outcomes among trauma-exposed sexual minority women and transgender/nonbinary people: Study protocol for a mixed-method pilot trial

Abstract

Background

Sexual minority women (SMW) and transgender and/or nonbinary (TNB) individuals report an elevated prevalence of posttraumatic stress disorder (PTSD) symptoms and negative alcohol-related outcomes compared to heterosexual women and cisgender people. SMW and TNB individuals also face barriers to utilizing treatment, which can result in delayed or missed appointments. Accessible, feasible, and effective treatment approaches, such as web-based expressive writing (EW) treatments, are needed to address PTSD and negative alcohol-related outcomes in these populations.

Method

We describe the design of a mixed-method pilot randomized controlled trial which will compare an EW treatment adapted for SMW and TNB people (stigma-adapted EW) and trauma (i.e., non-adapted) EW with an active (neutral-event) control to determine acceptability and feasibility of a future fully powered randomized controlled trial. The sample will include 150 trauma-exposed SMW and TNB individuals from across the United States who will be randomly assigned to stigma-adapted EW (n = 50), trauma EW (n = 50), or control (n = 50). Participants will be assessed before treatment, one-week after the first writing session, and three-months after the first writing session. This paper identifies steps for evaluating the acceptability and feasibility of the proposed study and determining changes in outcomes resulting from adapted and non-adapted EW treatments to inform refinements. This paper also highlights our strategy for testing theory-driven mediators and moderators of treatment outcomes.

Conclusions

This mixed-method pilot trial will inform the first fully powered, self-administered, brief web-based treatment to reduce PTSD symptom severity and negative alcohol-related outcomes among trauma-exposed SMW and TNB individuals.

Highlights

• •Sexual minority women and gender expansive people are at risk of trauma and stigma.
• •This population also faces barriers to using mental and behavioral health treatment.
• •We note our approach for adapting and testing expressive writing for these groups.
• •We also discuss our plan for testing mediators and moderators of treatment outcomes.
• •Results can improve clinical relevance of online treatments for PTSD and alcohol.

1. Introduction

Sexual minority women (SMW; e.g., lesbian, bisexual) and transgender/nonbinary (TNB) individuals report an elevated prevalence of posttraumatic stress disorder (PTSD), negative alcohol-related outcomes (e.g., hazardous or harmful drinking which increases risk of negative consequences, heavy drinking quantity/frequency), and their comorbidity compared to heterosexual women and cisgender individuals [1,2]. For example, one recent meta-analysis demonstrated that SMW have 2.15 times the odds of meeting criteria for probable PTSD and report greater PTSD symptom severity compared to heterosexual women [2]. Further, findings from United States (U.S.) national samples highlighted that compared to heterosexual women, SMW are over twice as likely to report hazardous drinking and meet criteria for alcohol use disorder [1]. Findings also suggest that compared to heterosexual women, SMW have 4.51 times the odds of meeting criteria for probable comorbid PTSD and hazardous drinking [2]. TNB individuals are also more likely than cisgender sexual minority individuals and heterosexual individuals to meet criteria for PTSD and are at greater risk of reporting severe PTSD symptoms, heavy episodic drinking, and alcohol-related consequences [1,2]. One recent study that used Veterans Health Administration medical record data from 1999 to 2021 found that the prevalence of PTSD was 1.5–1.8 times higher among transgender veterans than among cisgender veterans [3]. Moreover, findings from the National College Health Assessment Survey suggest that TNB people have more heavy episodic drinking occasions than cisgender people [4].

These disparities are rooted in SMW's and TNB individuals' disproportionate exposure to stigma and associated stress responses (i.e., minority stressors), trauma, and inadequate social safety [[5], [6], [7]]. Some research suggests a dose-response relationship between adverse experiences (e.g., minority stressors, childhood maltreatment) and risk of PTSD and negative alcohol-related outcomes among SMW and TNB individuals [8]. Alcohol is often used to reduce distressing negative internal experiences, including PTSD symptoms [9]. Using alcohol to cope with PTSD can increase risk of re-victimization, chronic PTSD symptoms, and development of alcohol use disorder symptoms due to persistent hyperarousal, avoidance behaviors, and fear-extinction resistance [9]. Yet, knowledge gaps remain regarding evidence-based practices for reducing PTSD symptom severity and negative alcohol-related outcomes among SMW and TNB people.

1.1. Defining SMW and TNB people

Sexual orientation refers to an individual's sexual identity and sexual behavior concerning the genders to which they are attracted [[10], [11], [12]]. Sexual minority status is distinct from gender minority status, yet some people may identify as both sexual and gender minorities. Gender identity refers to a person's inner sense of their own gender [13]. Cisgender people are those whose gender identities align with sociocultural expectations for their sex assigned at birth, while transgender describes people whose gender identities diverge from sociocultural expectations for their sex assigned at birth [14]. Nonbinary is an umbrella term for people who do not identify within the Western colonialist gender binary (man/woman). Nonbinary people may describe their gender as “nonbinary” or use other terms, such as genderqueer [14,15]. There is considerable overlap between transgender and nonbinary identities, with many nonbinary people identifying as transgender [15]. In this paper, we use the term “TNB” to refer collectively to transgender men, transgender women, and nonbinary people. Further, this pilot trial focuses on sexual minority people who identify their gender as cisgender women, transgender women, transgender men, and/or nonbinary, and thus likely have experienced gender-based stigma.

1.2. Treatment-utilization barriers among SMW and TNB individuals

SMW and TNB individuals often experience unique treatment-utilization barriers, such as anticipated oppression-based stigma and providers’ lack of knowledge concerning unique strengths and stigma-related issues facing this community, which can result in delayed or missed appointments [16]. SMW and TNB individuals are also at increased risk of being uninsured and feeling dissatisfied with treatment [16]. Moreover, compared to PTSD and hazardous drinking alone, comorbid PTSD and hazardous drinking is associated with worse PTSD and alcohol treatment prognosis and greater treatment dropout and functional impairment in the general population [17]. Due to these barriers, SMW and TNB individuals may utilize needed care at a lower prevalence than their heterosexual, cisgender counterparts and seek help only when experiencing severe PTSD and negative alcohol-related outcomes [16].

1.3. Existing PTSD and alcohol treatments for SMW and TNB individuals

While there exists no empirical evidence documenting whether sexual or gender minority status moderates the effectiveness of PTSD treatments [18], SMW and TNB individuals may not benefit from existing PTSD treatments to the same extent as cisgender, heterosexual people [19]. As a result, recent literature has identified clinical considerations and guidelines for treating PTSD among sexual and gender minority people [[18], [19], [20]]. Despite the promise of culturally adapted PTSD treatments for sexual and gender minority people [18], recent systematic reviews and meta-analyses of psychological treatments for PTSD determined that no studies have been adapted for trauma-exposed SMW or TNB individuals [21].

Most current evidence-based treatment models targeting PTSD (e.g., cognitive processing therapy, prolonged exposure) do not explicitly consider SMW's and TNB individuals' unique needs. For instance, no PTSD treatment, to our knowledge, addresses trauma-exposed SMW's and TNB individuals' (1) comorbid health needs, including stigma-related hypervigilance and emotion-driven behaviors (e.g., alcohol use); (2) barriers to treatment utilization and retention, such as limited disclosure of adversity or of sexual and gender minority identities due to enacted and anticipatory stigma from treatment providers; and (3) social determinants of PTSD, such as sexual and gender identity-related stigma, intersectional stressors, and inadequate social safety [18,20,22]. Nevertheless, the dearth of prior research limits our ability to draw conclusions about the efficacy of adapted and non-adapted PTSD treatment among SMW and TNB people [18].

There is also a notable lack of alcohol treatments specifically tailored for SMW and TNB individuals [1,23,24]. Recent findings suggest that <1% of alcohol treatments have examined sexual identity differences in treatment outcomes, and <18% of substance use facilities in the U.S. have specific programming for sexual and gender minority people [18,25]. Of the few existing studies that examined the efficacy of adapted alcohol treatment for SMW, results suggest that correcting drinking and coping norms via personalized normative feedback, compared to control topics, was associated with a reduction in drinking among SMW [26]. Empowering Queer Identities in Psychotherapy (EQuIP), an adapted cognitive behavioral treatment for SMW, found that while the immediate intervention group outperformed the waitlist control in reducing SMW's depression, anxiety, emotion dysregulation, and rumination, there were no significant effects for alcohol use [27]. To date, there are no adapted alcohol interventions for TNB individuals [23].

Among non-adapted alcohol treatments, one study found that among gay and lesbian couples with alcohol use disorders, those who received behavioral couples therapy plus individual-based treatment reported a lower proportion of heavy drinking days compared to those receiving individual therapy alone [28]. Another study examined the efficacy of substance use and PTSD treatment among transgender women [29]. This pilot study found that transgender women living with HIV who engaged in a 12-session Seeking Safety program (a manualized, present-focused, cognitive behavioral treatment) demonstrated reduced PTSD symptom severity and hazardous drinking levels [29]. Findings highlight the need to advance knowledge of the acceptability, feasibility, and outcomes of adapted and non-adapted treatment targeting PTSD and negative alcohol-related outcomes among SMW and TNB individuals.

1.4. Integrated treatments for PTSD and negative alcohol-related outcomes

Most findings suggest that integrated treatments (i.e., treatments targeting PTSD and alcohol use simultaneously rather than sequentially or in isolation) reduce PTSD symptom severity and substance misuse [30]. Other research has shown that integrated treatments are perceived as safe and feasible, and are preferred over non-integrated treatments among those receiving integrated treatments [29]. Yet, some research demonstrates that integrated treatments are not superior in reducing PTSD symptom severity and substance misuse compared to treatment as usual, alcohol-focused treatment, or trauma-focused treatment [30]. Nevertheless, existing recommendations emphasize the importance of delivering integrated treatment rather than treatment designed to address PTSD or alcohol use alone [30].

Integrated treatments have historically strongly encouraged or required long-term alcohol abstinence prior to treatment initiation (i.e., high-threshold designs) [30], which can serve as another treatment-utilization barrier for SMW and TNB individuals given an elevated prevalence of comorbid PTSD and hazardous drinking in these populations [2]. Recent literature has demonstrated that integrated treatments which do not require abstinence from substances, or low-threshold designs (e.g., Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure Therapy [COPE] [31]), significantly reduce PTSD symptom severity and substance misuse, including hazardous drinking [30,31]. To our knowledge, no low-threshold, integrated treatment that aims to reduce PTSD symptom severity and negative alcohol-related outcomes has been tested among trauma-exposed SMW and TNB individuals.

Despite the promise of existing integrated treatments, dropout rates are as high as 42%, limiting effectiveness of treatment [32]. Indeed, integrated treatments are time intensive with recommended treatment duration lasting 12 to 25 sessions over the course of three to six months [33]. Notably, dropout rates are also high for non-integrated PTSD and alcohol treatments. One recent systematic review noted that the aggregated dropout rate was 24.2% for trauma-focused PTSD treatments and 16.1% for non-trauma-focused PTSD treatments [32]. Another systematic review highlighted that the average dropout rate for in-person substance use treatment was 30.4% [34]. While dropout rates vary across treated populations, treatment targets, and treatment types, evidence suggests that treatments with more sessions and greater session length yield higher dropout rates [34]. As such, there is a need for brief, integrated treatments that reduce participant burden and are easily administered to those at heightened risk of PTSD and hazardous drinking, especially trauma-exposed SMW and TNB individuals.

1.5. Brief written narrative exposure treatment for PTSD

Recent clinical guidelines recommend that trauma-focused treatments include components of exposure and cognitive restructuring, such as written narrative exposure [35], as such treatments consistently demonstrated reduced PTSD symptom severity and comorbid depression and improved psychosocial functioning among trauma-exposed populations [36]. Written exposure therapy (WET) [37] represents one written narrative exposure treatment that has demonstrated efficacy in reducing PTSD symptoms among trauma-exposed populations [37]. Studies have shown that five sessions of WET lowers rates of treatment dropout and is noninferior in reducing PTSD symptoms compared to an intensive PTSD treatment (i.e., cognitive progressing therapy which includes cognitive processing and written exposure) [36]. In fact, one trial demonstrated that only 5% of veterans who received WET dropped out of treatment [36].

WET is informed by findings demonstrating that writing consecutively about traumatic events reduces PTSD symptoms, especially among those who write about the same index trauma for 30 min during each session [[38], [39], [40]]. As described in the WET protocol [37], the first session (lasting an hour) is an opportunity for therapists to provide participants with psychoeducation about PTSD and a rationale for engaging in five weekly 30-min writing exercises [36,37]. WET also consists of brief (10 min) check-ins with clinicians following writing sessions, thus the four remaining sessions last 40 min [37]. Weekly check-ins with clinicians provide an opportunity for participants to receive feedback about written narratives and discuss reactions to written content [37]. Participants are asked to write about trauma experiences using a distance (as opposed to immersive) perspective [37]. Mechanisms underlying the efficacy of WET may include activation of fear networks and extinction of conditioned responses to trauma cues, such as avoidance [36,37].

While WET represents a viable, brief treatment for improving mental health symptoms among those vulnerable to severe and chronic PTSD, some prior studies have excluded those with PTSD and co-occurring substance dependence [36], and no study to date has examined the efficacy of WET among SMW and TNB people. Further, no study, to our knowledge, has demonstrated the efficacy of WET in reducing negative alcohol-related outcomes or examined whether adapting WET to address SMW's and TNB individuals' stigma-related drivers of PTSD and negative alcohol-related outcomes, such as heterosexism, cissexism, racism, and sexism, is beneficial for these populations. Moreover, SMW and TNB people may encounter barriers to utilizing WET given its incorporation of clinician feedback. In contrast to WET, brief, self-administered, web-based treatments for PTSD and alcohol use, such as EW, may be cost effective, immediately available, and may expand the reach of treatment for SMW and TNB individuals. Self-administered EW may be especially appealing to SMW and TNB people who are hesitant to utilize clinician-facilitated treatment due to structural inequities and stigma-related barriers, such as discriminatory laws and policies, limited access to identity-affirmative treatments, enacted and anticipatory stigma from treatment providers, and lack of health insurance coverage [25,41]. Indeed, EW delivered without clinician feedback may increase the prevalence of authentic disclosure during writing sessions among SMW and TNB individuals due to promoting feelings of anonymity, confidentiality, and safety [42].

Further, given that most prior studies have demonstrated the efficacy of WET in reducing PTSD symptoms among those with a primary diagnosis of PTSD [36], it is unclear whether this intervention is suitable for trauma-exposed SMW and TNB individuals who experience subthreshold PTSD and alcohol use disorder symptoms. If left untreated, those with subthreshold PTSD and who report negative alcohol-related outcomes are likely to develop full PTSD and alcohol use disorders [43]. As such, there is a need for accessible and feasible brief writing treatments targeting PTSD and negative alcohol-related outcomes, such as EW, among community samples of SMW and TNB people who may be at risk of (but not meet criteria for) PTSD and alcohol use disorders [20,27,41].

1.6. An overview of EW treatments

EW treatments focus on written emotional disclosure of traumatic experiences and are cost-effective, culturally sensitive, and low-threshold (i.e., not requiring alcohol abstinence as a treatment goal) [39]. This brief treatment instructs participants to write about their deepest thoughts and feelings about stressful or traumatic experiences for 15–20 min for three-to-five sessions [39]. EW treatments are acceptable and feasible among under-resourced communities and groups at higher risk of poor mental health, such as those who experience trauma [44] and identify as sexual minority people [41,[45], [46], [47]]. EW may close gaps in accessing and utilizing mental and behavioral health treatment by reaching and retaining trauma-exposed populations with low care utilization and high dropout rates, especially when delivered online and as a stand-alone treatment (i.e., without clinician contact) [44]. However, it remains unknown whether EW without clinician feedback is acceptable and feasible among SMW and TNB people.

Research is mixed on salubrious effects of EW therapy for PTSD and alcohol-related outcomes [39,41,[48], [49], [50]]. Some studies have demonstrated overall efficacy of EW treatments in reducing PTSD (particularly among those with subthreshold PTSD [51]) versus journaling about neutral topics [39,48,49]. Conversely, other findings suggest that EW treatments lack long-term superiority to neutral writing in reducing severe PTSD symptoms [40]. Regarding negative alcohol-related outcomes, one recent study found no significant reductions in alcohol use quantity, perceived drinking norms, or alcohol-related problems when writing about negative drinking occasions compared to control (i.e., receiving personalized feedback about non-alcohol-related activities among college students) [50]. Specific to sexual minority people, one study found that expressively writing about minority stressors salient to sexual minority emerging adults did not effectively reduce hazardous drinking compared to neutral-event control [41].

Findings are mixed regarding whether EW promotes mental and behavioral health as a stand-alone treatment [48,49]. One study found that EW delivered without clinician contact was only slightly inferior to treatment as usual (e.g., psychotherapy) in reducing trauma-exposed individuals’ PTSD, depressive, and anxious symptoms [44]. Other results suggest that EW treatments are more effective in reducing PTSD symptom severity when delivered alongside therapist feedback [48] and in treating alcohol-related outcomes, such as negative alcohol consequences and perceived drinking norms, when combined with personalized normative drinking feedback [50]. No study has examined whether EW delivered remotely and as a stand-alone treatment is effective in reducing PTSD symptom severity and negative alcohol-related outcomes among trauma-exposed SMW and TNB people.

Culturally adapted (vs. non-adapted) treatments improve outcomes among minoritized individuals [19]. Research suggests that sexual and gender minority people with greater exposure to stigma-related stressors are more likely to benefit from treatments adapted to address these stressors [52]. Adapting EW treatments for specific populations includes modifying writing prompt instructions so EW exercises focus on specific topics [49]. For instance, positive outcomes are associated with writing about difficult experiences related to sexual identity and behavior [41,46,47] and heterosexism [45] among sexual and gender minority people. Tailored writing prompts enhance efficacy of EW compared to nontailored writing prompts [53]. Nonetheless, it is unclear whether stigma-adapted EW and non-adapted, trauma EW exert similar effects on PTSD symptom severity and negative alcohol-related outcomes compared to control.

1.7. Explanatory mechanisms of EW

Over the past two decades, research has increasingly focused on mechanisms underlying the efficacy of EW in the general population [54] and in sexual minority emerging adults [55]. As previously noted, identifying mechanisms of intervention effects can advance knowledge of how health disparities emerge and are ameliorated [55]. EW may work through exposure-based mechanisms, including habituation (decreased fear over repeated exposures, such as as reduced physiological reactivity) [48]. Yet, little evidence has documented habituation as a mediator of EW treatment efficacy [55,56]. Therefore, contemporary models of exposure therapy have increasingly relied on inhibitory learning theory to explain efficacy of EW and other exposure treatments [48,56]. Inhibitory learning consists of threat expectancy violation and new cue-response inhibitory associations [56]. That is, inhibitory learning involves a mismatch between expectancy and experience (e.g., inability vs. ability to tolerate negative thoughts, emotions, and bodily sensations) in response to feared stimuli [56]. This mismatch leads to extinction learning, as danger signals (e.g., trauma cues or reminders) are not always paired with trauma cognitions (e.g., “the world is unsafe,” “I am unsafe”) and thus new inhibitory meaning occurs [56].

Inhibitory learning may be evident among sexual minority populations as well. Specifically, one recent study demonstrated that engaging in expressive writing about difficult or painful experiences due to having a sexual minority identity yielded reductions in perceived stress and subsequently, improvements in depression, distress, and anxiety among sexual minority emerging adults [55]. Providing sexual minority emerging adults with opportunities to increase awareness and integration of sexual minority stressors in a safe environment—stressors which may have been avoided previously—may have helped to reduce pervasive fear and improve tolerance of minority stress responses. Moreover, engaging in expressive writing about sexual minority stigma may promote learning of extinction or inhibitory signals (e.g., that stigma-based rejection does not always occur when stigma cues, such as internalized stigma, are encountered) [55], resulting in reduced perceived stress [39,55]. Nevertheless, additional research is needed to elucidate symptom change processes in EW treatments by clarifying the temporal ordering of change in perceived stress, PTSD, and negative alcohol-related outcomes following EW treatments among SMW and TNB individuals [55].

Early findings suggest that EW reduces psychological distress through facilitating goal-directed inhibitory tasks, such as labeling (vs. avoiding) emotions [39,48]. Thus, use of emotion-processing words during EW may reflect affect tolerance and emotion regulation, promoting new inhibitory learning and therapeutic change [56]. Other research has found that EW promotes positive health effects when cognitive reappraisal strategies are employed (e.g., greater use of insight words) [48]. Cognitive-processing models posit that EW facilitates emotion regulation and meaning-making [48]. Key components of emotion regulation and meaning-making are having cognitive flexibility, adopting flexible and positive perspectives, and psychological distancing [57,58]. Yet, studies have not examined whether these findings generalize to trauma-exposed SMW and TNB individuals.

Some research has shown that self-conscious emotions, such as shame (i.e., negative evaluations of the self), may undergird the efficacy of EW treatments, especially for sexual and gender minority people [45]. In fact, and as noted recently [45], EW exercises are thought to ameliorate trauma-related symptoms due to naming and disclosing stressful experiences which often induce feelings of shame, such as sexual assault [39]. EW may reduce physiological stress caused by inhibition by reducing feelings of shame following written disclosure [55]. Thus, trauma-related shame and oppression-related shame (i.e., internalized stigma) may be especially salient mediators of EW efficacy among SMW and TNB individuals.

1.8. Moderators of EW treatment efficacy

Identifying moderators of EW treatment efficacy, such as sociodemographic characteristics, can facilitate improved treatment targeting [48,53]. Results from the few studies examining whether sociodemographic characteristics, such as race/ethnicity, sexual identity, and gender identity, moderate treatment efficacy are inconsistent [47,52,59]. For example, prior studies demonstrate that empirically supported mental health treatments were effective for youth regardless of racial/ethnic, sexual, or gender minority status [59]. In contrast, recent findings indicated that Black and Latino (vs. White) sexual minority men who received sexual minority-affirmative cognitive behavioral treatment reported greater reductions in comorbid mental and behavioral health concerns compared to control [60]. Differential vulnerability models suggest that those who experience multiple forms of oppression might be particularly sensitized to cumulative adversities [61,62] and thus may benefit more from stigma-coping strategies [60]. Moreover, some research has highlighted that EW may support those, including sexual minority men, who lack social support [47]. Thus, trauma-exposed SMW and TNB individuals who hold multiple minoritized statuses across race/ethnicity, sexual identity, and gender identity, and lack social support may uniquely benefit from writing about stigma and trauma.

Similarly, whether impairments in emotional processing, such as alexithymia and dissociation, moderate the effects of EW treatments is inconclusive [63]. Some research has found that among those with higher levels of alexithymia, writing exercises involving imaginal exposure were associated with inefficient emotional processing and avoidance [64]. Other findings suggest that EW treatments benefit those with alexithymia only if provided training in emotional processing skills (e.g., distress tolerance) [65]. Another study found that writing about stressful experiences was associated with greater dissociation [63]. In contrast, other results highlight that structured writing exercises delivered alongside cognitive-behavioral treatment reduced dissociation symptoms among those with PTSD [66]. Moreover, EW treatments may facilitate psychological distancing (i.e., processing emotions without activating excessive negative affect), leading to improved outcomes through reflective meaning-making and decreased emotional reactivity [54]. Yet, research has not examined whether alexithymia and dissociation—cognitive and affective processes that may overlap with psychological distancing—influence EW treatment effects among trauma-exposed SMW and TNB individuals.

Examining stigma-related stressors as key determinants of heterogeneous treatment effects represents an important advancement in intervention science [41,52]. Prior research has primarily examined sexual minority stigma as a moderator of responses to adapted and non-adapted evidence-based treatments among sexual minority people [52]. For instance, one study showed that higher levels of sexual identity-related stress were associated with greater benefits from an adapted EW treatment among sexual minority youth [41]. Scholars have called for research to expand these findings by examining intersectional stigma-related moderators of treatment efficacy [52,60,67]. Salient forms of stigma facing trauma-exposed SMW and TNB individuals include cultural and institutional betrayal (e.g., sexual and gender minority people minimizing the impact of trauma) [68], gender-based stressors (e.g., sexism), multiple forms of discrimination, and internalized heterosexism and sexism [5,20,45]. However, a paucity of research examines whether these intersectional stigma-related stressors shape responses to EW treatments in these populations.

Prior research has demonstrated effectiveness of EW across trauma type (e.g., sexual assault, physical assault, accident) [53]. For instance, research has shown that women with a history of childhood sexual abuse who were instructed to write about the impact of the sexual abuse reported reductions in sexual dysfunction [69]. Other research demonstrates positive benefits of expressive writing among individuals with medical trauma [44]. For SMW and TNB individuals, traumatic events may be related to their stigmatized sexual or gender identity [22]. Indeed, one recent study found that over 40% of trauma-exposed sexual minority individuals described trauma exposure as related to sexual minority identity; of this sample, over 32% reported sexual minority identity-related sexual violence and nearly 30% reported sexual minority identity trauma occurring in childhood and adolescence [22]. Yet, no research has examined trauma type or whether traumatic events are related to sexual or gender minority identities as moderators of responses to stigma-adapted and trauma EW treatments among trauma-exposed SMW and TNB people.

1.9. The current study

This protocol paper aims to provide a novel method for adapting and testing evidence-based EW treatments for trauma-exposed SMW and TNB individuals. We (1) describe the development and components of the proposed EW treatments; (2) discuss our plan for evaluating acceptability and feasibility of the proposed study; (3) identify steps for preliminarily detecting changes in treatment outcomes across condition, including (a) determining superiority of EW treatments compared to control in reducing PTSD symptom severity and negative alcohol-related outcomes and (b) examining within-group descriptive trends (e.g., means with respective standard deviations) and change scores from baseline (Hedges’ g effect sizes that adjust for small sample size) for each treatment group; and (4) highlight our strategy for preliminarily evaluating mediators and moderators of treatment outcomes. All treatment outcome results should be interpreted as preliminary trends given that this is a pilot randomized controlled trial. Findings will inform decisions on whether and how to proceed with a full-scale evaluation of the effectiveness of stigma-adapted EW and trauma EW treatments to reduce PTSD symptom severity and negative alcohol-related outcomes among SMW and TNB individuals.

1.10. Study hypotheses

1.10.1. Acceptability and feasibility

Findings will support the acceptability and feasibility of delivering stigma-adapted EW and trauma EW treatments to trauma-exposed SMW and TNB individuals.

1.10.2. Initial treatment outcomes and descriptive trends

Because this study's primary purpose is to identify its acceptability and feasibility, we will examine direction and magnitude of effect size estimates for PTSD symptom severity, hazardous drinking, heavy drinking quantity, and heavy drinking frequency across each intervention group. We will also examine within-group descriptive trends and change scores in PTSD symptom severity and negative alcohol-related outcomes over 1-week and 3-months post-intervention periods.

1.10.3. Nondirectional and exploratory mediation and moderation hypotheses

We will examine whether inhibitory, cognitive processing, and self-conscious affective mechanisms potentially mediate intervention effects on PTSD symptom severity and negative alcohol-related outcomes. We will also examine whether sociodemographic characteristics, cognitive and affective factors, intersectional stigma-related stressors, and trauma-related factors (i.e., trauma type and identity-related trauma) potentially moderate intervention effects on PTSD symptom severity and negative alcohol-related outcomes. Given inconsistencies in prior research and that this is a pilot trial, our mediation and moderation hypotheses are nondirectional and exploratory.

2. Material and methods

This trial has been reviewed by the Institutional Review Board at Syracuse University and registered with ClinicalTrials.gov (NCT05569915).

2.1. Trial design

This pilot randomized controlled trial will use a parallel, superiority design [70] where participants will be allocated 1:1:1 (unstratified) to stigma-adapted EW, trauma EW, or control (i.e., neutral-event control) (see Fig. 1). All results related to treatment outcomes will be interpreted as preliminary trends. Assessments will be completed online via self-report at baseline, immediately post-session across five consecutive writing days, 1-week post-treatment, and 3-months post-treatment.

Fig. 1.

Participant flow diagram.

2.2. Participants

Participants will be 150 SMW and TNB individuals who are aged 18 and older, report having experienced a Criterion A event for PTSD [71], have a working email address, can complete daily online assessments, currently live in the U.S., and report not receiving inpatient psychiatric support in the past six months. TNB individuals who identify as heterosexual will not be included. Participants will also be excluded if they do not meet inclusion criteria, if they display fraudulent, inattentive, or bot-like behavior across survey responses, or if they report active suicidal ideation with a plan and intent to act on that plan. We will enroll participants across PTSD symptom severity and negative alcohol-related outcomes given that central aims of this pilot randomized controlled trial are to determine acceptability and feasibility and preliminarily characterize treatment outcomes among a community sample of SMW and TNB individuals. Nevertheless, a sizable segment of the sample will likely endorse elevated PTSD symptom severity and negative alcohol-related outcomes based on prior findings [1,2].

Participants will be recruited via ads posted to social media platforms, listservs, and community organizations targeting sexual and gender minority people and people exposed to trauma. We will aim to maximize the sample's geographic diversity by targeting the four most populous cities, 20 randomly selected small urban areas, and 20 randomly selected rural counties in the U.S [72]. Participant recruiment and enrollment began in July 2023.

2.3. Procedures

2.3.1. Screening and retention

Participants will provide contact information and informed consent electronically. Following consent, participants will complete an online eligibility assessment. Participants will then receive an email link with instructions for the baseline assessment (prior to treatment initiation). There will be no expiration if participants do not complete the baseline assessment. Participants will be sent several reminder emails to complete the baseline assessment, as needed. Once the baseline assessment is completed, participants will be scheduled for a synchronous virtual screening assessment with a team member to confirm eligibility. Participants will have up to two weeks to complete the virtual screening assessment since completing the baseline assessment.

2.3.2. Baseline

The baseline assessment will contain measures assessing trauma, intersectional stigma-related stressors, coping strategies, mental and behavioral health symptoms, and post-treatment measures. All participants can earn $30 for completing the baseline assessment. Participants of color can earn an extra $5 for completing additional intersectional stress measures.

Following the baseline assessment and virtual screening assessment to confirm eligibility, participants will receive an email link containing instructions for the first writing session. Links to daily writing prompts and surveys will be emailed once daily at 6 p.m. Eastern for five consecutive days (Monday through Friday). The following day, participants with incomplete prompts and surveys will be sent email reminders at 10 a.m. Eastern. Participants have 24 h to complete each writing session and survey. Thus, participants will have up to 6 days to complete the 5-day EW intervention.

2.3.3. Randomization

After completing the baseline assessment, participants will be randomized using Qualtrics. We will monitor (relative) equivalence of sample size across conditions as participants complete the baseline assessment and virtual screener. Participants will be masked to condition assignment. Participants will be given examples about writing topics across conditions as providing examples enhances EW adherence and efficacy [41,49]. See Table 1 for detailed EW instructions across conditions.

Table 1.

Writing prompts across condition.

	Writing prompts: “For the next 15–20 min, we would like you to …”
Stigma-adapted expressive writing treatment group	“… write your very deepest thoughts and feelings about the most difficult or painful experience of stigma or bias (e.g., prejudice, bullying, rejection, discrimination) based on one or more of your identities (e.g., race/ethnicity, gender identity, sexual identity, religion) that you have faced. Write about the experience in as much detail as you can. Really get into it and freely express any and all emotions or thoughts that you have about the experience. In your writing, you might tie this experience to your childhood, your relationship with your caregivers, people you have loved or love now, or even your education or career. How is this experience related to who you would like to become, who you have been in the past, or who you are now? You might also write about the impact of this event on your feelings of safety, control, self-worth, self-esteem, and intimacy. How does this experience affect your ability to solve problems, meet future challenges, or deal with day-to-day stress? How have you tried to understand this difficult or painful experience of stigma or bias and make sense of it? Many people have not had a single painful experience of stigma or bias. You can write about the same experience every day or about several or different experiences where you were treated or judged differently based on your identities or background. Whatever you choose to write about, however, it is critical that you really let go and explore your very deepest emotions and thoughts. As you write, do not worry about punctuation or grammar. Just really let go and write as much as you can about the experience. All of your writing will be completely confidential. Please write for 15–20 min. The only rule is that once you begin writing, you continue until the time is up.”
Trauma expressive writing treatment group	“… write your very deepest thoughts and feelings about the most traumatic experience of your entire life or an extremely important stressful, upsetting, or emotional issue that has affected you and your life. Write about the experience in as much detail as you can. Really get into it and freely express any and all emotions or thoughts that you have about the experience. In your writing, you might tie this experience to your childhood, your relationship with your caregivers, people you have loved or love now, or even your education or career. How is this experience related to who you would like to become, who you have been in the past, or who you are now? You might also write about the impact of this event on your feelings of safety, control, self-worth, self-esteem, and intimacy. How does this experience affect your ability to solve problems, meet future challenges, or deal with day-to-day stress? How have you tried to understand this traumatic experience and make sense of it? Many people have not had a single experience that was traumatic, stressful, or upsetting. You can write about the same experience every day or about several or different experiences that were traumatic, stressful, or upsetting. Whatever you choose to write about, however, it is critical that you really let go and explore your very deepest emotions and thoughts. As you write, do not worry about punctuation or grammar. Just really let go and write as much as you can about the experience. All of your writing will be completely confidential. Please write for 15–20 min. The only rule is that once you begin writing, you continue until the time is up.”
Active neutral control	“… write about what you did yesterday from the time you got up until the time you went to bed. In your writing, we'd like you to be as objective as possible, by concentrating on the facts and details of how you spent your time. Please do not include your emotions or opinions, rather we want you to try to be completely objective. Feel free to be as detailed as possible. For example, you might start when your alarm went off and you got out of bed. You could include the things you ate, where you went, and which buildings or objects you passed by as you went from place to place. As you write, do not worry about punctuation or grammar. Just really let go and write as much as you can about what you did yesterday from the time you got up until the time you went to bed. The most important thing in your writing, however, is for you to describe what you did as accurately and as objectively as possible. All of your writing will be completely confidential. Please write for 15–20 min. The only rule is that once you begin writing, you continue until the time is up.”

Stigma-adapted EW. Participants in the stigma-adapted EW condition will be instructed to write about their very deepest thoughts and feelings about their most difficult or painful experience of stigma or bias based on one or more identities, consistent with research emphasizing the need to develop treatments targeting different and multiple sources of oppression facing SMW and TNB individuals [20,27,67]. These instructions were adapted from prior EW treatment studies with sexual minority people [41,[45], [46], [47]] and feedback provided by sexual and gender minority survivors who serve on our lab's community advisory board. To our knowledge, the current study is the first to instruct SMW and TNB individuals to write about stigma experiences that are not solely related to heterosexism.

Trauma EW. Participants in the trauma EW condition will receive standard EW instructions (i.e., to write about their deepest thoughts and feelings about the most traumatic experience or an extremely important stressful, upsetting, or emotional issue they have faced) [39]. While some traumatic events faced by SMW and TNB individuals may be motivated by bias or may be identity-related [22], participants in the trauma EW condition will not be instructed to write about traumatic events related to stigma or bias.

Control. Following standard protocols, participants in the control group will receive instructions to write objectively about that day's events [39].

Participant Engagement. Each writing session will contain and display a timer feature requiring participants to spend at least 15 min completing the writing prompt. Participants will receive instructions noting that after 16 min, a submit button will appear, allowing them to submit their written response. Instructions will also state that after 22 min, the writing response will auto-submit, and the page will advance.

2.3.4. Post-session and follow-up assessments

Post-session Assessments. Immediately following each writing session, participants will complete a brief survey assessing state physiological reactivity and anxiety, dissociation during writing, and past-24-h substance use. Participants will be asked whether they wrote about the same or different experience(s) on a previous day following writing sessions 2–5. Participants will receive $6 for completing each daily EW session, plus a $5 bonus for finishing all five consecutive entries, given that writing for at least three days improves efficacy [53].

Follow-up Assessments. Participants will also complete follow-up online assessments at 1 week post baseline and 3 months post baseline (see Table 2). Participants who miss follow-up assessments will receive reminder emails once per day, at 10 a.m. Eastern, for up to three times, until surveys are completed. Participants will have up to two weeks to complete the 1-week follow-up assessment and will have up to one month to complete the three-month follow-up assessment. Following their participation, participants will receive $10 for completing the 1-week follow-up online assessment and $25 for completing the 3-month follow-up assessment.

Table 2.

Assessment schedule.

Construct	Measure	Timeline
Primary outcome variables
PTSD symptoms	Psychometric Properties of the Posttraumatic Diagnostic Scale for DSM-5 (PDS-5)c	Pre, 1-week FU, 3-month FU
Hazardous drinking	Alcohol Use Disorders Identification Test (AUDIT)d,a	Pre, 3-month FU
Drinking quantity	Quantity of average weekly drinkinge	Pre, 1-week FU, 3-month FU
Heavy drinking frequency	Frequency of heavy drinking dayse	Pre, 1-week FU, 3-month FU
Mediator/Moderator variables
Demographic characteristics	Race/ethnicity	Pre
	Sexual identity
	Gender identity
Social support	Interpersonal Support Evaluation List – 12 (ISEL-12)f	Pre
Dissociation	Brief Dissociative Experiences Scale (DES-B) – Modifiedg	Pre, 1-week FU, 3-month FU
Alexithymia	Perth Alexithymia Questionnaire (PAQ)h	Pre, 1-week FU, 3-month FU
Discrimination	The Everyday Discrimination Scalei	Pre
Sexism	Experiences with Ambivalent Sexism Inventory (EASI-10)j	Pre
	Sexual Minority Women's Sexual Objectification Experiences Scalek
Cultural and institutional betrayal	Institutional Betrayal Trauma Questionnaire 2 (Revised)l	Pre
Self-stigma	Internalized Gender Biasm	Pre, 1-week FU, 3-month FU
	The Lesbian Internalized Homophobia Scalen
	LGBQ + Acceptance Concernsn
	LGBQ + Concealment Motivationn
	Internalized Homonegativityn
	LGBQ + Difficult Processn
Covariate variables
Demographic characteristicsb	Age	Pre
	Income
	Relationship status
	Sex assigned at birth

Note. Pre = prior to randomization, 1-week FU = 1-week follow-up, 3-month FU = 3-month follow-up.

^aWhile we will administer the full AUDIT at baseline (pre-treatment) and at the 3-month follow-up assessment, only the first three items of the AUDIT will be included in treatment outcome analyses given potential floor effects for items 4-10.

^bDemographic characteristics will be added to models as covariates if they are significantly different across randomization groups.

^cFoa EB, McLean CP, Zang Y, Zhong J, Powers MB, Kauffman BY, Rauch S, Porter K, Knowles K. Psychometric properties of the Posttraumatic Diagnostic Scale for DSM–5 (PDS–5). Psychol Assess. 2016; 28(10):1166–1171.

^dWorld Health Organization, Babor, Thomas F., Higgins-Biddle, John C., Saunders, John B. Monteiro, Maristela G. AUDIT: The Alcohol Use Disorders Identification Test: Guidelines for use in primary health care, 2nd ed. World Health Organization. 2001. https://apps.who.int/iris/handle/10665/67205.

^eSee http://www.niaaa.nih.gov/research/guidelines-and-resources/.

^fCohen S, Hoberman H. Interpersonal support evaluation list (ISEL). J Appl Soc Psychol. 1983; 13(1):99–125.

^gDalenberg C, Carlson E. New versions of the Dissociative Experiences Scale: The DES-R (revised) and the DES-B (brief). Paper presented at the International Society for Traumatic Stress Studies Annual Meeting. 2010; 26:203. https://istss.org/meetings-events/meeting-archives/2010-annual-meeting-archives.aspx.

^hPreece D, Becerra R, Robinson K, Dandy J, Allan A. The psychometric assessment of alexithymia: Development and validation of the Perth Alexithymia Questionnaire. Pers Individ Dif. 2018; 132:32–44.

ⁱWilliams DR, Yu Y, Jackson JS, Anderson NB. Racial differences in physical and mental health: Socioeconomic status, stress, and discrimination. J Health Psychol. 1997; 2:335–351.

^jSalomon K, Bosson JK, El-Hout M, Kiebel E, Kuchynka SL, Shepard SL. The Experiences with Ambivalent Sexism Inventory (EASI). Basic Appl Soc Psychol. 2020; 42(4):235–253.

^kTebbe EA, Moradi B, Wilson E, Bell HL, Connelly K, Lenzen A. Development and psychometric evaluation of the Sexual Minority Women's Sexual Objectification Experiences Scale. J Couns Psychol. 2021; 68(5):501–514.

^lGómez JM. What's the harm? Internalized prejudice and cultural betrayal trauma in ethnic minorities. Am J Orthopsychiatry. 2019; 89(2):237–247.

^mPiggott M. Double jeopardy: Lesbians and the legacy of multiple stigmatized identities. Bachelor's thesis, Swinburne University of Technology, Australia. Retrieved from http://hdl.handle.net/1959.3/59613.

ⁿMohr JJ, Kendra MS. Revision and extension of a multidimensional measure of sexual minority identity: the Lesbian, Gay, and Bisexual Identity Scale. J Counsel Psychol. 2011; 58(2):234–245.

2.3.5. Manipulation check

We will assess participants' state dissociation, anxiety, and physiological responses after each writing session to ensure that those in the control condition are not distressed, indicating a potential experimental manipulation issue. Similarly, three items will also be administered at the end of the three-month follow-up survey assessing whether participants found the writing exercises stressful, frustrating, or embarrassing and whether they knew other people who participated in the study to account for expectancy effects. Throughout the trial, team members (unmasked to condition) will review writing responses across all conditions to monitor participant adherence, ensure that responses are reflective of each respective prompt (i.e., to examine whether expected content differences across three conditions are found), and detect systematic intergroup differences not related to the EW treatments [74]. We will also employ linguistic analyses (described in detail below) following data collection to determine participants’ adherence to writing prompts across condition (e.g., whether participants in the stigma EW condition expressed thoughts and emotions about painful stigma or bias incidents).

2.3.6. Acceptability and feasibility

Four open-ended questions will be administered at the end of the three-month follow-up survey via Qualtrics to assess acceptability of this EW treatment [45]. Participants will also be asked whether there was adequate rationale for the writing exercises in the instructions, whether writing exercises were stressful, and participants’ likelihood of recommending writing exercises to other SMW and TNB individuals. We will also assess whether writing exercises would have been more helpful if participants could process their reactions with a therapist and whether participants would prefer not to receive feedback from a therapist about written responses. Finally, we will assess perceived costs and benefits of participating. Qualitative exit interviews (N = 20) will also be conducted to assess perceived acceptability and feasibility. We will also monitor recruitment, effort required, and number of risk assessments conducted.

Treatment delivery feasibility will be operationalized as participants completing three or more writing sessions [49]. Feasibility will also be conceptualized as retention (whether participants complete the last study phase), completeness (number of prompts completed across all participants out of the total number possible number of writing prompts, word and sentence count across prompts) [75], compliance (proportion of participants who complete all assessments and writing prompts), response rates (average number of writing prompts completed by those who initiated EW exercises and percent of missing data across assessments and writing prompts).

2.3.7. Power analysis

Recent statistical modeling advises against using effect size estimates from pilot trials to establish efficacy [76]. Therefore, and as recommended [76], all findings will be used to estimate feasibility parameters to determine design decisions and improvements (e.g., number and duration of writing sessions, writing prompt instructions, recruitment and retention, outcome assessments) for a fully powered, definitive randomized controlled trial, rather than to detect intervention efficacy. Recommended pilot trial sample sizes range from 24 to 50 across treatment arms [77]. Thus, we will aim to enroll 150 participants (50 participants across three conditions) to maximize the interpretation of results and to account for 20% anticipated attrition.

2.4. Analytic plan

We will examine baseline comparability across conditions. Whether participants wrote about the same or different event(s), and demographic variables statistically different across conditions at baseline and associated with the outcome variables will be used as covariates. We will determine pattern of missingness. Post-hoc adjustment of p values will be performed when calculating effect sizes.

2.4.1. Acceptability and feasibility analyses

Conventional content analysis [78] will be employed to analyze acceptability of EW treatments for trauma-exposed SMW and TNB individuals. Descriptive statistics, univariate logistic regressions, Chi-square independence tests, post-hoc two proportions z-tests, and independent samples t-tests will be used to assess feasibility.

2.4.2. Initial outcome and descriptive trend analyses

We will employ mixed-effects linear, Poisson, or negative binomial regression analysis (depending on data dispersion) for PTSD [71] and negative alcohol-related outcomes [79]. We will examine potential changes in outcome variables between each active arm and control (i.e., between stigma-adapted EW and control; between trauma EW and control). Both active conditions are likely to exert similar effect sizes relative to the control condition, similar to prior studies containing two active writing conditions with similar sample sizes across conditions [41]. Nevertheless, the current study will assess whether comparable effect sizes are found for both active conditions, aligned with prior research [41]. We will also examine changes in outcome variables between each active arm (i.e., stigma-adapted EW vs. trauma EW).

Analyses will adhere to the intent-to-treatment principle to control for attrition bias [74]. We will perform sensitivity analyses using data only from study completers. Mixed-effects models will allow for missing data and include fixed effects for our independent variables of interest including time, treatment group, and an interaction term between time and treatment group (to determine whether outcome trajectories differ by treatment group over time), and a random effect for participants (to account for non-independence of measurements) with an exchangeable compound symmetry covariance matrix. Covariates will be included as fixed effects; models will be reduced to help with convergence, if needed. We will treat the time variable as a dummy variable for baseline vs. post-treatment time points (i.e., 1-week follow-up and 3-month follow-up). Following recommendations for pretest-posttest controlled designs and to account for repeated measures, effect sizes will be calculated by differences in the pretest-posttest measures between the active treatment and control group, weighted by the pooled standard deviation of the pretest measurement. Effect sizes will be computed using standardized mean differences (Cohen's d) to provide a measure of magnitude of effect.

We will also examine within-group descriptive trends (i.e., means with respective standard deviations, frequencies, percentages) across PTSD symptom severity and negative alcohol-related outcomes. Within-group statistical significance score calculations will be tested through two-tailed paired sample t-tests (or Wilcoxon's signed-rank tests if normality is not met). To examine practical significance, within-group effect size with Hedges' g correction with the respective 95% confidence interval will also be calculated for PTSD symptom severity and negative alcohol-related outcomes between baseline and follow-ups at 1-week and 3-months post-intervention.

2.4.3. Preliminary mediation and moderation analyses

Mediation. We will use the automated text analysis program, Linguistic Inquiry and Word Count (LIWC) [80], to measure language categories (i.e., emotion and cognitive processing words and linguistic distancing). As recommended [57], we will focus linguistic analyses on: (1) emotion-related words (i.e., positive and negative affect words reflective of writing tone); (2) cognitive processing words, including words reflecting insight and causation; and, (3) a composite linguistic measure of psychological distancing. The proportion of emotion-related, cognitive processing, and psychological distancing words will be collapsed across all writing prompt days. We hypothesize that linguistic variables will not mediate stigma-adapted EW and control differently than trauma EW and control. Thus, linguistic variables will be examined as mediators of the association between active treatment condition vs. control and primary outcomes (see Fig. 2).

Fig. 2.

Conceptual model of study hypotheses.

Self-reported perceived stress, trauma-related shame, and internalized stigma (i.e., internalized heterosexism and internalized sexism) at 1-week follow-up will be examined as potential mediators of the association between active treatment condition vs. control and primary outcomes assessed at 3-month follow-up.

Between-condition differences in (1) primary outcomes, (2) language use, (3) perceived stress, (4) trauma-related shame, and (5) internalized stigma (i.e., internalized heterosexism and internalized sexism), and the indirect effect of active treatment condition on primary outcomes through the three linguistic variables, perceived stress, trauma-related shame, and internalized stigma will be assessed with structural equation models in Mplus, using the full information maximum likelihood estimation with listwise deletion [81]. Separate models will be calculated for each mediator and outcome. We will control for total word count, age, and education level as covariates in all LIWC analyses. Across all models, we will control for baseline outcome variables. In the perceived stress and self-conscious affective models, we will also control for baseline perceived stress, baseline trauma-related shame, and baseline internalized stigma (mean levels of internalized heterosexism and internalized sexism summed to create an overall composite, standardized score) respectively. All parameters will be estimated through bootstrapping generated from 1000 resamples [81].

Moderation Analyses. We will employ separate mixed model analyses across our moderators to identify participants who could especially benefit from EW treatments. We will examine four sociodemographic moderators (race/ethnicity, sexual identity, gender identity, and social support); one moderator representing impairment in emotional processing (mean levels of alexithymia and dissociation summed to create an overall composite, standardized score); one moderator representing intersectional stigma-related stressors (mean levels of cultural and institutional betrayal, sexism, discrimination, internalized heterosexism, and internalized sexism summed to create an overall composite, standardized score); one moderator representing trauma type; and, one moderator representing identity-related trauma. We will run separate moderation analyses for each active condition compared to control. Post-hoc simple slopes analysis will be conducted.

3. Discussion

This paper describes the development and components of the proposed EW treatments and our plan for evaluating acceptability and feasibility and determining potential outcomes of adapted and non-adapted EW treatments to inform refinements. We also describe our plan for examining descriptive trends and within-group change scores from baseline for each treatment group. This paper also describes our strategy for preliminarily evaluating mediators and moderators of treatment outcomes. Results may inform needed sample size for a definitive trial and whether web-based stigma-adapted and trauma EW treatments are acceptable, feasible, and potentially effective among trauma-exposed SMW and TNB individuals who face an elevated prevalence of severe PTSD symptoms, negative alcohol-related outcomes, and treatment-utilization barriers. Findings may also point to modifications of existing EW treatments to enhance effectiveness in these populations.

If both active treatment conditions (stigma-adapted and trauma EW) demonstrate comparable effective sizes across outcomes, SMW and TNB individuals could select their preferred writing prompt based on several factors, including recency and salience of stigma-based experiences vs. trauma exposure or trauma cues, contributing to precision-medicine approaches to mental and behavioral health treatments [82].

Future definitive randomized controlled trials should employ clinician-administered instruments and assess EW outcomes objectively (e.g., via biomarkers) and for longer durations. Caution should be used when interpreting results of preliminary between- and within-group effect size estimates as they may either over- or underestimate true effect sizes. Studies using larger samples are needed to compare the efficacy of EW treatments focusing on stigma versus trauma and advance knowledge of mediators and moderators of treatment efficacy, compliance, and retention. Future research should also consider whether EW treatments targeting stigma and trauma simultaneously, sequentially, or delivered alongside other treatments, including WET for PTSD or EW with regular therapist contact [83], are also effective for trauma-exposed SMW and TNB individuals. Research might consider comparing adapted and non-adapted EW with adapted and non-adapted WET for PTSD [37] in reducing PTSD symptom severity and negative alcohol-related outcomes among SMW and TNB individuals. Informed by prior research [38,53], future studies might also consider randomizing participants to write about the same trauma event, the same stigma event, different trauma events, and different stigma events. This would enable researchers to assess whether, compared to repeated exposure to negative stimuli in general, repeated exposure to the same feared stimulus through written disclosure more effectively elicits prolonged and intense negative affect and pathological fear, and reduces avoidant responses characteristic of PTSD and negative alcohol-related outcomes among trauma-exposed SMW and TNB individuals. Finally, studies should examine whether EW treatments are cost-effective and scalable in these populations.

4. Conclusion

Acceptability, feasibility, and preliminary treatment outcome findings of this pilot randomized controlled trial can inform future large-scale, definitive trials to improve clinical relevance of technology-mediated, low-threshold treatments for SMW and TNB individuals at risk of severe PTSD symptoms and negative alcohol-related outcomes. Results may inform studies using computational text analysis to guide EW treatments for these populations. In sum, this pilot trial has the substantial potential to inform future full-scale randomized controlled trials to reach trauma-exposed SMW and TNB individuals from across the U.S. who are disproportionately impacted by PTSD, negative alcohol-related outcomes, and treatment utilization barriers.

Funding

This study was funded by the APF Walter Katkovsky Research Grants (PI: Scheer) and ORAU Ralph E. Powe Junior Faculty Enhancement Award – Health Disparities/Equity (PI: Scheer). The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the funders, including the National Institutes of Health. We would like to express our gratitude to the study participants.

Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Data availability

Data will be made available on request.