Therapists perspectives on the Early Intervention after Rape study: a qualitative process evaluation of a randomized controlled trial

ABSTRACT

Background: Early interventions using trauma-focused cognitive behavioural therapy have the potential to alleviate post-traumatic stress symptoms in individuals who have experienced recent sexual assault. Specialized Sexual Assault Centers (SACs) in Norway offers psychosocial support, however, this support varies across SACs and its efficacy has not been researched. The Early Intervention after Rape (EIR) study is a multisite randomized controlled trial designed to assess the efficacy and effectiveness of training SAC nurses and social workers to deliver a modified version of prolonged exposure therapy shortly after rape.

Objective: This article aims to present a qualitative process evaluation of the implementation of the EIR study across three SACs in Norway, from the perspective of nurses and social workers.

Method: We conducted semi-structured interviews with fifteen nurses and social workers, ten of whom received training in prolonged exposure therapy (mPE). We used Thematic Analysis to identify themes and subthemes.

Results: Thematic analysis yielded four significant themes for process evaluation: (1) The quality of the new intervention modified prolonged exposure was considered satisfactory through training and supervision and delivered with good adherence to the manual, although some therapists perceived the manual as too rigid; (2) Adoption dynamics within the SACs are complex and include both enthusiasm for clinical research as well as resistance to change; (3) Narrow inclusion criteria and burden with participation for patients may limit reach and representativeness of the RCT; (4) Unintended consequences were identified, such as delayed start, conflicting advices and cross-contamination, underscoring the ongoing necessity for process evaluation alongside RCTs.

Conclusion: This qualitative process evaluation offers insight into real-world clinical challenges with implementing a new intervention and conducting a multisite RCT within SACs in Norway. This study may inform opportunities to advance evidence-based practices for rape survivors seeking help.

Trial registration: ClinicalTrials.gov identifier: NCT05489133..

HIGHLIGHTS

• Process evaluations provide insight into the challenges and opportunities of conducting randomized controlled trials, and should be integrated in RCTs.

• Training and supervision are essential for ensuring high-quality implementation.

• Providing SAC therapists with effective treatment tools could improve services for rape survivors.

A recent population study in Norway revealed that 22% of women and 3% of men had experienced a lifetime incident of forced or incapacitated rape (Dale et al., 2023). Post-traumatic stress disorder (PTSD) is a common psychological consequence following trauma, with interpersonal sexual trauma, and particularly rape demonstrating the highest rates of PTSD compared to other traumas (Dworkin, 2020; Kessler et al., 2017; Scott et al., 2018).

The prevalence and severe impact of rape highlight the urgent need for effective preventive measures. Research has increasingly focused on identifying interventions that can prevent the development of PTSD in affected individuals (Bedard-Gilligan et al., 2020; Bragesjö et al., 2023; Covers et al., 2021; Foa et al., 2006; Gilmore et al., 2021; Miller et al., 2015; Nixon, 2012). Three systematic reviews and two meta-analyses conclude that early cognitive–behavioural interventions are safe and effective in preventing PTSD in female survivors of recent sexual assault (Dworkin & Schumacher, 2018; Oosterbaan et al., 2019; Short et al., 2020).

A study by Rothbaum and colleagues utilizing a modified version of prolonged exposure therapy (mPE) in the emergency department for trauma survivors showed a moderate decrease in post-traumatic stress symptoms and depression after four and twelve weeks. Notably, mPE had more pronounced effects for rape survivors compared to other trauma survivors, suggesting its potential efficacy as an early intervention for preventing post-traumatic stress symptoms among this population specifically (Rothbaum et al., 2012). Such findings underscore that early interventions using mPE may be important for mitigating the development of PTSD symptoms following rape.

The ongoing EIR study (Haugen et al., 2023) is set within the network of specialized sexual assault centers (SACs) across Norway. SACs offer medical treatment, forensic examination, and psychosocial treatment provided by teams of physicians, nurses, and social workers. Psychosocial treatment is tailored to individual needs and lacks standardization due to vague guidelines (Sosial- og helsedirektoratet, 2007), leading to significant variation in treatment quality across SACs. In the EIR study, the treatment as usual (TAU) represent an active control group and is compared to mPE for the efficacy of mitigating post-traumatic stress symptoms. The intervention consists of up to five weekly mPE sessions, initiated within 14 days post-rape, including psychoeducation, gradual exposure to trauma-related fears and trauma memory processing (Foa et al., 2020).

Training in mPE consisted of a mandatory four half-day workshop which provided comprehensive theoretical and practical training in mPE. Supervision was arranged both individually and in groups, with all mPE sessions audio-recorded for supervision purpose and adherence checks.

We hypothesize that individuals receiving mPE within two weeks post-rape will have fewer post-traumatic stress symptoms after three months and at subsequent follow-ups. Additionally, we expect the intervention to be safe when administered shortly after rape and delivered by trained nurses and social workers at the SACs. Enrollment for the EIR study commenced in June 2022 and will continue until the target of 185 participants is reached, anticipated around spring 2025.

Process evaluation methodology shifts the focus from efficacy outcomes to other aspects of complex research, such as contextual factors, barriers for implementation, or unforeseen events that may influence the outcomes in RCTs. The UK Medical Research Council (MRC) advocates process evaluations as essential alongside complex intervention trials (Skivington et al., 2021a, 2021b). Researchers should strive to consistently publish their process evaluation results through a separate publication from the RCTs main outcomes (Massazza et al., 2022).

1. Objective

In alignment with the UK MRC framework for evaluating complex trials, we formulated research questions to understand how the EIR study is implemented within three sexual assault centers in Norway. We aimed to comprehensively evaluate the study’s implementation process by focusing on four key process evaluation dimensions:

1. Quality of intervention delivery: To assess therapists’ experiences with training, supervision, and the delivery of modified prolonged exposure.

2. Adoption: To examine how the SAC therapists adopt the EIR study into their existing practices.

3. Reach: To evaluate therapists’ perception of the effectiveness of the intervention in serving the target population and the representativeness of the patient participants.

4. Unintended consequences: To identify any unforeseen consequences or challenges arising from the implementation of EIR study and assess their potential impact on the study’s outcomes.

2. Method

This qualitative analysis is based on interview data gathered from therapists in three SACs (Trondheim, Oslo and Vestfold), and was approved by the Regional Committee for Medical and Health Research Ethics (REK-Midt, #348496) on 16.12.21. All participants provided written or verbal consent prior to participating. Verbal consent was audio-recorded.

2.1. Participants

In the EIR study, all therapists at the three SACs were assigned to one of two groups: those delivering treatment as usual and those delivering mPE. Therapists in the mPE group underwent a specialized training workshop. All therapists were invited to take part in this process evaluation study through an email outlining its objectives. Ten mPE therapists consented to participate, two from Trondheim, two from Vestfold, and six from Oslo, whereas one declined participation due to no experience with delivering mPE to study patients, and another due to sick leave. Five TAU therapists consented to participate (two from Trondheim, one from Vestfold and two from Oslo). They were all female and ranged in age from 29 to 70 years (mean age = 49.8). Their experience with working at SACs and with sexually assaulted people ranged between 1 and 18 years (mean = 9.0). Representativeness was deemed sufficient with participants from both arms, all three sites, variations in professional background, and age.

2.2. Data collection

Data were collected between March and November 2023 and the interviews lasted between 41 and 83 min. Ten therapists were interviewed physically, and five were interviewed via video conference. A semi-structured interview guide was developed to capture the nuanced experiences, whilst simultaneously ensuring coverage of the study’s key areas of interest. The interview included eleven fixed and open-ended questions about the various facets of the EIR study. Moreover, eleven questions were specifically targeted to the mPE therapists, and seven to the TAU therapists. Interviews were audiotaped, de-identified and transcribed verbatim with participants’ consent. The interviews were conducted by the last author (MK), who is an independent researcher and not part of the EIR study.

2.3. Data analysis

Thematic analysis (TA) was chosen because it is ideal to identify patterns of meaning and broad themes across textual datasets, and to search for complex interactions between individuals, cultures, and contexts (Braun & Clarke, 2006; Braun & Clarke, 2022). The analysis is rooted in an experiential, realist perspective. The themes presented here were conceptualized through a combination of data-driven inductive analysis and theory-informed expectations. We adopted an open approach to the interview transcripts openly, allowing themes to develop naturally without preconceptions. In addition, our analysis was guided by process evaluation frameworks, as certain interview questions were intentionally designed to explore key factors such as adoption, implementation quality, and reach. The first and the last authors carried out the analysis according to the six phases of a TA (Braun & Clarke, 2022). After the last author transcribed the interviews, the first author familiarized herself with the data (step 1). Each transcript was read separately, and both authors independently structured the data into codes (step 2). We used both electronic software NVivo 14 (Lumivero, 2023) and hard copies of the data for creative colouring and mapping to prompt new reflections. Next, we clustered codes with related meaning to formulate initial candidate themes. For instance, initial themes such as ‘therapists concern on behalf of the patients’, e.g. worries that some patients are too vulnerable for participating in research or to receive the intervention mPE, were refined following a closer processing and exploration that led us to recognize two different underlying meanings: Balancing vulnerability (Theme 1) and Participant burden (Theme 3). Through an iterative, reflexive examination of the raw data, codes, and candidate themes underlying the respondents’ words, we developed a set of themes (step 3). All themes were then collaboratively reviewed with the research team to achieve consensus on those most relevant to answer our research questions (step 4 and 5). For this process evaluation, we selected themes most relevant for illuminating the EIR studys’ implementation process within the SACs. The themes discussed below represent the broader patterns we observed in the data (step 6, see Table 1).

Table 1.

Themes and sub-themes.

Theme	Description	Sub-theme
1. Quality of Intervention delivery	The degree to which the intervention is delivered as intended and adheres to the mPE manual	The training process
		Supervision
		Delivering mPE
		Adapting mPE to meet patient needs
		Balancing vulnerability
2. How the EIR study is Adopted within the SACs	To which degree the EIR study is integrated into existing practices	Contrast between old and new practice
3. Exploring Reach and Representativeness	The extent to which the intervention successfully serves the intended target population and the representativeness of the participants	Narrow pathways
		Participant burden
4. Unintended consequences	Unintended consequences that are not deliberately intended or anticipated that may affect the outcome, validity, reliability, and generalizability of evaluation findings	Delayed start
		Conflicting advice
		Cross-contamination

3. Results

We identified four main themes with sub-themes, encompassing factors from the process evaluation framework: quality of intervention delivery, adoption, reach, and unintended consequences. This section presents an in-depth examination of these themes with supporting quotes from therapists.

3.1. Theme 1. Quality of intervention delivery

3.1.1. The training process

Therapists valued the comprehensive training workshop but expressed mixed feelings about the effectiveness of digital meetings and role-playing. While the majority found the workshop satisfactory balanced between theory and practice, a subset of therapists found digital meetings to be overly intense. Opinions were divided regarding the effectiveness of role-playing as a learning technique; while some advocated for increased role-play activities, others questioned its practical relevance. Several therapists followed the recommendation to engage in role-play exercises with colleagues, while a few went a step further by practicing with spouses at home.

Some voiced a desire for more practical learning opportunities, such as observing authentic mPE sessions via video recordings. This preference for hands-on learning underscores therapists’ belief that practical application enhances learning beyond theoretical instructions.

3.1.2. Supervision

Supervision was deemed critical for quality intervention. All ten mPE therapists appreciated accessible and supportive supervision and felt confident in reaching out to the supervisor when encountering challenges.

I have attended every group supervision and find them beneficial. The follow-up has been excellent, I can see they are doing everything they can to ensure our success. (Therapist 7)

While group supervision faced challenges, such as scheduling conflicts and difficulty in identifying relevant topics for all, they emphasized the unique nature of each patient and the need for tailored supervision that focuses on individualized patient treatment rather than generalized oversight. Individual feedback from audio-recorded sessions was highlighted as exceptionally valuable for the trainees.

3.1.3. Delivering mPE

Therapists found the provision of a detailed manual to be highly beneficial, aiding the structure and content of mPE and enhancing confidence in delivering mPE safely during the first sessions. Initial sessions evoked feelings of stress and apprehension for some therapists, while others felt secure in their ability to deliver the intervention effectively due to the comprehensive training process. Most therapists reported a growing sense of ease and fluency with mPE over time, like one of them said:

I am becoming more confident. It is more at my fingertips, what mPE is about. (Therapist 7)

3.1.4. Adapting mPE to meet patient needs

Therapists expressed concerns about strict adherence to the manual, fearing it could overlook important patient issues. Moreover, some therapists articulated concerns about a perceived lack of conversational flow and noted that the structured nature of mPE sometimes came at the expense of engaging in ‘small talk’. Several therapists advocated for flexibility to better meet the patients’ needs but described uncertainty regarding the permissible boundaries for flexibility. Others expressed confidence in leaning on their clinical expertise to adapt the intervention as needed.

If a patient is crying and can’t bear to do exposure and go into detail, then I will adjust the amount of exposure. You want to support the patient, allowing her to do what she wants. (Therapist 9)

3.1.5. Balancing vulnerability

Most therapists acknowledged the potential of exposure therapy for overcoming trauma-related fear and avoidance. However, some emphasized that mPE might be too challenging for young patients with complex trauma or comorbidities, potentially worsening their condition and deterring them from seeking help.

It is not suitable for everyone, there will be a certain selection who actually have enough resources to take part in it … after all, we have vulnerable people coming, who may not have as many resources as what are required to carry out mPE. (Therapist 1)

Additionally, two therapists suggested that participants perceived as vulnerable or unstable might require stabilization before engaging in mPE and that it would be premature to initiate exposure.

There are people who come here who just need support, they are just crying. We just have to give them care and support. I would not start mPE with them at all. They need to be stabilized. (Therapist 12)

Although most therapists explicitly expressed believing that mPE and exposure therapies are safe, three therapists questioned if mPE could cause harm or exacerbate symptoms and reactions, such as suicidality and self-harm. They were concerned that stress reaction and strong emotional responses might render the intervention potentially harmful, particularly for those who might not tolerate the additional stress associated with it. As one TAU therapist described it:

Sometimes they are not ‘there’ at all, there is so much else going on. You have to deal with that first … If not, you might make things worse. (Therapist 14)

Therapists highlighted that mPE is not universally applicable, and several prerequisites for benefiting from mPE were mentioned: the ability to grasp and understand the rationale behind mPE, ability to maintain attendance to sessions, follow instructions, and complete homework tasks. A prevalent viewpoint among therapists was that the intervention was most appropriate for individuals who have their life in order. Termed ‘good girls’, the ideal mPE patient characteristics were described as a woman who demonstrates high levels of functionality, with a sense of stability and motivation.

They are the ones who have their lives in order, they have things that enable them to cope. They get a sense of mastery from this … ‘good girls’ who have a network and family who support them … For them, this is easy. (Therapist 7)

3.2. Theme 2. How the EIR study is adopted within the SACs

3.2.1. Contrast between old and new practice

While most therapists expressed enthusiasm for participating in research and introducing new methodologies to the SACs, some therapists described the contrast between the traditional approach and the new intervention mPE as challenging, particularly in how patients engage with their trauma. Traditionally, patients were reassured that discussing the assault was not necessary for healing. In contrast, mPE encourages direct engagement with the trauma memory. These considerations came from long-standing beliefs about patients’ autonomy and the voluntary nature of trauma disclosure. One mPE therapist described this shift:

We go more into the trauma itself, which we have not done before … We’ve beaten around the bush, about what their network is like, whether they struggle with sleep, or have problems eating … Now we talk about what actually happened. (Therapist 4)

While some therapists viewed the existing practice as effective and questioned the need for a new methodology, others recognized that focusing solely on general challenges and symptoms might overlook the core issue of the sexual assault itself. This sentiment was articulated by one therapist:

We are a sexual assault center. It's a bit strange that you can come to a sexual assault center and talk about anything other than the sexual assault itself. (Therapist 6)

3.3. Theme 3. Exploring reach and representativeness

3.3.1. Narrow pathways

Therapists found the inclusion criteria for the study too narrow, excluding many typical patients, which undermined the relevance of the study for the SACs.

Most patients do not fit the criteria … It is really the study that must be shaped to match the patients. Getting a patient to fit into a box is not always easy. (Therapist 6)

Exclusion criteria such as suicidal risk, severe drug or alcohol abuse, and amnesia for the assault were described by some therapists as common patient characteristics. It was emphasized that for a method to be relevant for the SACs, the study ought to be designed to accommodate the typical patients.

3.3.2. Participant burden

Concerns were raised about the demanding nature of participation in the EIR study, which could lead patients to withdraw. Therapists highlighted logistical challenges and the multitude of measurements, homework assignments, and interactions with various staff members.

If you are doing research, you should consider that in a trauma situation, the crisis reactions are quite strong … How can you make it easier for them? For some, just getting out the door is extremely difficult. So, I understand if they say no to participating. (Therapist 13)

However, some therapists noted that patients who have consented likely found the measurements and interviews manageable and even beneficial due to the increased attention and support.

3.4. Theme 4. Unintended consequences

3.4.1. Delayed start

Typically, when visiting a SAC after a sexual assault, patients are immediately scheduled for consultations during the first week. However, since study participants underwent various baseline measurements, the scheduling of the first psychosocial consultation could be delayed by one week. One therapist voiced a concern that this delay could compromise monitoring of physical injuries post-assault (e.g. bruises), and hamper the gathering of forensic evidence.

Consequently, this delay resulted in non-participants receiving psychosocial support earlier than study participants.

3.4.2. Conflicting advice

Two therapists expressed confusion over conflicting advice that they sought from different advisors. The SACs in Norway are inspired professionally and theoretically from various sources and have consulted with different professionals since their inception. Consequently, they use different therapeutic tools and methods. The research team had not anticipated that therapists might seek guidance from other professionals, nor were they prepared for the possibility that these professionals might advocate interventions conflicting with the overall rationale for mPE, e.g. recommending stabilization over exposure.

3.4.3. Cross-contamination

Strong efforts to prevent mPE therapists from treating TAU patients were sometimes unsuccessful, leading to potential cross-contamination of study groups. For practical reasons (e.g. shortage of therapists) or due to personal conviction (that it is best for patients to minimize the number of therapists they must relate to), some mPE therapists did TAU sessions. This clinical pragmatism prioritized patient continuity over scientific rigour. Although all mPE therapists stated that they deliberately avoided using mPE elements in the TAU condition, they acknowledged that the influence of knowledge gained from training may have permeated interactions, leading to increased attention to exposure-related concepts in the TAU condition, albeit without systematic implementation.

4. Discussion

This process evaluation used a qualitative approach to explore factors influencing the implementation of the EIR study within three SACs in Norway. The EIR study is the first randomized controlled trial to compare the efficacy and effectiveness of a new intervention, mPE, against the standard psychosocial treatments provided by the SACs in Norway. It necessitates a thorough investigation of potential parameters affecting the RCT outcomes. This evaluation identified key factors impacting the implementation of the EIR study, providing insights into the interconnectedness of culture dynamics, patient diversity, and the adoption of a new therapeutic method.

4.1. Building competence

SACs lack psychological staffing, and in Norway, trauma-focused interventions are traditionally overseen by clinical specialists in other departments (e.g. mental health, psychiatric department). Training SAC nurses and social workers in mPE represents a novel aspect of the EIR study, and by expanding their repertoire with evidence-based treatments (EBT), it optimizes resource utilization and clinical support available to survivors of rape within their trusted environments. It was therefore central to this evaluation to gain insight into the extent to which the intervention was delivered in accordance with the prescribed protocol, as well as how therapists experienced delivering mPE.

The quality of the intervention, or to what degree mPE is implemented with adherence, rely on factors such as proper training and sufficient supervision of the therapists involved. To enhance adoption and intervention delivery, training and supervision in the EIR study aimed to support therapists’ flexibility, and feedback from audio-recorded sessions gave the opportunity to discuss methodological flexibility and adaptations on an individual basis. Several studies have shown that combining workshop training with ongoing supervision is effective for community clinician to increase utilization of EBT for PTSD (Foa et al., 2020; Rosen et al., 2017; Ruzek et al., 2016; Ruzek et al., 2017). In USA, PE has been successfully disseminated to community clinics for rape survivors and different mental health practitioners (Cahill et al., 2006; Foa et al., 2005; Schnurr et al., 2007). For instance, Foa and colleagues trained therapists in a community clinic for rape survivors in PE and found that community therapists achieved patient outcomes that matched or exceeded those obtained by experts (Foa et al., 2005).

Feedback from therapists indicated satisfaction with the training and supervision and increasing confidence in delivering mPE. Audio-recording used to check for adherence to the manual also showed that therapists adhered well to the manual, indicating good quality of intervention delivery. However, some therapists found the mPE manual too rigid and advocated for a more adaptive approach. This reflects a common view among therapists that manualized treatments are rigid and inflexible (Johnson et al., 2016). The use of manualized treatments are often accompanied by concerns that they may limit therapists’ creativity and therapeutic freedom to individualize their sessions, and that it may interfere with the development of a strong therapeutic alliance, or be unsuitable for patients with severe or complex issues (Addis & Krasnow, 2000; Weisz et al., 2005).

In a study by Mazzucchelli and Sanders (2010), they argued that strict adherence to treatment manuals is neither necessary nor ideal. Instead, they advocate for therapists to deliver interventions flexibly, adapting them to the unique needs of each patient, while still preserving the evidence base of the treatment. They emphasize the importance of tailoring treatments to each patients’ circumstances while nurturing the therapeutic relationship. Achieving this requires therapists to develop the skills to effectively balance adaptation with adherence. To promote what they call practitioner generalization, the ability to use their clinical judgement to tailor interventions to the specific needs of patients, while maintaining fidelity to the core principles of the intervention, Mazzuchelli and colleagues propose several key factors: high-quality training, education on the evidence base, knowledge of population-specific factors, preparation for common therapeutic challenges, and continuous post-training support, among others. They argue that fostering practitioner generalization in this way can improve the implementation of EBTs that ultimately benefit the patient (Mazzucchelli & Sanders, 2010).

Levitt and colleagues tested a ‘flexible application’ of their evidence-based PTSD manual that focused on the understanding of the overarching principles and application of key treatment components. Results suggested that training for strict adherence to a protocol was not necessary to achieve effective implementation (Levitt et al., 2007). Similarly, a large-scale PE dissemination initiative was implemented by the Department of Veterans Affairs, involving more than a thousand clinicians receiving high-quality training and ongoing consultation (Karlin et al., 2010). Program evaluation yielded a significant 30% reduction in patients’ PTSD symptoms. Importantly, such initiatives represent real-world effectiveness despite complex clinical settings, and large variations in therapists’ training in PE.

4.2. Concerns about potential harm

While most therapists considered mPE safe and effective, a minority worried that its exposure components might exacerbate symptoms or trigger adverse reactions in vulnerable patients, such as heightened suicidality and self-harm. A few therapists even advocated for stabilization over exposure, especially for individuals with complex presentations of PTSD. This aligns with general concerns about exposure therapy (Feeny et al., 2003 Zoellner et al., 2011;). However, research consistently shows that symptom exacerbations from trauma-focused treatments are rare and temporary (Foa et al., 2002; Jayawickreme et al., 2017; Larsen et al., 2016). Studies have found no significant differences in symptom exacerbation across various PTSD treatments (Larsen et al., 2016), and has shown that neither trauma-related (e.g. type of trauma experience) nor diagnostic factors (e.g. comorbidity) were associated with symptom exacerbation or drop-out in trauma-focused therapy (Foa et al., 2002; Hembree et al., 2003; Larsen et al., 2016; van Minnen et al., 2015). Furthermore, evidence does not support the recommendation for a stabilization phase prior to providing trauma-focused treatment to persons with complex presentations of PTSD (De Jongh et al., 2016). Additionally, a core principle of the PE manual is to help patients build the capacity to tolerate distress throughout the course of treatment (Foa et al., 2020). Addressing these safety concerns with evidence from the literature is essential for promoting mPE adoption within SACs and should be considered a more integral part of the training process.

Negative attitudes, especially if rooted in misunderstandings about specific treatments, can act as barriers to using EBTs like PE (van Minnen et al., 2010). Concerns about patient decompensation during exposure therapy are common among therapists (Becker et al., 2004). In a study of over 1000 mental health providers, many expressed concerns that PE might exacerbate patients’ distress (Ruzek et al., 2014). However, these concerns diminished when therapists engaged in exposure exercises as part of their training and consultation. Meta-analyses indicate that didactic training in exposure therapy improves provider knowledge, fosters positive attitudes, and enhance self-efficacy in delivering exposure interventions. Having opportunities for practical training, to witness therapists conduct or directly engage in the treatment process, and observing that patients tolerate and benefit from exposure within a supportive framework, may be of particular importance regarding questions of appropriateness, for those considered as vulnerable. Such hands-on experiences help foster confidence and to demystify exposure therapy, enabling therapists to see firsthand how structured interventions can lead to positive outcome for patients (Trivasse et al., 2020).

4.3. Patient vulnerability in clinical research

Therapists voiced concerns about the burden of participating in the EIR study for patients, including the extensive engagement with the trauma memory and the numerous trauma-related questionnaires, interviews, and biological measurements (hair- and saliva collection and actigraphy). It is a common concern that participation in trauma research impacts participants negatively and causes distress. However, research with recently sexually assaulted women generally indicates that research participation is well-tolerated (Campbell et al., 2010; Ferrier-Auerbach et al., 2009; Short et al., 2024).

Recruiting recently traumatized individuals raises ethical considerations that merit careful attention, as outlined in the Helsinki Declaration (World Medical Association, 2001). The EIR study adopted a trauma-informed approach beyond the general requirements of the Helsinki Declaration, emphasizing survivors’ autonomy, control, and empowerment across all steps in the study (Substance Abuse and Mental Health Services Administration, 2014). For instance, SAC personnel were not directly involved in recruitment to prevent any perceived pressure on survivors to ensure that they do not feel obligated to participate in research to access care and support. To minimize participant burden, assessments were scheduled alongside other SAC appointments, and participants could complete questionnaires with assistance from personnel if needed. Participants also had the option to abstain from certain measurements (wearing actigraphy and collecting saliva or hair samples), and the right to withdraw from the study at any time without losing access to SAC services. User involvement has been integral to every aspect of the EIR study design, including consultations with individuals previously exposed to sexual trauma and professionals experienced in working with survivors. Screening and measurements have been meticulously planned and tested beforehand in a pilot feasibility study (Haugen et al., 2024).

4.4. Early intervention after rape: the window of opportunity

Therapists expressed concern about delayed consultations due to research requirements (screening and assessments). Early access to medical and psychosocial treatment could be crucial for ameliorating the psychological sequelae of trauma and facilitating the recovery process. What sets PTSD apart from other psychiatric conditions is its identifiable point of onset: the traumatic event itself. This critical period post-trauma presents a unique opportunity for intervention, where early and effective measures could mitigate PTSD symptoms (Dworkin & Schumacher, 2018; Oosterbaan et al., 2019; Roberts et al., 2019; Rothbaum et al., 2012; Short et al., 2020). This time-period is often referred to as ‘the window of opportunity’. However, international guidelines recommend active monitoring or ‘watchful waiting’ during the acute phase following rape, and recommends against universal psychological interventions (National Institute for Health and Care Excellence NG, 2018). Norwegian national guidelines, on the other hand, mandates SACs to provide acute psychosocial care, including crisis intervention and assistance in coping with psychological reactions immediately following the incident, and follow-up based on individual evaluation (Sosial- og helsedirektoratet, 2007).

The efficacy of psychosocial treatment provided by the SACs in Norway remains largely unexplored. Consequently, it is unclear whether the current services are beneficial for rape survivors. An evaluation of SACs conducted in 2012 highlighted significant variations in care and symptom monitoring practices, with a notable lack of continuity beyond the acute phase (Eide et al., 2012). A significant concern is the lack of designated personnel responsible for monitoring symptoms beyond the acute phase. This gap results in a loss of continuity when patients are either transferred to another level of the healthcare system or not transferred when needed. Consequently, the active monitoring may be challenging. Implementing an early intervention that involves both working with trauma-related reactions and monitoring of symptoms could provide a bridge between the two guidelines.

4.5. Addressing barriers

To overcome barriers to successful implementation, it is essential to address the therapists’ reservations about mPE. This can be achieved by combining enhanced education on the evidence base of PE with more hands-on practice. Future training should place greater emphasis on addressing concerns about the safety of exposure therapy for trauma survivors. By dispelling misconceptions and highlighting the proven safety and effectiveness of PE, training could foster greater willingness among therapists to adopt exposure-based practices, ultimately contributing to improved mental health care quality.

Competence-building is closely tied to therapists’ perceptions of patient vulnerability and their views on the safety and effectiveness of mPE. These factors directly impact therapists’ confidence in delivering mPE, influencing both the quality of the intervention and the likelihood of successful adoption. Addressing these interconnected themes during training is essential for improving both the delivery of mPE and its implementation outcomes.

4.6. Strengths and limitations

Concurrent process evaluations alongside randomized controlled trials provide crucial insight not captured by efficacy measures alone. The therapists’ experiences with implementing the EIR study provides important information that could improve future implementation and research at the SACs. Designed as both an efficacy and effectiveness trial to evaluate both the impact of mPE as an early intervention post-rape, but also using trained SAC nurses and social workers to deliver the intervention, enhances the generalizability of the results within real-world settings. However, the findings may not generalize beyond this specific context. The method's time and resource demands may limit scalability, as many SACs in Norway are lacking the necessary staffing.

We did not predetermine a sample size but instead aimed to include as many participants as possible. A key strength of this evaluation is that we successfully included nearly all therapists involved in the EIR study. Since all therapists who expressed interest in participating were included, it was not possible to extend the sample size any further. As noted by Braun and Clarke (2022) and Malterud et al. (2016), the sample size should be sufficient to address the research questions, with sufficient richness or information power in the generation of meaning (e.g. themes). Our data encompassed a diverse range of perspectives and viewpoints, providing the variation necessary to meet our research questions and the scope of the study. While we considered conducting follow-up interviews with certain participants, this was ultimately not pursued. However, participants were invited to share additional reflections via email, and a few did so, contributing further depth to the analysis.

The male therapist perspective is unfortunately absent, as all therapists involved in this study were female. To our knowledge, there are no men working as therapists at the three SACs included.

Semi-structured interviews allowed for nuanced exploration of therapist’s experiences. In thematic analysis, reflecting on one’s subjectivity is essential to understand how personal and professional experiences influence both data collection and interpretation. The use of an independent interviewer mitigated potential biases, fostering open and honest exchange. The interviewer (MK) had no prior involvement in the EIR study, which enhances the objectivity of the process. However, the inherent subjectivity in data analysis introduces the risk of interpretive and confirmation biases. The first authors (TH) role as a member of the research group, an experienced clinical psychologist, and the PE trainer in this context may have predisposed her to certain interpretations. Her advocacy for EBT for PTSD, combined with her knowledge of PE research – especially regarding common attitudinal barriers and misconceptions about PE – could have influenced her analytic focus. To address these potential biases, a reflective approach was carefully maintained throughout the analysis (Malterud, 2001). The first author actively engaged in self-reflection to critically examine how her professional and theoretical perspectives might shape her interpretations. This process aimed to ensure a balanced perspective that prioritized participants’ voices, minimizing the influence of her own clinical and theoretical inclinations. Additionally, multiple coders and reviewers were involved in re-evaluating interpretations, discussing impressions, and challenging assumptions, which further helped to reduce bias and enhance the reliability and depth of the findings.

Interviews were conducted during the initial phase of the EIR study, capturing early experiences. Conducting interviews at multiple time points could have provided insight into varying levels of experience in delivering mPE. At the time of this process evaluation, therapists had limited practice, treating between one to six patient each.

Incidents with cross-contamination between study groups was identified through this process evaluation, enabling the research group to address and correct it. Understanding and managing cross-contamination is crucial as it can significantly impact study outcome, potentially undermining the validity and integrity of the research by blurring distinctions between groups.

4.7. Implications

Implementing an evidence-based intervention like mPE and training therapists to administer it has the potential to greatly improve the quality of care for rape survivors, while also facilitate active monitoring of symptom progression post-trauma. If mPE proves effective in alleviating post-traumatic stress symptoms following rape, SAC therapists could play an even more pivotal role in promoting survivors’ well-being. However, therapists’ attitudes toward new practices influence the adoption and successful integration of such interventions into clinical practice. Addressing these attitudes thoughtfully and proactively is essential for the success of clinical trials and broader implementation efforts.

This qualitative process evaluation offers valuable insights into the challenges and opportunities of adopting and implementing new interventions in real-world clinical settings, ultimately advancing of evidence-based practices for the care of sexual assault survivors.

Funding Statement

This work was funded by the Research Council of Norway (project #320637), the Department of Clinical and Molecular Medicine, the Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), and from the Department of Obstetrics and Gynecology, St. Olavs Hospital, Trondheim University Hospital.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

Interview data are not available. The EIR study protocol has been previously published.