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European Journal of Psychotraumatology logoLink to European Journal of Psychotraumatology
. 2021 Jan 15;12(1):1851511. doi: 10.1080/20008198.2020.1851511

Effect of Prolonged Exposure, intensified Prolonged Exposure and STAIR+Prolonged Exposure in patients with PTSD related to childhood abuse: a randomized controlled trial

Efecto de la Exposición Prolongada, la Exposición Prolongada intensificada y STAIR + la Exposición Prolongada en pacientes con TEPT relacionado con el abuso infantil: un ensayo controlado aleatorio

延长暴露、强化延长暴露和STAIR +延长暴露对童年期虐待相关PTSD 患者的影响：一项随机对照 试验

Danielle A C Oprel a,b,*, Chris M Hoeboer a,b,✉,*, Maartje Schoorl a,b, Rianne A de Kleine a, Marylene Cloitre c,d, Ingrid G Wigard e, Agnes van Minnen f,g, Willem van der Does a,b,h
PMCID: PMC8500700  PMID: 34630934

ABSTRACT

Background: It is unclear whether the evidence-based treatments for PTSD are as effective in patients with CA-PTSD.

Objective: We aimed to investigate the effectiveness of three variants of prolonged exposure therapy.

Method: We recruited adults with CA-PTSD. Participants were randomly assigned to Prolonged Exposure (PE; 16 sessions in 16 weeks), intensified Prolonged Exposure (iPE; 12 sessions in 4 weeks followed by 2 booster sessions) or a phase-based treatment, in which 8 sessions of PE were preceded by 8 sessions of Skills Training in Affective and Interpersonal Regulation (STAIR+PE; 16 sessions in 16 weeks). Assessments took place in week 0 (baseline), week 4, week 8, week 16 (post-treatment) and at a 6-and 12-month follow-up. The primary outcome was clinician-rated PTSD symptom severity.

Results: We randomly assigned 149 patients to PE (48), iPE (51) or STAIR+PE (50). All treatments resulted in large improvements in clinician assessed and self-reported PTSD symptoms from baseline to 1-year follow-up (Cohen’s d > 1.6), with no significant differences among treatments. iPE led to faster initial symptom reduction than PE for self-report PTSD symptoms (t135 = −2.85, p = .005, d = .49) but not clinician-assessed symptoms (t135 = −1.65, p = .10) and faster initial symptom reduction than STAIR+PE for self-reported (t135 = −4.11, p < .001, d = .71) and clinician-assessed symptoms (t135 = −2.77, p = .006, Cohen’s d = .48) STAIR+PE did not result in significantly more improvement from baseline to 1-year follow-up on the secondary outcome emotion regulation, interpersonal problems and self-esteem compared to PE and iPE. Dropout rates did not differ significantly between conditions.

Conclusions: Variants of exposure therapy are tolerated well and lead to large improvements in patients with CA-PTSD. Intensifying treatment may lead to faster improvement but not to overall better outcomes.

The trial is registered at the clinical trial registry, number NCT03194113, https://clinicaltrials.gov/ct2/show/NCT03194113

KEYWORDS: Posttraumatic stress disorder, CA-PTSD, trauma-focused treatment, childhood trauma, prolonged exposure, STAIR, intensified treatment

HIGHLIGHTS

• Childhood abuse-related PTSD can be effectively treated with (variants of) exposure therapy. • STAIR+PE and intensified PE did not improve treatment outcomes compared to PE.• Intensified PE showed faster symptom improvement.

1. Introduction

Childhood physical and sexual abuse are important risk factors for the development of post-traumatic stress disorder (PTSD; Cougle, Timpano, Sachs-Ericsson, Keough, & Riccardi, 2010; Kessler et al., 2017). Both childhood abuse and childhood abuse-related PTSD (CA-PTSD) are associated with severe psychiatric symptoms and negative long-term outcomes (Cloitre et al., 2009; Gilbert et al., 2009; Norman et al., 2012), emphasizing the need for effective treatment. Clinical guidelines prescribe trauma-focused treatment as the first-line treatment of PTSD (Hamblen et al., 2019). Substantial empirical support exists for the effectiveness of trauma-focused treatment in PTSD (Ehring et al., 2014; Mavranezouli et al., 2020; Watts et al., 2013); however, there is ample room for improvement since about half of the patients still meet diagnostic criteria for PTSD after treatment and 25% drop-out (Bradley, 2005; Ehring et al., 2014; Watkins, Sprang, & Rothbaum, 2018). Furthermore, there is a limited number of studies assessing trauma-focused treatment among those with CA-PTSD and it is therefore uncertain how effective trauma-focused treatment is in this group of patients (Ehring et al., 2014).

Patients with CA-PTSD more often experience emotion regulation difficulties and interpersonal problems than patients with non-CA-PTSD (Cloitre, Miranda, Stovall-McClough, & Han, 2005; Gekker et al., 2018; Messman-Moore & Bhuptani, 2017). In addition, co-morbid diagnoses are more common in these patients – in particular depression, substance abuse and personality disorders (Dvir, Ford, Hill, & Frazier, 2014). Although comorbidity is also prevalent in non-CA-PTSD, prevalence rates of comorbidity are much higher in CA-PTSD, with moderate to large effect sizes (e.g. Gekker et al., 2018; Messman-Moore & Bhuptani, 2017)

A recent meta-analysis indicated that patients with PTSD related to childhood trauma do not benefit optimally from treatment. Compared with patients with PTSD related to trauma in adulthood, they improve less on PTSD symptoms, emotion regulation and interpersonal functioning (Karatzias et al., 2019). Another meta-analysis of dropout rates from psychotherapy found somewhat higher dropout rates from trauma-focused treatment in patients with CA-PTSD (24%; Ehring et al., 2014) than in patients with PTSD in general (18%; Lewis, Roberts, Gibson, & Bisson, 2020), suggesting that dropout rates are potentially high among those with CA-PTSD.

The aim of this study was to investigate whether the effectiveness and the dropout rates of trauma-focused treatment for PTSD can be improved in patients with CA-PTSD. Prolonged Exposure (PE), an established treatment of PTSD was compared with two adaptations of PE. The first was an intensified version of PE (iPE). We expected that offering several sessions per week would lead to faster improvement and lower drop-out rates (Ragsdale, Watkins, Sherrill, Zwiebach, & Rothbaum, 2020). In patients with (non-CA) PTSD, iPE led to faster improvement (Ehlers et al., 2014; Foa, McLean, Zang, & Consortium, 2018) and noninferior post-treatment outcomes (Foa et al., 2018) compared to standard (weekly) PE. Open studies in patients with chronic PTSD following multiple traumata and treatment attempts indicated that iPE may lead to fast improvement and low dropout rates (Hendriks, de Kleine, Broekman, Hendriks, & van Minnen, 2018) and that the results did not differ between patients with and without CA-PTSD (Wagenmans, Van Minnen, Sleijpen, & De Jongh, 2018). It is unclear, however, whether iPE improves treatment outcome of PE in patients with CA-PTSD. The second adaptation was a phase-based treatment in which PE is preceded by Skills Training in Affective and Interpersonal Regulation (STAIR). This treatment is based on the notion that emotion regulation and interpersonal problems interfere not only with daily life functioning but also the processing of trauma memories and that improvement in these capacities during the STAIR phase facilitates the effectiveness of PE (Cloitre, Koenen, Cohen, & Han, 2002). STAIR+PE has been demonstrated to be an effective treatment for CA-PTSD (Cloitre et al., 2002, 2010) and led to better outcomes and a lower dropout rate relative to a PE treatment that did not include STAIR (i.e. Supportive Counseling+PE) (Cloitre et al., 2010).

We tested the following hypotheses:

  1. iPE and STAIR+PE lead to more clinician-rated and self-reported PTSD symptom reduction than PE from baseline to follow-up.

  2. iPE leads to faster improvement, that is, iPE leads to more clinician-rated and self-reported PTSD symptom reduction than PE and STAIR+PE from baseline to the first assessment (week 4).

  3. STAIR+PE leads to more improvement in emotion regulation, interpersonal problems and self-esteem than PE and iPE from baseline to follow-up.

  4. iPE and STAIR+PE result in lower drop-out rates from treatment than PE.

2. Method

2.1. Study design and participants

In this randomized-controlled trial (RCT), ‘IMPACT’ (improving PTSD treatment for adults with childhood trauma), we compared the effectiveness of PE, iPE and STAIR+PE. The authors assert that all procedures contributing to this work complied with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. All procedures involving patients were approved by the Medical Ethical Committee of Leiden University Medical Centre (NL57984.058.16). More detailed information about the design can be found in the published study protocol (Oprel et al., 2018).

Participants were recruited in two outpatient mental health services specializing in the treatment of trauma-related disorders located in the Hague and Rotterdam, the Netherlands. Inclusion criteria were: 1) ages 18 to 65 years; 2) a PTSD diagnosis according to the DSM-5 classification established with the Clinician-Administered PTSD Scale (CAPS-5 see below), and at least moderate severity of PTSD-symptoms (CAPS-5 score ≥26) and at least one specific memory of the traumatic event; 3) Traumata related to childhood sexual and/or physical abuse that occurred before 18 years of age, committed by a primary caretaker or an authority figure as index event; 4) sufficient fluency in Dutch to complete the treatment and research protocols. Exclusion criteria were: 1) involvement in a compensation case or legal procedures concerning admission or stay in The Netherlands; 2) pregnancy given the limited available information about safety (Baas, van Pampus, Braam, Stramrood, & de Jongh, 2020), 3) severe nonsuicidal self-injury (NSSI) which required hospitalization during the past 3 months; 4) severe suicidal behaviour: a suicide attempt during the past 3 months or acute suicidal ideations with serious intent to die with a specific plan for suicide and preparatory acts; 5) severe disorder in the use of alcohol or drugs in last 3 months according to the Mini-International Neuropsychiatric Interview (MINI; Sheehan et al., 1998), 6) cognitive impairment (estimated IQ < 70); 7) changes in psychotropic medication in the 2 months prior to inclusion; and 8) engagement in any current psychological treatment. Written informed consent was obtained from all patients after receiving a complete description of the study.

2.2. Randomization and masking

Randomization was carried out on study-enrolment in a 1:1:1 ratio by an independent researcher from Leiden University based on a computerized randomization sequence of permutated blocks of six participants stratified by gender. All assessments were carried out by research assistants who were blind to treatment condition.

2.3. Procedures

Upon referral, a member of the research team provided study-information by telephone and scheduled the baseline assessment. In- and exclusion criteria were checked during this assessment. Eligible participants obtained more detailed study-information in a subsequent preparatory session. After this preparatory session and informed consent, randomization took place.

PE was delivered in 16 weekly face-to-face sessions of 90 min. PE is a form of cognitive behavioural therapy involving psychoeducation about PTSD, imaginal exposure (repeatedly recounting most disturbing traumatic memories) and exposure in vivo (repeatedly approaching trauma-related stimuli) (Foa, Hembree, & Rothbaum, 2007). In the 1st session, the therapist and patient constructed a case conceptualization including a hierarchy of traumatic experiences. Between sessions, patients were instructed to listen to the audiotaped exposure sessions on a daily basis and to complete exposure in vivo assignments. PE sessions were manualized (based on the protocol of Foa et al. (2007)) and one therapist was assigned to each patient.

iPE was delivered in 14 face-to-face sessions of 90 min. iPE started with 3 sessions per week for 4 weeks (12 sessions total) followed by 2 sessions after one and 2 months. iPE was implemented similarly to the PE condition, except for the time format of the sessions. iPE sessions were delivered alternately by two therapists per patient.

STAIR+PE was delivered in 8 weekly face-to-face sessions of 60 min for STAIR and 8 weekly face-to-face sessions of 90 min for PE. STAIR+PE comprised skill training and prolonged exposure. STAIR is a skill training programme with 4 sessions focused on improving emotion regulation skills followed by 4 sessions focused on developing interpersonal skills (Cloitre et al., 2002; Levitt & Cloitre, 2005). Between sessions, patients were instructed to practice skills. STAIR was followed by 8 sessions PE which was implemented similar to the PE condition. STAIR+PE sessions were manualized and one therapist was assigned to each patient.

Therapists’ adherence to the PE and STAIR protocols was ensured through training, an exam with pilot patients graded by supervisors, and weekly group supervision (supervisors: AvM and RAdK in PE; MC and IGW in STAIR). The therapists (n = 20; 18 females; Mage = 36, SDage = 7) had at least a masters’ degree in psychology and on average 10 years’ experience in mental health services (M = 10, SD = 7). They were trained in both methods and the therapists provided treatment in all conditions when practically possible. We randomly selected 10% of the total sessions (178 sessions) which were rated by independent observers for treatment adherence in the three conditions based on the original adherence rater checklist scale by Cloitre and colleagues and the Dutch translation of the original adherence rater checklist scale by Foa and colleagues. Protocol adherence was high during STAIR sessions (Msession elements completed = 98%, SD = 5%) and PE sessions (Msession elements completed = 90%, SD = 18%). Early therapy completion was allowed when patients scored below 16 on the PTSD checklist for DSM-5 (PCL-5; see below) for three consecutive weeks. Patients who completed treatment (including early completers) were considered treatment completers.

Demographic and clinical characteristics of participants were assessed at baseline (T0). All primary and secondary outcomes of this paper (see below) were assessed at T0, at T1 after 4 weeks (4 sessions STAIR+PE and PE or 12 sessions iPE), at T2 after 8 weeks (8 sessions STAIR+PE/and PE or 13 sessions iPE), at T3 after 16 weeks (post-treatment) and at 6-month (T4) and 12-month follow-ups (T5).

2.4. Outcome measures

The primary outcome was clinician-rated PTSD symptom severity as measured with the CAPS-5 (Boeschoten et al., 2018). The CAPS-5 is a 20-item clinical interview that assesses both DSM-5 PTSD diagnostic criteria and PTSD symptom severity. The score range is 0–80, with higher scores indicating greater severity. The CAPS-5 was administered over events that were most strongly related to current PTSD symptoms. For all participants, index events included sexual and/or physical abuse in childhood. Treatment response was defined as at least 6 points improvement on the CAPS-5 between baseline and participants’ last available measurement between baseline and 12-month follow-up (adapted from Schnurr & Lunney, 2016). Remission was defined as a response to treatment, a loss of PTSD diagnosis (measured with the CAPS-5) and CAPS-5 score below 12 based on the conservative notion that it is impossible to meet PTSD diagnosis with a score below 12 (Norman et al., 2019). Remission was also based on the participants’ last available measurement. The audiotapes of 20 randomly selected CAPS-5 interviews were independently re-assessed by one of the researchers who did not conduct any interview in the study himself and showed a high correlation of the total severity scores (Pearson’s correlation = .99) and diagnosis (Pearson’s correlation = .90) between assessors. Internal reliability of the CAPS-5 at baseline was moderately high (Cronbach’s α = .75).

Secondary outcome measures were the PTSD Checklist for DSM-5 (PCL-5; Blevins, Weathers, Davis, Witte, & Domino, 2015), the Difficulties in Emotion Regulation Scale (DERS; Lee, Witte, Bardeen, Davis, & Weathers, 2016) the Inventory of Interpersonal Problems (IIP-32; Barkham, Hardy, & Startup, 1996) and the Rosenberg Self-esteem Scale (RSES; Schmitt & Allik, 2005). The PCL-5 is a 20-item self-report questionnaire which assesses PTSD symptoms. Total PCL-5 score ranges between 0 and 80 with higher scores indicating higher symptom severity. Internal reliability of the PCL-5 at baseline was high (Cronbach’s α = .89). The DERS is a 36-item self-report questionnaire assessing emotion regulation difficulties. Total score ranges between 0 and 180 with higher scores indicating more difficulties. Internal reliability of the DERS at baseline was high (Cronbach’s α = .90). The IIP is a 32-item self-report questionnaire which measures interpersonal problems with an averaged total score between 0 and 4 with a higher score indicating more difficulties. Internal reliability of the IIP at baseline was high (Cronbach’s α = .87). The RSES is a 10-item self-report questionnaire which measures self-esteem with a total score between 0 and 30 with higher scores indicating higher self-esteem. Internal reliability of the RSES at baseline was high (Cronbach’s α = .87).

Baseline comorbid axis-1 disorders were assessed with the MINI (Sheehan et al., 1998) and baseline personality disorders were assessed with the Structured Clinical Interview for DSM-IV Personality Disorders (SCID-2; Weertman, Arntz, Dreessen, van Velzen, & Vertommen, 2003). Data about adverse events (untoward medical occurrence) and serious adverse events (i.e. an adverse event which is life-threatening requires inpatient hospitalization or potentially results in permanent impairment) were recorded by therapists during therapy and by research assistants during assessments.

2.5. Statistical analyses

We agreed upon a statistical analysis plan before the trial analysis (pre-registered at the Centre For Open Science; Hoeboer, 2019). We performed the analyses with R version 3.6.1 (R Core Team, 2018). The analyses were conducted on an intention-to-treat basis. Alpha was set at .05 for all analyses (two-tailed). To identify between-group differences with at least moderate effect size (d = .40) with an alpha of .05 (2-tailed) and a power of 0.8, 150 participants were recruited.

We used package lme4 for modelling the linear mixed effect models (Bates, Machler, Bolker, & Walker, 2015). The models were estimated with random intercepts for persons and random slope effects of time to account for the dependency in the data within persons (Hox, 2002; Kato et al., 2005). We modelled time with a piecewise linear growth curve model to account for a nonlinear decrease of symptoms over time since we expected a fast symptom decrease of the iPE condition from T0-T1. Additionally, we expected a different effect of time during treatment than during the follow-up period. This resulted in three different slopes with time point T0-T1 as the first slope (i.e. baseline to 4 weeks in treatment), T1-T3 (i.e. 4 weeks in treatment to post-treatment) as the second slope and T3-T5 (post-treatment to 1-year follow-up) as the third slope. To evaluate post-treatment differences between conditions, we recoded the intercept as T3 for all outcomes.

To test the first hypothesis, we performed two independent linear-mixed effect models with 1) CAPS-5 and 2) PCL-5 as the dependent variable. For both analyses, the condition was dummy coded with PE as comparator. The three slopes (i.e. T0-T1; T1-T3 and T3-T5), condition and their interaction effects were included in the models as fixed independent variables. We used the same models for the second hypothesis but recoded iPE as comparator condition. For the third hypothesis, we performed three independent linear mixed effect models with the DERS total score (emotion regulation), IIP total score (interpersonal skills) and RSES total score (self-esteem) as dependent variables and STAIR+PE as comparator condition. The three slopes, condition and their interaction effects were included in the model as fixed independent variables. To test the fourth hypothesis we used two chi-square tests of independence with the condition (iPE versus PE and STAIR+PE versus PE) versus drop-out rates to assess the difference in drop-out rates between the three conditions. Patients were regarded as treatment drop-out if they stopped therapy prematurely (including never starting treatment after randomization). We used fisher exact tests to assess differences between conditions in early completers (iPE versus PE and STAIR+PE versus PE) since one of the assumptions of chi-square tests of independence (five expected observations per cell) was not met in more than 20% of the cells (McHugh, 2013).

The assumptions of all analyses were met. We evaluated between-group effect sizes with modelled data following the method of Feingold and t-to-d conversion using function lme-dscore from R package EMAtools (Feingold, 2013; Kleiman, 2017). We used semi-parametric bootstrapping to derive the prediction intervals of the modelled data from the linear mixed-effect models to account for the uncertainty in the variance of the parameters due to the random effects using R package Bootmer (Bates et al., 2015). The trial is registered at the clinical trial registry, number NCT03194113.

3. Results

Between 23 November 2016 and 18 December 2018, 150 participants were randomly assigned to PE, iPE or STAIR+PE (see Figure 1 for the study flowchart). One participant was excluded after randomization because she no longer met inclusion criteria at the time of enrolment. Table 1 lists the baseline characteristics of the included participants (n = 149). There were significantly more early completers in the PE condition (23%) compared to iPE (2%; p = .001) and STAIR+PE (4%; p = .007). In total, 37 patients (25%) dropped out of treatment. We found no demographic or clinical characteristics which were related to drop-out from therapy. Change in PTSD symptoms from baseline to week 4 did not predict subsequent therapy drop-out. Little’s MCAR test indicates that missing cases may meet criteria for missing completely at random (χ2(244) = 241, p = .54).

Figure 1.

Figure 1.

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Flow diagram of recruitment and follow-up process

Table 1.

Baseline characteristics of the participants

  Total
(N = 149)		 PE
(n = 48)		 iPE
(n = 51)		 STAIR+PE
(n = 50)
Demographic characteristics, No. (%)        
Age, mean (SD), y 36.86 (11.75) 34.52 (11.05) 38.87 (11.57) 37.07 (12.39)
Gender (female) 114 (76.5) 37 (77.1) 38 (74.5) 39 (78.0)
Marital status (married/cohabitating) 56 (37.6) 15 (31.3) 25 (49.0) 16 (32.0)
Education (high)1 30 (20.1) 9 (18.8) 12 (23.5) 9 (18.0)
Job        
Employed 57 (38.3) 19 (39.6) 21 (41.2) 17 (34.0)
Incapacitated/on disability 37 (24.8) 14 (29.2) 7 (13.7) 16 (32.0)
Unemployed 55 (36.9) 15 (31.3) 23 (45.1) 17 (34.0)
Cultural background (non-Western)2 65 (43.3) 20 (41.7) 19 (36.5) 26 (52.0)
Trauma category (single or multiple) DSM 5A criterion CAPS        
Childhood sexual abuse 108 (72.5) 39 (81.3) 35 (68.6) 34 (68.0)
Childhood physical abuse 93 (62.4) 29 (60.4) 32 (62.7) 32 (64.0)
Sexual abuse in adulthood 29 (19.5) 12 (25.0) 9 (17.6) 8 (16.0)
Physical abuse in adulthood 42 (28.2) 16 (33.3) 15 (29.4) 11 (22.0)
Duration of PTSD, mean (SD), y 15.06 (12.49) 15.33 (10.21) 15.40 (12.89) 14.47 (14.19)
Any medication 96 (64.0) 32 (66.7) 34 (66.7) 30 (60.0)
Psychotropic medication 71 (47.7) 24 (50.0) 25 (49.0) 22 (44.0)
Antidepressants 39 (26.2) 16 (33.3) 13 (25.5) 10 (20.0)
Sedatives 42 (28.2) 17 (35.4) 11 (21.6) 14 (28.0)
Axis-1 MINI diagnosis        
Mean number, excluding PTSD (SD) 3.12 (1.91) 3.15 (1.89) 2.84 (1.79) 3.38 (2.03)
Current depression 85 (57.1) 27 (56.3) 25 (49.0) 33 (66.0)
Severe suicidality past month 64 (43.0) 23 (47.9) 21 (41.2) 20 (40.0)
Current bipolar disorder (type1/2) 10 (6.7) 4 (8.3) 3 (5.9) 3 (6.0)
Disorder alcohol/drug use past year 34 (22.8) 13 (27.1) 12 (23.5) 9 (18.0)
Current psychotic disorder 19 (12.8) 6 (12.5) 7 (13.7) 6 (12.0)
Any personality disorder diagnosis 90 (60.4) 33 (68.8) 26 (51.0) 31 (62.0)
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PE = Prolonged Exposure condition, iPE = intensive Prolonged Exposure condition, STAIR+PE = Skills Training in Affective and Interpersonal Regulation + Prolonged Exposure, SD = standard deviation, y = year, N = sample size, No. = number, NA = not applicable, MINI = Mini-International Neuropsychiatric Interview. 1high education = higher vocational education or university. 2non-Western cultural background = at least one parent was not born in a Western country.

Table 2 lists the modelled CAPS-5 and PCL-5 scores with bootstrapped 95% confidence intervals and effect sizes produced with the linear mixed model analyses. All conditions resulted in large improvements in PTSD symptoms from baseline to 1-year follow-up (see Figure 2 for modelled outcomes). iPE and STAIR+PE did not produce significantly larger reductions in CAPS-5 and PCL-5 scores than PE (comparator condition, hypothesis 1) from baseline to 1-year follow-up (via the three slopes) and did not result in lower CAPS-5 and PCL-5 scores post-treatment or at 1-year follow-up. Significant differences between iPE and PE in the decrease of symptoms from baseline to week 4 are described under hypothesis 2. Moreover, we found a smaller decrease in CAPS-5 scores (b = 3.92, t120 = 2.41, p = .02, d = .44) and PCL-5 scores (b = 7.32, t120 = 3.29, p = .001, d = .60) from week 4 to post-treatment in iPE compared to PE. From post-treatment to 1-year follow-up, STAIR+PE resulted in more improvement in CAPS-5 scores than PE (b = 2.77, t175 = 2.16, p = .03, d = .33).

Table 2.

Modelled outcomes for the three treatment conditions for all time points

  PE
 iPE
 STAIR+PE
Time Point Mean (95% CI) Eff. size1 Cum eff. size Mean (95% CI) Eff. size1 Cumeff. size Mean (95% CI) Eff. size1 Cumeff. size
CAPS-5                  
Baseline 41.3 (37.8–45.1)     39.4 (35.6–43.2)     43.5 (40.1–47.1)    
Week 4 33.1 (26.3–40.3) .75 .75 25.8 (18.9–33.3) 1.11 1.11 37.6 (31.0–44.8) .50 .50
Week 8 25.3 (20.0–30.9)     21.6 (16.4–27.1)     30.7 (25.4–36.4)    
Week 16 17.8 (12.1–23.8) 1.10 1.85 18.3 (12.6–24.3) .49 1.60 21.5 (15.6–27.6) 1.19 1.69
6 M FU 19.1 (13.5–25.1)     17.4 (11.9–23.2)     19.4 (13.8–25.2)    
12 M FU 19.9 (13.6–26.3) −.22 1.63 16.9 (10.8–23.3) .09 1.69 18.2 (12.0–24.5) .25 1.94
PCL-5                  
Baseline 51.3 (45.0–58.0)     48.6 (42.0–55.8)     50.4 (44.0–56.9)    
Week 4 45.3 (36.9–54.2) .46 .46 31.4 (22.8–40.0) 1.11 1.11 47.9 (39.2–56.6) .17 .17
Week 8 34.6 (28.5–40.9)     26.2 (20.0–32.3) .   38.5 (32.2–44.8)    
Week 16 23.5 (16.9–30.5) 1.25 1.71 22.9 (16.3–29.6) .43 1.54 27.1 (19.7–34.0) 1.14 1.31
6 M FU 22.1 (15.2–28.9)     21.0 (14.7–27.2)     24.9 (18.1–31.6)    
12 M FU 19.9 (12.2–27.7) .13 1.84 19.5 (12.6–26.6) .17 1.71 22.9 (15.5–30.2) .32 1.63
DERS                  
Baseline 117.5 (107.0–127.8)     114.0 (103.6–125.0)     117.5 (107.1–128.3)    
Week 4 114.0 (104.9–123.5) .17 .17 95.8 (86.9–104.6) .79 .79 116.9 (107.6–126.0) .01 .01
Week 8 104.0 (97.1–111.4)     91.6 (84.5–98.6)     108.5 (101.4–115.8)    
Week 16 93.8 (86.6–101.2) 1.05 1.22 89.0 (82.0–96.5) .30 1.09 95.2 (87.8–102.6) 1.05 1.06
6 M FU 93.7 (86.8–101.0)     86.8 (79.8–93.8)     91.2 (84.0–98.4)    
12 M FU 93.2 (84.4–102.3) −.07 1.15 84.8 (76.2–93.6) .25 1.34 85.7 (76.9–94.2) .68 1.74
IIP                  
Baseline 1.7 (1.4–2.0)     1.6 (1.3–1.9)     1.7 (1.4–2.0)    
Week 4 1.7 (1.4–2.0) .01 .01 1.4 (1.1–1.7) .31 .31 1.9 (1.5–2.2) −.32 −.32
Week 8 1.5 (1.2–1.8)     1.3 (1.0–1.6)     1.7 (1.4–2.0)    
Week 16 1.2 (0.9–1.6) .87 .88 1.3 (1.0–1.6) .29 .60 1.5 (1.2–1.8) .62 .30
6 M FU 1.2 (0.9–1.6)     1.2 (0.9–1.5)     1.3 (1.0–1.7)    
12 M FU 1.3 (1.0–1.7) −.27 .61 1.1 (0.8–1.5) .14 .74 1.2 (0.8–1.5) .55 .85
RSS                  
Baseline 11.7 (9.0–14.5)     13.3 (10.4–16.2)     11.3 (8.6–14.0)    
Week 4 13.0 (10.4–15.8) .36 .36 14.8 (12.2–17.4) .23 .23 11.7 (9.1–14.4) .07 .07
Week 8 13.9 (11.5–16.2)     16.3 (13.9–18.6)     13.2 (10.8–15.6)    
Week 16 14.8 (12.1–17.4) .33 .69 17.2 (14.7–19.7) .34 .57 14.6 (11.9–17.3) .56 .63
6 M FU 15.2 (12.7–17.8)     17.8 (15.4–20.3)     14.8 (12.2–17.4)    
12 M FU 16.0 (13.2–18.9) .20 .89 18.4 (15.7–21.1) .22 .79 15.2 (12.5–18.1) .14 .77
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Eff. = effect, Cum = cumulative, Baseline = T0, Week 4 = T1, Week 8 = T2, Week 16 = T3, 6 M FU = 6-month follow-up, 12 M FU = 12-month follow-up, PE = Prolonged Exposure condition, iPE = intensive Prolonged Exposure condition, PBT = Phase-Based Treatment, CAPS-5 = Clinician-Administered PTSD Scale, PCL-5 = PTSD Checklist for DSM-5, DERS = Difficulties in Emotion Regulation Scale, IIP = Inventory of Interpersonal Problems, RSS = Rosenberg Self-esteem Scale, CI = Confidence Interval.

1 Within-group effect size (Cohen’s d) of week 4 (baseline – week 4), week 16 (week 4 – week 16) and follow-up (week 16 – follow-up) based on modelled scores from LMM procedure. Positive values indicate improvements in symptoms.

graphic file with name ZEPT_A_1851511_F0002a_OC.jpg

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iPE (comparator condition, hypothesis 2) resulted in a larger decrease of PTSD symptoms than PE from baseline to week 4 on the PCL-5 (b = −10.11, t135 = −2.85, p = .005, d = .49), but not on the CAPS-5 (b = −4.82, t135 = −1.65, p = .10). iPE led to larger improvements than STAIR+PE from baseline to week 4, as measured with the CAPS-5 (b = −7.96, t135 = −2.77, p = .006, d = .48) and the PCL-5 (b = −14.32, t135 = −4.11, p < .001, d = .71).

We did not find larger improvements of emotion regulation (DERS), interpersonal problems (IIP) and self-esteem (RSES) in STAIR+PE (comparator condition, hypothesis 3) compared to PE and iPE from baseline to 1-year follow-up (via the three slopes). STAIR+PE did not result in significantly improved DERS, IPP and RSES scores compared to PE and iPE post-treatment or at 1-year follow-up. All three conditions resulted in large improvements (see Table 2). STAIR+PE led to less DERS symptom improvement than iPE from baseline to week 4 (b = 17.71, t133 = 3.30, p = .001, d = .57), but STAIR+PE caught up from week 4 to post-treatment (b = −6.23, t117 = −2.77, p = .007, d = .51). STAIR+PE showed significantly more symptom improvement in DERS scores from post-treatment to 1-year follow-up compared to PE (b = −5.42, t100 = −2.58, p = .01, d = .52). STAIR+PE led to less symptom improvement on IIP scores than iPE from baseline to week 4 (b = 0.32, t162 = 2.78, p = .006, d = .44), while STAIR+PE showed more improvement on IIP scores than PE post-treatment to follow-up (b = −.22, t163 = −3.50, p < .001, d = .58).

There were no significant differences in treatment drop-out (hypothesis 4) from PE (14 participants; 29%) compared to STAIR+PE (9 participants; 18%; χ2(1) = 1.70, p = .19) and from PE compared to iPE (14 participants; 27%; χ2(1) = .04, p = .85).

There were no significant differences between conditions in number of responders to treatment (PE = 71%, iPE = 73%, STAIR+PE = 70%), loss of PTSD diagnosis (PE = 48%, iPE = 59%, STAIR+PE = 58%) and remission rates (PE = 29%, iPE = 27%, STAIR+PE = 28%). This was based on the participants’ last available measurement. In the PE condition, one serious study-related adverse event was reported which included short hospitalization after a suicide attempt and one study-related adverse event included voluntary hospitalization due to increased suicidal ideations. In the iPE condition, one nonstudy-related adverse events included overmedication and one nonstudy-related adverse event included a suicide attempt without hospitalization. In the STAIR+PE condition, one serious study-related adverse event included short hospitalization after a suicide attempt. No deaths occurred.

Figure 2.

Figure 2.

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Modelled trajectories of the outcomes as a function of treatment condition per measurement time; Footnotes: T0 = baseline, T1 = 4 weeks, T2 = 8 weeks, T3 = 16 weeks, T4 = 6-month follow-up, T5 = 12-month follow-up

4. Discussion

Three variants of PE – ‘traditional’ PE, iPE and STAIR+PE – were each effective treatments of PTSD in patients with CA-PTSD. The baseline to follow-up effect sizes were large. Cohen’s d was larger than 1.6 in each condition (baseline assessment to 1-year follow-up), which far exceeds published effect sizes of control conditions in this population (which are small-medium; Ehring et al., 2014). The drop-out rate in the current study is not different than generally found for trauma-focused treatment in CA-PTSD (Ehring et al., 2014), but higher than found for patients with PTSD in general (Lewis et al., 2020). However, the definition of drop-out differs substantially between studies, which complicates direct comparisons (Ehring et al., 2014; Lewis et al., 2020). Adverse events were rare in all conditions. This adds to recent evidence that suggests that trauma-focused psychotherapy is not contra-indicated and a viable option in severely ill, vulnerable patient populations (van den Berg et al., 2015; van Minnen, Harned, Zoellner, & Mills, 2012).

The hypothesis that iPE and STAIR+PE result in larger PTSD symptom reductions compared to PE from baseline to 1-year follow-up was not supported. This was true both for interviewer-assessed and self-reported symptom severity. There were no significant differences between PE and iPE/STAIR+PE at post-treatment or at 1-year follow-up. We found that STAIR+PE led to more improvement than PE in the post-treatment to follow-up phase on interviewer-assessed but not self-reported PTSD symptoms. This finding is in line with a previous study which found a beneficial follow-up trajectory of STAIR+PE compared to Support+PE (Cloitre et al., 2010), but this did not lead to better outcomes of STAIR+PE at 1-year follow-up. The hypothesis that iPE would lead to faster symptom improvement than PE and STAIR+PE was partly supported. Compared with PE, iPE led to faster improvement on self-reported but not interviewer-assessed PTSD symptom severity. iPE led to faster improvement than STAIR+PE on both self-reported and interview-based assessments. These results replicate previous studies with iPE in non-CA-PTSD populations (Ehring et al., 2014; Foa et al., 2018). Taken together, iPE is promising for a fast and sustained symptom improvement.

The hypothesis that STAIR+PE leads to more improvement in emotion regulation, interpersonal problems and self-concept compared to PE and iPE was not supported. There were no significant differences between STAIR+PE and PE/iPE post-treatment or at 1-year follow-up. STAIR+PE showed more improvement in emotion regulation and interpersonal problems post-treatment to 1-year follow-up compared to PE, but not compared to iPE. The baseline to 1-year follow-up effect of the three treatments on emotion regulation (dPE = 1.15, diPE = 1.34, dSTAIR+PE = 1.74), interpersonal problems (dPE = .61, diPE = .74, dSTAIR+PE = .85) and self-esteem (dPE = .89, diPE = .79, dSTAIR+PE = .77) was (moderately) large. STAIR+PE led to comparable PTSD symptom reductions as PE despite the fact that patients received only 8 PE sessions in STAIR+PE (versus 16 in the PE condition). Conversely, iPE and PE improved emotion regulation, interpersonal problems, and self-esteem without any skill training and these improvements were reached significantly faster in iPE. This is in line with recent findings indicating that PE and iPE improve emotion regulation in patients with PTSD (Jerud, Zoellner, Pruitt, & Feeny, 2014; van Toorenburg et al., 2020).

The finding that STAIR+PE did not result in more improvements in emotion regulation and interpersonal problems is in contrast with the results of a previous study which found superior effects of STAIR+PE on these outcomes compared to support+PE at follow-up assessments (Cloitre et al., 2010). We considered two possible explanations for this. First, considering that both STAIR and PE improve emotion regulation and interpersonal problems, this inconsistency might be explained by the higher dosage of PE in our study compared to the control condition (support+PE). In other words, the difference between the two studies may be explained by the strength of the comparison condition. Second, the previous STAIR+PE studies used a modified version of PE which excluded in vivo exposure and introduced cognitive re-appraisal at the end of each exposure session identifying alternative interpersonal beliefs that had been generated during the STAIR work. These adaptations to PE after STAIR strengthened the linkage between STAIR and PE and may have contributed to its effectiveness.

Finally, the hypothesis that iPE (27% dropout) and STAIR+PE (18% dropout) would lead to lower dropout rates than PE (29% dropout) was not supported. PE led to significantly more early completers (23% early completers) compared to iPE (2% early completers) and STAIR+PE (4% early completers), but this may be related to the relatively large amount of exposure sessions in PE (16 sessions) compared to iPE (14 sessions) and STAIR+PE (8 sessions). Moreover, early completion in the iPE condition was hardly possible, since the PCL score had to be below 16 for three consecutive weeks and most iPE sessions were provided in only 4 weeks (12 of the 14 sessions). In conclusion, fast improvement seems most likely to occur with intensified treatment, what may be clinically relevant for some patients (Ehlers et al., 2014), but the other treatments catch up relatively quickly and all lead to a sustained response.

This study differs from previous CA-PTSD trials in the large sample size, the inclusion of patients with severe psychiatric symptoms, the cultural and socioeconomic diverse sample, multiple measurements during therapy and treatment adherence assessment. The effect sizes of all three conditions were better than expected since a previous meta-analysis indicated that patients with CA-PTSD may have suboptimal outcomes with standard trauma-focused interventions (Karatzias et al., 2019). However, iPE and STAIR+PE did not lead to larger PTSD symptom reductions or lower drop-out rates than PE. The two innovations provided comparable outcomes but did not improve treatment outcome in patients with CA-PTSD. This is in line with a meta-analysis that indicated that changed formats of PE do not improve outcomes of PE (Zhou et al., 2020).

This study has several limitations. Firstly, we did not include a control comparator condition, which precludes the calculation of controlled effect sizes. However, given the observed effect sizes and the speed of recovery, one may question the ethics of continued use of waiting list conditions in this population (Devilly & McFarlane, 2009). Secondly, our iPE condition included 3 sessions a week, whereas other studies on intensified trauma-focused treatment used 5 or more sessions a week (Ehlers et al., 2014; Foa et al., 2018). The effect of this format change on treatment outcome and drop-out rate is unknown. Thirdly, the study required that a participant agreed to be randomized to three different exposure treatments and therefore, there may have been a selection bias of patients who are willing to engage in this type of treatment. Fourthly, some patients received therapy for PTSD or other psychological problems between the 6-month and 12-month follow-up (number of sessions: MPE = 7.6; MSTAIR+PE = 4.7; MiPE = 7.9), so the symptom trajectory during follow-up cannot be unequivocally attributed to the allocated treatment.

The results of this study demonstrate that PE, iPE and STAIR+PE are effective treatments for CA-PTSD. Intensifying treatment may speed up recovery but does not lead to an overall better outcome. Moreover, all treatments led to improvements in emotion regulation, interpersonal problems and self-esteem from baseline to follow-up. Despite the large and sustained effects, there is ample room for further improvements and innovations. Attention to patient preferences regarding type and intensity of interventions may lead to greater patient engagement, treatment benefit and patient satisfaction (Delevry & Le, 2019). Studies that focus on personalizing treatment based on baseline patient characteristics or on patient preference are an important next step in treatment research among traumatized patient populations. In conclusion, iPE and STAIR+PE did not improve the overall outcome of PE. All treatments were effective for patients with CA-PTSD.

Supplementary Material

Supplemental Material
Click here for additional data file. (27.6KB, docx)

Acknowledgments

We want to thank all patients, therapists, students, research assistants and secretaries who participated in the study. We also want to thank Foundation Centrum ’45/ARQ National Psychotrauma Centre (Dr. J. ter Heide) for the help in participant recruitment.

Funding Statement

The study is funded by ZonMW (WvD, Netherlands Health Research Council; Doelmatigheidsonderzoek #843001705) and Innovatiefonds Zorgverzekeraars (DACO, #3.180).

Contributors

MS, DACO, WvD and AvM obtained funding and designed the study. DACO implemented the study at the PsyQ departments. DACO and CMH coordinated the recruitment of participants and data collection during the study. MS, RAdK, AvM and WvD supervised the study. CMH and DACO wrote the first draft of the manuscript. CMH did the statistical analyses. RAdK, MS, WvD, AvM, MC and IGW contributed to the writing of the manuscript. All authors read and approved the final version.

Disclosure statement

Dr. van Minnen reports personal fees from Royalties and fees, outside the submitted work; Dr. Cloitre reports personal fees from Royalites and fees British Psychological Society San Francisco University Department of Psychiatry during the conduct of the study; Drs. Oprel, Drs. Hoeboer, Dr. Schoorl, Dr. van der Does, Drs. Wigard and Dr. de Kleine report no financial relationships with commercial interests.

Supplementary material

Supplemental data for this article can be accessed here.

Data availability

The study protocol, statistical analysis plan and analytical codes are available at OSF and BMC Psychiatry. Anonymized individual patient data that underlie the results of this article will be available for individual participant data meta-analyses that have been approved by independent review committees after the publication of this article. Proposals for the use of data and requests for access should be directed to vanderdoes@fsw.leidenuniv.nl.

References

  1. Baas, M. A. M., van Pampus, M. G., Braam, L., Stramrood, C. A. I., & de Jongh, A. (2020). The effects of PTSD treatment during pregnancy: Systematic review and case study. European Journal of Psychotraumatology, 11(1), 1762310. [DOI] [PMC free article] [PubMed] [Google Scholar]
  2. Barkham, M., Hardy, G. E., & Startup, M. (1996). The IIP-32: A short version of the inventory of interpersonal problems. British Journal of Clinical Psychology, 35(1), 21–13. [DOI] [PubMed] [Google Scholar]
  3. Bates, D., Machler, M., Bolker, B. M., & Walker, S. C. (2015). Fitting linear mixed-effects models using lme4. Journal of Statistical Software, 67(1), 1–48. [Google Scholar]
  4. Blevins, C. A., Weathers, F. W., Davis, M. T., Witte, T. K., & Domino, J. L. (2015). The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and initial psychometric evaluation. Journal of Traumatic Stress, 28(6), 489–498. [DOI] [PubMed] [Google Scholar]
  5. Boeschoten, M. A., Van der Aa, N., Bakker, A., Ter Heide, F. J. J., Hoofwijk, M. C., Jongedijk, R. A., … Olff, M. (2018). Development and Evaluation of the Dutch Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). European Journal of Psychotraumatology, 9(1), 1546085. [DOI] [PMC free article] [PubMed] [Google Scholar]
  6. Bradley, R. (2005). A multidimensional meta-analysis of psychotherapy for PTSD (vol 162, pg 214, 2005). American Journal of Psychiatry, 162(4), 832. [DOI] [PubMed] [Google Scholar]
  7. Cloitre, M., Koenen, K. C., Cohen, L. R., & Han, H. (2002). Skills training in affective and interpersonal regulation followed by exposure: A phase-based treatment for PTSD related to childhood abuse. Journal of Consulting and Clinical Psychology, 70(5), 1067–1074. [DOI] [PubMed] [Google Scholar]
  8. Cloitre, M., Miranda, R., Stovall-McClough, K. C., & Han, H. (2005). Beyond PTSD: Emotion regulation and interpersonal problems as predictors of functional impairment in survivors of childhood abuse. Behavior Therapy, 36(2), 119–124. [Google Scholar]
  9. Cloitre, M., Stolbach, B. C., Herman, J. L., van der Kolk, B., Pynoos, R., Wang, J., & Petkova, E. (2009). A developmental approach to complex PTSD: Childhood and adult cumulative trauma as predictors of symptom complexity. Journal of Traumatic Stress, 22(5), 399–408. [DOI] [PubMed] [Google Scholar]
  10. Cloitre, M., Stovall-McClough, K. C., Nooner, K., Zorbas, P., Cherry, S., Jackson, C. L., … Petkova, E. (2010). Treatment for PTSD related to childhood abuse: A randomized controlled trial. American Journal of Psychiatry, 167(8), 915–924. [DOI] [PubMed] [Google Scholar]
  11. Cougle, J. R., Timpano, K. R., Sachs-Ericsson, N., Keough, M. E., & Riccardi, C. J. (2010). Examining the unique relationships between anxiety disorders and childhood physical and sexual abuse in the National Comorbidity Survey-Replication. Psychiatry Research, 177(1–2), 150–155. [DOI] [PubMed] [Google Scholar]
  12. Delevry, D., & Le, Q. A. (2019). Effect of treatment preference in randomized controlled trials: Systematic review of the literature and meta-analysis. Patient-Patient Centered Outcomes Research, 12(6), 593–609. [DOI] [PubMed] [Google Scholar]
  13. Devilly, G. J., & McFarlane, A. C. (2009). When wait lists are not feasible, nothing is a thing that does not need to be done. Journal of Consulting and Clinical Psychology, 77(6), 1159–1168. [DOI] [PubMed] [Google Scholar]
  14. Dvir, Y., Ford, J. D., Hill, M., & Frazier, J. A. (2014). Childhood maltreatment, emotional dysregulation, and psychiatric comorbidities. Harvard Review of Psychiatry, 22(3), 149–161. [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Ehlers, A., Hackmann, A., Grey, N., Wild, J., Liness, S., Albert, I., … Clark, D. M. (2014). A randomized controlled trial of 7-day intensive and standard weekly cognitive therapy for PTSD and emotion-focused supportive therapy. American Journal of Psychiatry, 171(3), 294–304. [DOI] [PMC free article] [PubMed] [Google Scholar]
  16. Ehring, T., Welboren, R., Morina, N., Wicherts, J. M., Freitag, J., & Emmelkamp, P. M. (2014). Meta-analysis of psychological treatments for posttraumatic stress disorder in adult survivors of childhood abuse. Clinical Psychology Review, 34(8), 645–657. [DOI] [PubMed] [Google Scholar]
  17. Feingold, A. (2013). A regression framework for effect size assessments in longitudinal modeling of group differences. Review of General Psychology, 17(1), 111–121. [DOI] [PMC free article] [PubMed] [Google Scholar]
  18. Foa, E. B., Hembree, E. A., & Rothbaum, B. O. (2007). Prolonged exposure therapy for PTSD: Emotional processing of traumatic experiences: Therapist guide. Oxford: Oxford University Press. [Google Scholar]
  19. Foa, E. B., McLean, C. P., Zang, Y., & Consortium, S. S. (2018). Effect of prolonged exposure therapy delivered over 2 Weeks vs 8 weeks vs present-centered therapy on PTSD symptom severity in military personnel: A randomized clinical trial (vol 319, pg 354, 2018). Jama-Journal of the American Medical Association, 320(7), 724. [DOI] [PMC free article] [PubMed] [Google Scholar]
  20. Gekker, M., Coutinho, E. S. F., Berger, W., Luz, M. P. D., Araujo, A. X. G., Pagotto, L., … Mendlowicz, M. V. (2018). Early scars are forever: Childhood abuse in patients with adult-onset PTSD is associated with increased prevalence and severity of psychiatric comorbidity. Psychiatry Research, 267, 1–6. [DOI] [PubMed] [Google Scholar]
  21. Gilbert, R., Widom, C. S., Browne, K., Fergusson, D., Webb, E., & Janson, S. (2009). Child Maltreatment 1 Burden and consequences of child maltreatment in high-income countries. Lancet, 373(9657), 68–81. [DOI] [PubMed] [Google Scholar]
  22. Hamblen, J. L., Norman, S. B., Sonis, J. H., Phelps, A. J., Bisson, J. I., Nunes, V. D., … Schnurr, P. P. (2019). A guide to guidelines for the treatment of posttraumatic stress disorder in adults: An update. Psychotherapy, 56(3), 359–373. [DOI] [PubMed] [Google Scholar]
  23. Hendriks, L., de Kleine, R. A., Broekman, T. G., Hendriks, G. J., & van Minnen, A. (2018). Intensive prolonged exposure therapy for chronic PTSD patients following multiple trauma and multiple treatment attempts. European Journal of Psychotraumatology, 9(1), 1425574. [DOI] [PMC free article] [PubMed] [Google Scholar]
  24. Hoeboer, C. M. (2019, July 19). Improving treatment for patients with childhood abuse related posttraumatic stress disorder (IMPACT study). Retrieved from osf.io/xthsc [DOI] [PMC free article] [PubMed] [Google Scholar]
  25. Hox, J. J. (2002). Multilevel analysis: Techniques and applications. Mahwah, NJ: Lawrence Erlbaum Associates. [Google Scholar]
  26. Jerud, A. B., Zoellner, L. A., Pruitt, L. D., & Feeny, N. C. (2014). Changes in emotion regulation in adults with and without a history of childhood abuse following posttraumatic stress disorder treatment. Journal of Consulting and Clinical Psychology, 82(4), 721–730. [DOI] [PMC free article] [PubMed] [Google Scholar]
  27. Karatzias, T., Murphy, P., Cloitre, M., Bisson, J., Roberts, N., Shevlin, M., … Hutton, P. (2019). Psychological interventions for ICD-11 complex PTSD symptoms: Systematic review and meta-analysis. Psychological Medicine, 49(11), 1761–1775. [DOI] [PubMed] [Google Scholar]
  28. Kato, B. S., Hoijtink, H., Verdellen, C., Hagenaars, M., van Minnen, A., & Keijsers, G. (2005). Application of multilevel models to structured repeated measurements. Quality & Quantity, 39(6), 711–732. [Google Scholar]
  29. Kessler, R. C., Aguilar-Gaxiola, S., Alonso, J., Benjet, C., Bromet, E. J., Cardoso, G., … Survey, W. W. M. H. (2017). Trauma and PTSD in the WHO World Mental Health Surveys. European Journal of Psychotraumatology, 8(sup5), 1353383. [DOI] [PMC free article] [PubMed] [Google Scholar]
  30. Kleiman, E. (2017). EMAtools: Data management tools for real-time monitoring/ecological momentary assessment data. Retrieved from https://CRAN.R-project.org/package=EMAtools [Google Scholar]
  31. Lee, D. J., Witte, T. K., Bardeen, J. R., Davis, M. T., & Weathers, F. W. (2016). A factor analytic evaluation of the difficulties in emotion regulation scale. Journal of Clinical Psychology, 72(9), 933–946. [DOI] [PubMed] [Google Scholar]
  32. Levitt, J., & Cloitre, M. (2005). A clinician’s guide to STAIR/MPE: Treatment for PTSD related to childhood abuse. Cognitive and Behavioral Practice, 12(1), 40–52. [Google Scholar]
  33. Lewis, C., Roberts, N. P., Gibson, S., & Bisson, J. I. (2020). Dropout from psychological therapies for post-traumatic stress disorder (PTSD) in adults: Systematic review and meta-analysis. European Journal of Psychotraumatology, 11(1), 1709709. [DOI] [PMC free article] [PubMed] [Google Scholar]
  34. Mavranezouli, I., Megnin-Viggars, O., Daly, C., Dias, S., Welton, N. J., Stockton, S., … Pilling, S. (2020). Psychological treatments for post-traumatic stress disorder in adults: A network meta-analysis. Psychological Medicine, 1–14. doi: 10.1017/S0033291720000070 [DOI] [PubMed] [Google Scholar]
  35. McHugh, M. L. (2013). The Chi-square test of independence. Biochemia Medica, 23(2), 143–149. [DOI] [PMC free article] [PubMed] [Google Scholar]
  36. Messman-Moore, T. L., & Bhuptani, P. H. (2017). A review of the long-term impact of child maltreatment on posttraumatic stress disorder and its comorbidities: An emotion dysregulation perspective. Clinical Psychology-Science and Practice, 24(2), 154–169. [Google Scholar]
  37. Norman, R. E., Byambaa, M., De, R., Butchart, A., Scott, J., & Vos, T. (2012). The long-term health consequences of child physical abuse, emotional abuse, and neglect: A systematic review and meta-analysis. PLoS Medicine, 9(11), e1001349. [DOI] [PMC free article] [PubMed] [Google Scholar]
  38. Norman, S. B., Trim, R., Haller, M., Davis, B. C., Myers, U. S., Colvonen, P. J., … Mayes, T. (2019). Efficacy of integrated exposure therapy vs integrated coping skills therapy for comorbid posttraumatic stress disorder and alcohol use disorder: A randomized clinical trial. JAMA Psychiatry, 76(8), 791–799. [DOI] [PMC free article] [PubMed] [Google Scholar]
  39. Oprel, D. A. C., Hoeboer, C. M., Schoorl, M., De Kleine, R. A., Wigard, I. G., Cloitre, M., … Van der Does, W. (2018). Improving treatment for patients with childhood abuse related posttraumatic stress disorder (IMPACT study): Protocol for a multicenter randomized trial comparing prolonged exposure with intensified prolonged exposure and phase-based treatment. BMC Psychiatry, 18(1). doi: 10.1186/s12888-018-1967-5 [DOI] [PMC free article] [PubMed] [Google Scholar]
  40. R Core Team . (2018). R: A language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing. [Google Scholar]
  41. Ragsdale, K. A., Watkins, L. E., Sherrill, A. M., Zwiebach, L., & Rothbaum, B. O. (2020). Advances in PTSD treatment delivery: Evidence base and future directions for intensive outpatient programs. Current Treatment Options in Psychiatry, 7(3), 291–300. [Google Scholar]
  42. Schmitt, D. P., & Allik, J. (2005). Simultaneous administration of the Rosenberg Self-Esteem Scale in 53 nations: Exploring the universal and culture-specific features of global self-esteem. Journal of Personality and Social Psychology, 89(4), 623–642. [DOI] [PubMed] [Google Scholar]
  43. Schnurr, P. P., & Lunney, C. A. (2016). Symptom benchmarks of improved quality of life in Ptsd. Depression and Anxiety, 33(3), 247–255. [DOI] [PubMed] [Google Scholar]
  44. Sheehan, D. V., Lecrubier, Y., Sheehan, K. H., Amorim, P., Janavs, J., Weiller, E., … Dunbar, G. C. (1998). The Mini-International Neuropsychiatric Interview (MINI): The development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. Journal of Clinical Psychiatry, 59, 22–33. [PubMed] [Google Scholar]
  45. van den Berg, D. P., de Bont, P. A., van der Vleugel, B. M., de Roos, C., de Jongh, A., Van Minnen, A., & van der Gaag, M. (2015). Prolonged exposure vs eye movement desensitization and reprocessing vs waiting list for posttraumatic stress disorder in patients with a psychotic disorder: A randomized clinical trial. JAMA Psychiatry, 72(3), 259–267. [DOI] [PubMed] [Google Scholar]
  46. van Minnen, A., Harned, M. S., Zoellner, L., & Mills, K. (2012). Examining potential contraindications for prolonged exposure therapy for PTSD. European Journal of Psychotraumatology, 3(1), 18805. [DOI] [PMC free article] [PubMed] [Google Scholar]
  47. van Toorenburg, M. M., Sanches, S. A., Linders, B., Rozendaal, L., Voorendonk, E. M., Van Minnen, A., & De Jongh, A. (2020). Do emotion regulation difficulties affect outcome of intensive trauma-focused treatment of patients with severe PTSD? European Journal of Psychotraumatology, 11(1), 1724417. [DOI] [PMC free article] [PubMed] [Google Scholar]
  48. Wagenmans, A., Van Minnen, A., Sleijpen, M., & De Jongh, A. (2018). The impact of childhood sexual abuse on the outcome of intensive trauma-focused treatment for PTSD. European Journal of Psychotraumatology, 9(1), 1430962. [DOI] [PMC free article] [PubMed] [Google Scholar]
  49. Watkins, L. E., Sprang, K. R., & Rothbaum, B. O. (2018). Treating PTSD: A review of evidence-based psychotherapy interventions. Frontiers in Behavioral Neuroscience, 12. doi: 10.3389/fnbeh.2018.00258 [DOI] [PMC free article] [PubMed] [Google Scholar]
  50. Watts, B. V., Schnurr, P. P., Mayo, L., Young-Xu, Y., Weeks, W. B., & Friedman, M. J. (2013). Meta-analysis of the efficacy of treatments for posttraumatic stress disorder. The Journal of Clinical Psychiatry, 74(6), e541–550. [DOI] [PubMed] [Google Scholar]
  51. Weertman, A., Arntz, A., Dreessen, L., van Velzen, C., & Vertommen, S. (2003). Short-interval test-retest interrater reliability of the Dutch version of the structured clinical interview for DSM-IV personality disorders (SCID-II). Journal of Personality Disorders, 17(6), 562–567. [DOI] [PubMed] [Google Scholar]
  52. Zhou, Y. G., Sun, L. N., Wang, Y., Wu, L. L., Sun, Z. E., Zhang, F., & Liu, W. Z. (2020). Developments of prolonged exposure in treatment effect of post-traumatic stress disorder and controlling dropout rate: A meta-analytic review. Clinical Psychology & Psychotherapy, 27(4), 449–462. [DOI] [PubMed] [Google Scholar]

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supplemental Material
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Data Availability Statement

The study protocol, statistical analysis plan and analytical codes are available at OSF and BMC Psychiatry. Anonymized individual patient data that underlie the results of this article will be available for individual participant data meta-analyses that have been approved by independent review committees after the publication of this article. Proposals for the use of data and requests for access should be directed to vanderdoes@fsw.leidenuniv.nl.

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