Improving PTSD Treatments for Adults With Childhood Trauma

Study Overview
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Brief Summary
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The aim of this project is to investigate the effectiveness of phase-based trauma-focused therapy (PBT) and intensive trauma-focused therapy (I-TFT) for adult patients with PTSD related to childhood abuse. We will carry out a RCT, randomizing 150 patients to receive either standard TFT, PBT or i-TFT. The effects will be assessed at two endpoints of treatment (4, 8 and 16 weeks) and after a 6 and 12 months follow-up in an intention-to-treat analysis.

Detailed Description
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The Dutch treatment guidelines recommend trauma-focused treatment (TFT) for PTSD. In TFT, patients are exposed to trauma reminders that they typically avoid, until their emotional reactions decline. This treatment has been found very effective for some patients but there is much room for improvement, particularly in PTSD related to childhood abuse (CA-PTSD). Symptom exacerbation, non-attendance and dropout rates of up to 40% have been observed in patients with CA-PTSD. Two alternative treatments have been proposed. Firstly, TFT may be preceded by emotion regulation and interpersonal skills training. This is called phase-based treatment (PBT). The rationale is that patients with CA-PTSD have affect regulation and interpersonal problems that interfere with effective delivery of TFT. These problems are rooted in the detrimental developmental effects of abuse (often by an attachment figure). PBT indeed resulted in more favorable outcomes and fewer dropouts. In international guidelines, PBT was recently recommended as treatment of choice for patients with CA-PTSD and comorbidity. Another innovative treatment is intensive TFT (i-TFT), which means delivering TFT in 4 instead of 16 weeks. The condensed format enhances learning and prevents the buildup of anticipatory anxiety, which in turn affects the patients' motivation. Patients with CA-PTSD are also characterized by high psychosocial stressors, leading to problems with treatment attendance and compliance. The condensed format may improve motivation, attendance and compliance. I-TFT was recently tested in a case series in patients with CA-PTSD and in a randomized controlled trial (RCT) with patients with adulthood-related PTSD. Both studies had very low dropout rates (0-3%) and fast recovery. The aim of the current study is to investigate the (cost)effectiveness of two innovative forms of trauma-focused therapy for patients with CA-PTSD: phase-based therapy (emotion regulation skills training followed bij PE) and intensive PE (i-PE). The effects will be assessed post-treatment and after a 6 and 12 months follow-up in an intention-to-treat analysis. Results will be disseminated and included in treatment guidelines. The ultimate goal is to improve quality of care and contribute to treatment innovation for this severely ill target population.

Official Title
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Improving PTSD Treatments for Adults With Childhood Trauma

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Trauma-focused treatment
* Behavioral: Emotion regulation training
* Behavioral: Intensive Trauma-focused treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of PTSD according to DSM-5, including at least one specific discrete memory of a traumatic event Multiple traumata related to childhood sexual/physical abuse that occurred before 18 years of age, and committed by a primary caretaker or an authority figure as index event Symptom severity: CAPS score > 25 Sufficient fluency in Dutch to complete the treatment and research protocols Exclusion Criteria: Involved in legal procedures concerning admission or stay in The Netherlands Involvement in compensation issues Pregnancy Severe non-suicidal self-injury (NSSI) in the last two months (hospital referral required) Suicidality in the last 2 months Alcohol or drug dependence in last 2 months Cognitive impairment (estimated IQ < 70) Changes in psychotropic medication in the two months prior to inclusion Current psychological treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trauma-Focused Treatment<br>Weekly sessions of prolonged exposure | Behavioral: Trauma-focused treatment<br>* Weekly sessions<br>* Other names: Imaginal exposure;|
| Active Comparator: Emotion Regulation Treatment<br>weekly sessions of emotion regulation and skills training. | Behavioral: Trauma-focused treatment<br>* Weekly sessions<br>* Other names: Imaginal exposure;Behavioral: Emotion regulation training<br>* Managing and tolerating negative emotions, e.g. anger, sadness. Weekly sessions; preparatory to Prolonged exposure treatment<br>|
| Active Comparator: Intensive Trauma-Focused Treatment<br>prolonged exposure, 3 sessions per week | Behavioral: Intensive Trauma-focused treatment<br>* Intensive version (3 sessions per week) of Trauma-focused treatment<br>* Other names: Intensive Prolonged Exposure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD symptom severity | Clinician Administered Posttraumatic Stress Inventory (CAPS-5) total score | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptom severity | total score on Inventory of Depressive Symptomatology (IDS) | 16 weeks | 
| Quality of Life score | EQ5D5L total score | 16 weeks | 
| Responder rate | Meeting pre-defined criteria for remission | 16 weeks | 
| Dropout rate | premature termination of treatment by patient | 16 weeks | 
| Emotion regulation | ICD-11 Trauma Questionnaire and Difficulties in Emotion Regulation Scale (DERS) | 16 weeks | 
| Self-reported PTSD symptoms | Post-traumatic Stress Disorder Checklist (PCL-5) | 16 weeks | 
| Interpersonal difficulties | ICD-11 Trauma Questionnaire and Inventory of Interpersonal Problems (IIP) | 16 weeks | 
| Self-concept | ICD-11 Trauma Questionnaire and Rosenberg self-esteem scale (RSS) | 16 weeks |