A Study on the Efficacy of Virtual Reality Exposure Therapy (VRET) for Survivors of Childhood Sexual Abuse and War Related Trauma

Study Overview
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Brief Summary
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Background: Childhood Sexual Abuse (CSA) and combat related war-trauma are associated with posttraumatic stress disorder (PTSD) and depression. PTSD is one of the most prevalent Diagnostic and Statistical Manual of Mental Disorders (DSM) axis 1 disorders for which psychotherapy is widely practiced. Depression is one of the most common co morbid disorders when PTSD is diagnosed. Exposure to the traumatic memories or cues of the traumatic event often plays an important role in reducing symptoms of PTSD. Also symptoms of PTSD and depression have been related to a reduced specificity in autobiographical memory. Objective: This study will examine the efficacy of a Virtual Reality Exposure Therapy (VRET) in a CSA and war related trauma sample by comparing it with treatment as usual (TAU). It will also attempt to develop protocols to implement this new technology into clinical practice and collect data to develop a treatment progress prediction model. Study design: A randomized controlled intervention study. Study population: 144 individuals with memories of CSA or war related trauma and symptoms of PTSD and/or depression. Intervention: VRET or TAU.

Official Title
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A Study on the Efficacy of Virtual Reality Exposure Therapy (VRET) for Survivors of Childhood Sexual Abuse and War Related Trauma

Conditions
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Posttraumatic Stress Disorder (PTSD), Depression

Intervention / Treatment
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* Behavioral: VRET
* Behavioral: TAU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: principal diagnosis meeting DSM-IV criteria for PTSD and/or major depression following CSA or war related trauma between the ages of 18 and 70-years-old having sufficient fluency in Dutch to complete treatment and research protocol Exclusion Criteria: current bipolar disorder current psychotic disorders current suicidality high dissociation level (Dissociative Experiences Scale (DES) cut-off score ≥ 40)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VRET<br>Virtual Reality Exposure Therapy (VRET) The experimental treatment VRET is offered with the Multi-Modal Memory Restructuring System (3MR system) and a therapy manual. Participants can use this system at home. Note: The 3MR system is offered via a computer screen, no head-mounted display (HMD) equipment is used in this study. | Behavioral: VRET<br> <br> * Other names: Virtual Reality Exposure Therapy (VRET);|
| Active Comparator: TAU<br>Treatment As Usual | Behavioral: TAU<br>* Treatment as usual offered by the participating mental health care organisations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Disorder (PTSD) Checklist Diagnostic & Statistical Manual of Mental Disorders (DSM) 5 (PCL-5) to measure change from baseline self-reported symptoms of PTSD at the endpoint of the therapy (after completing 12 sessions) and follow-ups | The PCL-5 is a brief assessment that identifies the presence and symptom severity of PTSD. We use the PCL-5 to measure self-reported symptoms of PTSD. | At pre (baseline), post (after 12 therapy sessions with a minimum of 6 weeks and a maximum of 12 weeks), and follow-up (3 and 12 months post treatment) measurements | 
| Beck Depression Inventory-II (BDI-II) to measure change from baseline self-reported symptoms of depression at the endpoint of the therapy (after completing 12 sessions) and follow-ups | The BDI-II is a self-report questionnaire which measures the severity of depression in 21 statements, with four levels of increasing severity each. We use the BDI-II to measure self-reported symptoms of depression. | At pre (baseline), post (with a minimum of 6 weeks and a maximum of 12 weeks), and follow-up (3 and 12 months post treatment) measurements | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Outcome Questionnaire-45-2 (OQ-45-2) to measure change from baseline self-reported symptoms and well-being at the endpoint of the therapy (after completing 12 sessions) and follow-ups | The OQ-45-2 is a questionnaire which measures well-being in three domains; symptom distress, interpersonal functioning and social role. We use the OQ-45-2 to measure improvement in well-being in participants as addition to the symptom checklists, and to make a useful translation of the research data into clinical practice. | At pre (baseline), post (with a minimum of 6 weeks and a maximum of 12 weeks) and follow up (3 and 12 months post treatment) measurements | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic Stress Disorder, Depression, Treatment, VRET