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

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.

Study Overview

• Status: Unknown
• Conditions: Depression; Posttraumatic Stress Disorder (PTSD)
• Intervention / Treatment: Behavioral: VRET; Behavioral: TAU

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Brabant
    • Den Bosch, Noord-Brabant, Netherlands
      • Recruiting
      • Reinier van Arkel Groep PTC ZN
      • Contact: Marieke van Meggelen, MSc; Phone Number: 0031(0)10-4088689
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3000 DR
      • Recruiting
      • Erasmus University Rotterdam
      • Contact: Marieke van Meggelen, MSc; Phone Number: 0031(0)10-4088689
    • Rotterdam/The Hague, Zuid-Holland, Netherlands
      • Recruiting
      • PsyQ
      • Contact: Marieke van Meggelen, MSc; Phone Number: 0031(0)10-4088689

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VRET; 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; Other Names: Virtual Reality Exposure Therapy (VRET)
Active Comparator: TAU; Treatment As Usual	Behavioral: TAU; Treatment as usual offered by the participating mental health care organisations

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Positive and Negative Affect Scale (PANAS) to measure change in self-reported emotional progress between therapy sessions	The PANAS is a self-report questionnaire to measure positive and negative affect. The PANAS measures specific feelings as 'interested', 'inspired' etc. We use the PANAS to measure change in these affects between therapy sessions.	Two times per week during 6 weeks
The 9-item depression module of the Patient Health Questionnaire (PHQ) to measure self-reported emotional progress between therapy sessions	The PHQ is a self-report questionnaire which scores the nine DSM-criteria for depression. We use the PHQ to measure change in the nine primary depression symptoms between therapy sessions.	Two times per week during 6 weeks
The shortened version (6 items) of the PCL-5 to measure change in self-reported emotional progress between therapy sessions	For general information PCL-5 see primary outcome section. We use 6 items of the PCL-5 to measure self-reported symptoms of PTSD between therapy sessions.	Two times per week during 6 weeks
The self-report questionnaire Patient's acceptance of a Self-Management health system to asses participants' acceptance of the used technology	The self-report questionnaire Patient's acceptance of a Self-Management health system is a questionnaire to evaluate participants' acceptance of the technology used during the current study. Outcomes are important because they might implicate alterations to strengthen usability of the technology.	Post treatment (after 6 weeks)
The Mini International Neuropsychiatric Interview 5.0.0. (MINI 5.0.0.) Dutch version to screen for Diagnostic and Statistical Manual of Mental Disorder (DSM)-IV diagnoses	The MINI 5.0.0. Dutch version is a semi-structured clinical interview to screen for DSM-IV diagnoses such as PTSD, major depression, bipolar disorder. We use the MINI 5.0.0. Dutch to check in- and exclusion criteria, and to determine change in diagnosis after therapy.	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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: University of Amsterdam; Erasmus University Rotterdam; Delft University of Technology; Netherlands Organisation for Scientific Research; PsyQ; Reinier van Arkel Groep, Psychotraumacentrum Zuid-Nederland

Publications and helpful links

Helpful Links

• Project website

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (Estimate): September 9, 2014

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Depression; Treatment; Posttraumatic Stress Disorder; VRET
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Wounds and Injuries; Trauma and Stressor Related Disorders; Depression; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; War-Related Injuries
• Other Study ID Numbers: CI1-12-S028-1