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

NCT02234076 | Unknown

• 1 other identifier: CI1-12-S028-1
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder (PTSD); Depression

Keywords

Posttraumatic Stress Disorder; Depression; Treatment; VRET

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

  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 Outcomes (5)

• The Positive and Negative Affect Scale (PANAS) to measure change in self-reported emotional progress 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

  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

  Two times per week during 6 weeks

Study Arms (2)

VRET

EXPERIMENTAL

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

TAU

ACTIVE COMPARATOR

Treatment As Usual

Behavioral: TAU

Interventions

VRET BEHAVIORAL

Also known as: Virtual Reality Exposure Therapy (VRET)

VRET

TAU BEHAVIORAL

Treatment as usual offered by the participating mental health care organisations

TAU

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• current bipolar disorder
• current psychotic disorders
• current suicidality
• high dissociation level (Dissociative Experiences Scale (DES) cut-off score ≥ 40)

Sponsors & Collaborators

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

Study Sites (3)

Reinier van Arkel Groep PTC ZN

's-Hertogenbosch, North Brabant, Netherlands

RECRUITING

Erasmus University Rotterdam

Rotterdam, South Holland, 3000 DR, Netherlands

RECRUITING

PsyQ

Rotterdam/The Hague, South Holland, Netherlands

RECRUITING

Related Links

• Project website

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Marieke van Meggelen, MSc

CONTACT

0031(0)10-4088689; m.vanmeggelen@fsw.eur.nl

Ingmar Franken, full professor

CONTACT

franken@fsw.eur.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychology

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: September 9, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

NL (3)