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

Erasmus University

Status: Unknown

Conditions: Posttraumatic Stress Disorder (PTSD); Depression

Treatments: Behavioral: VRET; Behavioral: TAU

Study type: Interventional

Funder types: Other

Identifiers

NCT02234076

CI1-12-S028-1

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

VRET

Experimental group

Description:

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.

Treatment:

Behavioral: VRET

TAU

Active Comparator group

Description:

Treatment As Usual

Treatment:

Behavioral: TAU