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

NCT ID: NCT02234076

Last Updated: 2016-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-10-31

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.

Detailed Description

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Conditions

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Posttraumatic Stress Disorder (PTSD) Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

VRET

Intervention Type BEHAVIORAL

TAU

Treatment As Usual

Group Type ACTIVE_COMPARATOR

TAU

Intervention Type BEHAVIORAL

Treatment as usual offered by the participating mental health care organisations

Interventions

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VRET

Intervention Type BEHAVIORAL

TAU

Treatment as usual offered by the participating mental health care organisations

Intervention Type BEHAVIORAL

Other Intervention Names

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Virtual Reality Exposure Therapy (VRET)

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Netherlands Organisation for Scientific Research

OTHER_GOV

Sponsor Role collaborator

Erasmus University Rotterdam

OTHER

Sponsor Role collaborator

Delft University of Technology

OTHER

Sponsor Role collaborator

University of Amsterdam

OTHER

Sponsor Role collaborator

PsyQ

OTHER

Sponsor Role collaborator

Reinier van Arkel Groep, Psychotraumacentrum Zuid-Nederland

UNKNOWN

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ingmar Franken

Professor of Clinical Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Reinier van Arkel Groep PTC ZN

's-Hertogenbosch, North Brabant, Netherlands

Site Status RECRUITING

Erasmus University Rotterdam

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

PsyQ

Rotterdam/The Hague, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Marieke van Meggelen, MSc

Role: CONTACT

0031(0)10-4088689

Ingmar Franken, full professor

Role: CONTACT

Facility Contacts

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Marieke van Meggelen, MSc

Role: primary

0031(0)10-4088689

Marieke van Meggelen, MSc

Role: primary

0031(0)10-4088689

Marieke van Meggelen, MSc

Role: primary

0031(0)10-4088689

Related Links

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Other Identifiers

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CI1-12-S028-1

Identifier Type: -

Identifier Source: org_study_id

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