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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02234076
• Other study ID #: CI1-12-S028-1
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2014
• Last updated: August 16, 2016
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: August 2016
• Source: Erasmus Medical Center
• Contact: Marieke van Meggelen, MSc
• Phone: 0031(0)10-4088689
• Email: m.vanmeggelen[@]fsw.eur.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• War-Related Injuries

Intervention

Behavioral:
• VRET

• TAU
Treatment as usual offered by the participating mental health care organisations

Locations

Country	Name	City	State
Netherlands	Reinier van Arkel Groep PTC ZN	Den Bosch	Noord-Brabant
Netherlands	Erasmus University Rotterdam	Rotterdam	Zuid-Holland
Netherlands	PsyQ	Rotterdam/The Hague	Zuid-Holland

Sponsors (7)

Lead Sponsor

Collaborator

Erasmus Medical Center

Erasmus Universiteit Rotterdam (EUR) (Erasmus University Rotterdam), Nederlandse Organisatie voor Wetenschappelijk Onderzoek Geesteswetenschappen (NWO) (The Netherlands Organisation for Scientific Research Humanities), PsyQ, Reinier van Arkel Groep, Psychotraumacentrum Zuid-Nederland, Technische Universiteit Delft (TUD) (Delft University of Technology), Universiteit van Amsterdam (UvA) (University of Amsterdam)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Other	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)	No
Other	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	No
Primary	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	No
Primary	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	No
Secondary	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	No

External Links

•   Project website