Clinical trial NCT02234076: A Study on the Efficacy of Virtual Reality Exposure Therapy (VRET) for Survivors of Childhood Sexual Abuse and War Related Trauma
Official title: A Study on the Efficacy of Virtual Reality Exposure Therapy (VRET) for Survivors of Childhood Sexual Abuse and War Related Trauma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Depression
Keywords: Posttraumatic Stress Disorder
Depression
Treatment
VRET
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Netherlands Organisation for Scientific Research
name: Erasmus University Rotterdam
name: Delft University of Technology
name: University of Amsterdam
name: PsyQ
name: Reinier van Arkel Groep, Psychotraumacentrum Zuid-Nederland
First posted: 2014-09-09
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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:
measure: 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
timeFrame: 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:
measure: The Positive and Negative Affect Scale (PANAS) to measure change in self-reported emotional progress between therapy sessions
timeFrame: Two times per week during 6 weeks
measure: The 9-item depression module of the Patient Health Questionnaire (PHQ) to measure self-reported emotional progress between therapy sessions
timeFrame: Two times per week during 6 weeks
measure: The shortened version (6 items) of the PCL-5 to measure change in self-reported emotional progress between therapy sessions
timeFrame: Two times per week during 6 weeks
measure: The self-report questionnaire Patient's acceptance of a Self-Management health system to asses participants' acceptance of the used technology
timeFrame: Post treatment (after 6 weeks)
measure: 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
timeFrame: 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
Locations:
city: Den Bosch
country: Netherlands
facility: Reinier van Arkel Groep PTC ZN
state: Noord-Brabant
city: Rotterdam/The Hague
country: Netherlands
facility: PsyQ
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus University Rotterdam
state: Zuid-Holland
Study officials:
References: