Depression, Posttraumatic Stress Disorder (PTSD)
Conditions
Keywords
Posttraumatic Stress Disorder, Depression, Treatment, VRET
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.
Interventions
BEHAVIORALVRET
BEHAVIORALTAU
Treatment as usual offered by the participating mental health care organisations
Sponsors
Netherlands Organisation for Scientific Research
Erasmus University Rotterdam
Delft University of Technology
University of Amsterdam
PsyQ
Reinier van Arkel Groep, Psychotraumacentrum Zuid-Nederland
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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. |
| 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The self-report questionnaire Patient's acceptance of a Self-Management health system to asses participants' acceptance of the used technology | Post treatment (after 6 weeks) | 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. |
| 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 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. |
| 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 | 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 | 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. |
| 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 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. |
| 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 | 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. |
Countries
Netherlands
Contacts
Primary ContactMarieke van Meggelen, MSc
Backup ContactIngmar Franken, full professor
Outcome results
None listed