The Role of Computerized Training in Post-Traumatic Stress Disorder

Ruhr University of Bochum1 site in 1 country80 target enrollmentFebruary 2016

ConditionsPost-Traumatic Stress Disorder

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Post-Traumatic Stress Disorder
Sponsor: Ruhr University of Bochum
Enrollment: 80
Locations: 1
Primary Endpoint: Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether a computerized training, "Cognitive Bias Modification" targetting appraisals (CBM-App), can reduce dysfunctional appraisals of trauma in patients with Post-Traumatic Stress Disorder (PTSD), compared to a control condition. Other outcomes measured include symptoms of PTSD and trauma-relevant dysfunctional cognitions. Participants are recruited from inpatients with PTSD admitted to the Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum.

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

May 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ruhr University of Bochum

Responsible Party

Principal Investigator

Marcella Woud

Postdoctoral Research Fellow

Ruhr University of Bochum

Eligibility Criteria

Inclusion Criteria

•Primary diagnosis of Post-Traumatic Stress Disorder according to ICD-10 (F43.1), and DSM-5 (as assessed via Clinician Adminstered PTSD Scale for DSM-5)
•motivated and willing to take part in the study (including questionnaire measures, computer training, filling out questionnaires after discharge)
•aged 18-60 years, male or female
•fluent in German

Exclusion Criteria

•Substance abuse/ substance dependence currently or in the past six months
•active suicidal thoughts or intentions
•psychotic disorder (past or present)
•learning disability/ intellectual impairment
•red-green colour blindness

Outcomes

Primary Outcomes

Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task

Time Frame: Post-intervention (~ 2 weeks post-baseline)

Secondary Outcomes

Intrusions Questionnaire(Baseline, Mid-intervention (~1 week post-baseline), Post-intervention (~2 weeks post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge)
Trauma Implicit Associations Test (IAT)(Baseline, Post-intervention (~2 weeks post-baseline))
Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task(Baseline, Mid-intervention (~1 week post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge)
Post-Traumatic Cognitions Inventory (PTCI)(Baseline, Mid-intervention (~1 week post-baseline), Post-intervention (~2 weeks post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge)
PTSD Checklist for DSM-5 (PCL-5)(Baseline, Mid-intervention (~1 week post-baseline), Post-intervention (~2 weeks post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge)