Clinical trial NCT02687555: The Role of Computerized Training in Post-Traumatic Stress Disorder
Official title: The Role of Computerized Training in Post-Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Post-Traumatic Stress Disorder
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: Daimler und Benz Stiftung
name: Technische Universität Dresden
First posted: 2016-02-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task
timeFrame: Post-intervention (~ 2 weeks post-baseline)
Secondary outcomes:
measure: Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task
timeFrame: Baseline, Mid-intervention (~1 week post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge
measure: Post-Traumatic Cognitions Inventory (PTCI)
timeFrame: 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
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 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
measure: Intrusions Questionnaire
timeFrame: 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
measure: Trauma Implicit Associations Test (IAT)
timeFrame: Baseline, Post-intervention (~2 weeks post-baseline)
Other outcomes:
measure: Hair Cortisol Concentration
timeFrame: Baseline, End of inpatient admission (~6 weeks post-baseline), 3 months post-discharge
measure: Participant Feedback Questionnaire
timeFrame: 3 months post-discharge
Locations:
city: Bochum
country: Germany
facility: Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum
state: North Rhine-Westphalia
Study officials:
affiliation: Ruhr University of Bochum
name: Marcella L Woud, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woud ML, Blackwell SE, Cwik JC, Margraf J, Holmes EA, Steudte-Schmiedgen S, Herpertz S, Kessler H. Augmenting inpatient treatment for post-traumatic stress disorder with a computerised cognitive bias modification procedure targeting appraisals (CBM-App): protocol for a randomised controlled trial. BMJ Open. 2018 Jun 30;8(6):e019964. doi: 10.1136/bmjopen-2017-019964.