The Role of Computerized Training in Post-Traumatic Stress Disorder

NCT02687555 | Completed Phase 1

• 3 other identifiers: 32-12/1420415-5477
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

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

  Post-intervention (~ 2 weeks post-baseline)

Secondary Outcomes (5)

• 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

• 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)

Other Outcomes (2)

• Hair Cortisol Concentration

  Baseline, End of inpatient admission (~6 weeks post-baseline), 3 months post-discharge

• Participant Feedback Questionnaire

  3 months post-discharge

Study Arms (2)

Intervention

EXPERIMENTAL

Computerized Cognitive Bias Modification of Appraisals (CBM-App), developed from that used by Woud et al. (2012,2013). The intervention comprises 8 sessions completed over a period of 2 weeks. The training takes place while participants are also receiving specialized inpatient treatment for PTSD at the Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum.

Behavioral: Cognitive Bias Modification of Appraisals (CBM-App)

Control

SHAM COMPARATOR

Computerized Peripheral Vision Task (PVT), developed from that used by Calkins et al. (2015). The intervention comprises 8 sessions completed over a period of 2 weeks. The training takes place while participants are also receiving specialized inpatient treatment for PTSD at the Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum.

Behavioral: Peripheral Vision Task (control condition)

Interventions

Cognitive Bias Modification of Appraisals (CBM-App) BEHAVIORAL

Intervention

Peripheral Vision Task (control condition) BEHAVIORAL

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead
• Daimler und Benz Stiftung: collaborator
• Technische Universität Dresden: collaborator

Study Sites (1)

Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Related Publications (1)

• 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.

  PMID: 29961004 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Marcella L Woud, PhD

  Ruhr University of Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 22, 2016
• Study Start: February 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)