The Role of Computerized Training in Post-Traumatic Stress Disorder

Sponsor
Ruhr University of Bochum (Other)
Overall Status
Completed
CT.gov ID
NCT02687555
Collaborator
Daimler und Benz Stiftung (Other), Technische Universität Dresden (Other)
80
1
2
38.9
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Bias Modification of Appraisals (CBM-App)
  • Behavioral: Peripheral Vision Task (control condition)
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Role of Computerized Training in Post-Traumatic Stress Disorder
Actual Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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)

Sham Comparator: Control

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)

Outcome Measures

Primary Outcome Measures

  1. Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task [Post-intervention (~ 2 weeks post-baseline)]

Secondary Outcome Measures

  1. 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]

  2. 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]

    The PTCI (Foa et al., 1999) is administered asking participants to report on their experience of post-traumatic cognitions in the previous week.

  3. 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]

    The PCL-5 (Weathers et al., 2013; German version by Ehring, Knaevelsrud, Krüger & Schäfer) is administered asking participants to report on their experience of post-traumatic symptoms in the previous week.

  4. 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]

    The intrusions questionnaire asks participants to report on the frequency and characteristics of intrusive memories of trauma in the preceding week

  5. Trauma Implicit Associations Test (IAT) [Baseline, Post-intervention (~2 weeks post-baseline)]

    As developed by Lindgren et al. (2013)

Other Outcome Measures

  1. Hair Cortisol Concentration [Baseline, End of inpatient admission (~6 weeks post-baseline), 3 months post-discharge]

  2. Participant Feedback Questionnaire [3 months post-discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum Bochum North Rhine-Westphalia Germany 44791

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Marcella L Woud, PhD, Ruhr University of Bochum

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marcella Woud, Postdoctoral Research Fellow, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT02687555
Other Study ID Numbers:
  • 32-12/14
  • 204
  • 15-5477
First Posted:
Feb 22, 2016
Last Update Posted:
Sep 17, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 17, 2019