The Role of Computerized Training in Post-Traumatic Stress Disorder

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.

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Cognitive Bias Modification of Appraisals (CBM-App); Behavioral: Peripheral Vision Task (control condition)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Bochum, North Rhine-Westphalia, Germany, 44791
      • Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task	Post-intervention (~ 2 weeks post-baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	The PTCI (Foa et al., 1999) is administered asking participants to report on their experience of post-traumatic cognitions in the previous week.	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)	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.	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	The intrusions questionnaire asks participants to report on the frequency and characteristics of intrusive memories of trauma in the preceding week	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)	As developed by Lindgren et al. (2013)	Baseline, Post-intervention (~2 weeks post-baseline)

Other Outcome Measures

Outcome Measure	Time Frame
Hair Cortisol Concentration	Baseline, End of inpatient admission (~6 weeks post-baseline), 3 months post-discharge
Participant Feedback Questionnaire	3 months post-discharge

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Collaborators: Technische Universität Dresden; Daimler und Benz Stiftung
• Investigators: Principal Investigator: Marcella L Woud, PhD, Ruhr University of Bochum

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: February 16, 2016
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimate): February 22, 2016

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 32-12/14; 204 (Fakultät für Psychologie Ethikkommission, Ruhr University of Bochum); 15-5477 (Other Identifier: Ethik-Kommission der Medizinischen Fakultät, Ruhr University of Bochum)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is planned to make individual participant data available on publication of the associated study results, via a publically-available data repository such as Open Science Framework. Data made available will be the research data reported in the publication, with the exception of any data that could compromise participant anonymity.