The Role of Computerized Training in Post-Traumatic Stress Disorder

Phase 1

Completed

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

• Registration Number: NCT02687555
• Lead Sponsor: Ruhr University of Bochum

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-16
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-22
• Primary Completion: 2019-01
• Study Completion: 2019-05
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Cognitive Bias Modification of Appraisals (CBM-App)	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.
Control	Peripheral Vision Task (control condition)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Trauma Implicit Associations Test (IAT)	Baseline, Post-intervention (~2 weeks post-baseline)	As developed by Lindgren et al. (2013)
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	The PTCI (Foa et al., 1999) is administered asking participants to report on their experience of post-traumatic cognitions in the previous week.
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.

Trial Locations

Locations (1)

Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum; 🇩🇪 Bochum, North Rhine-Westphalia, Germany