The Role of Computerized Training in Post-Traumatic Stress Disorder

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Computerized Training in Post-Traumatic Stress Disorder

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Cognitive Bias Modification of Appraisals (CBM-App)
* Behavioral: Peripheral Vision Task (control condition)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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)<br> <br> |
| Sham Comparator: Control<br>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)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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) |