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| ID | Type | Description | Link |
|---|---|---|---|
| 204 | Other Identifier | Fakultät für Psychologie Ethikkommission, Ruhr University of Bochum | |
| 15-5477 | Other Identifier | Ethik-Kommission der Medizinischen Fakultät, Ruhr University of Bochum |
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| Name | Class |
|---|---|
| Daimler und Benz Stiftung | UNKNOWN |
| Technische Universität Dresden | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Bias Modification of Appraisals (CBM-App) | Behavioral |
| ||
| Peripheral Vision Task (control condition) |
| Measure | Description | Time Frame |
|---|---|---|
| Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task | Post-intervention (~ 2 weeks post-baseline) |
| 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) |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcella L Woud, PhD | Ruhr University of Bochum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum | Bochum | North Rhine-Westphalia | 44791 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29961004 | Derived | 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. |
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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.
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Behavioral |
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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) |