Post-Traumatic Stress Disorder
Conditions
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.
Interventions
BEHAVIORALCognitive Bias Modification of Appraisals (CBM-App)
BEHAVIORALPeripheral Vision Task (control condition)
Sponsors
Daimler und Benz Stiftung
Technische Universität Dresden
Ruhr University of Bochum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task | Post-intervention (~ 2 weeks post-baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Trauma Implicit Associations Test (IAT) | Baseline, Post-intervention (~2 weeks post-baseline) | As developed by Lindgren et al. (2013) |
| 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 |
Other
| 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 |
Countries
Germany
Outcome results
None listed