The Role of Computerized Training in Post-Traumatic Stress Disorder

Ruhr University of Bochum

Status and phase: Completed; Phase 2; Phase 1

Conditions: Post-Traumatic Stress Disorder

Treatments: Behavioral: Cognitive Bias Modification of Appraisals (CBM-App); Behavioral: Peripheral Vision Task (control condition)

Study type: Interventional

Funder types: Other

Identifiers

NCT02687555

15-5477 (Other Identifier)

204

32-12/14

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Bias Modification of Appraisals (CBM-App)

Control

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Peripheral Vision Task (control condition)