The Role of Computerized Training in Post-Traumatic Stress Disorder

Post-Traumatic Stress Disorder Clinical Trial

Official title:

The Role of Computerized Training in Post-Traumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687555
• Other study ID #: 32-12/14
• Secondary ID: 20415-5477
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2016
• Est. completion date: May 2019

Study information

• Verified date: September 2019
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

• Peripheral Vision Task (control condition)

Locations

Country	Name	City	State
Germany	Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum	Bochum	North Rhine-Westphalia

Sponsors (3)

Lead Sponsor	Collaborator
Ruhr University of Bochum	Daimler und Benz Stiftung, Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hair Cortisol Concentration		Baseline, End of inpatient admission (~6 weeks post-baseline), 3 months post-discharge
Other	Participant Feedback Questionnaire		3 months post-discharge
Primary	Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task		Post-intervention (~ 2 weeks post-baseline)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Trauma Implicit Associations Test (IAT)	As developed by Lindgren et al. (2013)	Baseline, Post-intervention (~2 weeks post-baseline)