Back to results

The Role of Computerized Training in Post-Traumatic Stress Disorder

Primary Purpose

Post-Traumatic Stress Disorder

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Cognitive Bias Modification of Appraisals (CBM-App)

Peripheral Vision Task (control condition)

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task

Secondary Outcome Measures

Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task

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.

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.

Intrusions Questionnaire

The intrusions questionnaire asks participants to report on the frequency and characteristics of intrusive memories of trauma in the preceding week

Trauma Implicit Associations Test (IAT)

As developed by Lindgren et al. (2013)

Full Information

NCT ID

NCT02687555

First Posted

February 16, 2016

Last Updated

September 16, 2019

Sponsor

Ruhr University of Bochum

Collaborators

Daimler und Benz Stiftung, Technische Universität Dresden

1. Study Identification

Unique Protocol Identification Number

NCT02687555

Brief Title

The Role of Computerized Training in Post-Traumatic Stress Disorder

Official Title

The Role of Computerized Training in Post-Traumatic Stress Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

January 2019 (Actual)

Study Completion Date

May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruhr University of Bochum

Collaborators

Daimler und Benz Stiftung, Technische Universität Dresden

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Traumatic Stress Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Sham Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Bias Modification of Appraisals (CBM-App)

Intervention Type

Behavioral

Intervention Name(s)

Peripheral Vision Task (control condition)

Primary Outcome Measure Information:

Title

Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task

Time Frame

Post-intervention (~ 2 weeks post-baseline)

Secondary Outcome Measure Information:

Title

Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task

Time Frame

Baseline, Mid-intervention (~1 week post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge

Title

Post-Traumatic Cognitions Inventory (PTCI)

Description

The PTCI (Foa et al., 1999) is administered asking participants to report on their experience of post-traumatic cognitions in the previous week.

Time Frame

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

Title

PTSD Checklist for DSM-5 (PCL-5)

Description

Time Frame

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

Title

Intrusions Questionnaire

Description

The intrusions questionnaire asks participants to report on the frequency and characteristics of intrusive memories of trauma in the preceding week

Time Frame

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

Title

Trauma Implicit Associations Test (IAT)

Description

As developed by Lindgren et al. (2013)

Time Frame

Baseline, Post-intervention (~2 weeks post-baseline)

Other Pre-specified Outcome Measures:

Title

Hair Cortisol Concentration

Time Frame

Baseline, End of inpatient admission (~6 weeks post-baseline), 3 months post-discharge

Title

Participant Feedback Questionnaire

Time Frame

3 months post-discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcella L Woud, PhD

Organizational Affiliation

Ruhr University of Bochum

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum

City

Bochum

State/Province

North Rhine-Westphalia

ZIP/Postal Code

44791

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

Citations:

PubMed Identifier

29961004

Citation

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.

Results Reference

derived

Learn more about this trial

The Role of Computerized Training in Post-Traumatic Stress Disorder

We'll reach out to this number within 24 hrs