The Role of Computerized Training in Post-Traumatic Stress Disorder

NCT ID: NCT02687555

Last Updated: 2019-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Cognitive Bias Modification of Appraisals (CBM-App)

Intervention Type BEHAVIORAL

Control

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.

Group Type SHAM_COMPARATOR

Peripheral Vision Task (control condition)

Intervention Type BEHAVIORAL

Interventions

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Cognitive Bias Modification of Appraisals (CBM-App)

Intervention Type BEHAVIORAL

Peripheral Vision Task (control condition)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daimler und Benz Stiftung

UNKNOWN

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role collaborator

Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Marcella Woud

Postdoctoral Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcella L Woud, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruhr University of Bochum

Locations

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

Bochum, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29961004 (View on PubMed)

Other Identifiers

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204

Identifier Type: OTHER

Identifier Source: secondary_id

15-5477

Identifier Type: OTHER

Identifier Source: secondary_id

32-12/14

Identifier Type: -

Identifier Source: org_study_id

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