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The Role of Computerized Training in Post-Traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT02687555
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : September 17, 2019
Sponsor:
Collaborators:
Daimler und Benz Stiftung
Technische Universität Dresden
Information provided by (Responsible Party):
Marcella Woud, Ruhr University of Bochum

Tracking Information
First Submitted Date  ICMJE February 16, 2016
First Posted Date  ICMJE February 22, 2016
Last Update Posted Date September 17, 2019
Actual Study Start Date  ICMJE February 2016
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task [ Time Frame: Post-intervention (~ 2 weeks post-baseline) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
  • 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 ]
  • Post-Traumatic Cognitions Inventory (PTCI) [ 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 ]
    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) [ 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 ]
    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 [ 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 ]
    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) [ Time Frame: Baseline, Post-intervention (~2 weeks post-baseline) ]
    As developed by Lindgren et al. (2013)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 16, 2016)
  • Hair Cortisol Concentration [ Time Frame: Baseline, End of inpatient admission (~6 weeks post-baseline), 3 months post-discharge ]
  • Participant Feedback Questionnaire [ Time Frame: 3 months post-discharge ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Role of Computerized Training in Post-Traumatic Stress Disorder
Official Title  ICMJE The Role of Computerized Training in Post-Traumatic Stress Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post-Traumatic Stress Disorder
Intervention  ICMJE
  • Behavioral: Cognitive Bias Modification of Appraisals (CBM-App)
  • Behavioral: Peripheral Vision Task (control condition)
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Cognitive Bias Modification of Appraisals (CBM-App)
  • Sham Comparator: 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.
    Intervention: Behavioral: Peripheral Vision Task (control condition)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2016)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2019
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02687555
Other Study ID Numbers  ICMJE 32-12/14
204 ( Other Identifier: Fakultät für Psychologie Ethikkommission, Ruhr University of Bochum )
15-5477 ( Other Identifier: Ethik-Kommission der Medizinischen Fakultät, Ruhr University of Bochum )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Responsible Party Marcella Woud, Ruhr University of Bochum
Study Sponsor  ICMJE Ruhr University of Bochum
Collaborators  ICMJE
  • Daimler und Benz Stiftung
  • Technische Universität Dresden
Investigators  ICMJE
Principal Investigator: Marcella L Woud, PhD Ruhr University of Bochum
PRS Account Ruhr University of Bochum
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP