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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

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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Behavioral: Cognitive Bias Modification of Appraisals (CBM-App) Behavioral: Peripheral Vision Task (control condition) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Computerized Training in Post-Traumatic Stress Disorder
Actual Study Start Date : February 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
Behavioral: Peripheral Vision Task (control condition)



Primary Outcome Measures :
  1. Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task [ Time Frame: Post-intervention (~ 2 weeks post-baseline) ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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.

  3. 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.

  4. 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

  5. Trauma Implicit Associations Test (IAT) [ Time Frame: Baseline, Post-intervention (~2 weeks post-baseline) ]
    As developed by Lindgren et al. (2013)


Other Outcome Measures:
  1. Hair Cortisol Concentration [ Time Frame: Baseline, End of inpatient admission (~6 weeks post-baseline), 3 months post-discharge ]
  2. Participant Feedback Questionnaire [ Time Frame: 3 months post-discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687555


Locations
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Germany
Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum
Bochum, North Rhine-Westphalia, Germany, 44791
Sponsors and Collaborators
Ruhr University of Bochum
Daimler und Benz Stiftung
Technische Universität Dresden
Investigators
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Principal Investigator: Marcella L Woud, PhD Ruhr University of Bochum
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marcella Woud, Postdoctoral Research Fellow, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT02687555    
Other Study ID Numbers: 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 )
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
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.
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders