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Completed

NCT Number: NCT02687555

The Role of Computerized Training in Post-Traumatic Stress Disorder

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.

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Bochum, North Rhine-Westphalia, 44791, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Bias Modification of Appraisals (CBM-App)

Behavioral

Peripheral Vision Task (control condition)

Behavioral

Primary outcomes

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

    Time frame: Post-intervention (~ 2 weeks post-baseline)

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Collaborators

  • Daimler und Benz Stiftung
  • Technische Universität Dresden

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 22, 2016
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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