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Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT03116165
Recruitment Status : Terminated (Organisational changes in hospital which changed recruitment rates)
First Posted : April 14, 2017
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Erik Andersson, Karolinska Institutet

Brief Summary:
This study will examine the use of modified prolonged exposure therapy in trauma patients recently exposed to trauma in an emergency room to prevent the onset of post-traumatic stress disorder.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Behavioral: Modified prolonged exposure therapy Behavioral: Attention control Not Applicable

Detailed Description:

This study investigates if prolonged exposure is an effective treatment in reducing PTSD symptoms people who have recently experienced trauma. The study will also investigate predictive markers of PTSD, moderators of successful treatment and health economic aspects of the intervention.

Participants will first undergo an evaluation session that will include an interview (Immediate Stress Reaction Checklist) and questionnaires. Participants will subsequently be randomly assigned to receive either modified prolonged exposure therapy or attention control, starting the assigned intervention immediately. Participants in each arm will receive three weekly treatment sessions. Treatment will involve psychoeducation about common reactions to trauma, imaginal exposure (revisiting memories of a recent trauma out loud with a therapist and audio-recording these for review at home), exposure in vivo and breathing retraining. All participants will undergo assessments 2, 6 (primary endpoint) and 12 months after the intervention by blinded assessors. Patients unable to come to the clinic for follow-up assessments will be interviewed via telephone or skype. Source data will be quality monitored by an independent party (Karolinska trial alliance) according to the Helsinki Declaration.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder: An Randomized Controlled Trial in the Acute Trauma Care
Actual Study Start Date : April 18, 2017
Actual Primary Completion Date : December 11, 2017
Actual Study Completion Date : December 11, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Modified prolonged exposure therapy
Participants will receive three sessions of modified prolonged exposure therapy.
Behavioral: Modified prolonged exposure therapy
Participants will receive three sessions of modified prolonged exposure therapy.

Placebo Comparator: Attention control
Participants will receive three sessions of supportive counselling and psychoeducation
Behavioral: Attention control
Participants will receive three sessions of supportive counselling and psychoeducation




Primary Outcome Measures :
  1. CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS) [ Time Frame: Change 2-, 6- (primary endpoint) and 12 months after intervention ]
    Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD


Secondary Outcome Measures :
  1. PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5) [ Time Frame: Change 2-, 6- (primary endpoint) and 12 months after intervention ]
    Self-report questionnaire for the assessment of PTSD severity

  2. Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S) [ Time Frame: Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention ]
    Self-report questionnaire for the assessment of severity of depression

  3. Euroqol (EQ-5D) [ Time Frame: Measured 6 months after intervention ]
    Measure of general health and quality of life

  4. WHO Disability Assessment Schedule (WHODAS) [ Time Frame: Change 2-, 6- (primary endpoint) and 12 months after intervention ]
    Measure of general health and function

  5. Adverse events [ Time Frame: Change 2-, 6- (primary endpoint) and 12 months after intervention ]
    Measure of number adverse events

  6. Subjective unit of distress scale (SUD) [ Time Frame: Change at week 1, week 2 and week 3 ]
    Ratings of distress

  7. Intrusion diary [ Time Frame: Change at week 1, week 2 and week 3 ]
    A self-report diary on number of intrusions

  8. Insomnia Severity Index (ISI) [ Time Frame: Change 2-, 6- (primary endpoint) and 12 months after intervention ]
    Self-report questionnaire regarding insomnia

  9. Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: Change 2-, 6- (primary endpoint) and 12 months after intervention ]
    A measure to assess for social support

  10. Trimbos Institute of costs in psychiatry (TIC-P) [ Time Frame: Measured at 6 (primary endpoint) months after the intervention ]
    Self-report measure on societal costs



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presenting to the emergency department at the Karolinska University hospital Solna in the past 72 hours before the intervention
  • Meets diagnostic criterion A for post-traumatic stress disorder in the fifth version of Diagnostic and Statistical Manual of Mental Disorders, DSM-5

Exclusion Criteria:

  • Do not want to participate in the study
  • Ongoing intoxication (e.g. severe alcohol intoxication)
  • Other serious psychiatric comorbidity that demands attention (e.g. manic episode, acute suicidal ideation)
  • Not oriented
  • Not having a memory ot the tramatic event

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): NCT03116165


Locations
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Sweden
Karolinska Institutet
Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet

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Responsible Party: Erik Andersson, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03116165     History of Changes
Other Study ID Numbers: EPN 2015/1820-31
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders