Back to resultsCognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder
Primary Purpose
Post Traumatic Stress Disorder
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Modified prolonged exposure therapy
Attention control
Sponsored by
About this trial
This is an interventional prevention trial for Post Traumatic Stress Disorder
Eligibility 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
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Modified prolonged exposure therapy
Attention control
Arm Description
Participants will receive three sessions of modified prolonged exposure therapy.
Participants will receive three sessions of supportive counselling and psychoeducation
Outcomes
Primary Outcome Measures
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD
Secondary Outcome Measures
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
Self-report questionnaire for the assessment of PTSD severity
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Self-report questionnaire for the assessment of severity of depression
Euroqol (EQ-5D)
Measure of general health and quality of life
WHO Disability Assessment Schedule (WHODAS)
Measure of general health and function
Adverse events
Measure of number adverse events
Subjective unit of distress scale (SUD)
Ratings of distress
Intrusion diary
A self-report diary on number of intrusions
Insomnia Severity Index (ISI)
Self-report questionnaire regarding insomnia
Multidimensional Scale of Perceived Social Support (MSPSS)
A measure to assess for social support
Trimbos Institute of costs in psychiatry (TIC-P)
Self-report measure on societal costs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03116165
Brief Title
Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder
Official Title
Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder: An Randomized Controlled Trial in the Acute Trauma Care
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Organisational changes in hospital which changed recruitment rates
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
December 11, 2017 (Actual)
Study Completion Date
December 11, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
352 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified prolonged exposure therapy
Arm Type
Experimental
Arm Description
Participants will receive three sessions of modified prolonged exposure therapy.
Arm Title
Attention control
Arm Type
Placebo Comparator
Arm Description
Participants will receive three sessions of supportive counselling and psychoeducation
Intervention Type
Behavioral
Intervention Name(s)
Modified prolonged exposure therapy
Intervention Description
Participants will receive three sessions of modified prolonged exposure therapy.
Intervention Type
Behavioral
Intervention Name(s)
Attention control
Intervention Description
Participants will receive three sessions of supportive counselling and psychoeducation
Primary Outcome Measure Information:
Title
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
Description
Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD
Time Frame
Change 2-, 6- (primary endpoint) and 12 months after intervention
Secondary Outcome Measure Information:
Title
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
Description
Self-report questionnaire for the assessment of PTSD severity
Time Frame
Change 2-, 6- (primary endpoint) and 12 months after intervention
Title
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Description
Self-report questionnaire for the assessment of severity of depression
Time Frame
Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
Title
Euroqol (EQ-5D)
Description
Measure of general health and quality of life
Time Frame
Measured 6 months after intervention
Title
WHO Disability Assessment Schedule (WHODAS)
Description
Measure of general health and function
Time Frame
Change 2-, 6- (primary endpoint) and 12 months after intervention
Title
Adverse events
Description
Measure of number adverse events
Time Frame
Change 2-, 6- (primary endpoint) and 12 months after intervention
Title
Subjective unit of distress scale (SUD)
Description
Ratings of distress
Time Frame
Change at week 1, week 2 and week 3
Title
Intrusion diary
Description
A self-report diary on number of intrusions
Time Frame
Change at week 1, week 2 and week 3
Title
Insomnia Severity Index (ISI)
Description
Self-report questionnaire regarding insomnia
Time Frame
Change 2-, 6- (primary endpoint) and 12 months after intervention
Title
Multidimensional Scale of Perceived Social Support (MSPSS)
Description
A measure to assess for social support
Time Frame
Change 2-, 6- (primary endpoint) and 12 months after intervention
Title
Trimbos Institute of costs in psychiatry (TIC-P)
Description
Self-report measure on societal costs
Time Frame
Measured at 6 (primary endpoint) months after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
17177
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder
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