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

Post Traumatic Stress Disorder Clinical Trial

Official title:

Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder: An Randomized Controlled Trial in the Acute Trauma Care

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03116165
• Other study ID #: EPN 2015/1820-31
• Status: Terminated
• Phase: N/A
• Start date: April 18, 2017
• Est. completion date: December 11, 2017

Study information

• Verified date: May 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 352
• Est. completion date: December 11, 2017
• Est. primary completion date: December 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Modified prolonged exposure therapy
Participants will receive three sessions of modified prolonged exposure therapy.
• Attention control
Participants will receive three sessions of supportive counselling and psychoeducation

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change 2-, 6- (primary endpoint) and 12 months after intervention
Secondary	PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)	Self-report questionnaire for the assessment of PTSD severity	Change 2-, 6- (primary endpoint) and 12 months after intervention
Secondary	Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)	Self-report questionnaire for the assessment of severity of depression	Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
Secondary	Euroqol (EQ-5D)	Measure of general health and quality of life	Measured 6 months after intervention
Secondary	WHO Disability Assessment Schedule (WHODAS)	Measure of general health and function	Change 2-, 6- (primary endpoint) and 12 months after intervention
Secondary	Adverse events	Measure of number adverse events	Change 2-, 6- (primary endpoint) and 12 months after intervention
Secondary	Subjective unit of distress scale (SUD)	Ratings of distress	Change at week 1, week 2 and week 3
Secondary	Intrusion diary	A self-report diary on number of intrusions	Change at week 1, week 2 and week 3
Secondary	Insomnia Severity Index (ISI)	Self-report questionnaire regarding insomnia	Change 2-, 6- (primary endpoint) and 12 months after intervention
Secondary	Multidimensional Scale of Perceived Social Support (MSPSS)	A measure to assess for social support	Change 2-, 6- (primary endpoint) and 12 months after intervention
Secondary	Trimbos Institute of costs in psychiatry (TIC-P)	Self-report measure on societal costs	Measured at 6 (primary endpoint) months after the intervention