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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03116165
• Date of registration: 03/04/2017
• Prospective Registration: Yes
• Primary sponsor: Karolinska Institutet
• Public title: Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder
• Scientific title: Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder: An Randomized Controlled Trial in the Acute Trauma Care
• Date of first enrolment: April 18, 2017
• Target sample size: 352
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03116165
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Sweden

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Post Traumatic Stress Disorder

Intervention(s)

Behavioral: Modified prolonged exposure therapy

Behavioral: Attention control

Primary Outcome(s)

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]

Secondary Outcome(s)

Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S) [Time Frame: Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention]

Euroqol (EQ-5D) [Time Frame: Measured 6 months after intervention]

Intrusion diary [Time Frame: Change at week 1, week 2 and week 3]

Adverse events [Time Frame: Change 2-, 6- (primary endpoint) and 12 months after intervention]

Insomnia Severity Index (ISI) [Time Frame: Change 2-, 6- (primary endpoint) and 12 months after intervention]

Multidimensional Scale of Perceived Social Support (MSPSS) [Time Frame: Change 2-, 6- (primary endpoint) and 12 months after intervention]

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]

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

Trimbos Institute of costs in psychiatry (TIC-P) [Time Frame: Measured at 6 (primary endpoint) months after the intervention]

WHO Disability Assessment Schedule (WHODAS) [Time Frame: Change 2-, 6- (primary endpoint) and 12 months after intervention]

Secondary ID(s)

EPN 2015/1820-31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors