Concentrated Exposure Therapy for Post-traumatic Stress Disorder - a Cohort Study

Recruiting

• Conditions: PTSD
• Interventions: Behavioral: Concentrated cognitive behavioral therapy

• Registration Number: NCT05598099
• Lead Sponsor: Haukeland University Hospital

Brief Summary

Post-traumatic stress disorder (PTSD) is a prevalent and disabling condition. Trauma-focused psychotherapy, including cognitive behavioural therapy (CBT), are among the recommended first-line treatment alternatives. However, a substantial proportion of patients decline, drop-out or do not respond to current psychotherapies. Previous research suggests that intensive or concentrated formats of trauma-focused psychotherapy can lead to faster recover and lower attrition, but there are currently few studies of these approaches. The current study will investigate the acceptability. treatment satisfaction and preliminary changes in symptoms after four consecutive days of concentrated CBT for PTSD.

Detailed Description

The study will investigate the research questions in three stages. In the first stage four patients will be treated individually. In the second stage two groups of four patients will be treated, with at least a 1:1 ratio between therapists and patients per group. In the third stage 30 patients will be treated in groups of about four patients per group, with at least a 1:1 ratio between therapists and patients per group. The primary outcome measure is changes in PTSD-related symptoms as measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Acceptability will be measured as the proportion of patients accepting treatment when offered, while attrition is measured as the proportion of patients that withdraw from treatment after it has started. Several other measures will be collected to measure treatment satisfaction, related symptoms, and functional impairment.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-27
• Last Update Submitted: 2022-10-27
• Study First Posted: 2022-10-28
• Last Update Posted: 2022-10-28
• Study Start: 2022-11-01
• Primary Completion: 2025-01-10
• Study Completion: 2025-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• fulfills DSM-5 criteria for PTSD
• One or more single traumas in adolescence or adulthood
• Speaks and writes Norwegian

Exclusion Criteria

• New or unstable psychopharmacological treatment within last four weeks
• fulfills ICD-11 criteria for complex PTSD
• Ongoing substance abuse
• Ongoing danger of suicide
• Ongoing borderline personality disorder
• Ongoing psychosis
• Intellectual disability

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Combined Individual and group therapy over four consecutive days	Concentrated cognitive behavioral therapy	Treatment will be delivered in a mix of individual and group sessions over four consecutive days
Individual therapy over four consecutive days	Concentrated cognitive behavioral therapy	Treatment will be delivered individually over four consecutive days

Primary Outcome Measures

Name	Time	Method
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	Change in scores from three months after treatment to twelve months after treatment	Clinician-administered interview to diagnose and the severity of PTSD

Secondary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire 8 (CSQ-8)	Twelve months after treatment	Patient-rated questionnaire of treatment satisfaction

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Vestland, Norway