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Clinical Trials/NCT05598099
NCT05598099
Recruiting
N/A

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

Haukeland University Hospital1 site in 1 country42 target enrollmentNovember 1, 2022
ConditionsPTSD

Overview

Phase
N/A
Intervention
Not specified
Conditions
PTSD
Sponsor
Haukeland University Hospital
Enrollment
42
Locations
1
Primary Endpoint
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
January 10, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Haukeland University Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

Time Frame: Change in scores from three months after treatment to twelve months after treatment

Clinician-administered interview to diagnose and the severity of PTSD

Secondary Outcomes

  • Client Satisfaction Questionnaire 8 (CSQ-8)(Twelve months after treatment)

Study Sites (1)

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