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

Sponsor
Haukeland University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05598099
Collaborator
University of Bergen (Other)
42
1
26.3
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Concentrated cognitive behavioral therapy

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 Design

Study Type:
Observational
Anticipated Enrollment :
42 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Concentrated Exposure Therapy for Post-traumatic Stress Disorder - a Cohort Study
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jan 10, 2025
Anticipated Study Completion Date :
Jan 10, 2025

Arms and Interventions

Arm Intervention/Treatment
Individual therapy over four consecutive days

Treatment will be delivered individually over four consecutive days

Behavioral: Concentrated cognitive behavioral therapy
A psychological intervention consisting of psychoeducation and exposure therapy with the goal of changing the tolerability and negative interpretations of post-traumatic symptoms. The treatment is tailored to the individual patient through all stages, including relapse prevention and planning how to use treatment principles in daily life
Other Names:
  • Bergen 4-Day Treatment
  • Combined Individual and group therapy over four consecutive days

    Treatment will be delivered in a mix of individual and group sessions over four consecutive days

    Behavioral: Concentrated cognitive behavioral therapy
    A psychological intervention consisting of psychoeducation and exposure therapy with the goal of changing the tolerability and negative interpretations of post-traumatic symptoms. The treatment is tailored to the individual patient through all stages, including relapse prevention and planning how to use treatment principles in daily life
    Other Names:
  • Bergen 4-Day Treatment
  • Outcome Measures

    Primary Outcome Measures

    1. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [Change in scores from before treatment to one week after treatment]

      Clinician-administered interview to diagnose and the severity of PTSD

    2. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [Change in scores from one week after treatment to three months after treatment]

      Clinician-administered interview to diagnose and the severity of PTSD

    3. 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

    1. Client Satisfaction Questionnaire 8 (CSQ-8) [One week after treatment]

      Patient-rated questionnaire of treatment satisfaction

    2. Client Satisfaction Questionnaire 8 (CSQ-8) [Three months after treatment]

      Patient-rated questionnaire of treatment satisfaction

    3. Client Satisfaction Questionnaire 8 (CSQ-8) [Twelve months after treatment]

      Patient-rated questionnaire of treatment satisfaction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Haukeland University Hospital Bergen Vestland Norway 5021

    Sponsors and Collaborators

    • Haukeland University Hospital
    • University of Bergen

    Investigators

    • Principal Investigator: Anders L Thorsen, PhD, Haukeland University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Haukeland University Hospital
    ClinicalTrials.gov Identifier:
    NCT05598099
    Other Study ID Numbers:
    • B4DT-PTSD1
    First Posted:
    Oct 28, 2022
    Last Update Posted:
    Oct 28, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Haukeland University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 28, 2022