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

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 42

Contacts and Locations

• Study Contact: Name: Anders L Thorsen, PhD; Phone Number: +47 90367617; Email: anders.lillevik.thorsen@helse-bergen.no

Study Locations

• Norway
  • Vestland
    • Bergen, Vestland, Norway, 5021
      • Recruiting
      • Haukeland University Hospital
      • Contact: Anders L Thorsen, PhD; Phone Number: +47 90367617; Email: anders.lillevik.thorsen@helse-bergen.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with PTSD recruited from clinics and popular media referred to Clinic for 4-Day Treatment at Haukeland University Hospital, Bergen, Norway

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	Clinician-administered interview to diagnose and the severity of PTSD	Change in scores from before treatment to one week after treatment
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	Clinician-administered interview to diagnose and the severity of PTSD	Change in scores from one week after treatment to three months after treatment
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)	Clinician-administered interview to diagnose and the severity of PTSD	Change in scores from three months after treatment to twelve months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire 8 (CSQ-8)	Patient-rated questionnaire of treatment satisfaction	One week after treatment
Client Satisfaction Questionnaire 8 (CSQ-8)	Patient-rated questionnaire of treatment satisfaction	Three months after treatment
Client Satisfaction Questionnaire 8 (CSQ-8)	Patient-rated questionnaire of treatment satisfaction	Twelve months after treatment

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University of Bergen
• Investigators: Principal Investigator: Anders L Thorsen, PhD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): January 10, 2025
• Study Completion (Anticipated): January 10, 2025

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: CBT; Group therapy; Psychotherapy; CAPS; Treatment satisfaction
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: B4DT-PTSD1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Sharing of IPD is not planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No