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

NCT ID: NCT05598099

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-01-10

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.

Conditions

PTSD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Individual therapy over four consecutive days

Treatment will be delivered individually over four consecutive days

Concentrated cognitive behavioral therapy

Intervention Type: BEHAVIORAL

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

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

Concentrated cognitive behavioral therapy

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Bergen 4-Day Treatment

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders L Thorsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Haukeland University Hospital

Bergen, Vestland, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Anders L Thorsen, PhD

Role: CONTACT

anders.lillevik.thorsen@helse-bergen.no

90367617 ext. +47

Facility Contacts

Anders L Thorsen, PhD

Role: primary

anders.lillevik.thorsen@helse-bergen.no

90367617 ext. +47

Other Identifiers

B4DT-PTSD1

Identifier Type: -

Identifier Source: org_study_id