NCT05598099

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

2.2 years

First QC Date

October 24, 2022

Last Update Submit

October 27, 2022

Conditions

PTSD

Keywords

CBTCAPSGroup therapyPsychotherapyTreatment satisfaction

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Client Satisfaction Questionnaire 8 (CSQ-8)

    One week after treatment

  • Client Satisfaction Questionnaire 8 (CSQ-8)

    Three months after treatment

  • Client Satisfaction Questionnaire 8 (CSQ-8)

    Twelve months after treatment

Study Arms (2)

Individual therapy over four consecutive days

Treatment will be delivered individually over four consecutive days

Behavioral: Concentrated cognitive behavioral therapy

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

Interventions

Concentrated cognitive behavioral therapyBEHAVIORAL

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

Also known as: Bergen 4-Day Treatment
Combined Individual and group therapy over four consecutive daysIndividual therapy over four consecutive days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, Vestland, 5021, Norway

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Anders L Thorsen, PhD

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders L Thorsen, PhD

CONTACT

90367617anders.lillevik.thorsen@helse-bergen.no

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2022

First Posted

October 28, 2022

Study Start

November 1, 2022

Primary Completion

January 10, 2025

Study Completion

January 10, 2025

Last Updated

October 28, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Sharing of IPD is not planned

Locations

NO(1)