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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598099
• Other study ID #: B4DT-PTSD1
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: January 10, 2025

Study information

• Verified date: October 2022
• Source: Haukeland University Hospital
• Contact: Anders L Thorsen, PhD
• Phone: 90367617
• Email: anders.lillevik.thorsen[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: January 10, 2025
• Est. primary completion date: January 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Vestland

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Client Satisfaction Questionnaire 8 (CSQ-8)	Patient-rated questionnaire of treatment satisfaction	One week after treatment
Secondary	Client Satisfaction Questionnaire 8 (CSQ-8)	Patient-rated questionnaire of treatment satisfaction	Three months after treatment
Secondary	Client Satisfaction Questionnaire 8 (CSQ-8)	Patient-rated questionnaire of treatment satisfaction	Twelve months after treatment