Intensive Treatment Versus Standard Weekly Prolonged Exposure for Adults With Post-Traumatic Stress Disorder

NCT05934175 | Recruiting DMC

• 1 other identifier: 2023-02329-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare a novel, massed treatment format of prolonged exposure to gold standard trauma focused cognitive behavioral therapy (weekly delivered prolonged exposure) for post-traumatic stress disorder. The objective with this study is to investigate efficacy, mechanisms of change and cost effectiveness of intensive prolonged exposure (I-PE) in regular Swedish psychiatric care. Adult patients with post-traumatic stress disorder will be randomly assigned to receive either gold standard prolonged exposure weekly for 15 weeks or 5 days of intensive treatment with the addition of three booster sessions dispersed 1, 2 and 4 weeks after completion of the massed treatment period.

Conditions

Post Traumatic Stress Disorder

Keywords

PTSD; intensive treatment; prolonged exposure; massed treatment

Outcome Measures

Primary Outcomes (1)

• Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)

  The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.

  Baseline, 1-month (primary endpoint), 6-month and 12-month post-treatment

Secondary Outcomes (10)

• Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)

  Baseline, through the treatment period up to 15 weeks after inclusion and at 1-month, 6-month and 12-month post-treatment

• Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).

  Baseline, through the treatment period and 1-month, 6-month and 12-month post-treatment

• Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)

  Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment

• Change in quality of life measured by Euroqol, EQ-5D

  Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment

• Change in Assessing Quality of Life 6 Dimensions (AQoL-6D)

  Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment

Other Outcomes (4)

• Differences in treatment credibility between arms

  Immediately after the first treatment session

• Differences in experience of working alliance between arms

  Immediately after the third treatment session

• Adherence to treatment measured by the Therapist Adherence and Competence Rating Scale for prolonged exposure

  Gold standard PE: Each treatment session up to week 15. Intensive PE: Each treatment session up to week 5

Study Arms (2)

Intensive treatment with prolonged exposure

EXPERIMENTAL

Intensive prolonged exposure delivered for five consecutive days comprising nine individual sessions and five group sessions followed by three individual session one, two and four weeks afterwards.

Behavioral: Intensive treatment with prolonged exposure

Weekly delivered prolonged exposure

ACTIVE COMPARATOR

15 weekly delivered, individual prolonged exposure sessions (gold standard treatment)

Behavioral: Weekly delivered prolonged exposure

Interventions

Intensive treatment with prolonged exposure BEHAVIORAL

Intensive treatment with prolonged exposure

Intensive treatment with prolonged exposure

Weekly delivered prolonged exposure BEHAVIORAL

Weekly delivered prolonged exposure sessions for 15 weeks

Weekly delivered prolonged exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or above,
• Primary PTSD diagnosis
• Fluent in Swedish
• Sign informed consent
• Able to attend either I-PE or 15 weekly sessions of PE

You may not qualify if:

• Initiation or adjustment of any psychotropic medication within the last 4 weeks prior to commencement of treatment
• Serious mental health symptoms, such as mania, psychosis, alcohol, or substance use disorders or current suicide risk warranting immediate clinical attention
• Ongoing evidence-based trauma-focused psychological treatment
• Ongoing trauma-related threat (e.g. living with a violent spouse)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Traumaprogrammet, Psykiatri Sydväst

Stockholm, Sweden

RECRUITING

Related Publications (1)

• Bragesjo M, Fina B, Ivanova E, Ivanov VZ, Ruck C. Study protocol for a single-blind, parallel-group, randomized, controlled superiority trial of intensive versus weekly delivered prolonged exposure for adults with post-traumatic stress disorder. Trials. 2024 Jun 12;25(1):381. doi: 10.1186/s13063-024-08218-2.

  PMID: 38867309 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Maria Bragesjö, PhD

CONTACT

0703399387; maria.bragesjo@ki.se

Hannes Hedvall, MSc

CONTACT

0704430859; hannes.hedvall@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessors are used
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical psychologist, PhD

Model Details: Prolonged exposure will be offered in a massed format with a total of nine 60 minutes sessions of imaginal exposure and processing and five 2 hour group session with psychoeducation, rationales and in vivo exposure during one treatment week followed by three individual 60 minutes sessions 1, 2 and 4 weeks afterwards.

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 6, 2023
• Study Start: September 4, 2023
• Primary Completion: August 20, 2025
• Study Completion (Estimated): August 20, 2026
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)