Efficacy, Mechanisms of Change and Cost Effectiveness of Intensive Exposure-based Treatment for PTSD: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 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

Locations
Other Locations
Sweden
Traumaprogrammet, Psykiatri Sydväst
RECRUITING
Stockholm
Contact Information
Primary
Maria Bragesjö, PhD
maria.bragesjo@ki.se
0703399387
Backup
Hannes Hedvall, MSc
hannes.hedvall@regionstockholm.se
0704430859
Time Frame
Start Date: 2023-09-04
Estimated Completion Date: 2026-08-20
Participants
Target number of participants: 140
Treatments
Experimental: Intensive treatment with prolonged exposure
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.
Active_comparator: Weekly delivered prolonged exposure
15 weekly delivered, individual prolonged exposure sessions (gold standard treatment)
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet
Collaborators: Region Stockholm

This content was sourced from clinicaltrials.gov