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

NCT ID: NCT05934175

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-04

Study Completion Date

2026-08-20

Brief Summary

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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.

Detailed Description

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PTSD is one of the most common psychiatric disorders and is strongly linked to subsequent psychiatric and medical problems. Trauma-focused cognitive behavioral therapy (CBT-T) such as prolonged exposure is an effective treatment for PTSD and is recommended in most clinical guidelines as first-line treatment. However, the treatment period often lasts 3-5 months, which is believed to be a contributing factor to the high dropout rate that has suggested to be a major factor to why a significant proportion of patients fail to demonstrate clinically significant symptom change. In response, more intensive treatment approaches i have been developed based on the notion that frequency of treatment sessions are a potential mechanism for retention. Preliminary research shows intensive trauma focused treatment (I-PE) to be as effective as when the treatment is delivered by weekly sessions, but with the advantage that the recovery rate is faster and the proportion of patients who drop out decreases.

Before this type of treatment can be offered in regular care in Sweden, it needs to be further evaluated. If I-PE would be found to effective, this project has the potential to be the first step towards implementation of a novel, superior and more cost-effective mode of treatment delivery for adults with PTSD in regular Swedish health care. The intensive treatment format has yet to be directly compared to gold-standard CBT-T, and that is what we propose to do in this trial.

The study is a single-blind, parallel-group superiority randomized controlled trial with 140 patients (70 per arm) will compare intensive prolonged exposure to gold standard weekly delivered prolonged exposure. The primary outcome is the blind-rater administered Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).

Secondary outcomes are cost effectiveness, speed of response, response and remission rates, dropout rate, and negative effects. The investigators hypothesis that participants in the massed treatment format will improve faster than patients that receive weekly sessions, but for the rest of the secondary outcomes, the investigators have no directed hypotheses.

The trial will also be preregistered at the Open Science Framework.

Conditions

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Post Traumatic Stress Disorder

Keywords

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PTSD intensive treatment prolonged exposure massed treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Blinded assessors are used

Study Groups

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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.

Group Type EXPERIMENTAL

Intensive treatment with prolonged exposure

Intervention Type BEHAVIORAL

Intensive treatment with prolonged exposure

Weekly delivered prolonged exposure

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

Group Type ACTIVE_COMPARATOR

Weekly delivered prolonged exposure

Intervention Type BEHAVIORAL

Weekly delivered prolonged exposure sessions for 15 weeks

Interventions

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Intensive treatment with prolonged exposure

Intensive treatment with prolonged exposure

Intervention Type BEHAVIORAL

Weekly delivered prolonged exposure

Weekly delivered prolonged exposure sessions for 15 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Maria Bragesjo

Clinical psychologist, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Traumaprogrammet, Psykiatri Sydväst

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Maria Bragesjö, PhD

Role: CONTACT

Phone: 0703399387

Email: [email protected]

Hannes Hedvall, MSc

Role: CONTACT

Phone: 0704430859

Email: [email protected]

Facility Contacts

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Maria Bragesjö, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38867309 (View on PubMed)

Other Identifiers

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2023-02329-01

Identifier Type: -

Identifier Source: org_study_id