Clinical trial NCT05934175: Intensive Treatment Versus Standard Weekly Prolonged Exposure for Adults With Post-Traumatic Stress Disorder
Official title: Efficacy, Mechanisms of Change and Cost Effectiveness of Intensive Exposure-based Treatment for PTSD: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
intensive treatment
prolonged exposure
massed treatment
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2023-07-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)
timeFrame: Baseline, 1-month (primary endpoint), 6-month and 12-month post-treatment
Secondary outcomes:
measure: Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
timeFrame: Baseline, through the treatment period up to 15 weeks after inclusion and at 1-month, 6-month and 12-month post-treatment
measure: Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).
timeFrame: Baseline, through the treatment period and 1-month, 6-month and 12-month post-treatment
measure: Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
measure: Change in quality of life measured by Euroqol, EQ-5D
timeFrame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
measure: Change in Assessing Quality of Life 6 Dimensions (AQoL-6D)
timeFrame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
measure: Adverse events related to treatment measured by the Negative effects questionnaire
timeFrame: Immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
measure: Adverse events
timeFrame: Each treatment session and assessment point through study completion up to the 12-month follow up.
measure: Change in Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
timeFrame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
measure: Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
timeFrame: Immediately after treatment completion
measure: Number of drop-outs from treatment and assessment
timeFrame: Baseline up to the 12-month follow up.
Other outcomes:
measure: Differences in treatment credibility between arms
timeFrame: Immediately after the first treatment session
measure: Differences in experience of working alliance between arms
timeFrame: Immediately after the third treatment session
measure: Adherence to treatment measured by the Therapist Adherence and Competence Rating Scale for prolonged exposure
timeFrame: Gold standard PE: Each treatment session up to week 15. Intensive PE: Each treatment session up to week 5
measure: Change in emotional responding measured by the Subjective Distress Scale
timeFrame: Gold standard PE: Each treatment session up to week 15. Intensive PE: Each treatment session up to week 5
Locations:
city: Stockholm
country: Sweden
facility: Traumaprogrammet, Psykiatri Sydväst
Study officials:
References: