Intensive Treatment Versus Standard Weekly Prolonged Exposure for Adults With Post-Traumatic Stress Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intensive treatment with prolonged exposure, Weekly delivered prolonged exposure.
- Who it may be relevant to
- Registry conditions: Post Traumatic Stress Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy, Mechanisms of Change and Cost Effectiveness of Intensive Exposure-based Treatment for PTSD: a Randomized Controlled Trial
Overview
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. Qualitative interviews will be conducted with therapists to explore their experiences of delivering intensive treatment for PTSD, with particular focus on perceived benefits and challenges, clinical processes, patient engagement, and the impact of the intensive format on therapeutic work.
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.
Interventions
- Behavioral Intensive treatment with prolonged exposure
Intensive treatment with prolonged exposure - Behavioral Weekly delivered prolonged exposure
Weekly delivered prolonged exposure sessions for 15 weeks
Primary outcome measures
- Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5) [Time frame: Baseline, 1-month (primary endpoint), 6-month and 12-month post-treatment]
Secondary outcome measures (11)
- Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5) [Time frame: 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). [Time frame: 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) [Time frame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment]
- Change in quality of life measured by Euroqol, EQ-5D [Time frame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment]
- Change in Assessing Quality of Life 6 Dimensions (AQoL-6D) [Time frame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment]
- Adverse events related to treatment measured by the Negative effects questionnaire [Time frame: Immediately after treatment completion, 1-month, 6-month and 12-month post-treatment]
- Adverse events [Time frame: Each treatment session and assessment point through study completion up to the 12-month follow up.]
- Change in Treatment Inventory of Costs in Psychiatric Patients (TIC-P) [Time frame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment]
- Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8). [Time frame: Immediately after treatment completion]
- Number of drop-outs from treatment and assessment [Time frame: Baseline up to the 12-month follow up.]
- Qualitative interviews with therapist delivering the intervention [Time frame: Assessed after completion of at least one full course of intensive PTSD treatment, during the study recruitment period (up to 30 months).]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Traumaprogrammet, Psykiatri Sydväst — Stockholm
Publications
- 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
Identifiers
NCT: NCT05934175 · 2023-02329-01