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

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.

• Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5) [Срок оценки: 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). [Срок оценки: 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) [Срок оценки: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment]
• Change in quality of life measured by Euroqol, EQ-5D [Срок оценки: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment]
• Change in Assessing Quality of Life 6 Dimensions (AQoL-6D) [Срок оценки: 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 [Срок оценки: Immediately after treatment completion, 1-month, 6-month and 12-month post-treatment]
• Adverse events [Срок оценки: 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) [Срок оценки: 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). [Срок оценки: Immediately after treatment completion]
• Number of drop-outs from treatment and assessment [Срок оценки: Baseline up to the 12-month follow up.]
• Qualitative interviews with therapist delivering the intervention [Срок оценки: Assessed after completion of at least one full course of intensive PTSD treatment, during the study recruitment period (up to 30 months).]