Comparing intensive and standard treatment for PTSD in adults
Efficacy, Mechanisms of Change and Cost Effectiveness of Intensive Exposure-based Treatment for PTSD: a Randomized Controlled Trial
NA · Karolinska Institutet · NCT05934175
This study is testing if a new, more intense 5-day therapy for PTSD can help adults recover faster and better than the usual weekly sessions over 15 weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet (other) |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05934175 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare a novel intensive treatment format of prolonged exposure therapy with the standard weekly prolonged exposure therapy for adults suffering from post-traumatic stress disorder (PTSD). Participants will be randomly assigned to either receive the intensive treatment over 5 days with follow-up booster sessions or the traditional weekly sessions over 15 weeks. The study will evaluate the efficacy, mechanisms of change, and cost-effectiveness of the intensive approach in regular psychiatric care in Sweden. The goal is to determine if the intensive format can improve retention rates and recovery times for patients with PTSD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have a primary diagnosis of PTSD and are fluent in Swedish.
Not a fit: Patients currently undergoing other trauma-focused psychological treatments or those with serious mental health symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more effective and efficient treatment option for adults with PTSD, potentially reducing dropout rates and speeding up recovery.
How similar studies have performed: Preliminary research has shown that intensive trauma-focused treatment approaches can be as effective as traditional methods, suggesting potential success for this novel comparison.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Stockholm
- Traumaprogrammet, Psykiatri Sydväst — Stockholm, Sweden (RECRUITING)
Study contacts
- Study coordinator: Maria Bragesjö, PhD
- Email: maria.bragesjo@ki.se
- Phone: 0703399387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post Traumatic Stress Disorder, PTSD, intensive treatment, prolonged exposure, massed treatment