Comparing a new 4-day therapy to standard treatment for OCD
Four-day Intensive Treatment Versus Standard Cognitive Behavioral Therapy for Adults With Obsessive-compulsive Disorder: a Single-blind, Randomized Controlled Non-inferiority Trial
This study is testing a new 4-day therapy for OCD to see if it works just as well as the usual 14-week treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 2 sites (Stockholm and 1 other locations) |
| Trial ID | NCT05608278 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a novel, condensed cognitive behavioral therapy known as Bergen 4-Day Treatment (B4DT) against the traditional gold standard cognitive behavioral therapy (CBT) for adults with obsessive-compulsive disorder (OCD). Participants will be randomly assigned to either receive standard CBT over 14 weeks or the intensive B4DT over just four days. The primary outcome will be measured using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) 14 weeks after treatment initiation, with secondary outcomes assessing cost-effectiveness, response rates, and potential negative effects. The study seeks to determine if B4DT is non-inferior to standard CBT in reducing OCD symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a primary diagnosis of OCD and a Y-BOCS score of 16 or higher.
Not a fit: Patients with other planned psychological treatments for OCD, recent CBT experience, or certain psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more efficient treatment option for OCD, potentially reducing the time patients need to spend in therapy.
How similar studies have performed: Previous studies have shown promising results for B4DT, but this is the first direct comparison with gold-standard CBT.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥ 18 years of age. 2. Primary diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5). 3. Clinician-rated Y-BOCS score of ≥ 16 4. Written informed consent. 5. To be willing and able to attend treatment at any one of the two treatment clinics, regardless of the clinic where the initial assessment took place (the two clinics are located at different locations in Stockholm, about 20 Km apart). 6. Be fluent in Swedish. Exclusion Criteria: 1. Other psychological treatment for OCD planned during trial period. 2. Completed CBT with ERP for OCD in the last 12 months. 3. Changes in psychotropic medication within the last 2 months. 4. Bipolar disorder. 5. Psychosis. 6. Alcohol or substance dependence. 7. Organic brain disorder. 8. Hoarding disorder or OCD with primary hoarding symptoms. 9. Suicidal ideation that would warrant close monitoring.
Where this trial is running
Stockholm and 1 other locations
- Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Stockholms Läns Landsting — Stockholm, Sweden (Recruiting)
- Psykiatri sydväst — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Christian Rück, PhD
- Email: christian.ruck@ki.se
- Phone: +46704843392
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.