Four-day Intensive Treatment Versus Standard Cognitive Behavioral Therapy for Adults With Obsessive-compulsive Disorder

Not Applicable

Recruiting

• Conditions: Obsessive-Compulsive Disorder

• Registration Number: NCT05608278
• Lead Sponsor: Karolinska Institutet

Brief Summary

The goal of this clinical trial is to compare a novel, condensed version of cognitive behavioral therapy (Bergen 4-Day Treatment, B4DT) to the gold standard psychological treatment (gold-standard CBT) for obsessive compulsive disorder (OCD).

The main question it aims to answer is:

• Is B4DT non-inferior to standard cognitive behavioral therapy (CBT) with regard to OCD symptoms 14 weeks after treatment start?

Adult patients with obsessive compulsive disorder will be randomly assigned to receive either gold standard CBT one to two times per week for 14 weeks, or 4 days of B4DT during one week.

Detailed Description

Obsessive-compulsive disorder is a persistent and disabling psychiatric disorder. Individual cognitive behavioral therapy (CBT) with exposure and response prevention (ERP) is an effective treatment for OCD and is recommended as a first-line intervention. However, patients need to remain in treatment for several months and even after that, around 50% remain symptomatic despite this lengthy treatment. In response to this, a novel, condensed version of CBT, B4DT, has been developed. B4DT has shown promising results in several uncontrolled trials and one randomized controlled trial with inactive control, however it has yet to be directly compared to gold-standard individual CBT.

This single blind, randomized controlled trial with 120 patients (60 per arm) will compare B4DT to gold standard CBT. The primary outcome is the blind-rater administered Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The investigators hypothesize that B4DT will be non-inferior to gold standard CBT 14 weeks after treatment start. The non-inferiority margin is set at 4 points on the Y-BOCS.

Secondary outcomes are cost effectiveness, speed of response, response and remission rates, dropout rate, and negative effects. The investigators hypothesise that participants that receive B4DT will improve faster than patients that receive standard CTB, but for the rest of the secondary outcomes, the investigators have no directed hypotheses.

A more detailed preregistration, and all analysis scripts, are available at Open Science Framework (https://osf.io/w5bfp/).

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-08
• Study Start: 2022-11-17
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-04
• Last Update Posted: 2023-03-07
• Primary Completion: 2024-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), clinician-administered	Change from baseline to 14 weeks after treatment start. Additional measures at week 4 and 7, and at the 7- and 16-month follow-up	Clinician administered scale that measures the severity of obsessions and compulsions. Ten questions, with scores ranging from 0 to 4 (most severe), address time, interference, distress, resistance and control over obsessions and compulsions (total score range from 0 to 40).

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression - Severity (CGI-S)	14 weeks after treatment start. Additional measures at week 4 and 7, and at the 7- and 16-month follow-up	Used to assess rates of response and remission. The Clinical Global Impression - Severity (CGI-S) and Clinical Global Impression - Improvement (CGI-I) Scales will be used to assess overall clinical severity and consequent treatment response (scores of "very much improved" (1) or "much improved" (2) will define treatment response according to previous trials in tic disorders.
Clinical Global Impression - Improvement (CGI-I)	14 weeks after treatment start. Additional measures at week 4 and 7, and at the 7- and 16-month follow-up	Used to assess rates of response and remission. The Clinical Global Impression - Severity (CGI-S) and Clinical Global Impression - Improvement (CGI-I) Scales will be used to assess overall clinical severity and consequent treatment response (scores of "very much improved" (1) or "much improved" (2) will define treatment response according to previous trials in tic disorders.
Dropout rate in both arms	Gold standard CBT: week 15. B4DT: week 3.	A dropout will be defined as a patient in the B4DT arm that participates in less than 1.5 full days at the clinic, or a patient in the gold standard CBT arm that participates in less than 8 CBT sessions.
Treatment Inventory of Costs in Psychiatric Patients (TIC-P)	Pre-treatment, at week 15, and at the 7- and 16-month follow-ups	Self-rated questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder. The TIC-P questionnaire measures costs in two dimensions: use of health resources and loss of productivity. Lower cost is better.
Negative Effects Questionnaire (NEQ)	14 weeks after treatment start. Additional measures at the 7- and 16-month follow-ups	Self-rated questionnaire on negative effects. It contains 32 items that are scored on a five point Likert-scale (0-4) and differentiates between negative effects that are attributed to treatment and those possibly caused by other circumstances. The total score of the NEQ ranges from 0 to 80 points, a higher score reflects more negative effects.
Assessing Quality of Life 6 Dimensions (AQoL-6D)	Change from baseline to 14 weeks after treatment start. Additional measures at the 7- and 16-month follow-ups	Used to assess cost-effectiveness. 20 questions that assess different aspects of quality of life. The AQoL provides a utility score that ranges from 1.00 (full health) to 0.00 (death-equivalent health states) to -0.04 (health states worse than death).

Trial Locations

Locations (2)

Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Stockholms Läns Landsting; 🇸🇪 Stockholm, Sweden

Psykiatri sydväst; 🇸🇪 Stockholm, Sweden