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

NCT05608278 | Unknown

• 1 other identifier: OCD - B4DT vs standard CBT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Cognitive Behavioral Therapy; Obsessive-Compulsive Disorder; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), clinician-administered

  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).

  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

Secondary Outcomes (6)

• 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

• 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

• Dropout rate in both arms

  Gold standard CBT: week 15. B4DT: week 3.

• Treatment Inventory of Costs in Psychiatric Patients (TIC-P)

  Pre-treatment, at week 15, and at the 7- and 16-month follow-ups

• Negative Effects Questionnaire (NEQ)

  14 weeks after treatment start. Additional measures at the 7- and 16-month follow-ups

Other Outcomes (7)

• Patient Exposure/Response Prevention Adherence Scale (PEAS)

  Gold standard CBT: week 4, 7, and 15. B4DT: week 3.

• Yale-Brown Obsessive Compulsive Scale-Self-Rated (Y-BOCS-SR)

  Pre-treatment, at week 15, and at the 7- and 16-month follow-ups

• Montgomery-Åsberg Depression Rating Scale-Self-Rated (MADRS-S)

  Pre-treatment, at week 15, and at the 7- and 16-month follow-ups

Study Arms (2)

Bergen 4-Day Treatment (B4DT)

EXPERIMENTAL

Patients in this arm will receive an intensive treatment delivered mostly in group format. The group sizes will be 3-6 participants with a 1:1 patient to therapist ratio. In the week before the intensive part of the treatment, participants will have two scheduled phone/video calls with a therapist. Day 1 (half-day) of the intensive treatment includes psychoeducation and deciding on exposure tasks. Days 2 and 3 (whole days) focus on individually tailored and therapist-assisted ERP in as many most relevant settings as possible. In the evenings, patients are encouraged to continue with self-guided ERP and may receive therapist support via text messages or phone calls on demand. On day 3, patients can invite relatives to a psychoeducation session. Day 4 (half-day) of the intensive treatment focuses on treatment summary and relapse prevention, as well as planning self-guided ERP for the upcoming 3 weeks. After 16 weeks, participants have individual follow-up sessions without ERP.

Behavioral: Bergen 4-Day Treatment (B4DT)

Gold standard cognitive behavioral therapy (gold standard CBT)

ACTIVE COMPARATOR

Patients will receive 16 sessions of individual CBT for OCD with an emphasis on ERP, delivered over a time period of 14 weeks according to a validated protocol. Sessions will be held twice weekly at a specialist clinic during the first 2 weeks and once a week for the remaining 12 weeks. Sessions 1-2 contain psychoeducation about OCD and CBT, goal setting, and planning of ERP exercises. Sessions 3-14 include therapist-guided ERP (at the clinic, in the patients' homes or elsewhere as needed) with planned self-practice ERP between sessions. Sessions 15-16 contain a summary of the treatment and lessons learned, as well as relapse prevention and planning of continued self-practice ERP.

Behavioral: Gold standard cognitive behavioral therapy (gold standard CBT)

Interventions

Bergen 4-Day Treatment (B4DT) BEHAVIORAL

Novel CBT treatment

Bergen 4-Day Treatment (B4DT)

Gold standard cognitive behavioral therapy (gold standard CBT) BEHAVIORAL

Gold standard CBT treatment

Gold standard cognitive behavioral therapy (gold standard CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age.
• Primary diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5).
• Clinician-rated Y-BOCS score of ≥ 16
• Written informed consent.
• 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).
• Be fluent in Swedish.

You may not qualify if:

• Other psychological treatment for OCD planned during trial period.
• Completed CBT with ERP for OCD in the last 12 months.
• Changes in psychotropic medication within the last 2 months.
• Bipolar disorder.
• Psychosis.
• Alcohol or substance dependence.
• Organic brain disorder.
• Hoarding disorder or OCD with primary hoarding symptoms.
• Suicidal ideation that would warrant close monitoring.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Helse-Bergen HF: collaborator

Study Sites (2)

Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Stockholms Läns Landsting

Stockholm, Sweden

RECRUITING

Psykiatri sydväst

Stockholm, Sweden

RECRUITING

Related Publications (1)

• Ivanova E, Fondberg R, Flygare O, Sannemalm M, Asplund S, Dahlen S, Sampaio F, Andersson E, Mataix-Cols D, Ivanov VZ, Ruck C. Study protocol for a single-blind, parallel-group, randomised, controlled non-inferiority trial of 4-day intensive versus standard cognitive behavioural therapy for adults with obsessive-compulsive disorder. BMJ Open. 2023 Dec 14;13(12):e076361. doi: 10.1136/bmjopen-2023-076361.

  PMID: 38101824 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Christian Rück, PhD

CONTACT

+46704843392; christian.ruck@ki.se

Robin Fondberg, PhD

CONTACT

+46709850426; robin.fondberg@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 8, 2022
• Study Start: November 17, 2022
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2025
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The supporting information will become available for everybody on Open Science Framework (https://osf.io/w5bfp/) before inclusion of the first participant. We will not delete anything, potential changes will be transparently reported through time stamped documents. We plan to submit the raw data to SND after completion. We will never delete it.
• Access Criteria: Approved ethics application.

Locations

SE (2)