Towards Personalized Medicine for OCD

NCT03852186 | Completed DMC

• 1 other identifier: VD-2018-376
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

Obsessive compulsive disorder (OCD) is one of the most disabling anxiety disorders occurring in about 2 out of a 100 adults. Untreated, OCD is a chronic and deteriorating condition, negatively impacting multiple areas of life with high personal and socioeconomic costs. In Denmark, anxiety disorders are estimated to be the most expensive of all psychiatric disorders and the most common reason for forced retirement. In many countries including DK, CBT is the recommended, first-line treatment for OCD. All individuals who seek treatment in the Danish Regions are offered CBT. However, reviews show that up to 50% of patients either do not respond to CBT or terminate treatment prematurely. Despite this large number of non-responders, no significant progress for OCD treatment has been made since initial efficacy trials. Alternatives to CBT are needed . Acceptance and Commitment therapy (ACT) is an innovative psychotherapy that can potentially help individuals with OCD who do not benefit from CBT. ACT targets the habitual thinking and behaviors that mark OCD by aiming to increase value-based behavior. OCD often co-occurs with depression and other anxiety disorders making treatment more difficult. ACT is a transdiagnostic treatment targeting symptoms that are common to anxiety and mood disorders. Preliminary findings indicate that ACT may be an effective treatment for OCD. However, these findings constitute a low level of evidence. Before ACT can be declared as an effective treatment for OCD, it needs to be demonstrated in randomize controlled trials, in which ACT is compared to legitimate, active treatments, such as CBT. This project will test the effectiveness of group-based ACT by comparing it to the first-line treatment, group-CBT in 180 participants referred for treatment in a specialized outpatient clinic at the Mental Health Services, Capital Region of Denmark. Furthermore, moderators and predictors of treatment response will be investigated.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (2)

• Yale Brown obsessive compulsive scale

  Semi-structured interview, total score consists of all items of all items summed up, likert scale minimum 0- maximum 4, higher values predict worse OCD-symptoms

  25 minutes

• Quality of Life Inventory

  Self-report measure, 16 items, minimum -3 - maximum 3. Higher scores indicate higher quality of life. measuring outcome in terms of an overall life satisfaction score, likert scale 0-6

  20 minutes

Study Arms (2)

Cognitive behavioral therapy

ACTIVE COMPARATOR

Manualized group-based cognitive behavioual therapy delivered by clinical psychologists and psychiatrists. The treatment consists of 14 sessions of each 2 hours.

Behavioral: Cognitive behavioral therapy

Acceptance and commitment therapy

EXPERIMENTAL

Manualized group-based Acceptance and Commitment therapy delivered by clinical psychologists and psychiatrists. The treatment consists of 14 sessions of each 2 hours.

Behavioral: Acceptance and commitment therapy

Interventions

Cognitive behavioral therapy BEHAVIORAL

Group based psychotherapy

Cognitive behavioral therapy

Acceptance and commitment therapy BEHAVIORAL

Group based psychotherapy

Acceptance and commitment therapy

Eligibility Criteria

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

You may qualify if:

• have OCD as their primary diagnosis
• are between 18-65 years
• are free of alcohol and substance abuse
• are not receiving any other psychotherapy during the study
• are medication-free or stabilized on psychotropic medication
• speak and understand Danish
• provide written consent

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

University Hospital Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy; Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

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

Model Details: Multicenter Non-inferiority Block Randomized Controlled Trial

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 25, 2019
• Study Start: March 2, 2019
• Primary Completion: August 31, 2023
• Study Completion: June 25, 2025
• Last Updated: June 29, 2025

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)