Towards Personalized Medicine for OCD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03852186|
Recruitment Status : Not yet recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder||Behavioral: Cognitive behavioral therapy Behavioral: Acceptance and commitment therapy||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Towards Personalized Medicine for OCD|
|Estimated Study Start Date :||March 2, 2019|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||August 31, 2022|
Active Comparator: Cognitive behavioral therapy
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
Group based psychotherapy
Experimental: Acceptance and commitment therapy
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
Group based psychotherapy
- Yale Brown obsessive compulsive scale [ Time Frame: 25 minutes ]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
- Quality of Life Inventory [ Time Frame: 20 minutes ]
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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852186
|Contact: Sara KK Nielsen, PhD||004538644800||Sara.email@example.com|
|University Hospital Copenhagen||Enrolling by invitation|
|Copenhagen, Denmark, 2100|