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Towards Personalized Medicine for OCD

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ClinicalTrials.gov Identifier: NCT03852186
Recruitment Status : Not yet recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Sara Kerstine Kaya Nielsen, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Behavioral: Cognitive behavioral therapy Behavioral: Acceptance and commitment therapy Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852186


Contacts
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Contact: Sara KK Nielsen, PhD 004538644800 Sara.kerstine.kaya.nielsen@regionh.dk

Locations
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Denmark
University Hospital Copenhagen Enrolling by invitation
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark

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Responsible Party: Sara Kerstine Kaya Nielsen, Postdoctoral Researcher, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03852186     History of Changes
Other Study ID Numbers: VD-2018-376
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders