Back to resultsAssisting Obsessive Compulsive Disorder (OCD) Patients With Discontinuing Long-term Serotonin Reuptake Inhibitors (SRIs)
Primary Purpose
Obsessive Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unified Protocol (UP)
Taper and Monitoring (TAP-M)
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive Compulsive Disorder
Eligibility Criteria
Inclusion Criteria:
- 18 or older
- Presence of mild to moderate OCD symptoms
- Patient's treating clinician agrees that SRI discontinuation is clinically appropriate
- Adequate trial of SRI (≥10 weeks) in the current treatment episode
- Maintenance on SRI dose that has not increased due to significant clinical worsening in the two years prior to enrollment
- English speaking
Exclusion Criteria:
- Clinically significant suicidality or a suicide attempt within the past year
- Presence of any clinical features warranting a higher level of care (partial or inpatient hospitalization)
- Current or recent (past 6 months) alcohol or drug dependence or abuse
- Current or past psychotic disorder or bipolar disorder
- Moderate to severe depression, as indicated by a Hamilton Rating Scale for Depression (HRSD) (17-item) ≥ 14 or recent major depressive episode (past 6 months)
- History of severe OCD (YBOCS ≥ 28)
- Prior adverse experience with SRI discontinuation
- Primary compulsive hoarding
- Cognitive impairment that would interfere with study participation
- Concomitant psychosocial treatment w/ proven efficacy in the treatment of OCD
- Previous adequate trial of exposure-based treatment (e.g., history of 12 or more sessions) in past 5 years
- Use of non-SRI psychotropic medications for OCD in the 3 months prior to enrollment.
Sites / Locations
- Butler Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Unifed Protocol (UP) for Discontinuation
Taper and Monitoring (TAP-M)
Arm Description
Unified Protocol (UP) for Discontinuation is delivered in 14 weekly individual sessions of 45-60 minutes followed by 3 booster sessions scheduled at two, four and eight weeks thereafter. The UP is a cognitive behavioral treatment that focuses on increasing emotional awareness and cognitive flexibility, preventing behavioral and emotional avoidance, and situational and interoceptive emotion-focused exposure. Participants will also receive 7 biweekly medication management sessions over 14 weeks with a study psychiatrist to facilitate gradual taper of SRI medication.
Taper and Monitoring (TAP-M) is delivered in biweekly individual sessions over 14 weeks, with booster sessions at two, four, and eight weeks thereafter. TAP-M consists of assessment and monitoring. Participants will also receive 7 biweekly medication management sessions over 14 weeks with a study psychiatrist to facilitate gradual taper of SRI medication.
Outcomes
Primary Outcome Measures
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Secondary Outcome Measures
Full Information
NCT ID
NCT02103621
First Posted
April 1, 2014
Last Updated
June 13, 2018
Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02103621
Brief Title
Assisting Obsessive Compulsive Disorder (OCD) Patients With Discontinuing Long-term Serotonin Reuptake Inhibitors (SRIs)
Official Title
Discontinuation of Long-term SRIs in Obsessive Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will address questions of fundamental clinical significance including: (1) whether OCD patients maintained on long term SRIs can be discontinued without symptom exacerbation, (2) whether trans-diagnostic cognitive-behavioral treatment will reduce worsening following discontinuation compared to Taper and Monitoring, and (3) whether predictors of successful SRI discontinuation can be identified.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unifed Protocol (UP) for Discontinuation
Arm Type
Experimental
Arm Description
Unified Protocol (UP) for Discontinuation is delivered in 14 weekly individual sessions of 45-60 minutes followed by 3 booster sessions scheduled at two, four and eight weeks thereafter. The UP is a cognitive behavioral treatment that focuses on increasing emotional awareness and cognitive flexibility, preventing behavioral and emotional avoidance, and situational and interoceptive emotion-focused exposure. Participants will also receive 7 biweekly medication management sessions over 14 weeks with a study psychiatrist to facilitate gradual taper of SRI medication.
Arm Title
Taper and Monitoring (TAP-M)
Arm Type
Active Comparator
Arm Description
Taper and Monitoring (TAP-M) is delivered in biweekly individual sessions over 14 weeks, with booster sessions at two, four, and eight weeks thereafter. TAP-M consists of assessment and monitoring. Participants will also receive 7 biweekly medication management sessions over 14 weeks with a study psychiatrist to facilitate gradual taper of SRI medication.
Intervention Type
Behavioral
Intervention Name(s)
Unified Protocol (UP)
Intervention Type
Behavioral
Intervention Name(s)
Taper and Monitoring (TAP-M)
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame
14 weeks post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 or older
Presence of mild to moderate OCD symptoms
Patient's treating clinician agrees that SRI discontinuation is clinically appropriate
Adequate trial of SRI (≥10 weeks) in the current treatment episode
Maintenance on SRI dose that has not increased due to significant clinical worsening in the two years prior to enrollment
English speaking
Exclusion Criteria:
Clinically significant suicidality or a suicide attempt within the past year
Presence of any clinical features warranting a higher level of care (partial or inpatient hospitalization)
Current or recent (past 6 months) alcohol or drug dependence or abuse
Current or past psychotic disorder or bipolar disorder
Moderate to severe depression, as indicated by a Hamilton Rating Scale for Depression (HRSD) (17-item) ≥ 14 or recent major depressive episode (past 6 months)
History of severe OCD (YBOCS ≥ 28)
Prior adverse experience with SRI discontinuation
Primary compulsive hoarding
Cognitive impairment that would interfere with study participation
Concomitant psychosocial treatment w/ proven efficacy in the treatment of OCD
Previous adequate trial of exposure-based treatment (e.g., history of 12 or more sessions) in past 5 years
Use of non-SRI psychotropic medications for OCD in the 3 months prior to enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina L Boisseau, Ph.D.
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assisting Obsessive Compulsive Disorder (OCD) Patients With Discontinuing Long-term Serotonin Reuptake Inhibitors (SRIs)
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