Assisting Obsessive Compulsive Disorder (OCD) Patients With Discontinuing Long-term Serotonin Reuptake Inhibitors (SRIs)

Study Overview
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Brief Summary
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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.

Official Title
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Discontinuation of Long-term SRIs in Obsessive Compulsive Disorder

Conditions
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Obsessive Compulsive Disorder

Intervention / Treatment
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* Behavioral: Unified Protocol (UP)
* Behavioral: Taper and Monitoring (TAP-M)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unifed Protocol (UP) for Discontinuation<br>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. | Behavioral: Unified Protocol (UP)<br> <br> |
| Active Comparator: Taper and Monitoring (TAP-M)<br>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. | Behavioral: Taper and Monitoring (TAP-M)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) |  | 14 weeks post baseline |