Discontinuation of Long-term SRIs in Obsessive Compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Unifed Protocol (UP) for Discontinuation
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.
干预措施: Unified Protocol (UP) (Behavioral)
Taper and Monitoring (TAP-M)
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.
干预措施: Taper and Monitoring (TAP-M) (Behavioral)
结局指标
主要结局
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
时间窗: 14 weeks post baseline
次要结局
未报告次要终点