Senzoku Intervention of Schema Therapy for Aid and Recovery From Chronic Depression (SISTAR*CD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Treatment response (% change from baseline to at 104 weeks)
研究概览
简要总结
To compare the efficacy of schema therapy versus active monitoring for women with chronic depression receiving psychiatric care.
详细描述
A randomized, assessor-blind, single center, superiority trial will be conducted. Participants will be referred to clinical psychologists in a private counseling office (Senzoku Stress Coping Support Office, in Japan). Eligible participants will be women with chronic depression receiving psychiatric care. Participants will receive schema therapy or active monitoring during 2 years. Primary outcome will be treatment response. A total sample size of 64 (32 in each group) would be required to provide 80% power at a 2-sided significance level of 5% to detect a risk difference of 35% (response rate: 55% for schema therapy vs. 20% for active monitoring), assuming a dropout rate of 10%.
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)
盲法说明
Outcome assessors of the primary outcome will be blinded to treatment assignments.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Persistent depressive disorder including chronic major depressive disorder and dysthymic disorder assessed by the Structured Clinical Interview for DSM
- •Scores of at least 14 on the GRID-HAMD
- •Psychiatric treatment duration for depression of at least 3 years
排除标准
- •Psychiatric hospitalization within 30 days prior to the enrollment
- •Ineligible to receive the protocol treatment during 2 years
- •Schizophrenia
- •Bipolar disorders
- •Intellectual disabilities
- •Neurocognitive disorders
- •Substance-related disorders
研究组 & 干预措施
Schema therapy
Schema therapy in an individual format will be implemented by clinical psychologists. The treatment period will be 2 years with biweekly 50-minute sessions (up to 48 sessions).
干预措施: Schema therapy (Behavioral)
Active monitoring
Active monitoring by telephone will be implemented by clinical psychologists. The treatment period will be 2 years with monthly 10-minute sessions (up to 24 sessions).
干预措施: Active monitoring (Behavioral)
结局指标
主要结局
Treatment response (% change from baseline to at 104 weeks)
时间窗: Baseline, 104 weeks
Treatment response was defined as 50% or greater reduction in depressive symptoms (the 17-item GRID-Hamilton Depression Rating Scale; GRID-HAMD) at 104 weeks compared with baseline. The GRID-HAMD will be administered by clinical psychologists who will be blinded to treatment assignments.
次要结局
- Medical costs(baseline through 104 weeks (assessed at each session))
- Remission(104 weeks)
- Change in observer-rated depression severity (24-item HAMD)(Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks)
- Change in self-rated depression severity(Baseline, 52 weeks, 104 weeks)
- Change in observer-rated depression severity (17-item HAMD)(Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks)
- Change in self-rated quality of life(Baseline, 52 weeks, 104 weeks)
研究者
Yasuyuki Okumura
Principal Investigator
Institute for Health Economics and Policy, Japan