Stress Management and Resiliency Training (SMART) Integrated Into Comprehensive Treatment of Major Depression: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in Connor-Davidson Resilience Scale Score
研究概览
简要总结
The investigators are doing this research study to find out if the Stress Management and Resiliency Training (SMART) therapy will help subjects with their major depression treatment.
详细描述
The investigators propose to conduct an initial feasibility study in a sample of patients in treatment for major depression using SMART. The intervention will be weekly group therapy session of SMART for 8 weeks duration. Once enrolled, participants will complete a Structured Clinical Interview for Diagnosis (SCID). The SCID will primarily serve to confirm a diagnosis of Major Depressive Disorder. Each study intervention group (3-4 groups) will be composed of 6-8 research participants per group. There will be no comparison group. The investigators aim to assess adherence with goal of 75% completion of the 8 sessions of SMART and of the homework assignments. Resilience will be measured with the Connor-Davidson resilience scale. Secondary outcomes will include subjective and objective clinical rating scales for major depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Attending the Mayo Clinic Depression Center and Behavioral Health Clinic at Mayo Clinic Health System, Austin, Minnesota
- •DSM-V diagnostic confirmation of major depressive disorder (MDD)
- •Baseline PHQ-9 scores in the range of ≥6-≤19, and HAMD-17 score 8-18, or QIDS-C16 score of 6-20
- •Able to speak English
- •Participants will continue taking any prescribed medications from their clinical treatment team
- •Patients with co-morbid secondary diagnoses of persistent depressive disorder and generalized anxiety disorders will be included in the study.
排除标准
- •Participants with bipolar disorder
- •Active psychosis
- •Active suicidal ideations
- •Active substance abuse meeting criteria for substance use disorders except nicotine
- •Obsessive compulsive disorder
- •Active Panic disorder with agoraphobia, other phobic disorder
- •Active Posttraumatic stress disorder
- •Active Severe personality disorders.
研究组 & 干预措施
Depressed Subjects
Subjects will undergo an 8 week behavioral program with Stress Management and Resiliency Training.
干预措施: Stress Management and Resiliency Training (Behavioral)
结局指标
主要结局
Change in Connor-Davidson Resilience Scale Score
时间窗: baseline, 8 weeks
The Connor-Davidson Resilience Scale (CD-RISC), a 25-item scale, was developed to measure resiliency. CD-RISC has been evaluated and has been found to have good internal consistency (α = .89), test-retest reliability (intraclass correlation coefficient = .87), and positive correlation with multiple related measures with ability to distinguish between participants with lesser and greater resilience. The scores can range from 0 to 100. The mean score in a general population sample was 80.7 and in psychiatric outpatients 68. A positive change with increasing scores will indicate improvement in resilience.
次要结局
- Change in Hamilton Rating Scale for Depression Score(baseline, 8 weeks)
- Change in Patient Health Questionnaire-9 Score(baseline, 8 weeks)
- Change in Quick Inventory of Depressive Symptoms Score(baseline, 8 weeks)
- Change in Generalized Anxiety Disorder-7 Score(baseline, 8 weeks)
- Change in Perceived Stress Scale Score(baseline, 8 weeks)
研究者
Ashok Seshadri
Consultant, Instructor in Psychiatry
Mayo Clinic