"Relief": A Behavioral Intervention for Depression and Chronic Pain in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 3
- 主要终点
- Client Satisfaction Questionnaire (CSQ)
研究概览
简要总结
Chronic pain and depression frequently co-exist in late and mid-life and contribute to increased disability, high health care costs, psychiatric comorbidity, and suicide. The investigators will recruit 60 adults from Weill Cornell Medical Associates primary care practices; participants will be randomized to either Relief (a 9 session behavioral intervention) or usual care/referral for mental health care. Research assessments are conducted with both groups at study entry (Baseline), 6, 9, and 12 weeks.
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
Research assistants will be blind to who is receiving Relief and who is not.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 years
- •PHQ-9 greater than or equal to 10
- •Non-cancer related chronic pain, defined as pain during most days over the past 3 months by patient report
- •Capacity to consent
排除标准
- •DSM-5 Axis 1 other than depression and anxiety disorders
- •Montreal Cognitive Assessment (MoCA) < 24
- •Active suicidal ideation, i.e. MADRS Suicide Item greater than or equal to 4
- •Severe or life-threatening medical illness.
- •Patients on psychotropics, opioids or benzodiazepines will be included if they do not meet DSM-5 criteria for opioid, anxiolytics or other substance abuse disorders
结局指标
主要结局
Client Satisfaction Questionnaire (CSQ)
时间窗: 12 weeks
A questionnaire that evaluates participants' satisfaction with treatment; ranging from 1 (needs have not been met/dissatisfied) to 4 (almost all needs have been met/very satisfied). Domain 1 measures met needs. Scores range from 0-4 and higher scores indicate more needs met. Domain 2 measures satisfaction with services. Scores range from 0-4 and higher scores indicate more satisfaction with services. Domain 3 measures willingness to return. Scores range from 0-4 and higher scores indicate greater willingness to return.
Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: Baseline, 6, 9, and 12 weeks
The MADRS is a 10 item questionnaire assessing severity of depression by scoring participants on mood, anxiety, sleep, concentration, appetite, and suicidal thoughts. The lowest score is 0, no depression symptoms, and the highest possible score is 60, severe depression symptoms.
Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ)
时间窗: Baseline, 6, 9, and 12 weeks
The RMDQ includes a scale assessing how much pain the participant has experienced in the past week, with 0 indicating no pain and 10 indicating pain as bad as he/she can imagine; scores will be listed under domain 1. In addition, the RMDQ also includes a series of questions related to pain disability, with 0 indicating no pain-related disability, and 24 indicating severe pain-related disability; scores will be listed under domain 2.
次要结局
- Change in Mood, as Measured by the Daily Photographic Affect Meter (PAM)(Daily for 12 weeks)
- Activities Monitoring(Daily for 12 weeks)