Relief-Hybrid: A Behavioral Intervention for Depression and Chronic Pain in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 5
- 主要终点
- Change in depression symptoms, as measured by the Montgomery Asberg Depression Rating Scale (MADRS)
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. Older and middle-aged depressed-pain patients: a) are mainly treated in primary care practices; and b) are often prescribed medication, which increases the risk for addiction to opioids and benzodiazepines. Despite the need and desire by the patients and providers for primary care behavioral intervention, behavioral interventions are scarce in primary care.
To address this need, Relief-Hybrid was created. Subjects are randomized to either the Relief-Hybrid intervention or to Referral to Mental Health/Usual Care. Subjects in both arms will complete research assessments at 6, 9, and 12 weeks. Subjects in the Relief-Hybrid arm will receive 5 weekly sessions with the study therapist (licensed social workers, LCSWs) and 4 self-administered, mobile technology-assisted sessions.
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 blinded as to who is receiving Relief-Hybrid and who is receiving Usual Care.
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
- •50 years or older
- •PHQ-9 score greater or equal to 10
- •Chronic pain (non-cancer related, most days over the past 3 months)
- •Capacity to consent
排除标准
- •DSM-5 Axis 1 diagnoses other than depression and anxiety disorders
- •Montreal Cognitive Assessment (MoCA) < 24
- •Active suicidal ideation (MADRS item #10 greater 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
Change in depression 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 meaning no pain and 10 meaning pain as bad as he/she can imagine. 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.
Change in Mood, as measured by the Daily Photographic Affect Meter (PAM)
时间窗: Daily for 12 Weeks
The PAM is used for assessing mood and emotional state. Participants can either score a "positive" or "negative" affect value.
次要结局
- Affect, as measured by the Positive and Negative Affect Schedule (PANAS).(Baseline, 6, 9, and 12 weeks)
- Mood, as measured by the Mood Likert Scale(Daily for 12 weeks)
- Pain, as measured by the Pain Likert Scale(Daily for 12 weeks)
- Stress, as measured by the Stress Likert Scale(Daily for 12 weeks)
- Interoceptive Awareness, as measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA)(Baseline, 6, 9, and 12 weeks)
- Activities Monitoring(Daily for 12 Weeks)