Effectiveness of a Supported Self-Care Intervention for Depression Compared to an Unsupported Intervention in Older Adults With Chronic Physical Illnesses (DIRECT-sc)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire (PHQ-9) depression severity measure
研究概览
简要总结
When patients present with both a chronic disease and depression, family physicians agree that treatment and follow-up is more complicated and that patients' health suffers as a result. Programs to help depressed patients learn skills to help manage their mood have been developed (depression self-care), using workbooks and audio-visual materials. The programs show promise, but little is known about how these self-care programs may work for patients with depression and chronic disease.
Researchers are proposing a study to evaluate a depression self-care programme for patients age 40 and over who have at least mild depressive symptoms as well as a chronic physical illness and who are treated primarily by a family physician. All study participants (250 patients selected from different family medicine clinics in Montreal) will receive a package of depression self-care materials which include the Antidepressant Skills Workbook, developed in Canada, available in French and English, and used in several provinces in depression self-management programs; a video on depression; a mood monitoring tool; an information booklet to give to family members; and information on additional resources (books, internet materials, and local community groups). The participants will be assigned to one of two groups randomly (like a coin toss): one group will receive the materials only, the other group will receive the materials as well as regular telephone support for up to 6 months by a trained coach who will answer any questions the participant may have on the materials they are working with.
All participants who agree to be in the study will be interviewed three times: once at the beginning of the study, then at 3 months and finally at 6 months. Patients' depression scores will be evaluated to determine the effectiveness of the self-care programme with and without the support of the coach. Researchers will also look at the effect that self-care may have on use and costs of health services, and whether engaging in self-care has an impact on health behaviours (like exercise, taking medications correctly and smoking and alcohol consumption).
All study data will be anonymous; any information that could potentially allow identification of a participant will be removed.
详细描述
Contact principal investigator for references/citations.
- PRINCIPAL RESEARCH QUESTIONS AND HYPOTHESES We propose to conduct an RCT to measure the effectiveness of a telephone-based supported self-care intervention for depression in comparison to an unsupported self-care intervention among community-dwelling persons aged 40 and over with depression (diagnoses and symptoms) and comorbid chronic physical illnesses in primary care settings.
We propose to conduct a pragmatic trial that will be relevant to health policy. In keeping with this, we will endeavor to make the methods of recruitment and intervention delivery similar to those that would be used in "real-life" implementation.
All outcomes will be assessed at the end of the intervention (6 months). Because the effects of the intervention on healthcare services utilization may not be seen within this time window, we will assess utilization and costs at both 6 and 12 months.
Primary research question: What is the effectiveness of the supported versus unsupported intervention as evaluated by the severity of depressive symptoms at 6 month follow-up?
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 40 or more;
- •with one or more doctor-diagnosed chronic physical illnesses or chronic pain at least 6 months duration;
- •and with persistent depressive symptoms (≥ 1 month)
排除标准
- •PHQ-9 score of less than 5,
- •resident in a nursing home,
- •suicidal,
- •receiving CBT from any health professional,
- •unable to read in either English or French,
- •more than mild cognitive impairment,
- •any other impairment that would prevent them from participating in telephone interviews
结局指标
主要结局
Patient Health Questionnaire (PHQ-9) depression severity measure
时间窗: Screening, 3 months, 6 months
9 item depression severity scale (self-report)
次要结局
- Health services utilization and costs(Baseline, 3 months, 6 months and 12 months.)
- General health status (SF-12)(Baseline and 6 months)
- Depression diagnoses(Screening and 6 months)
- Changes in depression treatment(Baseline and 6 months)
- Activation (Using the Patient Activation Measure - PAM)(Baseline and 6 months)
- Self-efficacy for depression self-care(Baseline, 3 months and 6 months)
- Engagement in social and leisure-time activities(Baseline and 6 months)
- Smoking and alcohol consumption(Baseline and 6 months)
- Medication adherence(Baseline and 6 months)
- Satisfaction with care(6 months)
- Severity of anxiety symptoms (GAD-7)(Screening, 3 months, 6 months)
- Exercise (International Physical Activity Questionnaire)(Baseline, 6 months)
- Self-care tool use(3 months, 6 months)
研究者
Jane McCusker, MD DrPH
Principal investigator, principal scientist
McGill University