Step Up Wellness Program for Depression, Physical Inactivity, and Smoking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Depression Score
研究概览
简要总结
This randomized pilot study will evaluate the feasibility and acceptability of a phone-based wellness program for improving mood, physical activity, and smoking abstinence rates among people with depression who also are physically inactive and smoke cigarettes.
详细描述
This pilot study will evaluate the feasibility, acceptability, and potential effectiveness of the Step Up Wellness Program among people with depression who also are physically inactive and smoke cigarettes.
Participation in this study will last 6 months. All participants will complete a baseline survey and then be assigned randomly to receive the Step Up Wellness Program or usual care for 3 months. Participants in the Step Up program will receive weekly phone calls from a study health coach. During these calls, the coach will discuss ways to improve and manage mood, increase physical activity, and prepare to quit smoking. Participants will also be given materials to review and homework assignments between calls. Participants in the usual care group will receive standard care which includes referrals for treatment of depression and nicotine dependence, as well as self-help information on physical activity. All participants will be surveyed at 4 and 6 months post-enrollment. Participants will also provide qualitative feedback on the program.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Member of Group Health insurance plan
- •Aged 18 to 75
- •Experiencing at least moderate depressive symptoms
- •Low physical activity defined as failure to meet Centers for Disease Control (CDC) guidelines for weekly activity OR low to moderate physical activity as assessed by International Physical Activity Questionnaire (IPAQ)
- •Current smoker
- •Has a phone
- •Able to read and speak in English
- •No mobility or physical impairments that would prevent engaging in moderate physical activity
- •Without a hearing impairment that would prevent participation with the phone-based counseling or assessments
排除标准
- •Self-report of bipolar disorder or schizophrenia
- •Currently receiving specialty mental health care or smoking cessation treatment
- •If on an antidepressant, has been taking it less than 30 days
研究组 & 干预措施
Usual Care Control
Participants will receive usual care which includes advice to stop smoking and referral to standard care treatment available through participants' health insurance and health plan.
干预措施: Usual care (Behavioral)
Step Up Intervention
Participants will receive the Step Up Wellness Program. The intervention is detailed below.
干预措施: Step Up Wellness Program (Behavioral)
结局指标
主要结局
Depression Score
时间窗: 6 months
% with significant change (50% reduction in SCL \[Symptom Checklist\] depression score)
Abstinent From Smoking
时间窗: 6 months
self-reported 7 day point prevalent abstinence with non-responders coded as smokers
Days Walk Per Week
时间窗: 6 months
Mean change in days walk per week from baseline
Minutes Per Week of Moderate Physical Activity
时间窗: 6 months
Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)
Minutes Per Week of Vigorous Physical Activity
时间窗: 6 months
Mean change from baseline assessed using IPAQ physical activity scale
次要结局
- Number of Cigarettes Smoked Per Day(4 months)
- Quit Attempt(6 months)