Initiating and Maintaining Physical Activity in Individuals With Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- To measure the acceptability, feasibility, and safety of the program via scores on the Client Satisfaction Questionnaire (CSQ)
研究概览
简要总结
The investigators propose a randomized clinical trial in which 24 individuals with bipolar disorder are assigned to one of three arms, with each successive arm having an added component that may serve to increase and maintain physical activity:
- brief advice (BA) to exercise (control condition);
- BA + supervised & home-based exercise (SHE) + health education (HE) contact control; and
- BA + SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise (CBEX).
The primary aim is to assess and optimize the safety, feasibility, acceptability of each intervention component, as well as barriers limiting their effectiveness. The investigators will also compare the preliminary efficacy of the 3 arms for increasing physical activity during the 12-week intervention phase. The investigators hypothesize that BA + SHE + CBEX will be superior to BA + SHE + HE, and that BA + SHE + HE will be superior to BA alone in terms of objectively measured MVPA levels. The investigators will also compare the longer-term impact of the three arms on objectively-measured minutes of MVPA at 6-month follow-up (i.e., follow-up phase). Hypotheses are the same as for the intervention phase.
详细描述
The investigators propose a randomized clinical trial in which 24 individuals with bipolar disorder are assigned to one of three arms, with each successive arm having an added component that may serve to increase and maintain physical activity:
- brief advice (BA) to exercise (control condition);
- BA + supervised & home-based exercise (SHE)+health education (HE) contact control; and
- BA+SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise (CBEX).
There are two phases for participants: intervention phase (3 months), which consists of intensive contact, and the follow-up phase (3 months). BA will consist of one, 45-minute session about public health recommendations, and strategies for getting started. SHE will be a 12-week intervention consisting of 1x/week supervised exercise plus exercise prescriptions for home-based exercise with the goal of gradually achieving the public health recommendation of 150 minutes/week of moderate-to-vigorous physical activity (MVPA), CBEX and HE sessions will be individual, 30-minute, weekly sessions during the intervention phase. CBEX will address barriers to physical activity that are particularly pronounced in depression -i.e., anhedonia, decreased motivation, and decreased energy, as well as poor problem-solving skills. During the follow-up phase, groups who received SHE during the intervention phase will receive brief, monthly phone check-ins from an exercise specialist.
Primary Aims:
- To assess and optimize the safety, feasibility, acceptability of each intervention component, as well as barriers limiting their effectiveness in order to inform future steps in this research (i.e., a larger scale clinical trial).
- To compare the preliminary efficacy of the 3 arms for increasing physical activity during the 12-week intervention phase. The investigators hypothesize that BA + SHE + CBEX will be superior to BA + SHE + HE, and that BA + SHE + HE will be superior to BA alone in terms of objectively measured MVPA levels.
- To compare the longer-term impact of the three arms on objectively-measured minutes of MVPA at 6-month follow-up (i.e., follow-up phase). Hypotheses are the same as for the intervention phase (aim #2).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low-active, i.e., have not participated regularly (more than 6 weeks in the last 12 weeks) in moderate-to-vigorous physical activity (MVPA) for no greater than 90 minutes per week for the past 12 weeks AND is not enrolled in a current program designed to increase physical activity (such as Miriam weight loss program, intensive physical therapy, or other research projects related to physical activity)
- •Able to walk one mile. The cardiorespiratory fitness test requires the participant to walk one mile.
- •Medically cleared for MVPA, documented by a note from their primary care provider.
- •No significant medical condition or physical disability that would interfere with physical activity or study participation. The investigators will exclude individuals with significant cardiovascular disease, hematologic disorders, and autoimmune disorders. The investigators will also exclude individuals who are planning a surgery in the next 9 months and those with dementia.
- •Meet criteria for BDI, BDII or BD NOS assessed by relevant modules of the Structured Interview for DSM Disorders (SCID)
- •Range scores for depression. Participants must have a QIDS score that is ≤
- •No Current/Recent Manic/Hypomanic Episode. Participants cannot meet criteria for mania or Hypomania in the past month as assessed by the relevant module of the SCID.
- •No current anorexia or bulimia diagnosis (past 3months). Rationale: The investigators have concerns about the safety of physical activity for individuals with these disorders.
- •No current psychotic symptoms (in past month), no history of schizophrenia and other psychotic disorders
- •No hazardous drug or alcohol use in the past 6 months, as assessed by: a. no substance abuse treatment in the past 6 months; and b. does not meet criteria for a moderate or severe substance use disorder in the past 6 months.
- •Depression is not very severe, i.e., QIDS score is <
- •At high levels of depression severity, participants are at risk for psychiatric hospitalization, suicidality, and other problems that would interfere with physical activity. The investigators will provide referrals if needed for these individuals.
- •No suicidality requiring immediate treatment. The investigators will take necessary steps to ensure these individuals get appropriate assessment.
- •Not pregnant or planning on becoming pregnant in the next year. Although exercise is recommended for most pregnant women, risks and benefits of exercise, and type of exercise recommended, may change when one is pregnant.
- •Able to consent and complete study assessments. Participants must be able to understand English well enough to consent and complete assessments. Further, if participants are aged 60 or older, or if there is any concern about their cognitive capacity, participants will undergo a brief cognitive functioning screener, the Montreal Cognitive Assessment (MoCA). Participants must achieve a score within 1 SD of the mean for their age and education level to participate in the study (32).
- •Able to make one of the 2 available exercise class times.
- •Receiving medication treatment for bipolar disorder
- •Body weight does not exceed 375 lbs. Most of our exercise machines do not accommodate individuals with a higher body weight. As a result, if the investigators recruit these individuals, they may not have the machines available to allow them to exercise.
排除标准
- 未提供
研究组 & 干预措施
BA + SHE + HE
Brief advice to exercise + supervised & home-based exercise + health education
干预措施: SHE (Behavioral)
BA + SHE + HE
Brief advice to exercise + supervised & home-based exercise + health education
干预措施: HE (Behavioral)
BA + SHE + CBEX
Brief advice to exercise + supervised & home-based exercise + cognitive-behavioral sessions focused on increasing and maintaining exercise
干预措施: SHE (Behavioral)
BA + SHE + CBEX
Brief advice to exercise + supervised & home-based exercise + cognitive-behavioral sessions focused on increasing and maintaining exercise
干预措施: CBEX (Behavioral)
BA only
Brief advice to exercise. This serves as a control condition.
干预措施: BA (Behavioral)
BA + SHE + CBEX
Brief advice to exercise + supervised & home-based exercise + cognitive-behavioral sessions focused on increasing and maintaining exercise
干预措施: BA (Behavioral)
BA + SHE + HE
Brief advice to exercise + supervised & home-based exercise + health education
干预措施: BA (Behavioral)
结局指标
主要结局
To measure the acceptability, feasibility, and safety of the program via scores on the Client Satisfaction Questionnaire (CSQ)
时间窗: at 3 months
CSQ scores range from 8 to 32. Higher scores indicate a greater degree of satisfaction.
To measure the acceptability, feasibility, and safety of the program via adherence to weekly SHE and HE or CBEX sessions
时间窗: from baseline to 3 months
Participants attended between 0 and 11 SHE and HE or CBEX sessions. Higher scores indicate higher adherence.
To measure the acceptability, feasibility, and safety of the program via completion of 3 month and 6 month interviews
时间窗: at 3 months, 6 months
To compare the preliminary efficacy of the 3 arms for increasing physical activity during the 12-week intervention phase via International Physical Activity Questionnaire (IPAQ)
时间窗: from baseline to 3 months
The IPAQ measures minutes of moderate-vigorous physical activity (MVPA) per week. Scores range from 0 to no maximum number.
To compare preliminary long-term effect of the 3 arms on minutes of MVPA at 6-month follow-up via International Physical Activity Questionnaire (IPAQ)
时间窗: from 3 months to 6 months
The IPAQ measures minutes of moderate-vigorous physical activity (MVPA) per week. Scores range from 0 to no maximum number.
次要结局
未报告次要终点