Mindfulness for Symptom Reduction: A Transplant Candidate Study in Program Grant Studies of Organ Transplantation in Animals and Man 2P01 DK013083
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- State-Trait Anxiety Inventory
研究概览
简要总结
The purpose of this study is to determine whether telephone-adapted Mindfulness Based Stress Reduction (tMBSR) - a program of mindfulness meditation and gentle Hatha yoga delivered mostly by phone, is an effective program to reduce symptoms (anxiety, depression, sleep) and improve quality of life for people waiting for a kidney transplant. Participants will be randomly assigned to tMBSR or to a support group emphasizing communication skills and selecting resources. Both 8-week programs include an initial in-person meeting, 6 weekly teleconference calls, and conclude with an in-person meeting. Participants will complete questionnaires at 3 timepoints over 6 months, and if they receive a transplant, will complete additional questionnaires. Participants will complete sleep diaries and wear Actiwatches (similar to a wristwatch) for one week before programs start, and when programs end, to measure sleep. Participants will provide saliva samples, over 3 days before programs start, and again when programs end, to measure salivary cortisol, an indicator of stress. tMBSR participants will record daily home meditation practice.
详细描述
Primary Aims
- Test the efficacy of a telephone-adapted Mindfulness-Based Stress Reduction (tMBSR) program to reduce symptoms and improve the quality of life of kidney transplant candidates by 8-weeks and by 6-month follow-up.
- Evaluate the impact of tMBSR on sleep measured by actigraphy, and on physiologic stress, as indicated by alteration in the slope of diurnal salivary cortisols, measured before and at the end of the 8-week active intervention period.
Secondary Aims
- Evaluate the impact of tMBSR on perceptions of transplant surgery (treatment satisfaction, pain) and of Health Related Quality of Life (HRQL) at 2-, 6- and 12-mos post-transplant surgery.
- Design a full-scale randomized controlled trial (RCT) of the effectiveness and cost-effectiveness of tMBSR.
Hypotheses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidate on the United Network for Organ Sharing (UNOS) wait list for a kidney or kidney-pancreas or evaluated as eligible for candidacy at the UMN
- •Aged 18 or older
- •English-speaking
- •Mentally intact
- •Able to use the telephone to participate in 6 weekly teleconferences
- •Able to attend 2 in-person classes in a Minnesota Metro area
- •Able to comply with study monitoring requirements
- •Receiving standard medical follow-up care
- •Willing to complete the informed consent process
排除标准
- •Prior transplant
- •Medically unstable (a hospital admission for non-elective purposes in the last 3 months or major non-transplant surgery planned in the next 3 months)
- •Serious preexisting mental health issues: suicidality or thought disorder/psychosis; or delirium or substance abuse
- •Not expected to be on the waiting list > 3 months (e.g., acceptable living donor has been identified and scheduled)
- •Prior MBSR class or regularly practicing mindfulness meditation (twice a week or more)
- •Not receiving standard medical care.
结局指标
主要结局
State-Trait Anxiety Inventory
时间窗: Baseline, 8 weeks, 26 weeks
The STAI is a 20 item scale that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety. The norm for working adults is a score of 34.
次要结局
- Short Form -12 MCS(baseline, 8 and 26 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(baseline, 8 weeks, 26 weeks)
- Center for Epidemiologic Studies Depression Scale (CESD)(baseline, 8 weeks, 26 weeks)
- SF-12 PCS(baseline, 8 weeks, 26 weeks)