Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- sleep quality as determined by the Insomnia Severity Index (ISI)
研究概览
简要总结
The purpose of this research study is to test whether Brief Behavioral Treatment for Insomnia (BBTI) delivered over the phone or Brief Mindfulness Training (BMT) delivered over the phone is better able to improve the symptoms of insomnia, reduce chronic pain, and slow the pace of biological aging in individuals with HIV and Chronic Pain.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each subject must meet all of the following criteria and be confirmed with electronic medical records:
- •Confirmed HIV diagnosis and currently a patient in the WashU Infectious Disease Clinic
- •Age 25-65 years
- •All people with HIV must be currently receiving stable antiretroviral therapy
- •People with HIV with insomnia must report Insomnia Severity Index >/= 15 at initial screening and meet DSM-5 diagnostic criteria for insomnia including sleep difficulty that occurs at least 3 times per week and has been a problem for at least 3 consecutive months
- •People with HIV must also report the presence of chronic pain on the Brief Chronic Pain Screening Questionnaire and rate their chronic pain as >/= 3 on a 0-10 scale of intensity.
排除标准
- •Subjects will not be enrolled if any of the following criteria exist and confirmed with electronic medical records:
- •History of stroke in past 12 months
- •Active cancer with treatment
- •Heart disease
- •Uncontrolled hypertension
- •Active pregnancy
- •Reynaud's disease
- •Traumatic injury or surgical procedure within the last 12 months
- •Acute infection as suggested by thermometry temperature >100.4
- •Serious psychiatric disorder (bipolar disorder, psychotic disorder)
- •Active suicidal ideation
- •Evidence for severe obstructive sleep apnea (AHI >30/hr) according to Home Sleep Monitoring or presence of another sleep disorder other than insomnia (i.e., not insomnia) as indicated by SCISD-R
研究组 & 干预措施
Brief Behavioral Treatment for Insomnia (BBTI)
BBTI is comprised of four, 30-min weekly sessions, each of which will be administered via telephone. BBTI, utilizes two critical behavioral principles: sleep restriction and stimulus control.
干预措施: Brief Behavioral Treatment for Insomnia (BBTI) (Behavioral)
Brief Mindfulness Training (BMT)
Brief Mindfulness Training (BMT) is comprised of four, 30-min weekly sessions, each of which will be delivered via telephone. BMT utilizes concepts of being aware of what the body is sensing and feeling in the moment in order to achieve a state of calmness and relaxation.
干预措施: Brief Mindfulness Training (BMT) (Behavioral)
结局指标
主要结局
sleep quality as determined by the Insomnia Severity Index (ISI)
时间窗: 4 months
Sleep quality as determined by the Insomnia Severity Index (ISI), a brief screening tool for insomnia, seven-item questionnaire that asks respondents to rate the nature and symptoms of their sleep problems using a Likert-type scale. Scoring: Add the scores for all seven items (questions 1 + 2 + 3 + 4 + 5 +6 + 7) = \_\_\_\_\_\_\_ your total score Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
pain severity and interference (BPI-SF).
时间窗: 4 months
Pain severity and interference as measured by the Brief Pain Inventory - Short Form, (BPI-SF), a self-administered questionnaire designed to assess both the severity of pain and its impact on daily function. Scoring: Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least, average. Higher scores indicate greater pain severity, range 0-10) Pain Interference Score = Mean of items 9A-9G (interference of pain with: general activity, mood, walking, normal work, relations, sleep, enjoyment of life. Higher scores indicate greater pain interference, range 0-10)
次要结局
- pace of biological aging (DunedinPACE).(4 months)
- pace of biological aging (DunedinPACE).(4 months)
- Quality of life (SF-36)(4 months)
研究者
Burel Goodin
Professor of Anesthesiology
Washington University School of Medicine