Maintaining Behavior Change: An Evaluation of a Habit-based Sleep Health Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Composite Scale of Morningness
研究概览
简要总结
The study will test a sleep-health intervention that leverages the science on habit formation. It will evaluate if adding a text messaging intervention improves habit formation. The participants will be 18-30 years old.
详细描述
The study will test a sleep-health intervention that leverages the science on habit formation. Additionally, the investigators will evaluate whether adding a text messaging intervention improves habit formation. The participants will be 18-30 years old. This is a distinct developmental period in which priorities shift toward self-sufficiency and personal responsibility, which are supported by developing adaptive habits.
Main Aim. To evaluate if adding a text messaging intervention, derived from learning theory, to HABITs improves the utilization of sleep health behavior and improves sleep and circadian outcomes and functioning in the five health-relevant domain outcomes in the short (post-treatment) and longer term (6 and 12-months later), relative to HABITs without text messaging.
Main Hypothesis. Relative to HABITs, youth in HABITs+Texts will (a) establish stronger sleep health behavior habits, (b) report utilizing more sleep health behaviors and (c) exhibit improved sleep and circadian functioning and lower health-relevant risk. These effects will be observed at post-treatment as well as 6 and 12-months later.
Exploratory Aim: To evaluate if the Habit-based Sleep Health Intervention ('HABITs') is associated with an improvement in the utilization of sleep health behavior, an improvement in sleep and circadian outcomes and an improvement in functioning in the five health-relevant domain outcomes in the short (post-treatment) and longer term (6 and 12-months later), relative to baseline.
Exploratory Hypothesis. Combining across the HABITs and HABITs+Texts treatment arms, receiving either intervention will be associated with (a) improved sleep health behavior habits, (b) more utilization of sleep health behaviors, (c) improved sleep and circadian functioning and (d) lower health-relevant risk at post-treatment, 6- and 12-month follow-up, relative to baseline.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scoring less than or equal to 26 on the Composite Scale of Morningness OR Mid-point of sleep later than 4:30 AM for 18-24 yo and 3:50 AM for 25-30 yo on work-free/weekend days over the past month OR Night-to-night variation in sleep and wake times across one month of 2 hours or more.
- •'At risk' in one of the five health domains: the emotional domain, the cognitive domain, the behavioral domain, the physical domain and the social domain. "Risk" is defined as scoring 4 or higher on one item from an adapted version of the Work and Social Adjustment Scale.
- •Age between 18 and
- •English language fluency.
- •Able and willing to give informed assent.
- •If taking medication for sleep, the dose and frequency of use must have been stable for at least 4 weeks.
排除标准
- •Presence of substance abuse/dependence, mental illness, physical illness, suicidality or developmental disorder only if it makes participation in the study unfeasible or if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed due to participating in this study.
- •Evidence of sleep apnea, restless legs or periodic limb movements during sleep. Youth presenting with provisional diagnoses of any of these disorders will be referred for a non-study polysomnography evaluation and will be enrolled only if the diagnosis is disconfirmed or if the disorder is treated.
- •Night shifter worker where the shift is scheduled between the hours of midnight to 6am > 2 nights per week.
- •Pregnancy or breast-feeding.
结局指标
主要结局
Composite Scale of Morningness
时间窗: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Sum of 13-item; Mix of 4-point and 5-point response scale. Scores can range from 13 (extreme evening) to 55 (extreme morning).
Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment (PROMIS-SRI)
时间窗: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Sum of 8-items rated on a 5-point response scale. Scores can range from 8 to 40 (Higher score means more Sleep Related impairment)
Adapted version of the Work and Social Adjustment Scale
时间窗: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
A measure of emotional, cognitive, physical, social and behavioral risk. The 5 items are each rated on a 0-8 scale. The 5 individual item scores will be summed into a total score (range: 0 to 40; Higher score means worse outcome).
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD)
时间窗: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Sum of 8-items rated on a 5-point response scale. Scores can range from 8 to 40 (Higher score means more Sleep Disturbance)
Self-Report Automaticity Habits Index integrated with the Utilization Scale
时间窗: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
16-item; 0-4 scale. Scores can range from 0 to 64 (Higher score means more automaticity in utilization).
Utilization Scale
时间窗: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
16-item; 0-4 scale. Scores can range from 0 to 64 (Higher score means more utilization).
Composite Sleep Health Score
时间窗: Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up
Composite Sleep Health Score which is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint fluctuation), Satisfaction (Sleep quality question on PROMIS-SD), Alertness (Daytime sleepiness question on PROMIS-SRI), Timing (Mean midpoint), Efficiency (Sleep efficiency) and Duration (Total Sleep Time). The Sleep Health Composite was constructed such that higher score indicates better sleep health.
次要结局
- Pittsburgh Sleep Quality Index(Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up)
- PROMIS-Cognitive Function(Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up)
- PROMIS-Ability to participate(Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up)
- Sleep Diary(Baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up)
- Actigraphy(Baseline to 1-week post treatment)
- Depression, Anxiety, and Stress Scale (DASS)(Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up)
- Brief Sensation Seeking Scale(Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up)
- Ecological Momentary Assessment Composite Risk Score of Functioning - Emotion(Change from baseline to 1-week post treatment)
- Ecological Momentary Assessment Composite Risk Score of Functioning - Cognitive Domain(Change from baseline to 1-week post treatment)
- Ecological Momentary Assessment Composite Risk Score of Functioning - Physical Domain(Change from baseline to 1-week post treatment)
- Physical Health Questionnaire(Change from baseline to 1-week post treatment, 6-month follow-up and 12-month follow-up)
- Ecological Momentary Assessment Composite Risk Score of Functioning - Social Domain(Change from baseline to 1-week post treatment)
- Ecological Momentary Assessment (EMA) Composite Risk Score of Functioning - Behavioral Domain(Change from baseline to 1-week post treatment)
- Self Report Habit Index: Primary habit bundle to dismantle(At the end of the 2nd through last treatment session, which starts 2 to 3 weeks after the beginning of treatment. Also at 1-week post treatment, 6-month follow-up and 12-month follow-up)
- Self Report Habit Index: Primary habit bundle to build(At the end of the 2nd through last treatment session, which starts 2 to 3 weeks after the beginning of treatment. Also at 1-week post treatment, 6-month follow-up and 12-month follow-up)
研究者
Allison Harvey
Professor of Clinical Psychology
University of California, Berkeley