Intervention to Improve Sleep, Cognition, and Behavioral Health in Firefighters
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Recruitment capability
研究概览
简要总结
The purpose of this pilot study is to examine the feasibility and acceptability of an app-based sleep program designed to help firefighters improve their sleep.
详细描述
The purpose of this pilot study is to examine the feasibility and acceptability of an app-based sleep program designed to help firefighters improve their sleep. This trial will recruit firefighters working on the Central Coast of California. Upon completing screening procedures and an informed consent, participants will be asked to complete questionnaires related to sleep, behavioral health, and cognition and sleep patterns will be objectively assessed using research grade wrist-worn accelerometers. Participants will then be randomized to receive the Sleep Well intervention (mobile iOS app + monthly phone coaching; N=25) or a control condition (handout on sleep in firefighters; N=25). Over a three month study period, participants randomized to the Sleep Well intervention will be asked to 1) track their sleep, physical activity, eating, and stress; 2) complete weekly, in-app learning modules informed by social cognitive theory and cognitive behavioral therapy for insomnia covering topics such as sleep hygiene, bedtime routines, healthy eating and activity patterns, and managing stress; and 3) participate in three monthly coaching phone calls with a trained study interventionist. After the three month study period, all participants will be asked to repeat baseline assessments. Those in the Sleep Well intervention group will also be asked for user feedback. Quantitative data will inform feasibility of digitally delivered, behavioral sleep programming designed for firefighters. Findings will inform intervention strategies targeting healthy sleep behaviors to improve health and cognition in firefighters and guide the study protocol for a full-scale trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •based on self report:
- •Current CalFire Wildfire firefighter in Central Coast region or City of San Luis Obispo Firefighter (non-volunteer and not a primarily administrator status)
- •English Speaking
- •Have an iPhone /iPad
- •Age >= 18
- •Self-reported interest in improving sleep functioning.
排除标准
- 未提供
研究组 & 干预措施
Sleep Education Control Group
The Sleep Education Control Arm will be provided basic Sleep Education materials that are Standard of Care and available to all Firefighters.
干预措施: Standard of Care (Investigator Choice) (Behavioral)
Sleep Well Intervention Group
The Sleep Well Intervention Group will receive access to a digital Sleep Health App designed for Firefighters and will be asked to participate in monthly coaching phone calls aimed at improving their sleep health.
干预措施: Sleep enhancement intervention (Behavioral)
结局指标
主要结局
Recruitment capability
时间窗: From Baseline through Study Completion (12 weeks).
Recruitment capability: Number of participants enrolled per month (target of 5 enrolled per month)
Intervention Fidelity
时间窗: From Baseline through Study Completion (12 weeks).
Fidelity: The extent to which an intervention is delivered as intended (target: \>80% fidelity score).
Intervention Adherence
时间窗: From Baseline (week 0) through Study Completion (12 weeks).
Change in sleep behaviors assessed via in-app tracking (i.e., self-report of sleep behaviors over the study intervention period).
Acceptability
时间窗: At Study Completion (12 weeks).
Participants will be asked to rate the usefulness and satisfaction with app and phone-sessions, using a questionnaire that includes rating scales of various aspects of the program.
Retention
时间窗: At Baseline (week 0) through Study Completion (week 12).
Retention: Number of participants who remained in the study throughout the project period of the total number of participants recruited at baseline (Target of 80% retention rate; Reasons for dropout will be collected);
Assessment procedures
时间窗: At baseline (week 0) through Study Completion (week 12).
Assessment procedures: The extent to which study assessments can be administered as planned; assessment procedures are acceptable to participants; and data collection is complete.
Adherence
时间窗: At baseline (week 0) through Study completion (week 12).
Logins on the mobile Sleep Well App (Goal: \>75% of expected logins on the mobile Sleep Well app)
次要结局
- Sleep, movement, and light exposure(7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12).)
- BMI(At Baseline (week 0) and at Study Completion (week 12).)
- Depressive symptoms(At Baseline (week 0) and at Study Completion (week 12).)
- Caffeine(At Baseline (week 0) and at Study Completion (week 12).)
- Anxiety(At Baseline (week 0) and at Study Completion (week 12).)
- Stress(At Baseline (week 0) and at Study Completion (week 12).)
- Quality of Life(At Baseline (week 0) and at Study Completion (week 12).)
- Psychomotor Vigilance(At Baseline (week 0) and at Study Completion (week 12).)
- Sleep Diary(7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12).)
- Epworth Sleepiness Scale (ESS) Score(Baseline (Week 0) to Post-Intervention (Week 12))
- Pittsburgh Sleep Quality Index (PSQI) Global Score(Baseline (Week 0) to Post-Intervention (Week 12))
研究者
Selene Tobin
Assistant Professor
California Polytechnic State University-San Luis Obispo