A Pilot Study of Cognitive Behavioral Therapy - Insomnia (CBT-I) Among Professional Firefighters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Feasibility as measured by attendance, attrition, and adherence to intervention components.
研究概览
简要总结
The primary aim of this study is to investigate the feasibility, acceptability, and preliminary efficacy of an adapted Cognitive Behavioral Therapy - Insomnia (CBT-I) intervention in improving sleep in a firefighter population.
详细描述
After being informed about the study and potential risks, participants will be randomized to the intervention group (group to receive CBT-I) or the no-intervention control group. All participants in the study will complete three assessment visits; one prior to the start of the intervention, one immediately following the 6-week intervention, and one 3-months post-intervention. The intervention group will engage in 6-weeks of CBT-I training aimed at targeting sleep and sleep-related concerns faced as a result of occupational considerations.
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
- 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
- •English-speaking
- •full-time professional firefighter
- •At least 18 years of age
- •A global Pittsburgh Sleep Quality Index score ≥ 5 (Grandner et al., 2006)
- •Be willing and able to participate in all study activities including pre-, post-, and 3-month follow up assessments and 6-weeks of the CBT-I intervention
- •Agree to random assignment to one of two conditions (treatment or control group)
- •Have access to an email account
- •Be willing to wear the Fitbit Inspire HR device throughout the duration of the intervention and for two weeks following completion of the 6-week intervention
排除标准
- •Endorsement of prior involvement in formal CBT-I interventions
- •Unwillingness to give written informed consent
结局指标
主要结局
Feasibility as measured by attendance, attrition, and adherence to intervention components.
时间窗: From intervention Week 1 to intervention Week 6
Feasibility will be measured via attendance, attrition rates, and completion of sleep diaries Participant weekly CBT-I attendance will be tracked and analyzed based upon average percentage of total number of sessions attended. Adherence to intervention components will be tracked via compliance with recommendations for the previous week. After each session, sleep diaries for that week will be examined by research assistants and recorded dichotomously as to whether "Yes, the participant was adherent" or "No, the participant was not adherent". An adherence percentage will be calculated.
Change in Scores on the Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire designed to assess sleep quality and sleep disfunction throughout the previous month. Global scores range between 0-21 with higher scores indicating greater sleep dysfunction.
Acceptability as measured by mean acceptability ratings on four Likert-style questions.
时间窗: 6 weeks (i.e., post-intervention)
Acceptability will be assessed using four self-report questions derived from similar studies, and calculated via mean acceptability ratings on a scale of 0-6. These items will include the degree to which the participant liked the program, whether they found the home practice/requirements reasonable, whether they would recommend the program, and whether they would take the program again in the future. Each item is responded to on a 7-point Likert-type scale ranging from 0 to 6, with higher scores indicating greater acceptability.
Total Sleep Time Change as Measured by Actigraphy in the Fitbit Inspire HR
时间窗: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention)
Fitbit Inspire HR wrist worn devices will be used to assess mean sleep patterns and sleep-related activity. The Fitbit Inspire HR may be worn consistently for up to 5-days and records wrist movement and heart rate variability to estimate sleep onset, waking, and sleep stages without need for the wearer to actively manipulate the device.
次要结局
- General Health as Measured Through the Medical Outcomes Study 12-item Short-Form Survey (SF12v2)(Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up))
- Family Functioning as Measured Through the McMaster Family Assessment Device - General Functioning Scale (FAD-GFS)(Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up))
- Depression, Anxiety, and Stress as Measured Through the Depression, Anxiety, and Stress Scales 21 (DASS-21).(Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up))
- Vigilant Attention as Measured Through the Psychomotor Vigilance Task (PVT).(Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up))
- PTSD as Measured Through the PTSD Checklist for DSM-5 (PCL-5)(Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up))
- Fidelity of Intervention Protocol Across Sessions(6 weeks (i.e., post-intervention))