Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi): A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
The purpose of this study is to investigate the mechanisms of change in Cognitive Behavioral Therapy for insomnia (CBTi) in a sample of adults aged 50-65. This study aims to evaluate the pre-post treatment change in sleep, circadian rhythms, biomarkers, cognitive performance, and structural and functional magnetic resonance imaging scans (MRI).
详细描述
Baseline Part 1:
- Online demographic and contact information
- Schedule Baseline Part 2 with the investigators via online link
- 1 week of daily sleep diaries
Baseline Part 2:
- Internet-based interview with the investigators to confirm study eligibility requirements
- Online self-report questionnaires
- 2 weeks of daily sleep diaries
- 2 weeks of sleep/wake assessment wearing a watch-like activity monitor (Actiwatch)
Objective 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)
盲法说明
The participant and outcomes assessor will not be aware of participant study conditions.
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50-65
- •Normal hearing with or without hearing aids
- •Ability to speak and read English and ability to give informed consent
- •Possession of a computer with video and audio capabilities
- •Meets DSM-5 Criteria for Insomnia Disorder
- •Internet speed sufficient for participating in teletherapy (e.g., Zoom Health) or SHUTi (for iCBTi group)
- •MoCA scores ≥24 will be deemed normal cognitive status and considered eligible for study participation and/or assessed by the ability to comprehend the baseline screening questionnaires
- •Willing to refrain from new external behavioral health or medication treatment for issues pertaining to sleep during participation in the study
- •Indication that the individual plans to be in the area for the 6 months following the first baseline assessment
排除标准
- •Failure to meet the above "inclusion criteria"
- •Current circadian rhythm disorder, sleep deprivation, or hypersomnia and related sleep disorders (assessed with clinical interview and/or self-report) as CBTi has not been validated in these populations. Verified by self-report and/or clinical interview (SCISD-R)
- •Untreated sleep disordered breathing (e.g., obstructive sleep apnea) assessed by self-report, clinical interview, and/or diagnostic sleep study (i.e., baseline sleep study PSG)
- •Failing to meet criteria for MRI scan (e.g., having metallic implants); see Pre-screen MRI Checklist for full list of exclusions for MRI scans.
- •Fear/phobia of needles (conflict with blood draw) and/or small spaces (conflict with MRI scanner)
- •Current suicide risk meriting crisis intervention as assessed by the Patient Health Questionnaire (PHQ-9) and/or disclosure of serious suicidal ideation
- •Pregnancy (self-report, proposed instruments and treatments have not been validated in this population)
- •Sleep efficiency > 85%, assessed by the sleep diary
- •Serious mental health diagnosis (e.g., bipolar disorder or psychosis) assessed by structured interview (M.I.N.I.)
- •Currently engaged in evidence-based psychotherapy for Insomnia (i.e., Cognitive Behavioral Therapy) by self-report
- •Failure to follow protocol (e.g., consistent "no show" for appointments, answering questionnaires dishonestly, refusal to complete more than 2 assessments [e.g., fMRI and Neuropsych])
研究组 & 干预措施
In-person CBTi
CBTi of variable treatment length will be administered by trained study staff in-person.
干预措施: In-Person Cognitive Behavioral Therapy for Insomnia (Behavioral)
Telehealth CBTi
CBTi of variable treatment length will be administered by trained study staff via HIPAA-compliant tele-video conference.
干预措施: Telehealth Cognitive Behavioral Therapy for Insomnia (Behavioral)
Internet CBTi
Self-paced CBTi of variable treatment length will be administered via Sleep Healthy Using The Internet (SHUTi).
干预措施: Internet Cognitive Behavioral Therapy for Insomnia (Behavioral)
Waitlist Control
Treatment will be postponed by 12 weeks.
结局指标
主要结局
Insomnia Severity Index
时间窗: 12-week Post-treatment
Self-reported severity of insomnia symptoms is assessed once at posttreatment.
Insomnia Severity Index
时间窗: Pre-treatment
Self-reported severity of insomnia symptoms is assessed once at baseline.
Insomnia Severity Index
时间窗: During treatment
Self-reported severity of insomnia symptoms is assessed weekly through the duration of treatment.
次要结局
- Diary-assessed Sleep(12 week Post-treatment)
- Diary-assessed Sleep(Pre-treatment)
- Diary-assessed Sleep(During treatment)