NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers: Examination of Sleep, Arousal, Mood, Cognitive, and Immune Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Completion
研究概览
简要总结
The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver and PWD dyads). We will measure both the short term (post-treatment) and long term (6 and 12 months) effects of the intervention on CG sleep, arousal, inflammation, health, mood, burden and cognitive function, and PWD sleep.
详细描述
Over the next 30 years, more than 10 million persons living with dementia in the US will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers (CG) and persons with dementia (PWD) alike, but increases caregiver risk of insomnia and related negative health outcomes, including depression, anxiety, cognitive disturbances and poor quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is an effective and established evidence based treatment for adults of all ages. Although relatively understudied in dementia caregivers, the research suggests CBT-I is also efficacious in caregivers. Our team developed a brief (4 session) CBT-I protocol adapted for dementia caregivers and has shown in person and remote (i.e. telehealth) delivery of this protocol significantly reduces insomnia and improves mood (moderate to large effects). Given demands on caregiver time and limited availability of trained CBT-I providers, we developed a web-based version of this treatment (NiteCAPP) to increase accessibility of this efficacious treatment for rural dementia CGs. NiteCAPP will allow for flexible at home scheduling, and the skills needed to monitor caregiver treatment progress can be quickly and efficiently taught to healthcare providers. The Cognitive Activation Theory of Stress provides a framework for our basic premise that CGs experience insomnia, arousal and inflammation that prompt sympathetic activation and hypothalamic-pituitary-adrenal (HPA) disruption that have negative effects on health. The proposed trial tests the novel hypothesis that NiteCAPP will improve CG health, mood, burden and cognition by targeting their shared mechanisms - sleep, arousal and inflammation - thereby, returning sympathetic and HPA functioning to normal. Another novel aspect of the proposed trial is inclusion of behavioral strategies to target the PWD sleep. Objectives: The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver and PWD dyads). We will measure both the short term (post-treatment) and long term (6 and 12 months) effects of the intervention on CG sleep, arousal, inflammation, health, mood, burden and cognitive function, and PWD sleep.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregiver Eligibility. Inclusion criteria:
- •CG living with PWD,
- •willing to be randomized,
- •read/understand English,
- •insomnia diagnosis,
- •no prescribed or over the counter sleep meds for 1+ mo, or stabilized 6+ mos.
- •Insomnia:
- •complaints for 6+ mos,
- •adequate opportunity and circumstances for sleep,
- •1+ of the following: difficulty falling asleep, staying asleep or waking too early,
- •daytime dysfunction (mood, cognitive, social, occupational) due to insomnia,
- •baseline diaries indicate >30 mins of sleep onset latency or wake after sleep onset on 3+ nts.
- •PWD Eligibility.
- •probable/possible Alzheimer's Disease (self-report or primary care provider written confirm),
- •1+ problem on Nighttime Behavior Inv. 3+ nts/wk,
- •tolerate actigraphy,
- •no sleep meds 1+ mo or stabilized 6+ mos,
- •untreated sleep disorder for which CBT-I is not recommended (e.g., apnea),
- •scoring <32 on Sleep Apnea scale, Sleep Disorders Ques.
排除标准
- •unable to consent,
- •cognitive impairment [Telephone Interview for Cognitive Status (TICS) <25],
- •sleep disorder other than insomnia [i.e., apnea (apnea/hypopnea index-AHI >15)],
- •bipolar or seizure disorder,
- •other major psychopathology except depression or anxiety (e.g., suicidal, psychotic),
- •severe untreated psychiatric comorbidity,
- •psychotropic or other medications (e.g., beta-blockers) that alter sleep,
- •non-pharmacological tx for sleep or mood outside current trial.
研究组 & 干预措施
NiteCAPP CARES
Cognitive Behavioral Treatment-Insomnia. Web-based intervention that will include 4 weekly sessions and 4 bimonthly boosters. Each session is to be completed individually by CG (with PWD to extent able) in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed. Session 1 focuses on sleep education, sleep hygiene, and stimulus control. Session 2 focuses on sleep compression, relaxation, and problem solving. Session 3 focuses on coping and stress management and cognitive therapy. Session 4 focuses on a review of skills and plan for maintenance of behavior change.
干预措施: NiteCAPP CARES (Behavioral)
NiteCAPP SHARES
Sleep Hygiene and Related Education. Web-based intervention that will include 4 weekly sessions and 4 bimonthly boosters. Each session is to be completed individually by CG (with PWD to extent able) in a single sitting (less than 45 mins). Each session should be completed in 7 days with next session released only after prior one completed. Session 1 focuses on expanded sleep education and sleep hygiene. Session 2 focuses insomnia education and sleep hygiene support. Session 3 focuses on targeted sleep education and sleep in dementia. Session 4 focuses on a review of skills and plan for maintenance of behavior change. Boosters review skills, encourage practice, and troubleshoot issues.
干预措施: NiteCAPP SHARES (Behavioral)
结局指标
主要结局
Completion
时间窗: Single administration at 8 weeks
Percentage of sessions completed out of the 4 sessions/modules included in NiteCAPP and WebSHE.
Adherence
时间窗: Single administration at 8 weeks
Percentage of the intervention instructions followed as indicated on the treatment adherence logs completed each day during treatment.
Change in Pain Intensity - Daily Electronic Sleep Diaries
时间窗: Daily at baseline, 8 weeks, 6 month and 12 follow up
Daily electronic dairies will record pain intensity; range: 0-100 (no pain- most intense)
Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries
时间窗: Daily at baseline, 8 weeks, 6 month and 12 follow up
Daily electronic dairies will record daily medication consumption
Change in Dysfunctional Beliefs About Sleep (DBAS)
时间窗: Single administration at baseline, 8 weeks, 6 month and 12 follow up
A self-report measure of sleep-related arousal. This measure consists of 30 questions intended to measure 5 dimensions: misconceptions about the causes of insomnia, misattributions or amplifications of the consequences, unrealistic expectations, control, and predictability of sleep and faulty beliefs about sleep promoting practices. Although the original scale used a 100 mm VAS, subsequent research with the DBAS has used an 11-point Likert scale (0 = strongly disagree, 10 = strongly agree), and the latter response method will be used.
Internet Intervention Utility Questionnaire
时间窗: Single administration at 8 weeks
Questionnaire with 15 items, including two open-ended questions, that assesses the usability, like-ability, and usefulness of online interventions using a 5-point Likert scale from 1-not at all to 5-very. The two open-ended questions ask the participant to list the most and least helpful parts of the program
Change in Pain Unpleasantness - Daily Electronic Sleep Diaries
时间窗: Daily at baseline, 8 weeks, 6 month and 12 follow up
Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)
Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries
时间窗: Daily at baseline, 8 weeks, 6 month and 12 follow up
Daily electronic dairies will record wake after sleep onset (number of minutes)
Change in Sleep Onset Latency- Daily Electronic Sleep Diaries
时间窗: Daily at baseline, 8 weeks, 6 month and 12 follow up
Daily electronic dairies will record sleep onset latency (number of minutes)
Change in Fatigue - Daily Electronic Sleep Diaries
时间窗: Daily at baseline, 8 weeks, 6 month and 12 follow up
Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)
Change in Kingston Caregiver Stress Scale (KCSS)
时间窗: Single administration at baseline, 8 weeks, 6 month and 12 follow up
A 10-item scale that asks caregivers to rate on a scale from 1 (no stress) to 5 (extreme stress) how much stress they experience related to various aspects of caregiving.
Change in Peripheral Arousal
时间窗: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Holter monitor assessed 5 min ECG recordings at rest at home (enhancing ecological validity). Variables: RMSDNN (root mean sqrd standard dev. of N-N intervals), pNN50 (percent of N-N intervals less than 50 ms), LF over HF (high frequency divided by low frequency ratio; index of autonomic nervous system regulation).
Change in Blood-based Biomarker Tau
时间窗: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Neurodegenerative
Satisfaction Survey
时间窗: Single administration at 8 weeks
Survey that assesses the patient's experience and satisfaction with treatment.
Insomnia Severity Index
时间窗: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used as an outcome assessment in insomnia treatment research.
Change in Sleep Efficiency- Daily Electronic Sleep Diaries
时间窗: Daily at baseline, 8 weeks, 6 month and 12 follow up
Daily electronic dairies will record sleep efficiency
Change in Perceived Stress Scale
时间窗: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Perceived Stress Scale is a self-report measure of how life situations are perceived as stressful. The scale consists of 15 items corresponding to everyday situation and participants are asked to rate on a Likert scale from 0 (never) to 4 (very often) how
Change in Inflammation
时间窗: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Blood based biomarkers will be examined at each assessment period. Biomarkers include: inflammatory (HS-CRP, IL-6), neurodegenerative ( AβB42, tau levels)
Change in Blood-based Biomarker AβB42
时间窗: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Neurodegenerative
Daily Electronic Sleep Diaries
时间窗: Daily at baseline, 8 weeks, 6 month and 12 follow up
Completed each morning (\~5 mins) during each assessment period. Electronic daily diaries collecting self-reported information on caregiver sleep onset latency (time to fall asleep), wake after sleep onset (time awake after sleep onset to last awakening), and sleep efficiency (total sleep time divided by time in bed and multiplied by 100). We developed and tested these electronic diaries.
Change in Blood-based Biomarker Interleukin 6 IL-6)
时间窗: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Inflammation
次要结局
- Change in Cognitive Failures Questionnaire (CFQ)(Single administration at baseline, 8 weeks, 6 month and 12 follow up)
- Change in Objective Wake After Sleep Onset (Actigraph)(Daily at baseline, 8 weeks, 6 month and 12 follow up)
- Change in NIH Toolbox(Single administration at baseline, 8 weeks, 6 month and 12 follow up)
- Change in Depression (Beck Depression Inventory-II)(Single administration at baseline, 8 weeks, 6 month and 12 follow up)
- Change in Caregiver Burden (Zarit Burden Scale)(Single administration at baseline, 8 weeks, 6 month and 12 follow up)
- Change in Dementia Patient's Caregiver Quality of Life Scale(Single administration at baseline, 8 weeks, 6 month and 12 follow up)
- Change in Daily Joggle Battery(Daily at baseline, 8 weeks, 6 month and 12 follow up)
- Change in State-Trait Anxiety Inventory (STAI)(Single administration at baseline, 8 weeks, 6 month and 12 follow up)
- Change in 36-Item Short Form Survey (SF-36)(Single administration at baseline, 8 weeks, 6 month and 12 follow up)
- Change in Objective Sleep Onset Latency (Actigraph)(Daily at baseline, 8 weeks, 6 month and 12 follow up)
- Change in Objective Sleep Efficiently (Actigraph)(Daily at baseline, 8 weeks, 6 month and 12 follow up)