NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers
- Conditions
- InsomniaDementia
- Interventions
- Behavioral: NiteCAPP CARESBehavioral: NiteCAPP SHARES
- Registration Number
- NCT04896775
- Lead Sponsor
- University of South Florida
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NiteCAPP CARES 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. NiteCAPP SHARES 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.
- Primary Outcome Measures
Name Time Method Completion Single administration at 8 weeks Percentage of sessions completed out of the 4 sessions/modules included in NiteCAPP and WebSHE.
Adherence 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 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 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) 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 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 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 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 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 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) 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 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 Single blood draw at baseline, 8 weeks, 6 month and 12 follow up Neurodegenerative
Satisfaction Survey Single administration at 8 weeks Survey that assesses the patient's experience and satisfaction with treatment.
Insomnia Severity Index 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 Daily at baseline, 8 weeks, 6 month and 12 follow up Daily electronic dairies will record sleep efficiency
Change in Perceived Stress Scale 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 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 Single blood draw at baseline, 8 weeks, 6 month and 12 follow up Neurodegenerative
Daily Electronic Sleep Diaries 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) Single blood draw at baseline, 8 weeks, 6 month and 12 follow up Inflammation
- Secondary Outcome Measures
Name Time Method Change in Cognitive Failures Questionnaire (CFQ) Single administration at baseline, 8 weeks, 6 month and 12 follow up A 25-item scale measuring subjective cognition. Caregivers rate on a scale of 0 (never) to 4 (very often) how often they experience cognitive mistakes and errors in daily tasks.
Change in Objective Wake After Sleep Onset (Actigraph) Daily at baseline, 8 weeks, 6 month and 12 follow up Wake after sleep onset via Actiwatch-2
Change in NIH Toolbox Single administration at baseline, 8 weeks, 6 month and 12 follow up Caregivers will complete this 20-min computerized battery in single sitting. Domains tested include processing speed and attention, visuospatial ability and memory, verbal learning and memory, and executive functioning and working memory. Cognitive domains tested are ones that research has shown are impacted by caregiving.
Change in Depression (Beck Depression Inventory-II) Single administration at baseline, 8 weeks, 6 month and 12 follow up BDI contains 21 items that measure severity of depressive symptomatology on a three-point scale (0 = absence of symptoms, 3 = most severe). Respondents answer for the previous week. Total scores range from 0 to 63. Ranges for clinical levels of depression are 0 to 13 (minimal), 14 to 19 (mild), 20 to 28 (moderate), and 29 to 63 (severe).
Change in Caregiver Burden (Zarit Burden Scale) Single administration at baseline, 8 weeks, 6 month and 12 follow up Self-report measure of caregiver burden. 12-item scale that asks caregivers to rate from never (0) to nearly always (4) how often they experience feelings of stress or burden across various aspects and situations of caregiving.
Change in Dementia Patient's Caregiver Quality of Life Scale Single administration at baseline, 8 weeks, 6 month and 12 follow up A 20-item questionnaire measuring the CG's quality of life.
Change in Daily Joggle Battery Daily at baseline, 8 weeks, 6 month and 12 follow up Completed each morning (\~15-mins) for 7 days during each assessment period. Caregivers will complete this online neuropsychological battery. Practice effects limited by: 16 versions, randomized presentation order, and 12 or more wks before repeating any version. Domains tested include processing speed and attention, visuospatial ability and memory, verbal learning and memory, and executive functioning and working memory. Cognitive domains tested are ones that research has shown are impacted by caregiving. Daily testing enhances ecological validity.
Change in State-Trait Anxiety Inventory (STAI) Single administration at baseline, 8 weeks, 6 month and 12 follow up Inventory that asks respondents to rate how true 20 self-descriptive statements (e.g., I feel calm) are on a 4-point scale (1 = not at all, 4 = very much so). Typically, respondents are asked to rate statements according to how they generally feel (trait-anxiety scale) and how they feel in the current moment (state-anxiety scale). Total scores range from 20 to 80, with higher scores indicating greater maladjustment.
Change in 36-Item Short Form Survey (SF-36) Single administration at baseline, 8 weeks, 6 month and 12 follow up The SF-36 is a 36-item scale that assesses health status and quality of life The SF-36 includes eight domains: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems); bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. Participants respond based on how they have felt over the previous week. The items use Likert-type scales, some with 5 or 6 points and others with 2 or 3 points. The SF-36 is a sensitive indicator of CG mental and physical health.
Change in Objective Sleep Onset Latency (Actigraph) Daily at baseline, 8 weeks, 6 month and 12 follow up Sleep Onset Latency via Actiwatch-2
Change in Objective Sleep Efficiently (Actigraph) Daily at baseline, 8 weeks, 6 month and 12 follow up Sleep Efficiency via Actiwatch-2
Trial Locations
- Locations (1)
University of South Florida
🇺🇸Tampa, Florida, United States