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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
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.
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.
University of South Florida
Tampa, Florida, United States
RECRUITINGCompletion
Percentage of sessions completed out of the 4 sessions/modules included in NiteCAPP and WebSHE.
Time frame: Single administration at 8 weeks
Adherence
Percentage of the intervention instructions followed as indicated on the treatment adherence logs completed each day during treatment.
Time frame: Single administration at 8 weeks
Internet Intervention Utility Questionnaire
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
Time frame: Single administration at 8 weeks
Satisfaction Survey
Survey that assesses the patient's experience and satisfaction with treatment.
Time frame: Single administration at 8 weeks
Insomnia Severity Index
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.
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Daily Electronic Sleep Diaries
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.
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
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Change in Pain Intensity - Daily Electronic Sleep Diaries
Daily electronic dairies will record pain intensity; range: 0-100 (no pain- most intense)
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in Pain Unpleasantness - Daily Electronic Sleep Diaries
Daily electronic dairies will record pain unpleasantness; range: 0-100 (none- most unpleasantness)
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries
Daily electronic dairies will record wake after sleep onset (number of minutes)
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in Sleep Onset Latency- Daily Electronic Sleep Diaries
Daily electronic dairies will record sleep onset latency (number of minutes)
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in Sleep Efficiency- Daily Electronic Sleep Diaries
Daily electronic dairies will record sleep efficiency
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in Fatigue - Daily Electronic Sleep Diaries
Daily electronic dairies will record insomnia severity; range: 0-100 (no insomnia - most severe)
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries
Daily electronic dairies will record daily medication consumption
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in Perceived Stress Scale
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
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Kingston Caregiver Stress Scale (KCSS)
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.
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Dysfunctional Beliefs About Sleep (DBAS)
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.
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Peripheral Arousal
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).
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Inflammation
Blood based biomarkers will be examined at each assessment period. Biomarkers include: inflammatory (HS-CRP, IL-6), neurodegenerative ( AβB42, tau levels)
Time frame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Change in Blood-based Biomarker Interleukin 6 IL-6)
Inflammation
Time frame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Change in Blood-based Biomarker AβB42
Neurodegenerative
Time frame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Change in Blood-based Biomarker Tau
Neurodegenerative
Time frame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Change in State-Trait Anxiety Inventory (STAI)
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.
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Depression (Beck Depression Inventory-II)
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).
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in 36-Item Short Form Survey (SF-36)
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.
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Caregiver Burden (Zarit Burden Scale)
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.
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Cognitive Failures Questionnaire (CFQ)
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.
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Dementia Patient's Caregiver Quality of Life Scale
A 20-item questionnaire measuring the CG's quality of life.
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Objective Wake After Sleep Onset (Actigraph)
Wake after sleep onset via Actiwatch-2
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in Objective Sleep Onset Latency (Actigraph)
Sleep Onset Latency via Actiwatch-2
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in Objective Sleep Efficiently (Actigraph)
Sleep Efficiency via Actiwatch-2
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in NIH Toolbox
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.
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Daily Joggle Battery
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.
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up