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Chronic insomnia affects up to 63% of family dementia caregivers. Research suggests that chronic insomnia prompts changes in central stress processing that have downstream negative effects on health and mood, as well as on cognitive, inflammatory, and neurodegenerative functioning. We hypothesize that cognitive behavioral therapy for insomnia (CBT-I) will reverse those downstream effects by improving insomnia and restoring healthy central stress processing. Rural caregivers are particularly vulnerable, but they have limited access to CBT-I; therefore, we developed an accessible digital version using community input (NiteCAPP CARES).
This trial will evaluate the acceptability, feasibility, and short-term and long-term effects of NiteCAPP CARES on the sleep and stress mechanisms underlying poor caregiver health and functioning.
Dyads (n=100) consisting of caregivers with chronic insomnia and their coresiding persons with dementia will be recruited from Columbia and surrounding areas in Missouri, United States. Participant dyads will be randomized to 4 weeks (plus 4 bimonthly booster sessions) of NiteCAPP CARES or a web-based sleep hygiene control (NiteCAPP SHARES). Participants will be assessed at baseline, after treatment, and 6- and 12-month follow-ups. The following assessments will be completed by caregivers: 1 week of actigraphy and daily diaries measuring sleep, Insomnia Severity Index, arousal (heart rate variability), inflammation (blood-derived biomarkers: interleukin-6 and C-reactive protein), neurodegeneration (blood-derived biomarkers: plasma amyloid beta [Aβ40 and Aβ42], total tau, and phosphorylated tau [p-tau181 and p-tau217]), cognition (Joggle battery, NIH Toolbox for Assessment of Neurological and Behavioral Function, and Cognitive Failures Questionnaire), stress and burden, health, and mood (depression and anxiety). Persons with dementia will complete 1 week of actigraphy at each time point.
Recruitment procedures started in February 2022. All data are expected to be collected by 2026. Full trial results are planned to be published by 2027. Secondary analyses of baseline data will be subsequently published.
This randomized controlled trial tests NiteCAPP CARES, a web-based CBT-I for rural caregivers. The knowledge obtained will address not only what outcomes improve but also how and why they improve and for how long, which will help us to modify NiteCAPP CARES to optimize treatment potency and support future pragmatic testing and dissemination.
ClinicalTrials.gov NCT04896775; https://clinicaltrials.gov/ct2/show/NCT04896775
PRR1-10.2196/37874
Approximately 16 million Americans serve as unpaid informal caregivers (CGs), providing 18.6 billion hours of care, which translates into US $244 billion in health care savings [
It has been shown by our team as well as another group of researchers that in-person brief CBT-I (bCBT-I) improves CG sleep and mood (small to large effects) [
Several considerations were taken into account in the development of NiteCAPP CARES. For instance, given prior work showing that providing CGs with behavioral sleep instructions for their persons with dementia led to improved sleep in persons with dementia (measured using actigraphy) [
Research suggests that CG chronic insomnia results in changes in central stress processing that have downstream negative effects on health and daytime functioning. CGs experience increased subjective stress and arousal because they witness the distress experienced by persons with dementia and because of the physical and time demands of caregiving [
CGs also face mental and physical health–related challenges regarding mood and cognition, as well as neurodegenerative and inflammatory biomarkers. Sleep may play a role in CGs’ high levels of anxiety and depression [
The Cognitive Activation Theory of Stress [
Conceptual model. Aim 1 (not shown) examines feasibility and acceptability of NiteCAPP CARES and NiteCAPP SHARES. Sleep change in person with dementia will be examined as an outcome (aim 4) and a potential moderator (exploratory aim: dashed lines) of the relationship between changes in caregiver (CG) primary and secondary outcomes. Refer to the Outcomes section for a list of potential mediators (eg, adherence) and moderators (eg, sleep change in person with dementia, interpersonal processes, and shared lifestyle factors). Biomarkers of neurodegeneration and inflammation will be examined as exploratory CG secondary outcomes (dotted box outline). NiteCAPP CARES: cognitive behavioral therapy for insomnia; NiteCAPP SHARES: active web-based sleep hygiene and related education control.
The base NiteCAPP platform was developed in 2019 by the study team and was based on a 4-session CBT-I treatment protocol developed by the first author (CSM) and used for research [
The overarching goal of this randomized controlled trial (RCT) is to evaluate the acceptability, feasibility, and short-term and long-term effects of NiteCAPP CARES on the sleep and stress mechanisms underlying poor CG health and functioning. Our first specific aim is to examine the feasibility and acceptability of NiteCAPP CARES and an active web control (sleep hygiene and related education [NiteCAPP SHARES]). We hypothesize that NiteCAPP CARES and NiteCAPP SHARES will have high rates of completion (≥75% of sessions), adherence (≥75% of the techniques implemented), satisfaction (≥7.5 out of 10 on the Satisfaction Survey), and utility (≥3.5 out of 5 on the Internet Intervention Utility Questionnaire).
Our second specific aim is to examine the effects of NiteCAPP CARES on the primary (mechanistic) CG outcomes in our theory-driven conceptual model; that is, to examine the effects of 4 weeks of CBT-I compared with 4 weeks of NiteCAPP SHARES on CG sleep (insomnia severity and self-reported sleep onset latency, wake time after sleep onset, and sleep efficiency) and arousal immediately after treatment and at 6- and 12-month follow-ups. We hypothesize that compared with NiteCAPP SHARES, NiteCAPP CARES will improve CG sleep and decrease arousal.
Our third specific aim is to examine the effects of NiteCAPP CARES on the secondary CG outcomes in our theory-driven conceptual model; that is, to examine the effects of 4 weeks of CBT-I compared with weeks of NiteCAPP SHARES on CG health, mood, burden, cognition, inflammation, and neurodegeneration immediately after treatment and at 6- and 12-month follow-ups. We hypothesize that compared with NiteCAPP SHARES, NiteCAPP CARES will improve these CG outcomes.
Our fourth specific aim is to test the effect of NiteCAPP CARES on persons with dementia, the secondary outcome in our theory-driven conceptual model; that is, to examine the effects of 4 weeks of CBT-I compared with 4 weeks of NiteCAPP SHARES on sleep change in persons with dementia (objective measurement through actigraphy and total sleep time) immediately after treatment and at 6- and 12-month follow-ups. We hypothesize that compared with NiteCAPP SHARES, NiteCAPP CARES will improve sleep in persons with dementia.
Our exploratory aim is to examine the relationships between CG primary and secondary outcome changes and their potential mediators (eg, adherence) and moderators (eg, sleep change in persons with dementia, interpersonal processes, and shared lifestyle factors).
Dyads (n=100) consisting of CGs with chronic insomnia and their coresiding persons with dementia will be recruited from Columbia and surrounding areas in Missouri, United States, and randomized to 4 sessions of NiteCAPP CARES or NiteCAPP SHARES. The groups will receive bimonthly boosters. Baseline and posttreatment assessments as well as 6-month and 12-month follow-ups will measure sleep, arousal, biomarkers of inflammation and neurodegeneration, health, mood, burden, and cognition.
Graduate therapists and assessors will obtain written informed consent from CGs and persons with dementia, if possible. If the person with dementia is unable to consent (determined by consultation with the first author [CSM]), a legally authorized representative must sign a consent form on their behalf. If the person with dementia becomes unable to provide consent during the course of the study, the legally authorized representative will be asked to reconsent on behalf of the care recipient. Dyads in both groups will receive US $125 at baseline, US $150 after treatment, US $175 at 6-month follow-up, and US $200 at 12-month follow-up, as well as treatment at no cost. NiteCAPP SHARES participants will be offered NiteCAPP CARES at no cost after the study.
The CG inclusion criteria are as follows: (1) aged ≥18 years, (2) CG living with persons with dementia, (3) willing to be randomized, (4) able to read and understand English, (5) diagnosed with insomnia [
The CG exclusion criteria are as follows: (1) unable to consent, (2) cognitive impairment (based on score of ≤25 on the Montreal Cognitive Assessment), (3) sleep disorder other than insomnia (ie, apnea (Apnea-Hypopnea Index score>15), (4) bipolar or seizure disorder, (5) other major psychopathology except depression or anxiety (eg, suicidal or psychotic), (6) severe untreated psychiatric comorbidity, (7) psychotropic or other medications (eg, clonidine) that alter sleep, and (8) nonpharmacological treatment for sleep or mood outside of current trial.
The inclusion criteria for persons with dementia are as follows: (1) probable or possible Alzheimer disease (self-report or primary care physician’s written confirmation), (2) at least one problem on the Nighttime Behavior Inventory ≥3 nights per week, (3) able to tolerate actigraphy, (4) not taking any new sleep medications for ≥1 month or stabilized ≥6 months, (5) untreated sleep disorder for which CBT-I is not recommended (ie, sleep apnea), and (6) scoring <32 on the sleep apnea scale on the Sleep Disorders Questionnaire.
Computer randomization will be performed by the team’s biostatistician, using a permuted block randomization technique stratified by baseline sleep medication use (yes or no) [
A sleep psychologist (principal investigator CSM) will diagnose insomnia and make referrals for other suspected sleep disorders (eg, apnea). Screening will be carried out in four stages:
Stage 1: brief screener (15 minutes). The project coordinator will (1) conduct a brief structured interview to address the inclusion and exclusion criteria and establish a probable insomnia diagnosis and (2) administer the Montreal Cognitive Assessment (CG must score >25, a cutoff chosen to maintain consistency with our prior clinical trial).
Stage 2: clinical interview (50 minutes). The assessor will (1) conduct a semistructured sleep and psychiatric interview and (2) facilitate and assist with web-based baseline questionnaire completion.
Stage 3: apnea testing (1 overnight session). This consists of 1 night of at-home sleep testing using disposable WatchPAT One devices (Itamar Medical Ltd) to rule out sleep disorders other than insomnia (ie, apnea). The assessor will instruct CGs on how to use WatchPAT One devices in their own homes so that the CGs can sleep in their own beds. Referrals will be made for those disqualified. The WatchPAT One (a wrist-worn device with 2 finger sensors) measures peripheral arterial tone, oximetry, actigraphy, HR, body position, and snoring.
Stage 4: sleep diary confirmation of insomnia (5 minutes per day). Electronic baseline diaries will confirm insomnia diagnosis and must show >30 minutes of sleep onset latency or wake after sleep onset on ≥3 nights over 7 days. Diaries will be collected electronically through Qualtrics software with personal web-enabled devices or (if needed) study-provided devices and internet service.
Both arms (NiteCAPP CARES and NiteCAPP SHARES) include 4 web-based sessions and 4 bimonthly, 20-minute boosters (
Both interventions will be dyadic, and CGs will work with persons with dementia to implement behavioral strategies similar to those used by McCrae et al [
Session and booster timeline. The randomization numbers refer to dyads (ie, caregivers and their coresiding persons with dementia). B: booster session; F6: 6-month follow-up; F12: 12-month follow-up; NiteCAPP CARES: cognitive behavioral therapy for insomnia; NiteCAPP SHARES: active web-based sleep hygiene and related education control.
Sleep hygiene will be taught, and participants are instructed to adhere to the following rules (the goal of sleep hygiene is to eliminate sleep-interfering behaviors):
avoid caffeine after noon
within 2 hours of going to bed, avoid exercise and heavy meals
within 1 hour of bedtime, avoid screen time
use the bed for sleeping only
The therapist moderator and caregiver and person with dementia will work together to create a sleep prescription and set regular bed and wake times consistent with the prescription. Caregiver and person with dementia will be instructed to practice relaxation techniques. Caregiver will be provided suggestions on how to solve the challenges associated with caregiving for a person with dementia.
Sleep prescription for caregiver and person with dementia will be updated as appropriate. Coping and stress management techniques will be taught. Caregiver and person with dementia will be taught how to identify maladaptive thoughts and replace them with balanced thoughts.
Sleep prescription for caregiver and person with dementia will be updated as appropriate. Caregiver and person with dementia will be provided information on how to maintain sleep changes.
In this brief (approximately 20 minutes) telephone session, techniques from sessions 1 to 4 will be reviewed. The therapist moderator will encourage continued practice of techniques and assist in troubleshooting of problems.
Participants are provided sleep education regarding sleep and the brain, mood, behavior, health, and weight. Sleep hygiene will be taught and participants are instructed to adhere to the following rules (the goal of sleep hygiene is to eliminate sleep-interfering behaviors):
avoid caffeine after noon
within 2 hours of going to bed, avoid exercise and heavy meals
within 1 hour of bedtime, avoid screen time
use the bed for sleeping only
Participants are provided education on sleep stages and cycles, sleep disorders, and safety precautions regarding sleep.
Participants are provided targeted sleep education and education about sleep in dementia.
Sleep prescription for caregiver and person with dementia will be updated as appropriate. Caregiver and person with dementia will be provided information on how to maintain sleep changes.
In this brief (approximately 20 minutes) telephone session, techniques from sessions 1 to 4 will be reviewed. The therapist moderator will encourage continued practice of techniques and assist in troubleshooting of problems.
The 3-step method formulated by Lichstein [
Moderators use web-based manuals. Practice begins with mock web-based sessions (ie, moderator and patient interactions), followed by web-based sessions with volunteers. The principal investigator (CSM), a licensed psychologist who is board certified in behavioral sleep medicine, will score all training sessions. Training lasts approximately 8 weeks until the moderators obtain mastery (scoring 100 on each session’s
Each week, participants will be emailed a link to their assigned session. Automatic prompts and moderator emails will be used to encourage session completion. To ensure treatment comprehension, participants will be encouraged to ask questions using the embedded communication portal. Moderators will monitor and respond within 24 hours to messages sent through the system. Web-based materials will describe and reinforce treatment content. Time spent viewing web-based sessions will be monitored and recorded. Participants will complete a brief web-based quiz at the end of session 2.
To ensure that assignments are completed (eg, relaxation session completed and instructions followed), web-based materials contain simple written instructions. Participants will maintain daily electronic diaries and logs. Participants will complete a patient satisfaction and experience survey at the posttreatment and follow-up assessments. Reasons for withdrawal will be assessed using a withdrawal questionnaire.
At the end of session 2, participants will complete a treatment credibility questionnaire. The treatment credibility questionnaire is a 4-item scale that assesses the participant’s reaction to therapist and treatment efficacy, and participants provide ratings of 1 (strongly disagree) to 10 (strongly agree). Higher scores represent better treatment credibility.
A summary of study outcome measures is provided in
Outcome measures.
Outcome category and measure | Details | ||
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Percentage of sessions completed | Percentage of sessions completed |
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Five instructions followed on logs | Percentage of instructions followed as indicated on treatment adherence logs |
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Internet Intervention |
This is a 16-item measure designed to assess usability, likeability, usefulness, understandability, and convenience of an internet intervention using a 5-point Likert scale, ranging from 0 (not at all) to 4 (very); 2 additional open-ended questions ask about the most and least helpful aspects of the program. |
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Satisfaction Survey | This is a 9-item measure designed to provide feedback on the study, including its structure, assessments, scheduling, working with study staff, and the usability of the intervention platforms using a 10-point Likert scale, ranging from 1 (strongly disagree) to 10 (strongly agree), and open-ended questions. |
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Daily sleep diaries | Daily electronic diaries assess caregiver sleep onset latency (lights out until sleep onset), wake after sleep onset, and sleep efficiency (total sleep time/time in bed × 100%). |
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Insomnia Severity Index [ |
This is a 7-item measure designed to assess the nature, severity, and impact of insomnia using a 5-point Likert scale, ranging from 0 (no problem) to 4 (very severe problem). |
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Peripheral arousal: HRVa | HRV will be assessed using a Holter monitor during an established stress reactivity protocol. Participants will be seated at rest and undergo Holter monitoring procedures: (1) 5 minutes, baseline; (2) 30 seconds, vibrotactile stimuli (Conair WM200X) at 80 Hz oscillations applied to left hand; (3) 3 minutes, recovery; (4) 30 seconds, vibrotactile stimuli applied to right hand; (5) 3 minutes, recovery; (6) cold pressor stimulation to right hand (place hand at bottom of bowl of ice water calibrated to 4 °C); (7) 3 minutes, recovery; and (8) cold pressor stimulation to left hand. Time and spectral analysis of short-term HRV during baseline, vibration, and cold pressor stimuli will be conducted using Pathfinder software (Spacelabs Healthcare). Time (reflects beat-to-beat variability: RMSSD,b pNN50c) and frequency (reflects underlying HRd rhythms: high, 0.15-0.4 Hz; low, 0.04-0.15 Hz; very low, <0.04 Hz, and LFe:HFf ratio] domains will be examined. Vibration and cold pressor hand placement order will be counterbalanced every 10 participants to account for order effects. |
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Chronic stress: hair cortisol | With permission, research staff will cut hair strands as close as possible to scalp (forearm if needed [ |
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Perceived Stress Scale [ |
This is a 10-item measure designed to assess past-month stress levels in response to everyday situations using a 4-point Likert scale ranging from 0 (never) to 4 (very often). |
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Kingston Caregiver Stress Scale [ |
This is a 10-item measure designed to assess three categories—caregiving, family, and financial issues—using a 5-point Likert scale ranging from 1 (feeling fine or no stress) to 5 (extreme stress). |
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Dysfunctional Beliefs and Attitudes about Sleep [ |
This is a 30-item measure designed to assess dysfunctional beliefs and attitudes about sleep using a 10-point Likert scale ranging from 0 (strongly disagree) to 10 (strongly agree). |
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SF-36g [ |
This is a 36-item measure designed to assess quality of life using a 5-point Likert scale ranging from 1 (poor) to 5 (excellent). |
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Beck Depression Inventory [ |
This is a 21-item measure designed to assess depressive symptomatology using a 4-point Likert scale ranging from 0 (absence of symptoms) to 3 (severe). |
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State-Trait Anxiety Inventory [ |
This is a 20-item measure designed to assess anxiety using a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so). |
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Zarit Burden Scale [ |
This is a 22-item measure designed to assess burden using a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). |
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Quality of life of caregiver of patient with dementia [ |
This is a 20-item measure designed to assess how caregiver quality of life changes after beginning caregiving using yes or no questions and a 10-point sliding scale ranging from 0 (easy) to 10 (hard). |
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Daily Joggle battery [ |
Web-based battery designed to assess daily cognitive performance in multiple domains, including processing speed and attention (psychomotor vigilance and digit symbol substitution tasks), visuospatial ability and memory (visual object learning and line orientation tasks), verbal learning and memory (auditory verbal learning task), and executive functioning and working memory (abstract matching and n-back tasks). |
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NIH Toolbox for Assessment of Neurological and Behavioral Function [ |
Computerized measure designed to assess cognitive performance in multiple domains, including processing speed and attention (pattern comparison task), visuospatial ability and memory (picture sequence learning task), verbal learning and memory (auditory verbal learning task), and executive functioning and working memory (dimensional card sort and a flanker inhibition tasks). |
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Cognitive Failures Questionnaire [ |
This is a 25-item measure designed to assess an individual’s perception of their own daily cognitive failures (eg, absentmindedness and memory errors) using a 5-point Likert scale ranging from 0 (never) to 4 (very often). |
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Blood-based biomarkers | High-sensitivity CRPh and IL-6i. Plasma proteins are digested with trypsin, and peptides specific for CRP and IL6 are quantified using multiple reaction monitoring mass spectrometry. |
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Blood-based biomarkers | Aβj40/42, tau, p-tauk-181, and p-tau-217. Plasma is extracted (Aβ40/42), or plasma proteins are digested with trypsin, and peptides are quantified using multiple reaction monitoring mass spectrometry. |
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Actiwatch 2 (Philips Respironics) is a watch-like device that will be worn 24/7 during each 1-week assessment to monitor light and gross motor activity. Data will be analyzed using 30-second epochs and a validated algorithm (Actiware-Sleep version 3.3; Mini Mitter Co, Inc) to estimate total wake time. | |
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Demographics | Socioeconomic status, race and ethnicity, education level, marital status, financial strain, residence, menopause symptoms, medications, comorbidities, distance (miles) to the nearest provider, and rurality (Rurality Index [ |
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Patient-Caregiver Functional Unit Scale [ |
This is a 43-item measure designed to assess how much assistance the person with dementia needs and caregiver feelings about helping using yes or no questions and 2 types of Likert scales: a 3-point scale ranging from 0 (without help) to 2 (completely unable) and a 4-point scale ranging from 0 (no) to 3 (both physically and emotionally difficult). |
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Godin-Shephard Leisure-Time Physical Activity Questionnaire [ |
This is a 3-item measure designed to assess how many times per week an individual engages in mild, moderate, or strenuous activity and asks the number of times per week the items were accomplished. |
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Fruit and vegetable servings | Amount of fruit and vegetable servings per day |
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Respite | Amount and type of respite |
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Assistance | Assistance provided by secondary informal caregivers (number, relationship, hours: face-to-face vs other). |
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Dementia Severity Rating Scale [ |
This is an 11-item measure designed to assess severity of functional and cognitive decline in patients with Alzheimer disease using various Likert scales. |
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Neuropsychology Inventory Nighttime Behavior Scale [ |
This is an 8-item measure designed to assess frequency and severity of detrimental sleep behaviors, such as wandering, in the dementia patient using yes or no questions. |
aHRV: heart rate variability.
bRMSSD: root mean square of successive RR interval differences. RR interval is the time between 2 detected heartbeats, calculated for every QRS event.
cpNN50: The proportion of NN50 divided by the total number of NN (R-R) intervals. NN50 is the number of times successive heartbeat intervals exceed 50 ms. RR interval is the time between 2 detected heartbeats, calculated for every QRS event. NN interval is the time (normalized) between 2 detected heartbeats, calculated for every QRS event.
dHR: heart rate.
eLF: low frequency.
fHF: high frequency.
gSF-36: Short Form-36 Health Survey Questionnaire.
hCRP: C-reactive protein.
iIL-6: interleukin-6.
jAβ: plasma amyloid beta.
kp-tau: phosphorylated tau.
Schedule of outcome measures.
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Baseline | Treatment | After treatment | Boosters | 6-month follow-up | 12-month follow-up |
Assessment period, weeks | 1 | 4 | 1 | 1 | 1 | 1 |
Screening, apnea testing, consent and assent, and demographics | ✓ |
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HRV,a ISI,b PSS,c KCGSS,d inflammation and neurodegeneration biomarkers, cortisol, actigraphy, SF-36,e BDI,f STAI,g DBS,h ZBS,i QoL,j daily Joggle battery, NIH Toolbox for Assessment of Neurological and Behavioral Function, CFQ,k P-CG FUS,l G-S L-T PAQ,m fruit and vegetable servings per day, respite, secondary CGn outcomes, DSRS,o NPI,p and NBSq | ✓ |
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✓ |
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✓ | ✓ |
Electronic daily diaries | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
aHRV: heart rate variability.
bISI: Insomnia Severity Index.
cPSS: Perceived Stress Scale.
dKCGSS: Kingston Caregiver Stress Scale.
eSF-36: Short Form-36 Health Survey Questionnaire.
fBDI: Beck Depression Inventory.
gSTAI: State-Trait Anxiety Inventory.
hDBS: Dysfunctional Beliefs about Sleep.
iZBS: Zarit Burden Scale.
jQoL: Quality of life of caregiver of patient with dementia.
kCFQ: Cognitive Failures Questionnaire.
lP-CG FUS: Patient-Caregiver Functional Unit Scale.
mG-S L-T PAQ: Godin-Shephard Leisure-Time Physical Activity Questionnaire.
nCG: caregiver.
oDSRS: Dementia Severity Rating Scale.
pNPI: Neuropsychological Inventory.
qNBS: Nighttime Behavior Scale.
Schedule of process measures.
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Baseline | Treatment | After treatment | Boosters | 6-month follow-up | 12-month follow-up |
Assessment period (weeks) | 1 | 4 | 1 | 1 | 1 | 1 |
Treatment integrity: delivery and receipt and enactment |
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✓ |
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✓ |
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Treatment credibility: quiz and improvement expectancy |
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✓ | ✓ |
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✓ | ✓ |
Sleep knowledge and working alliance |
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✓ | ✓ | ✓ | ✓ | ✓ |
The study timeline is provided in
Study timeline.
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Project year | ||||||||||
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1 | 2 | 3 | 4 | 5 | ||||||
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First half | Second half | First half | Second half | First half | Second half | First half | Second half | First half | Second half | |
Develop manual of operating procedures, register with ClinicalTrials.gov, publish trial protocol, and train moderators and assessors | ✓ |
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Recruit, collect baseline measurements, and deliver treatment |
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✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
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Collect assessment after treatment |
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✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
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Collect 6- and 12-month follow-up assessments |
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✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
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Offer and provide NiteCAPP CARESa to NiteCAPP SHARESb participants |
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✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Final data analysis and dissemination (continues after grant ends) and final report |
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✓ | ✓ |
aNiteCAPP CARES: cognitive behavioral therapy for insomnia.
bNiteCAPP SHARES: active web-based sleep hygiene and related education control.
Power will be simulated using SAS 9.4 statistical software (SAS Institute Inc) using a generalized estimating equations (GEE) design (clusters are individuals measured over 4 time points) with an autoregressive working correlation structure (correlation decreases as time point distance increases,
All analyses will use intent-to-treat using all randomized participants. All assumptions will be tested. If the normality assumption is violated, the nonparametric Mann-Whitney
The feasibility and acceptability of NiteCAPP CARES and NiteCAPP SHARES will be evaluated using average completion rates (number of sessions completed), adherence (measured through sleep diaries and logs), and satisfaction and utility ratings. These variables will be compared for NiteCAPP CARES and NiteCAPP SHARES using independent samples 2-tailed
A mediated GEE model [
Mediated generalized estimating equations model. Analyses will also be conducted examining the paths from after treatment to 6-month follow-up and from 6-month follow-up to 12-month follow-up. Base: baseline; CG: caregiver; F6: 6-month follow-up; F12: 12-month follow-up; NiteCAPP CARES: cognitive behavioral therapy for insomnia; NiteCAPP SHARES: active web-based sleep hygiene and related education control; Post: after treatment.
We will evaluate primary and secondary outcome change relationships and their potential mediators and moderators (
The SAS PROC GEE weighted model handles missing data completely at random or at random. When measures are collected over time, some participants may not complete the study. Unlike repeated measures ANOVA, which excludes them from analysis, weighted GEE retains them (increasing power and producing unbiased estimates).
Patients and the public are not involved in any of the following study procedures: development of research questions and outcome measures or plan for results dissemination. The Community Advisory Board (CAB) will assess the burden of the intervention and may help with recruitment. Every participant will fill out a patient satisfaction and experience survey after treatment and at 6-month and 12-month follow-ups. This questionnaire asks CGs and persons with dementia which modules were most and least useful for them, how they felt about the length of the program, suitability for CGs and persons with dementia, and so on. Trial results will be communicated to participants and the public through peer-reviewed manuscripts.
All procedures were approved by the University of Missouri Institutional Review Board on May 6, 2021 (2053682); safety officer Dr Susan McCurry on November 24, 2021; the National Institute of Aging (NIA) on January 26, 2022; and the University of South Florida Institutional Review Board on March 10, 2022 (003936). The NIA and the safety officer reviewed and approved the study protocol, manual of operating procedures, informed consent form, and monitoring plan with emphasis on data integrity and patient safety issues in November 2021. The safety officer will review these biannually. Any changes to these procedures that are recommended by the safety officer will be adopted with institutional review board and NIA approval. The safety officer will review adverse events and monitor study results, focusing on efficacy, recruitment progress, randomization, compliance, retention, protocol adherence, operating procedures, forms completion, intervention effects, participant safety, and minority inclusion. The principal investigator (CSM) registered the study with ClinicalTrials.gov (NCT04896775) on May 21, 2021, and will submit annual reports to the funding agency.
Our team includes a CAB comprising 8 CGs, 4 persons with dementia, and 4 local experts. The CAB structure and procedures are based on the CAB Toolkit described by Kubicek and Robles [
This work is supported by the National Institutes of Health’s NIA (R01AG066081). Recruitment procedures started in February 2022. All data are expected to be collected by 2026. Full trial results are planned to be published by 2027. Secondary analyses of baseline data will be subsequently published.
We will present the findings at national conferences, including the Associated Professional Sleep Societies (APSS or SLEEP) and the Gerontological Society of America, in the final year of the project. An abstract reporting the findings of the preproposal focus group was presented at the August 2020 internet-based SLEEP meeting, and a brief report based on these findings is currently under review. The web-based treatment materials will be shared electronically and will be widely available to clinicians. The findings will also be disseminated to the dementia and dementia caregiving communities through websites and other resources. The team’s community CG advocate and CAB will be involved in planning for broad dissemination to the dementia and CG communities. They will also help to ensure that materials used to disseminate findings are written for, and easily understood by, lay audiences in rural areas.
The overarching goal of this RCT is to evaluate the acceptability, feasibility, and short-term and long-term effects of NiteCAPP CARES on the sleep and stress mechanisms underlying poor CG health and functioning. To the best of our knowledge, there is no current web-based CBT-I treatment that is tailored for CGs of persons with dementia and none that involve the person with dementia in treatment.
This study includes several strengths. It is a novel 4-week web-based CBT-I (NiteCAPP CARES) in CGs and persons with dementia (using a dyadic approach) that integrates sleep education, sleep hygiene, stimulus control, sleep compression, relaxation, problem solving, coping and stress management, and cognitive restructuring techniques. This study uses a rigorous methodology and NiteCAPP CARES will be examined in comparison with an active web control (NiteCAPP SHARES). Long-term follow-ups at 6 and 12 months will enable examination of the persistence of the behavioral outcomes of NiteCAPP CARES. The potential limitations include participant attrition at follow-up, which may contribute to selection bias associated with systematic differences between participants completing NiteCAPP CARES and those completing NiteCAPP SHARES.
Future directions for this RCT include a multisite effectiveness trial to determine generalizability across different areas. In addition, once NiteCAPP CARES is enhanced based on the results of this RCT, it needs to be tested within other populations (nonrural CGs and other underserved populations) for broader dissemination. Finally, dismantling studies could examine the most effective components of NiteCAPP CARES treatment to further streamline the treatment.
This RCT tests NiteCAPP CARES, a web-based CBT-I for rural CGs. The Cognitive Activation Theory of Stress and our research as well as research conducted by others [
Peer-reviewer report from the Center for Scientific Review Special Emphasis Panel Member Conflict: Stress, Sleep, Disparities, and Aging (National Institutes of Health, USA).
autonomic nervous system
plasma amyloid beta
brief cognitive behavioral therapy for insomnia
Community Advisory Board
cognitive behavioral therapy for insomnia
caregiver
generalized estimating equations
heart rate
heart rate variability
cognitive behavioral therapy for insomnia
active web-based sleep hygiene and related education control
randomized controlled trial
The authors would like to acknowledge the ongoing contributions and support from study participants as well as the study staff (research assistants and other site staff) responsible for trial setup, participant recruitment, data collection, and data management. This work is supported by the National Institute on Aging of the National Institutes of Health (R01AG066081).
The study sponsor was not actively responsible or involved in the study design and will have no involvement in collection, management, analysis, or interpretation of data. The sponsor will have no involvement in future manuscript preparation and decision to submit for publication. This research was conducted using previous patient involvement in the pilot study. Patients were invited to comment on the feasibility and acceptability design of NiteCAPP CARES, and they indicated that more simple language would be preferable. In response, for this randomized controlled trial, we edited NiteCAPP CARES to simplify the language. Patients were invited to contribute to the writing and editing of this document for readability or accuracy.
All authors made substantial contributions to the concept and design of the study. CSM and AFC drafted the initial protocol, with input from all authors. MG and AFC drafted the statistical analysis plan. CSM and BM drafted the biomarker data collection plan. MP assisted in web development. CSM and DQB drafted the screening procedures. DQB, JS, and MR drafted the recruitment and referral procedures. MG, NN, and AFC conducted the initial data processing. CSM, AFC, MAS, and AS drafted the manuscript. CSM, AFC, MAS, and AS revised the manuscript. All authors reviewed and approved the revised manuscript.
DBB has consulted for Yamo Pharmaceuticals LLC, Impel Pharmaceuticals Inc, Quadrant Biosciences, Stalicla Biosciences, and Scioto Biosciences Inc, and has spoken for Biogen Inc not related to their product. None of these are related to the work herein.