InsomniaNiteCAPPNCT04896775
NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers
A study testing NiteCAPP CARES and NiteCAPP SHARES in people with Insomnia and Dementia, run by University of South Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- NiteCAPP CARES and NiteCAPP SHARES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2022to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caregiver Eligibility. Inclusion criteria: 1. 18+ yrs, 2. CG living with PWD, 3. willing to be randomized, 4. read/understand English, 5. insomnia diagnosis, 6. no prescribed or over the counter sleep meds for 1+ mo, or stabilized 6+ mos.
- Insomnia: 1. complaints for 6+ mos, 2. adequate opportunity and circumstances for sleep, 3. 1+ of the following: difficulty falling asleep, staying asleep or waking too early, 4. daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, 5. baseline diaries indicate >30 mins of sleep onset latency or wake after sleep onset on 3+ nts.
- PWD Eligibility. 1. probable/possible Alzheimer's Disease (self-report or primary care provider written confirm), 2. 1+ problem on Nighttime Behavior Inv. 3+ nts/wk, 3. tolerate actigraphy, 4. no sleep meds 1+ mo or stabilized 6+ mos, 5. untreated sleep disorder for which CBT-I is not recommended (e.g., apnea), 6. scoring <32 on Sleep Apnea scale, Sleep Disorders Ques.
Who cannot join
- CG Exclusion criteria: 1. unable to consent, 2. cognitive impairment [Telephone Interview for Cognitive Status (TICS) <25], 3. sleep disorder other than insomnia [i.e., apnea (apnea/hypopnea index-AHI >15)], 4. bipolar or seizure disorder, 5. other major psychopathology except depression or anxiety (e.g., suicidal, psychotic), 6. severe untreated psychiatric comorbidity, 7. psychotropic or other medications (e.g., beta-blockers) that alter sleep, 8. non-pharmacological tx for sleep or mood outside current trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of South Florida
Tampa, Florida, 33612
Christina McCrae, 813-974-1804, christinamccrae@usf.edu
About this study
Official title: NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers: Examination of Sleep, Arousal, Mood, Cognitive, and Immune Outcomes
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.
Read the 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.
- Being tested
- NiteCAPP CARES, NiteCAPP SHARES
- Keywords
- Dementia Caregiver
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiteCAPP CARESBehavioural
Also called Web CBT-I
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 SHARESBehavioural
Also called Web Sleep Hygiene and Related Education (Web-SHARE)
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.
| Study group | Role | What they receive |
|---|---|---|
| NiteCAPP CARES | Experimental | 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. Receives: Behavioral: NiteCAPP CARES |
| NiteCAPP SHARES | Experimental | 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. Receives: Behavioral: NiteCAPP SHARES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion
Percentage of sessions completed out of the 4 sessions/modules included in NiteCAPP and WebSHE.
Measured: Single administration at 8 weeks
Adherence
Percentage of the intervention instructions followed as indicated on the treatment adherence logs completed each day during treatment.
Measured: 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
Measured: Single administration at 8 weeks
Satisfaction Survey
Survey that assesses the patient's experience and satisfaction with treatment.
Measured: 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.
Measured: 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.
Measured: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in Pain Intensity - Daily Electronic Sleep Diaries
Daily electronic dairies will record pain intensity; range: 0-100 (no pain- most intense)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Change in Blood-based Biomarker Interleukin 6 IL-6)
Inflammation
Measured: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Change in Blood-based Biomarker AβB42
Neurodegenerative
Measured: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Change in Blood-based Biomarker Tau
Neurodegenerative
Measured: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Secondary outcomes (11)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in Objective Sleep Onset Latency (Actigraph)
Sleep Onset Latency via Actiwatch-2
Measured: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in Objective Sleep Efficiently (Actigraph)
Sleep Efficiency via Actiwatch-2
Measured: 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.
Measured: 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.
Measured: Daily at baseline, 8 weeks, 6 month and 12 follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start2 Feb 2022
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina S McCrae, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896775
- Sponsor's protocol ID
- STUDY004494
- Acronym
- NiteCAPP
- Status last verified
- Apr 2026
- First submitted
- 5 May 2021
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ory MG, Hoffman RR 3rd, Yee JL, Tennstedt S, Schulz R. Prevalence and impact of caregiving: a detailed comparison between dementia and nondementia caregivers. Gerontologist. 1999 Apr;39(2):177-85. doi: 10.1093/geront/39.2.177.
PubMed 10224714Rowe MA, McCrae CS, Campbell JM, Benito AP, Cheng J. Sleep pattern differences between older adult dementia caregivers and older adult noncaregivers using objective and subjective measures. J Clin Sleep Med. 2008 Aug 15;4(4):362-9.
PubMed 18763429Vitaliano PP, Murphy M, Young HM, Echeverria D, Borson S. Does caring for a spouse with dementia promote cognitive decline? A hypothesis and proposed mechanisms. J Am Geriatr Soc. 2011 May;59(5):900-8. doi: 10.1111/j.1532-5415.2011.03368.x.
PubMed 21568959Joling KJ, van Hout HP, Schellevis FG, van der Horst HE, Scheltens P, Knol DL, van Marwijk HW. Incidence of depression and anxiety in the spouses of patients with dementia: a naturalistic cohort study of recorded morbidity with a 6-year follow-up. Am J Geriatr Psychiatry. 2010 Feb;18(2):146-53. doi: 10.1097/JGP.0b013e3181bf9f0f.
PubMed 20104070Markowitz JS, Gutterman EM, Sadik K, Papadopoulos G. Health-related quality of life for caregivers of patients with Alzheimer disease. Alzheimer Dis Assoc Disord. 2003 Oct-Dec;17(4):209-14. doi: 10.1097/00002093-200310000-00003.
PubMed 14657784Curtis AF, Williams JM, McCoy KJM, McCrae CS. Chronic Pain, Sleep, and Cognition in Older Adults With Insomnia: A Daily Multilevel Analysis. J Clin Sleep Med. 2018 Oct 15;14(10):1765-1772. doi: 10.5664/jcsm.7392.
PubMed 30353817McCrae CS, Dzierzewski JM, McNamara JP, Vatthauer KE, Roth AJ, Rowe MA. Changes in Sleep Predict Changes in Affect in Older Caregivers of Individuals with Alzheimer's Dementia: A Multilevel Model Approach. J Gerontol B Psychol Sci Soc Sci. 2016 May;71(3):458-62. doi: 10.1093/geronb/gbu162. Epub 2014 Nov 26.
PubMed 25429026McCrae CS, Vatthauer KE, Dzierzewski JM, Marsiske M. Habitual Sleep, Reasoning, and Processing Speed in Older Adults with Sleep Complaints. Cognit Ther Res. 2012 Apr;36(2):156-164. doi: 10.1007/s10608-011-9425-4.
PubMed 23243328Livingston WS, Rusch HL, Nersesian PV, Baxter T, Mysliwiec V, Gill JM. Improved Sleep in Military Personnel is Associated with Changes in the Expression of Inflammatory Genes and Improvement in Depression Symptoms. Front Psychiatry. 2015 Apr 30;6:59. doi: 10.3389/fpsyt.2015.00059. eCollection 2015.
PubMed 25983695Heinzelmann M, Lee H, Rak H, Livingston W, Barr T, Baxter T, Scattergood-Keepper L, Mysliwiec V, Gill J. Sleep restoration is associated with reduced plasma C-reactive protein and depression symptoms in military personnel with sleep disturbance after deployment. Sleep Med. 2014 Dec;15(12):1565-70. doi: 10.1016/j.sleep.2014.08.004. Epub 2014 Sep 10.
PubMed 25311836McCrae CS, Curtis AF, Cottle A, Beversdorf DB, Shenker J, Mooney BP, Popescu M, Rantz M, Groer M, Stein P, Golzy M, Stearns MA, Simenson A, Nair N, Rowe MA. Impact of Web-Based Cognitive Behavioral Therapy for Insomnia on Stress, Health, Mood, Cognitive, Inflammatory, and Neurodegenerative Outcomes in Rural Dementia Caregivers: Protocol for the NiteCAPP CARES and NiteCAPP SHARES Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 14;11(6):e37874. doi: 10.2196/37874.
PubMed 35700020
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers: Examination of Sleep, Arousal, Mood, Cognitive, and Immune Outcomes
- ClinicalTrials.gov ID
- NCT04896775
- Acronym / sponsor ID
- NiteCAPP / STUDY004494
- Keywords
- Dementia Caregiver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NiteCAPP CARES | Experimental | Behavioral: NiteCAPP CARESCognitive 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 | Experimental | Behavioral: NiteCAPP SHARESSleep 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Caregiver Eligibility. Inclusion criteria: 1. 18+ yrs, 2. CG living with PWD, 3. willing to be randomized, 4. read/understand English, 5. insomnia diagnosis, 6. no prescribed or over the counter sleep meds for 1+ mo, or stabilized 6+ mos.
- Insomnia: 1. complaints for 6+ mos, 2. adequate opportunity and circumstances for sleep, 3. 1+ of the following: difficulty falling asleep, staying asleep or waking too early, 4. daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, 5. baseline diaries indicate >30 mins of sleep onset latency or wake after sleep onset on 3+ nts.
- PWD Eligibility. 1. probable/possible Alzheimer's Disease (self-report or primary care provider written confirm), 2. 1+ problem on Nighttime Behavior Inv. 3+ nts/wk, 3. tolerate actigraphy, 4. no sleep meds 1+ mo or stabilized 6+ mos, 5. untreated sleep disorder for which CBT-I is not recommended (e.g., apnea), 6. scoring <32 on Sleep Apnea scale, Sleep Disorders Ques.
Key exclusion criteria (1 listed)
- CG Exclusion criteria: 1. unable to consent, 2. cognitive impairment [Telephone Interview for Cognitive Status (TICS) <25], 3. sleep disorder other than insomnia [i.e., apnea (apnea/hypopnea index-AHI >15)], 4. bipolar or seizure disorder, 5. other major psychopathology except depression or anxiety (e.g., suicidal, psychotic), 6. severe untreated psychiatric comorbidity, 7. psychotropic or other medications (e.g., beta-blockers) that alter sleep, 8. non-pharmacological tx for sleep or mood outside current trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiteCAPP CARESAlso: Web CBT-IWeb-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. | Behavioural | NiteCAPP CARES |
| NiteCAPP SHARESAlso: Web Sleep Hygiene and Related Education (Web-SHARE)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. | Behavioural | NiteCAPP SHARES |
Primary outcome
Completion
Time frame: Single administration at 8 weeks
Percentage of sessions completed out of the 4 sessions/modules included in NiteCAPP and WebSHE.
Adherence
Time frame: Single administration at 8 weeks
Percentage of the intervention instructions followed as indicated on the treatment adherence logs completed each day during treatment.
Internet Intervention Utility Questionnaire
Time frame: 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
Satisfaction Survey
Time frame: Single administration at 8 weeks
Survey that assesses the patient's experience and satisfaction with treatment.
Insomnia Severity Index
Time frame: 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.
Daily Electronic Sleep Diaries
Time frame: 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 Pain Intensity - Daily Electronic Sleep Diaries
Time frame: 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 Pain Unpleasantness - Daily Electronic Sleep Diaries
Time frame: 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
Time frame: 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
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Daily electronic dairies will record sleep onset latency (number of minutes)
Change in Sleep Efficiency- Daily Electronic Sleep Diaries
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Daily electronic dairies will record sleep efficiency
Change in Fatigue - Daily Electronic Sleep Diaries
Time frame: 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 Sleep and Pain Medication - Daily Electronic Sleep Diaries
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Daily electronic dairies will record daily medication consumption
Change in Perceived Stress Scale
Time frame: 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 Kingston Caregiver Stress Scale (KCSS)
Time frame: 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 Dysfunctional Beliefs About Sleep (DBAS)
Time frame: 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.
Change in Peripheral Arousal
Time frame: 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 Inflammation
Time frame: 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 Interleukin 6 IL-6)
Time frame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Inflammation
Change in Blood-based Biomarker AβB42
Time frame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Neurodegenerative
Change in Blood-based Biomarker Tau
Time frame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Neurodegenerative
11 secondary outcomes
Change in State-Trait Anxiety Inventory (STAI)
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Depression (Beck Depression Inventory-II)
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in 36-Item Short Form Survey (SF-36)
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Caregiver Burden (Zarit Burden Scale)
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Cognitive Failures Questionnaire (CFQ)
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Dementia Patient's Caregiver Quality of Life Scale
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Objective Wake After Sleep Onset (Actigraph)
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in Objective Sleep Onset Latency (Actigraph)
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in Objective Sleep Efficiently (Actigraph)
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Change in NIH Toolbox
Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
Change in Daily Joggle Battery
Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 10224714Ory MG, Hoffman RR 3rd, Yee JL, Tennstedt S, Schulz R. Prevalence and impact of caregiving: a detailed comparison between dementia and nondementia caregivers. Gerontologist. 1999 Apr;39(2):177-85. doi: 10.1093/geront/39.2.177.
- Background: PubMed 18763429Rowe MA, McCrae CS, Campbell JM, Benito AP, Cheng J. Sleep pattern differences between older adult dementia caregivers and older adult noncaregivers using objective and subjective measures. J Clin Sleep Med. 2008 Aug 15;4(4):362-9.
- Background: PubMed 21568959Vitaliano PP, Murphy M, Young HM, Echeverria D, Borson S. Does caring for a spouse with dementia promote cognitive decline? A hypothesis and proposed mechanisms. J Am Geriatr Soc. 2011 May;59(5):900-8. doi: 10.1111/j.1532-5415.2011.03368.x.
- Background: PubMed 20104070Joling KJ, van Hout HP, Schellevis FG, van der Horst HE, Scheltens P, Knol DL, van Marwijk HW. Incidence of depression and anxiety in the spouses of patients with dementia: a naturalistic cohort study of recorded morbidity with a 6-year follow-up. Am J Geriatr Psychiatry. 2010 Feb;18(2):146-53. doi: 10.1097/JGP.0b013e3181bf9f0f.
- Background: PubMed 14657784Markowitz JS, Gutterman EM, Sadik K, Papadopoulos G. Health-related quality of life for caregivers of patients with Alzheimer disease. Alzheimer Dis Assoc Disord. 2003 Oct-Dec;17(4):209-14. doi: 10.1097/00002093-200310000-00003.
- Background: PubMed 30353817Curtis AF, Williams JM, McCoy KJM, McCrae CS. Chronic Pain, Sleep, and Cognition in Older Adults With Insomnia: A Daily Multilevel Analysis. J Clin Sleep Med. 2018 Oct 15;14(10):1765-1772. doi: 10.5664/jcsm.7392.
- Background: PubMed 25429026McCrae CS, Dzierzewski JM, McNamara JP, Vatthauer KE, Roth AJ, Rowe MA. Changes in Sleep Predict Changes in Affect in Older Caregivers of Individuals with Alzheimer's Dementia: A Multilevel Model Approach. J Gerontol B Psychol Sci Soc Sci. 2016 May;71(3):458-62. doi: 10.1093/geronb/gbu162. Epub 2014 Nov 26.
- Background: PubMed 23243328McCrae CS, Vatthauer KE, Dzierzewski JM, Marsiske M. Habitual Sleep, Reasoning, and Processing Speed in Older Adults with Sleep Complaints. Cognit Ther Res. 2012 Apr;36(2):156-164. doi: 10.1007/s10608-011-9425-4.
- Background: PubMed 25983695Livingston WS, Rusch HL, Nersesian PV, Baxter T, Mysliwiec V, Gill JM. Improved Sleep in Military Personnel is Associated with Changes in the Expression of Inflammatory Genes and Improvement in Depression Symptoms. Front Psychiatry. 2015 Apr 30;6:59. doi: 10.3389/fpsyt.2015.00059. eCollection 2015.
- Background: PubMed 25311836Heinzelmann M, Lee H, Rak H, Livingston W, Barr T, Baxter T, Scattergood-Keepper L, Mysliwiec V, Gill J. Sleep restoration is associated with reduced plasma C-reactive protein and depression symptoms in military personnel with sleep disturbance after deployment. Sleep Med. 2014 Dec;15(12):1565-70. doi: 10.1016/j.sleep.2014.08.004. Epub 2014 Sep 10.
- Derived from this study: PubMed 35700020McCrae CS, Curtis AF, Cottle A, Beversdorf DB, Shenker J, Mooney BP, Popescu M, Rantz M, Groer M, Stein P, Golzy M, Stearns MA, Simenson A, Nair N, Rowe MA. Impact of Web-Based Cognitive Behavioral Therapy for Insomnia on Stress, Health, Mood, Cognitive, Inflammatory, and Neurodegenerative Outcomes in Rural Dementia Caregivers: Protocol for the NiteCAPP CARES and NiteCAPP SHARES Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 14;11(6):e37874. doi: 10.2196/37874.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina S McCrae principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NiteCAPP CARES and NiteCAPP SHARES in people with Insomnia and Dementia, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina S McCrae (813-974-1804, christinamccrae@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion (time frame: Single administration at 8 weeks). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04896775, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.