NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers

NCT04896775 | Recruiting DMC

• 1 other identifier: STUDY004494
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver and PWD dyads). We will measure both the short term (post-treatment) and long term (6 and 12 months) effects of the intervention on CG sleep, arousal, inflammation, health, mood, burden and cognitive function, and PWD sleep.

Conditions

Insomnia; Dementia

Keywords

Dementia Caregiver

Outcome Measures

Primary Outcomes (21)

• Completion

  Percentage of sessions completed out of the 4 sessions/modules included in NiteCAPP and WebSHE.

  Single administration at 8 weeks

• Adherence

  Percentage of the intervention instructions followed as indicated on the treatment adherence logs completed each day during treatment.

  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

  Single administration at 8 weeks

• Satisfaction Survey

  Survey that assesses the patient's experience and satisfaction with treatment.

  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.

  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.

  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)

  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)

  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)

  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)

  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

  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)

  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

  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

  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.

  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.

  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).

  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)

  Single blood draw at baseline, 8 weeks, 6 month and 12 follow up

• Change in Blood-based Biomarker Interleukin 6 IL-6)

  Inflammation

  Single blood draw at baseline, 8 weeks, 6 month and 12 follow up

• Change in Blood-based Biomarker AβB42

  Neurodegenerative

  Single blood draw at baseline, 8 weeks, 6 month and 12 follow up

• Change in Blood-based Biomarker Tau

  Neurodegenerative

  Single blood draw at baseline, 8 weeks, 6 month and 12 follow up

Secondary Outcomes (11)

• Change in State-Trait Anxiety Inventory (STAI)

  Single administration at baseline, 8 weeks, 6 month and 12 follow up

• Change in Depression (Beck Depression Inventory-II)

  Single administration at baseline, 8 weeks, 6 month and 12 follow up

• Change in 36-Item Short Form Survey (SF-36)

  Single administration at baseline, 8 weeks, 6 month and 12 follow up

• Change in Caregiver Burden (Zarit Burden Scale)

  Single administration at baseline, 8 weeks, 6 month and 12 follow up

• Change in Cognitive Failures Questionnaire (CFQ)

  Single administration at baseline, 8 weeks, 6 month and 12 follow up

Other Outcomes (5)

• Change in Neuropsychiatric Inventory(NPI) Nighttime Behavior Scale

  Single administration at baseline, 8 weeks, 6 month and 12 follow up

• Change in Dementia Severity Rating Scale

  Single administration at baseline, 8 weeks, 6 month and 12 follow up

• Change in Patient-Caregiver Functional Unit Scale (PCFUS)

  Single administration at baseline, 8 weeks, 6 month and 12 follow up

Study Arms (2)

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.

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.

Behavioral: NiteCAPP SHARES

Interventions

NiteCAPP CARES BEHAVIORAL

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.

Also known as: Web CBT-I

NiteCAPP CARES

NiteCAPP SHARES BEHAVIORAL

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.

Also known as: Web Sleep Hygiene and Related Education (Web-SHARE)

NiteCAPP SHARES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 10224714 BACKGROUND

• Rowe 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.

  PMID: 18763429 BACKGROUND

• Vitaliano 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.

  PMID: 21568959 BACKGROUND

• Joling 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.

  PMID: 20104070 BACKGROUND

• Markowitz 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.

  PMID: 14657784 BACKGROUND

• Curtis 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.

  PMID: 30353817 BACKGROUND

• McCrae 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.

  PMID: 25429026 BACKGROUND

• McCrae 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.

  PMID: 23243328 BACKGROUND

• Livingston 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.

  PMID: 25983695 BACKGROUND

• Heinzelmann 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.

  PMID: 25311836 BACKGROUND

• McCrae 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.

  PMID: 35700020 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Dementia

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders

Study Officials

• Christina S McCrae

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina S McCrae

CONTACT

813-974-1804; christinamccrae@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 21, 2021
• Study Start: February 2, 2022
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)