Clinical trial NCT04896775: NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers
Official title: NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers: Examination of Sleep, Arousal, Mood, Cognitive, and Immune Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Dementia
Keywords: Dementia Caregiver
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Over the next 30 years, more than 10 million persons living with dementia in the US will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers (CG) and persons with dementia (PWD) alike, but increases caregiver risk of insomnia and related negative health outcomes, including depression, anxiety, cognitive disturbances and poor quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is an effective and established evidence based treatment for adults of all ages. Although relatively understudied in dementia caregivers, the research suggests CBT-I is also efficacious in caregivers. Our team developed a brief (4 session) CBT-I protocol adapted for dementia caregivers and has shown in person and remote (i.e. telehealth) delivery of this protocol significantly reduces insomnia and improves mood (moderate to large effects). Given demands on caregiver time and limited availability of trained CBT-I providers, we developed a web-based version of this treatment (NiteCAPP) to increase accessibility of this efficacious treatment for rural dementia CGs. NiteCAPP will allow for flexible at home scheduling, and the skills needed to monitor caregiver treatment progress can be quickly and efficiently taught to healthcare providers. The Cognitive Activation Theory of Stress provides a framework for our basic premise that CGs experience insomnia, arousal and inflammation that prompt sympathetic activation and hypothalamic-pituitary-adrenal (HPA) disruption that have negative effects on health. The proposed trial tests the novel hypothesis that NiteCAPP will improve CG health, mood, burden and cognition by targeting their shared mechanisms - sleep, arousal and inflammation - thereby, returning sympathetic and HPA functioning to normal. Another novel aspect of the proposed trial is inclusion of behavioral strategies to target the PWD sleep. Objectives: The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver and PWD dyads). We will measure both the short term (post-treatment) and long term (6 and 12 months) effects of the intervention on CG sleep, arousal, inflammation, health, mood, burden and cognitive function, and PWD sleep.

Eligibility criteria: Inclusion:

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.

Exclusion:

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.

Primary outcomes:
measure: Completion
timeFrame: Single administration at 8 weeks
measure: Adherence
timeFrame: Single administration at 8 weeks
measure: Internet Intervention Utility Questionnaire
timeFrame: Single administration at 8 weeks
measure: Satisfaction Survey
timeFrame: Single administration at 8 weeks
measure: Insomnia Severity Index
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Daily Electronic Sleep Diaries
timeFrame: Daily at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Pain Intensity - Daily Electronic Sleep Diaries
timeFrame: Daily at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Pain Unpleasantness - Daily Electronic Sleep Diaries
timeFrame: Daily at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries
timeFrame: Daily at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Sleep Onset Latency- Daily Electronic Sleep Diaries
timeFrame: Daily at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Sleep Efficiency- Daily Electronic Sleep Diaries
timeFrame: Daily at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Fatigue - Daily Electronic Sleep Diaries
timeFrame: Daily at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries
timeFrame: Daily at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Perceived Stress Scale
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Kingston Caregiver Stress Scale (KCSS)
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Dysfunctional Beliefs About Sleep (DBAS)
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Peripheral Arousal
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Inflammation
timeFrame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Blood-based Biomarker Interleukin 6 IL-6)
timeFrame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Blood-based Biomarker AβB42
timeFrame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Blood-based Biomarker Tau
timeFrame: Single blood draw at baseline, 8 weeks, 6 month and 12 follow up
Secondary outcomes:
measure: Change in State-Trait Anxiety Inventory (STAI)
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Depression (Beck Depression Inventory-II)
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in 36-Item Short Form Survey (SF-36)
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Caregiver Burden (Zarit Burden Scale)
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Cognitive Failures Questionnaire (CFQ)
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Dementia Patient's Caregiver Quality of Life Scale
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Objective Wake After Sleep Onset (Actigraph)
timeFrame: Daily at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Objective Sleep Onset Latency (Actigraph)
timeFrame: Daily at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Objective Sleep Efficiently (Actigraph)
timeFrame: Daily at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in NIH Toolbox
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Daily Joggle Battery
timeFrame: Daily at baseline, 8 weeks, 6 month and 12 follow up
Other outcomes:
measure: Change in Neuropsychiatric Inventory(NPI) Nighttime Behavior Scale
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Dementia Severity Rating Scale
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Patient-Caregiver Functional Unit Scale (PCFUS)
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Change in Godin Leisure-Time Exercise Questionnaire
timeFrame: Single administration at baseline, 8 weeks, 6 month and 12 follow up
measure: Satisfaction Survey
timeFrame: Single administration at post-treatment - 8 weeks
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Christina S McCrae
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.