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

Overview

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.

Interventions

• Behavioral NiteCAPP CARES
  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 manageme
• Behavioral NiteCAPP SHARES
  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 dementi

Primary outcome measures

• Completion [Time frame: Single administration at 8 weeks]
• Adherence [Time frame: Single administration at 8 weeks]
• Internet Intervention Utility Questionnaire [Time frame: Single administration at 8 weeks]
• Satisfaction Survey [Time frame: Single administration at 8 weeks]
• Insomnia Severity Index [Time frame: Single administration at baseline, 8 weeks, 6 month and 12 follow up]
• Daily Electronic Sleep Diaries [Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up]
• Change in Pain Intensity - Daily Electronic Sleep Diaries [Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up]
• Change in Pain Unpleasantness - Daily Electronic Sleep Diaries [Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up]
• Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries [Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up]
• Change in Sleep Onset Latency- Daily Electronic Sleep Diaries [Time frame: Daily at baseline, 8 weeks, 6 month and 12 follow up]

Secondary outcome measures (11)

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of South Florida — Tampa

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. PMID 10224714
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT04896775 · STUDY004494

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗