Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

NCT04632628 | Recruiting

• 1 other identifier: 2017125
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Over the next 30 years, more than 10 million persons living with dementia in the United States will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers and persons with dementia alike, but increases the caregiver's 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 a highly effective and established evidence based treatment for adults of all ages. Although relatively understudied in dementia caregivers, the research by our group and others suggests CBT-I is also efficacious in caregivers. Our team developed a brief (4 session) CBT-I protocol specifically adapted for dementia caregivers (CBT-I) and has shown in person and remote (i.e. telehealth) delivery of this protocol significantly reduces insomnia symptoms and improves mood (moderate to large effects). Given demands on caregivers' time and limited availability of trained CBT-I providers, a web-based version of CBT-I (WebCBT-I; the online treatment will be called NiteCAPP) is needed to increase the accessibility of this efficacious treatment. WebCBT-I 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 overarching goal of this project is to develop and test WebCBT-I in caregivers of persons with dementia. Objectives

1. 1.To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in dementia caregivers with insomnia.
2. 2.To examine changes in the primary clinical outcomes, including complaints of poor sleep, and fatigue.
3. 3.To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health.
4. 4.To examine the mechanistic variables, including arousal (heart rate variability, HRV).

Conditions

Insomnia Chronic; Dementia

Keywords

Dementia Caregiver; Sleep; Behavioral Interventions; Online Behavioral Intervention; Insomnia; Dementia

Outcome Measures

Primary Outcomes (11)

• Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency

  Subjective sleep onset latency (time to fall asleep)

  6 weeks

• Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset

  Subjective time awake after sleep onset

  6 weeks

• Daily Electronic Sleep and Pain Diaries - Total Sleep Time

  Subjective total sleep time

  6 weeks

• Daily Electronic Sleep and Pain Diaries - Sleep Efficiency

  Subjective sleep efficiency

  6 weeks

• Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness

  Pain Intensity \& Unpleasantness

  6 weeks

• Daily Electronic Sleep and Pain Diaries - Medication Consumption

  Sleep and pain medication consumption

  6 weeks

• Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency

  Objective sleep onset latency (time to fall asleep)

  6 weeks

• Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset

  Objective time awake after sleep onset

  6 weeks

• Objective Daily Sleep Actiwatch-2 - Total Sleep Time

  Objective total sleep time

  6 weeks

• Objective Daily Sleep Actiwatch-2 - Sleep Efficiency

  Objective sleep efficiency

  6 weeks

• Insomnia Severity Index

  Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity

  6 weeks

Secondary Outcomes (12)

• State Trait Anxiety Inventory (STAI-Y1)

  6 weeks

• Beck Depression Inventory Second Edition (BDI- II)

  6 weeks

• Perceived Stress Scale (PSS)

  6 weeks

• Kingston Caregiver Stress Scale

  6 weeks

• Dysfunctional Attitudes/Beliefs about Sleep (DBAS)

  6 weeks

Study Arms (1)

NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia

EXPERIMENTAL

This is a pilot trial with one treatment condition (CBT-I).

Behavioral: Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)

Interventions

Web-based Cognitive Behavior Therapy for Insomnia (CBT-I) BEHAVIORAL

Participants will complete 4 web-based CBT- I sessions. Lesson 1: Sleep Hygiene and Stimulus Control Lesson 2: Sleep Restriction and Relaxation Strategies Lesson 3: Identifying and Restructuring Dysfunction Thoughts Lesson 4: Practical Recommendations, Review, and Maintenance of Change

NiteCAPP: Online Cognitive Behavioral Therapy for Insomnia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + yrs
• Dementia caregiver living with person with dementia
• willing to be randomized, 4. read/understand English
• insomnia diagnosis
• no prescribed or over-the-counter sleep meds or stabilized 6+ weeks.
• Insomnia:
• complaints for 6+ mos
• adequate opportunity and circumstances for sleep
• + of the following: difficulty falling asleep, staying asleep, or waking too early
• daytime dysfunction (mood, cognitive, social, occupational) due to insomnia
• Screening interview indicates Insomnia Severity Index score ≥11 or Insomnia Severity Index score 9-10
• baseline diaries indicate \>30 mins of sleep onset latency or wake after sleep onset on 3+ nts.

You may not qualify if:

• unable to consent
• cognitive impairment \[Telephone Interview for Cognitive Status (TICS) \<25 or Mini Mental State Examination (MMSE) \<26\]
• sleep disorder other than insomnia \[i.e., sleep apnea (apnea/hypopnea index, AHI \>15)\]
• bipolar or seizure disorder
• other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychosis)
• severe untreated psychiatric comorbidity
• psychotropic or other medications (e.g., beta-blockers) that alter sleep
• non-pharmacological tx for sleep or mood outside current trial.
• PERSONS WITH DEMENTIA
• + yrs
• Persons with dementia living with caregiver
• Have an eligible caregiver
• willing to be randomized
• Person with dementia or legally authorized representative is unable to consent

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

RECRUITING

Related Publications (47)

• 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

• Fonareva I, Amen AM, Zajdel DP, Ellingson RM, Oken BS. Assessing sleep architecture in dementia caregivers at home using an ambulatory polysomnographic system. J Geriatr Psychiatry Neurol. 2011 Mar;24(1):50-9. doi: 10.1177/0891988710397548.

  PMID: 21320949 BACKGROUND

• Beaudreau SA, Spira AP, Gray HL, Depp CA, Long J, Rothkopf M, Gallagher-Thompson D. The relationship between objectively measured sleep disturbance and dementia family caregiver distress and burden. J Geriatr Psychiatry Neurol. 2008 Sep;21(3):159-65. doi: 10.1177/0891988708316857. Epub 2008 May 23.

  PMID: 18503035 BACKGROUND

• Creese J, Bedard M, Brazil K, Chambers L. Sleep disturbances in spousal caregivers of individuals with Alzheimer's disease. Int Psychogeriatr. 2008 Feb;20(1):149-61. doi: 10.1017/S1041610207005339. Epub 2007 Apr 30.

  PMID: 17466086 BACKGROUND

• McCurry SM, Logsdon RG, Teri L, Vitiello MV. Sleep disturbances in caregivers of persons with dementia: contributing factors and treatment implications. Sleep Med Rev. 2007 Apr;11(2):143-53. doi: 10.1016/j.smrv.2006.09.002. Epub 2007 Feb 6.

  PMID: 17287134 BACKGROUND

• McCrae CS, Wilson NM, Lichstein KL, Durrence HH, Taylor DJ, Bush AJ, Riedel BW. 'Young old' and 'old old' poor sleepers with and without insomnia complaints. J Psychosom Res. 2003 Jan;54(1):11-9. doi: 10.1016/s0022-3999(02)00543-3.

  PMID: 12505551 BACKGROUND

• Mahoney DF. Vigilance. Evolution and definition for caregivers of family members with Alzheimer's disease. J Gerontol Nurs. 2003 Aug;29(8):24-30. doi: 10.3928/0098-9134-20030801-07.

  PMID: 13677157 BACKGROUND

• McCrae CS, Curtis AF, Williams JM, Dautovich ND, McNamara JPH, Stripling A, Dzierzewski JM, Chan WS, Berry RB, McCoy KJM, Marsiske M. Efficacy of brief behavioral treatment for insomnia in older adults: examination of sleep, mood, and cognitive outcomes. Sleep Med. 2018 Nov;51:153-166. doi: 10.1016/j.sleep.2018.05.018. Epub 2018 Jun 2.

  PMID: 30195661 BACKGROUND

• Edinger JD, Wohlgemuth WK, Krystal AD, Rice JR. Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial. Arch Intern Med. 2005 Nov 28;165(21):2527-35. doi: 10.1001/archinte.165.21.2527.

  PMID: 16314551 BACKGROUND

• McCrae CS, McGovern R, Lukefahr R, Stripling AM. Research Evaluating Brief Behavioral Sleep Treatments for Rural Elderly (RESTORE): a preliminary examination of effectiveness. Am J Geriatr Psychiatry. 2007 Nov;15(11):979-82. doi: 10.1097/JGP.0b013e31813547e6.

  PMID: 17974868 BACKGROUND

• Glass J, Lanctot KL, Herrmann N, Sproule BA, Busto UE. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ. 2005 Nov 19;331(7526):1169. doi: 10.1136/bmj.38623.768588.47. Epub 2005 Nov 11.

  PMID: 16284208 BACKGROUND

• Allain H, Bentue-Ferrer D, Polard E, Akwa Y, Patat A. Postural instability and consequent falls and hip fractures associated with use of hypnotics in the elderly: a comparative review. Drugs Aging. 2005;22(9):749-65. doi: 10.2165/00002512-200522090-00004.

  PMID: 16156679 BACKGROUND

• Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Aug 4;163(3):191-204. doi: 10.7326/M14-2841.

  PMID: 26054060 BACKGROUND

• Bertisch SM, Herzig SJ, Winkelman JW, Buettner C. National use of prescription medications for insomnia: NHANES 1999-2010. Sleep. 2014 Feb 1;37(2):343-9. doi: 10.5665/sleep.3410.

  PMID: 24497662 BACKGROUND

• Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2):125-33. doi: 10.7326/M15-2175. Epub 2016 May 3.

  PMID: 27136449 BACKGROUND

• McCurry SM, Gibbons LE, Logsdon RG, Vitiello MV, Teri L. Insomnia In Caregivers Of Persons With Dementia: Who Is At Risk And What Can Be Done About It? Sleep Med Clin. 2009 Dec 1;4(4):519-526. doi: 10.1016/j.jsmc.2009.07.005.

  PMID: 20046806 BACKGROUND

• McCrae CS, Tierney CG, McNamara JP. Behavioral intervention for insomnia: Future directions for nontraditional caregivers at various stages of care. Clinical gerontologist. 2006;29(2):95-114.

  BACKGROUND

• McCurry SM, Logsdon RG, Vitiello MV, Teri L. Successful behavioral treatment for reported sleep problems in elderly caregivers of dementia patients: a controlled study. J Gerontol B Psychol Sci Soc Sci. 1998 Mar;53(2):P122-9. doi: 10.1093/geronb/53b.2.p122.

  PMID: 9520929 BACKGROUND

• McCrae CS, Tierney CG, McNamara JP. Behavioral Intervention for Insomnia: Future Directions for Nontraditional Caregivers at Various Stages of Care. Clinical Geropsychologist. 2005;29(2):95-115.

  BACKGROUND

• Lichstein KL, Wilson NM, Johnson CT. Psychological treatment of secondary insomnia. Psychol Aging. 2000 Jun;15(2):232-40. doi: 10.1037//0882-7974.15.2.232.

  PMID: 10879578 BACKGROUND

• Grant JS, Bartolucci AA, Elliot TR, Giger JN. Sociodemographic, physical, and psychosocial characteristics of depressed and non-depressed family caregivers of stroke survivors. Brain Inj. 2000 Dec;14(12):1089-100. doi: 10.1080/02699050050203586.

  PMID: 11147581 BACKGROUND

• Nezu AM, Nezu CM, Perri MG. Psychotherapy for adults within a problem-solving framework: Focus on depression. J Cogn Psychother. 1990;4(3):247-256.

  BACKGROUND

• Pinquart M, Sorensen S. Differences between caregivers and noncaregivers in psychological health and physical health: a meta-analysis. Psychol Aging. 2003 Jun;18(2):250-67. doi: 10.1037/0882-7974.18.2.250.

  PMID: 12825775 BACKGROUND

• Schulz R, Martire LM. Family caregiving of persons with dementia: prevalence, health effects, and support strategies. Am J Geriatr Psychiatry. 2004 May-Jun;12(3):240-9.

  PMID: 15126224 BACKGROUND

• Sakurai S, Onishi J, Hirai M. Impaired autonomic nervous system activity during sleep in family caregivers of ambulatory dementia patients in Japan. Biol Res Nurs. 2015 Jan;17(1):21-8. doi: 10.1177/1099800414524050. Epub 2014 Feb 25.

  PMID: 25504947 BACKGROUND

• Hasuo H, Kanbara K, Sakuma H, Yoshida K, Uchitani K, Fukunaga M. Self-Care System for Family Caregivers of Cancer Patients Using Resonant Breathing with a Portable Home Device: A Randomized Open-Label Study. J Palliat Med. 2019 Jan;22(1):18-24. doi: 10.1089/jpm.2018.0230. Epub 2018 Sep 5.

  PMID: 30183463 BACKGROUND

• Lee KC, Yiin JJ, Chao YF. Effect of integrated caregiver support on caregiver burden for people taking care of people with cancer at the end of life: A cohort and quasi-experimental clinical trial. Int J Nurs Stud. 2016 Apr;56:17-26. doi: 10.1016/j.ijnurstu.2016.01.002. Epub 2016 Jan 12.

  PMID: 26794928 BACKGROUND

• Schulz R, O'Brien AT, Bookwala J, Fleissner K. Psychiatric and physical morbidity effects of dementia caregiving: prevalence, correlates, and causes. Gerontologist. 1995 Dec;35(6):771-91. doi: 10.1093/geront/35.6.771.

  PMID: 8557205 BACKGROUND

• Yates ME, Tennstedt S, Chang BH. Contributors to and mediators of psychological well-being for informal caregivers. J Gerontol B Psychol Sci Soc Sci. 1999 Jan;54(1):P12-22. doi: 10.1093/geronb/54b.1.p12.

  PMID: 9934391 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

• Caswell LW, Vitaliano PP, Croyle KL, Scanlan JM, Zhang J, Daruwala A. Negative associations of chronic stress and cognitive performance in older adult spouse caregivers. Exp Aging Res. 2003 Jul-Sep;29(3):303-18. doi: 10.1080/03610730303721.

  PMID: 12775440 BACKGROUND

• Vitaliano PP, Zhang J, Young HM, Caswell LW, Scanlan JM, Echeverria D. Depressed mood mediates decline in cognitive processing speed in caregivers. Gerontologist. 2009 Feb;49(1):12-22. doi: 10.1093/geront/gnp004. Epub 2009 Mar 18.

  PMID: 19363000 BACKGROUND

• Mackenzie CS, Smith MC, Hasher L, Leach L, Behl P. Cognitive functioning under stress: evidence from informal caregivers of palliative patients. J Palliat Med. 2007 Jun;10(3):749-58. doi: 10.1089/jpm.2006.0171.

  PMID: 17592987 BACKGROUND

• Oken BS, Fonareva I, Wahbeh H. Stress-related cognitive dysfunction in dementia caregivers. J Geriatr Psychiatry Neurol. 2011 Dec;24(4):191-8. doi: 10.1177/0891988711422524.

  PMID: 22228825 BACKGROUND

• Astell A, Alm N, Gowans G, Ellis M, Dye R, Vaughan P. Involving older people with dementia and their carers in designing computer based support systems: some methodological considerations. Universal Access in the Information Society. 2009;8(1):49.

  BACKGROUND

• Lichstein KL, Riedel BW, Grieve R. Fair tests of clinical trials: A treatment implementation model. Advances in Behaviour Research and Therapy. 1994;16(1):1-29.

  BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Hopkins R, Kilik L. Kingston Caregiver Stress Scale administration and interpretation manual. Kingston, Canada: Geriatric Psychiatry Programme, Providence Care, Mental...; 2012.

  BACKGROUND

• Morin CM. Insomnia: Psychological assessment and management.Guilford Press; 1993.

  BACKGROUND

• Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.

  PMID: 21532953 BACKGROUND

• Slotkin J, Kallen M, Griffith J, et al. NIH toolbox technical manual. Bethesda, MD: National Institutes of Health. 2012.

  BACKGROUND

• Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x.

  PMID: 7126941 BACKGROUND

• Thomas P, Lalloue F, Preux PM, Hazif-Thomas C, Pariel S, Inscale R, Belmin J, Clement JP. Dementia patients caregivers quality of life: the PIXEL study. Int J Geriatr Psychiatry. 2006 Jan;21(1):50-6. doi: 10.1002/gps.1422.

  PMID: 16323256 BACKGROUND

• Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.

  PMID: 11574710 BACKGROUND

• Beck AT, Steer RA, Garbin MG. Beck Depression Inventory-Second Edition.San Antonio, TX: The Psychological Corporation; 1996.

  BACKGROUND

• Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. State-Trait Anxiety Inventory, Form Y.Palo Alto, CA: Consulting Psychologists Press; 1983.

  BACKGROUND

• McCrae CS, Curtis AF, Stearns MA, Nair N, Golzy M, Shenker JI, Beversdorf DQ, Cottle A, Rowe MA. Development and Initial Evaluation of Web-Based Cognitive Behavioral Therapy for Insomnia in Rural Family Caregivers of People With Dementia (NiteCAPP): Mixed Methods Study. JMIR Aging. 2023 Aug 24;6:e45859. doi: 10.2196/45859.

  PMID: 37616032 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 McCrae

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina S McCrae

CONTACT

573-882-0982; mccraec@health.missouri.edu

Riley Stephens

CONTACT

573-882-8881; rstephens@health.missouri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 17, 2020
• Study Start: November 14, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

US (1)