Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

Overview

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

Interventions

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

Primary outcome measures

• Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency [Time frame: 6 weeks]
• Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset [Time frame: 6 weeks]
• Daily Electronic Sleep and Pain Diaries - Total Sleep Time [Time frame: 6 weeks]
• Daily Electronic Sleep and Pain Diaries - Sleep Efficiency [Time frame: 6 weeks]
• Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness [Time frame: 6 weeks]
• Daily Electronic Sleep and Pain Diaries - Medication Consumption [Time frame: 6 weeks]
• Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency [Time frame: 6 weeks]
• Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset [Time frame: 6 weeks]
• Objective Daily Sleep Actiwatch-2 - Total Sleep Time [Time frame: 6 weeks]
• Objective Daily Sleep Actiwatch-2 - Sleep Efficiency [Time frame: 6 weeks]

Secondary outcome measures (12)

• State Trait Anxiety Inventory (STAI-Y1) [Time frame: 6 weeks]
• Beck Depression Inventory Second Edition (BDI- II) [Time frame: 6 weeks]
• Perceived Stress Scale (PSS) [Time frame: 6 weeks]
• Kingston Caregiver Stress Scale [Time frame: 6 weeks]
• Dysfunctional Attitudes/Beliefs about Sleep (DBAS) [Time frame: 6 weeks]
• Caregiver Functional Unit Scale [Time frame: 6 weeks]
• Online Cognitive Assessment - Stroop [Time frame: 6 weeks]
• Online Cognitive Assessment - Sternberg [Time frame: 6 weeks]
• Online Cognitive Assessment - Wisconsin Card Sorting Task [Time frame: 6 weeks]
• Cognitive Failures Questionnaire [Time frame: 6 weeks]
• Dementia Patient's Caregiver Quality of Life Scale [Time frame: 6 weeks]
• Zarit Burden Scale [Time frame: 6 weeks]

Eligibility criteria

CAREGIVER

Inclusion criteria

• 18+ 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
• 1+ 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.

Exclusion criteria

• 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

Inclusion criteria

• 18+ yrs
• Persons with dementia living with caregiver
• Have an eligible caregiver
• willing to be randomized

Exclusion criteria

• Person with dementia or legally authorized representative is unable to consent

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

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Missouri — Columbia

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT04632628 · 2017125

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗