Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

Обзор

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).

Вмешательства

• Поведенческое 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

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

CAREGIVER

Критерии включения

• 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.

Критерии исключения

• 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

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Missouri — Columbia

Публикации

• 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

Идентификаторы

NCT: NCT04632628 · 2017125

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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