Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

Dementia Clinical Trial

— NiteCAPP  

Official title:

Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04632628
• Other study ID #: 2017125
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2022
• Est. completion date: March 31, 2027

Study information

• Verified date: February 2024
• Source: University of South Florida
• Contact: Christina S McCrae
• Phone: 573-882-0982
• Email: mccraec[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Insomnia Chronic
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Electronic Sleep and Pain Diaries - Sleep Onset Latency	Subjective sleep onset latency (time to fall asleep)	6 weeks
Primary	Daily Electronic Sleep and Pain Diaries - Wake-time After Sleep Onset	Subjective time awake after sleep onset	6 weeks
Primary	Daily Electronic Sleep and Pain Diaries - Total Sleep Time	Subjective total sleep time	6 weeks
Primary	Daily Electronic Sleep and Pain Diaries - Sleep Efficiency	Subjective sleep efficiency	6 weeks
Primary	Daily Electronic Sleep and Pain Diaries - Pain Intensity & Unpleasantness	Pain Intensity & Unpleasantness	6 weeks
Primary	Daily Electronic Sleep and Pain Diaries - Medication Consumption	Sleep and pain medication consumption	6 weeks
Primary	Objective Daily Sleep Actiwatch-2 - Sleep Onset Latency	Objective sleep onset latency (time to fall asleep)	6 weeks
Primary	Objective Daily Sleep Actiwatch-2 - Wake-time After Sleep Onset	Objective time awake after sleep onset	6 weeks
Primary	Objective Daily Sleep Actiwatch-2 - Total Sleep Time	Objective total sleep time	6 weeks
Primary	Objective Daily Sleep Actiwatch-2 - Sleep Efficiency	Objective sleep efficiency	6 weeks
Primary	Insomnia Severity Index	Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity	6 weeks
Secondary	State Trait Anxiety Inventory (STAI-Y1)	Assessment of anxiety symptoms - min: 0 max:60; higher score means higher anxiety	6 weeks
Secondary	Beck Depression Inventory Second Edition (BDI- II)	Depressive symptom assessment - min: 0 max: 63; Higher score means higher severity of depression	6 weeks
Secondary	Perceived Stress Scale (PSS)	Perception of stress - min: 0; max:40 - higher scores indicate higher perceived stress	6 weeks
Secondary	Kingston Caregiver Stress Scale	Caregiver stress measurement - min:10 max:50 - higher score indicates higher caregiver stress	6 weeks
Secondary	Dysfunctional Attitudes/Beliefs about Sleep (DBAS)	evaluates sleep-related beliefs, expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues - higher scores indicates more dysfunctional beliefs and attitudes	6 weeks
Secondary	Caregiver Functional Unit Scale	Assessment of the stability of the patient-caregiver dyad - higher score indicates lower stability	6 weeks
Secondary	Online Cognitive Assessment - Stroop	Determine level of cognitive functioning	6 weeks
Secondary	Online Cognitive Assessment - Sternberg	Determine level of cognitive functioning	6 weeks
Secondary	Online Cognitive Assessment - Wisconsin Card Sorting Task	Determine level of cognitive functioning	6 weeks
Secondary	Cognitive Failures Questionnaire	Self-reported failures in perception, memory, and motor function - min:0 max: 100 - higher score indicates greater cognitive failure	6 weeks
Secondary	Dementia Patient's Caregiver Quality of Life Scale	Assessment of caregiver quality of life - min: 0 max:100 - higher score indicates good quality of life	6 weeks
Secondary	Zarit Burden Scale	Caregiver burden measurement - min: 0 max: 48 - higher score indicated higher caregiver burden	6 weeks