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Behavioural Intervention

Web-based Sleep Interventions for Caregiver Insomnia (NiteCAPP Trial)

N/A

Recruiting

Led By Christina S McCrae

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up daily at baseline, 8 weeks, 6 month and 12 follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a web-based sleep intervention will help rural caregivers of people with dementia, by improving sleep, arousal, stress, inflammation, and related health concerns.

Who is the study for?

This trial is for adult caregivers living with someone who has dementia and insomnia. Caregivers must have their own insomnia diagnosis, not be on recent sleep meds, and read English. The person with dementia must also suffer from insomnia but can't be on new sleep meds or have untreated sleep disorders like severe apnea.

What is being tested?

The NiteCAPP study tests two web-based programs (CARES & SHARES) designed to help rural caregivers of dementia patients manage insomnia. It looks at how well these programs work right after treatment and checks again after 6 and 12 months for any changes in the caregiver's sleep, health, mood, stress levels, and cognitive function.

What are the potential side effects?

Since this trial involves non-medical interventions like web-based programs focusing on behavioral strategies for managing insomnia, typical medication side effects are not expected. However, participants may experience frustration or discomfort if they find the technology challenging or if there's no improvement in their symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ daily at baseline, 8 weeks, 6 month and 12 follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~daily at baseline, 8 weeks, 6 month and 12 follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and daily at baseline, 8 weeks, 6 month and 12 follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence

Change in Blood-based Biomarker AβB42

Interleukins

+17 more

Secondary study objectives

Change in 36-Item Short Form Survey (SF-36)

Change in Caregiver Burden (Zarit Burden Scale)

Change in Cognitive Failures Questionnaire (CFQ)

+8 more

Other study objectives

Change in Dementia Severity Rating Scale

Change in Godin Leisure-Time Exercise Questionnaire

Change in Neuropsychiatric Inventory(NPI) Nighttime Behavior Scale

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: NiteCAPP SHARESExperimental Treatment1 Intervention

Sleep Hygiene and Related Education. 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 dementia. Session 4 focuses on a review of skills and plan for maintenance of behavior change. Boosters review skills, encourage practice, and troubleshoot issues.

Group II: NiteCAPP CARESExperimental Treatment1 Intervention

Cognitive Behavioral Treatment-Insomnia. 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 management and cognitive therapy. Session 4 focuses on a review of skills and plan for maintenance of behavior change.

Do I qualify?Apply below to find out