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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
NiteCAPP Trial 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.Check my eligibility
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.See study design
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.
NiteCAPP Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence
Change in Blood-based Biomarker AβB42
Interleukins
+17 moreSecondary outcome measures
Change in 36-Item Short Form Survey (SF-36)
Change in Caregiver Burden (Zarit Burden Scale)
Change in Cognitive Failures Questionnaire (CFQ)
+8 moreOther outcome measures
Change in Dementia Severity Rating Scale
Change in Godin Leisure-Time Exercise Questionnaire
Change in Neuropsychiatric Inventory(NPI) Nighttime Behavior Scale
+2 moreNiteCAPP 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.
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Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
361 Previous Clinical Trials
627,894 Total Patients Enrolled
9 Trials studying Insomnia
934 Patients Enrolled for Insomnia
University of South FloridaLead Sponsor
408 Previous Clinical Trials
186,746 Total Patients Enrolled
3 Trials studying Insomnia
1,568 Patients Enrolled for Insomnia
Christina S McCraePrincipal InvestigatorUniversity of South Florida
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had trouble sleeping for over 6 months, affecting my daily life.I am over 18, live with someone who has dementia, can read English, have insomnia, and haven't used sleep meds recently or have used them consistently for 6+ months.
Research Study Groups:
This trial has the following groups:- Group 1: NiteCAPP CARES
- Group 2: NiteCAPP SHARES
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings left for this research endeavor?
"Per the clinicaltrials.gov records, this research study seeks to make enrolments and was initially made available on February 2nd 2022 with its most recent update happening at the end of October in 2022."
Answered by AI
What effects are researchers hoping to observe by the end of this clinical trial?
"This clinical trial will evaluate the efficacy of pain relief and a possible improvement in quality of life through single blood draws at baseline, 8 weeks, 6 months and 12 follow up time frames. Secondary outcomes to be measured include Internet Intervention Utility Questionnaire (IIUQ) scores ranging from 0-65, Dementia Patient's Caregiver Quality of Life Scale questionnaires with 20 items measuring CG's QOLs, as well as changes in depression severity via Beck Depression Inventory-II scored on a scale between 0 to 63."
Answered by AI
How many participants have enrolled in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical examination is still enrolling patients and was originally listed on February 2nd 2022. The study aims to find 100 participants from 1 center."
Answered by AI
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