Improving sleep health for family caregivers
Improving Sleep Health Outcomes for Family Caregivers
This pilot will test a caregiver-tailored program combining cognitive behavioral therapy, mindfulness, and practical caregiving guidance to see if it helps family caregivers who live with and report problems sleeping.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Case Western Reserve University Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07513246 on ClinicalTrials.gov |
What this trial studies
This pilot randomized clinical trial tests the Caregiver TranS-C, an adaptation of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction that integrates cognitive behavioral therapy, mindfulness, and caregiving-specific guidance. Eligible participants are adults who live with and have been caregiving for a community-dwelling relative or friend for at least six months and who report sleep problems by PROMIS or other sleep-health measures. The trial will randomize participants to the adapted intervention and collect measures of feasibility, acceptability, and preliminary effects on sleep health and psychological well-being. The single-site study is conducted at Case Western Reserve University in Cleveland, Ohio.
Who should consider this trial
Good fit: Adults aged 18 or older who live with and have been caring for a relative or friend with chronic health conditions for at least six months and who report sleep problems, and who can read and understand English.
Not a fit: People caring for someone in hospice or with a terminal illness, night-shift or rotating-shift workers, pregnant individuals, or caregivers without sleep problems are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could improve caregivers' sleep quality, daytime functioning, and overall psychological well-being.
How similar studies have performed: Cognitive behavioral therapy for insomnia and mindfulness approaches have improved sleep in other populations and versions of TranS-C have shown promise, but this specific caregiver-tailored adaptation is novel and not yet tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Assist a community-dwelling adult relative or friend with chronic health conditions and have been in this caregiving role for at least 6 months * Live with the care recipient * Have a self-reported sleep problem evidenced by one of the following criteria: 1. a raw score ≥ 25 (T-score ≥ 55.3) on the PROMIS-Sleep Disturbance Short Form 8b measure \[A T-score of 55 represents 1/2 standard deviation above the population mean\], or 2. self-reported suboptimal sleep health on at least one of the sleep health dimensions (regularity, satisfaction, alertness, timing, efficiency, and duration) * Able to speak, read, and understand English Exclusion Criteria: * Caring for an adult with a terminal illness or enrolled in hospice * Night shift or rotational-shift worker * Current pregnancy
Where this trial is running
Cleveland, Ohio
- Case Western Reserve University — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Elliane Irani, PhD, RN — Case Western Reserve University
- Study coordinator: Elliane Irani, PhD, RN
- Email: exi26@case.edu
- Phone: 216-368-0437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.