Improving Sleep Health Outcomes for Family Caregivers

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Western Reserve University
Study ID
NCT07513246
Status
Recruiting
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Conditions

  • Family Caregivers
  • Sleep

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction — BEHAVIORAL
    Tailored intervention that integrates cognitive behavioral therapy, mindfulness, and caregiving guidance.

Study Details

This pilot study is intended to evaluate the feasibility, acceptability, and preliminary efficacy of an adapted sleep health intervention for family caregivers. The researchers are piloting a randomized clinical trial to test the Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction (Caregiver TranS-C), a tailored intervention that integrates cognitive behavioral therapy, mindfulness, and caregiving guidance. The caregiving-tailored adaptation of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) has the potential to improve sleep health outcomes and enhance psychological well-being in family caregivers.

Key Dates

Start date
Jun 26, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction
    The Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction (Caregiver TranS-C) is a tailored intervention that integrates cognitive behavioral therapy, mindfulness, and caregiving guidance. A 12-week intervention, consisting of 4 bi-weekly in-person sessions and 2 bi-weekly follow-up calls phone calls, Caregiver TranS-C includes four cross-cutting modules: case formulation, sleep and circadian education, behavior change and motivation, and goal setting. The modules are tailored to each participants' baseline sleep assessment.
  • No Intervention: Enhanced Usual Care (EUC)
    Participants randomized to the Enhanced Usual Care (EUC) control group will receive no intervention during the 14-week study period. Upon completion of the study, participants in the EUC group will receive their sleep report along with sleep health recommendations, the intervention workbook, and a list of caregiving resources.

Primary Outcome Measure

Change in Sleep Regularity [ Time Frame: Baseline and 14 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Western Reserve UniversityClevelandOhio44106
Elliane Irani, PhD, RN
[email protected]
216-368-0437

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Case Western Reserve University· Cleveland, OH

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