Sleep Health Intervention for Family Caregivers

Overseen By Elliane Irani, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: Terminal illness, Hospice, Night shift, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Elliane Irani, PhD, RN

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

Inclusion Criteria

I have helped an adult relative or friend with long-term health issues for 6 months or more.

Live with the care recipient

Have a self-reported sleep problem evidenced by a raw score ≥ 25 (T-score ≥ 55.3) on the PROMIS-Sleep Disturbance Short Form 8b measure or self-reported suboptimal sleep health on at least one sleep health dimension

Exclusion Criteria

Caring for an adult with a terminal illness or enrolled in hospice

Night shift or rotational-shift worker

Current pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction (Caregiver TranS-C), a 12-week intervention with cognitive behavioral therapy, mindfulness, and caregiving guidance.

12 weeks

4 bi-weekly in-person sessions, 2 bi-weekly follow-up phone calls

Follow-up

Participants are monitored for changes in sleep health outcomes and psychological well-being after the intervention

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction

How Is the Trial Designed?

Group I: Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction Experimental Treatment 1 Intervention

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.

Group II: Enhanced Usual Care (EUC) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+