Sleep Health Intervention for Family Caregivers

EI
Overseen ByElliane Irani, PhD, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Case Western Reserve University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new sleep program for individuals caring for family members with chronic health issues. The program, known as the Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction, combines cognitive behavioral therapy (a type of talk therapy), mindfulness, and caregiving guidance to enhance sleep and mental well-being. Participants will either engage in this program or continue their usual care, with the program group attending sessions over several months. Suitable candidates are those who assist an adult relative or friend with ongoing health problems, live with that person, and experience sleep issues such as poor sleep quality or irregular sleep patterns. As an unphased trial, this study provides a unique opportunity to explore innovative sleep solutions tailored for caregivers.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for family caregivers?

Previous studies have shown that the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is safe and well-tolerated. Research indicates that participants typically experience positive results without major side effects. These studies have tested the program in various settings, focusing on improved sleep and mental health. Although this version for family caregivers is new, the basic TranS-C model has consistently proven safe for diverse groups.12345

Why are researchers excited about this trial?

Researchers are excited about the Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction because it combines cognitive behavioral therapy, mindfulness, and caregiving guidance into a single, comprehensive program. Unlike standard treatments that typically focus on just one aspect of sleep issues, this intervention tailors its approach to individual needs, addressing sleep problems holistically. By integrating education, behavior change techniques, and personalized goal setting, it offers a more flexible and potentially effective solution for improving sleep health among family caregivers.

What evidence suggests that the Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction is effective for improving sleep health in family caregivers?

Research has shown that the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) effectively improves sleep problems. One study found that this method helped people with serious mental illnesses sleep better and feel better overall. Participants in this trial may receive the Caregiver TranS-C, a version of this treatment designed specifically for family caregivers. It combines cognitive behavioral therapy, mindfulness, and caregiving advice. By focusing on sleep and daily routines, the intervention aims to enhance sleep quality and overall well-being for caregivers. Early results suggest that these tailored treatments can lead to better sleep and reduced stress.12678

Who Is on the Research Team?

EI

Elliane Irani, PhD, RN

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for adults (18+) who live with and care for a friend or relative with a chronic health condition (not terminal) for at least 6 months, have sleep problems, speak English, and are not pregnant or working night/rotating shifts.

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
See 2 more

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

Trial Overview

The study tests a tailored program combining cognitive behavioral therapy, mindfulness, and caregiving advice to help family caregivers improve their sleep. Participants are randomly assigned to receive this intervention.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Family Caregiver Transdiagnostic Intervention for Sleep and Circadian DysfunctionExperimental Treatment1 Intervention
Group II: Enhanced Usual Care (EUC)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials
314
Recruited
236,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39443066/

The Transdiagnostic Intervention for Sleep and Circadian ...

The transdiagnostic intervention for sleep and circadian dysfunction (TranS-C) was developed to provide one protocol that treats a range of sleep and ...

Outcomes From the Transdiagnostic Sleep and Circadian ...

A randomized controlled trial of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to improve serious mental illness outcomes ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36927461/

The Transdiagnostic Intervention for Sleep and Circadian ...

Aim 1 will compare TranS-C (combined Adapted and Standard) with UC-DT on improvements in sleep and circadian problems, functional impairment, ...

Improving Sleep Health Outcomes for Family Caregivers

The Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction (Caregiver TranS-C) is a tailored intervention that ...

Outcomes from the Transdiagnostic Sleep and Circadian ...

A randomized controlled trial of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to improve serious mental illness outcomes ...

NCT02469233 | A Transdiagnostic Sleep and Circadian ...

The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules ...

The Transdiagnostic Intervention for Sleep and Circadian ...

The Transdiagnostic Intervention for Sleep and Circadian Dysfunction ... We also used patient-reported data on history of psychiatric diagnoses.

Insomnia as a transdiagnostic factor across chronic illnesses ...

• Night eating syndrome considered a dysfunction of the circadian rhythm with a dissociation between eating and sleeping. • Core criteria include a daily ...