Improving Sleep Health Outcomes for Family Caregivers

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Family Caregivers
• Intervention / Treatment: Behavioral: Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elliane Irani, PhD, RN; Phone Number: 216-368-0437; Email: exi26@case.edu

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Case Western Reserve University
      • Contact: Elliane Irani, PhD, RN; Phone Number: 216-368-0437; Email: exi26@case.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction; Tailored intervention that integrates cognitive behavioral therapy, mindfulness, and caregiving guidance.; Other Names: Caregiver TranS-C
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sleep Regularity	Sleep regularity will be measured with two nonparametric circadian parameters - interdaily stability and intradaily variability - derived from a 7-day, wrist-worn actigraph. Higher interdaily stability paired with lower intradaily variability at 14 weeks compared to baseline indicates more regular sleep.	Baseline and 14 Weeks
Change in Sleep Timing	Sleep timing will be measured using the 7-day average of midpoint sleep between bedtime and waketime, as derived from a 7-day, wrist-worn actigraph. The midpoint of sleep is the clock time marking the halfway point between sleep onset and offset and is used as a measure of circadian rhythm where a later midpoint may indicate circadian dysrhythmia. An earlier midpoint clock time at 14 weeks compared to baseline indicates improvement in circadian rhythm.	Baseline and 14 Weeks
Change in Sleep Efficiency	Sleep efficiency, derived as an average from a 7-day, wrist-worn actigraph, will be calculated as the ratio of total sleep time to the total time spent in bed (total sleep time/time in bed x 100%). Higher sleep efficiency percentage at 14 weeks compared to baseline indicates improved sleep efficiency.	Baseline and 14 Weeks
Change in Sleep Duration	Sleep duration, a 7-day average of total sleep time in minutes, calculated as the total time slept (time in bed minus sleep onset latency and wake after sleep onset), as measured by a 7-day, wrist-worn actigraph. Higher sleep duration minutes at 14 weeks compared to baseline indicates improved sleep duration.	Baseline and 14 Weeks
Change in Sleep Satisfaction	Sleep satisfaction will be measured using the 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale, a self-reported measure to assess sleep disturbance severity. Each item is scored on a 5-point Likert scale from 1 (Not at all) to 5 (Very much). Total raw scores range from 8-40 with higher scores indicating greater sleep disturbance symptoms. A lower raw score at 14 weeks compared to baseline indicates improved sleep satisfaction.	Baseline and 14 Weeks
Change in Daytime Alertness	Daytime alertness will be measured using the 8-item Epworth Sleepiness Scale (ESS). The ESS is a self-reported survey designed to evaluate symptoms of daytime sleepiness. Each item is scored on a 4-point Likert scale from 0 (Would never doze off or fall asleep) to 3 (High chance of dozing off or falling asleep). Total raw scores range from 0-24 with higher scores indicating greater daytime sleepiness symptoms. A lower raw score at 14 weeks compared to baseline indicates improved daytime alertness.	Baseline and 14 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Perceived Stress	Perceived stress as measured by the 10-item Perceived Stress Scale (PSS), a self-report questionnaire which measures perceptions of recent stress. Each item is scored on a 5-point Likert scale from 0 (Never) to 4 (Very often). Total raw scores range from 0-40 with higher scores indicating higher levels of psychological stress. A lower raw score at 14 weeks compared to baseline indicates improved perceived psychological stress.	Baseline and 14 Weeks
Change in Depressive Symptoms	Depressive symptoms as measured by the 10-item Center for Epidemiologic Studies Depression Scale (CES-D-10), a self-report tool for measuring depressive symptoms in the general population. Each item is scored on a 4-point Likert scale from 0 (rarely or none of the time) to 3 (Most of the time). Total raw scores range from 0-30 with higher scores indicating greater depressive symptoms. A lower raw score at 14 weeks compared to baseline indicates improved symptoms.	Baseline and 14 Weeks

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Investigators: Principal Investigator: Elliane Irani, PhD, RN, Case Western Reserve University

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal and Neural Physiological Phenomena; Nervous System Physiological Phenomena; Sleep
• Other Study ID Numbers: STUDY20250016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No