Improving Sleep Health Outcomes for Family Caregivers

June 16, 2026 updated by: Elliane Irani, Case Western Reserve University
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Elliane Irani, PhD, RN
  • Phone Number: 216-368-0437
  • Email: exi26@case.edu

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Sleep Regularity
Time Frame: Baseline and 14 Weeks
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
Time Frame: Baseline and 14 Weeks
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
Time Frame: Baseline and 14 Weeks
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
Time Frame: Baseline and 14 Weeks
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
Time Frame: Baseline and 14 Weeks
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
Time Frame: Baseline and 14 Weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Perceived Stress
Time Frame: Baseline and 14 Weeks
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
Time Frame: Baseline and 14 Weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Case Western Reserve University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elliane Irani, PhD, RN, Case Western Reserve University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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