Family CaregiversNCT07513246

Improving Sleep Health Outcomes for Family Caregivers

A study testing Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction in people with Family Caregivers and Sleep, run by Case Western Reserve University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Family Caregivers, Sleep
What is being tested?: Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 26 Jun 2025to 30 Nov 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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:
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
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

Who cannot join

Caring for an adult with a terminal illness or enrolled in hospice
Night shift or rotational-shift worker
Current pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Case Western Reserve University
Cleveland, Ohio, 44106

Other trials in United States

About this study

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.

Conditions: Family Caregivers, Sleep
Being tested: Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Family Caregiver Transdiagnostic Intervention for Sleep and Circadian DysfunctionBehavioural
Also called Caregiver TranS-C
Tailored intervention that integrates cognitive behavioral therapy, mindfulness, and caregiving guidance.

Study groups in NCT07513246
Study group	Role	What they receive
Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction	Experimental	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. Receives: Behavioral: Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction
Enhanced Usual Care (EUC)	No 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 14 Weeks

Secondary outcomes (2)

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.
Measured: 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.
Measured: Baseline and 14 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 202530 Nov 2026

First posted7 Apr 2026
Study start26 Jun 2025
Primary completion30 Nov 2026 (estimated)
Study completion30 Nov 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Family CaregiversStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07513246
Sponsor's protocol ID: STUDY20250016
Status last verified: Apr 2026
First submitted: 1 Apr 2026
Last updated: 17 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Family Caregivers trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Sleep Health Outcomes for Family Caregivers
ClinicalTrials.gov ID: NCT07513246
Acronym / sponsor ID: STUDY20250016
Conditions: Family Caregivers, Sleep
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 31 participants (actual)
Lead sponsor: Case Western Reserve UniversityUniversity, hospital or other
Study start: 26 Jun 2025 (actual)
Primary completion: 30 Nov 2026 (estimated)
Study completion: 30 Nov 2026 (estimated)
First posted: 7 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction	Experimental	Behavioral: Family Caregiver Transdiagnostic Intervention for Sleep and Circadian DysfunctionThe 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.
Enhanced Usual Care (EUC)	No 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 may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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:
Able to speak, read, and understand English

Key exclusion criteria (3 listed)

Caring for an adult with a terminal illness or enrolled in hospice
Night shift or rotational-shift worker
Current pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Family Caregiver Transdiagnostic Intervention for Sleep and Circadian DysfunctionAlso: Caregiver TranS-CTailored intervention that integrates cognitive behavioral therapy, mindfulness, and caregiving guidance.	Behavioural	Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction

Primary outcome

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.
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.
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.
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.
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.
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.

2 secondary outcomes

Change in Perceived Stress
Time frame: Baseline and 14 Weeks
Change in Depressive Symptoms
Time frame: Baseline and 14 Weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
Individual participant dataSharing planned: No

Related trials for Family Caregivers

Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Enrolling by invitation
BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery)
Traumatic Brain Injury
Not yet recruiting
Parenting Program for Young Children With Spina Bifida
Spina Bifida
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elliane Irani, PhD, RN principal investigator

Case Western Reserve University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Sleep Regularity (time frame: Baseline and 14 Weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07513246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.