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OpenTrials
Active, Not Recruiting

NCT Number: NCT07513246

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Exclusion criteria

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

Treatment and study plan

Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction

Behavioral

Tailored intervention that integrates cognitive behavioral therapy, mindfulness, and caregiving guidance.

Other names: Caregiver TranS-C

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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