Family Caregivers, Sleep
Conditions
Brief summary
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.
Interventions
BEHAVIORALFamily Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction
Tailored intervention that integrates cognitive behavioral therapy, mindfulness, and caregiving guidance.
Sponsors
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Regularity | 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 | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Stress | 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. |
| Change in Depressive Symptoms | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElliane Irani, PhD, RN
Case Western Reserve University
Outcome results
None listed