Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers

University of Virginia

Status: Completed

Conditions: Sleep Initiation and Maintenance Disorders; Insomnia; Family Caregivers

Treatments: Behavioral: SHUTi (Sleep Healthy Using the Internet)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04986904

HSR210255

R21TR003522 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The overall objective of this mixed-methods proposal is to answer the focused research question: What tailoring is necessary and sufficient to achieve optimal engagement with and efficacy of Sleep Healthy Using the Internet (SHUTi) for caregivers? The SHUTi program is a fully-automated Internet-delivered cognitive-behavioral therapy for insomnia (CBT-I) program. We will identify caregiving-related user- and environment characteristics that affect the use and impact of SHUTi, and other Internet interventions more broadly, for caregivers. We will recruit 100 high-intensity caregivers with insomnia to complete a baseline assessment of insomnia and caregiving context. Caregivers will then receive access to SHUTi in an open-label trial. At the end of the 9-week intervention period, caregivers will complete post-assessment and be categorized according to their level of engagement with the 6 SHUTi intervention lessons (or weekly "Cores"). We will test whether caregivers' engagement with SHUTi (i.e., being a non-user vs. incomplete user vs. complete user) is associated with their caregiving-related user characteristics (i.e., caregiving strain, self-efficacy, and guilt) and environment characteristics (i.e., proximity to care recipient; care recipient functional, cognitive, and behavioral status; caregiving tasks). Caregivers' barriers to and motivations for SHUTi engagement will be described from open-ended survey responses specific to participants' level of engagement as part of post-assessment. We will identify non-users' barriers to SHUTi adoption, the extent to which barriers were related to caregiving, and what modifications may have increased their motivation to try SHUTi. We will also identify users' (incomplete and complete) SHUTi usage barriers and motivations, the extent to which these were related to caregiving, and how tailoring may improve usage by increasing salience to caregivers. Thematic coding will also examine how caregivers' recommendations generalize to other evidence-based digital health interventions. Among caregivers using SHUTi, we will test whether the effects of SHUTi on cognitive mechanisms of change targeted by SHUTi (i.e., more adaptive sleep beliefs, internalized sleep locus of control) are associated with differences in caregiving-related user or environment characteristics.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Self-report providing high-intensity unpaid care (e.g., practical, medical, and/or emotional support) to a family member or "family-like" close individual, operationalized as a function of time spent caregiving and care task involvement.
• Self-report expecting to continue provide high-intensity care for at least another 3 months.
• Have access to any Internet-enabled device (computer, tablet, smartphone) and willing to be emailed about the study.
• Insomnia severity index score >= 10
• Residing in the United States or U.S. territory
• English literacy

Exclusion criteria

• Unusual average bed/wake times, including for shift work
• Current behavioral/psych treatment for insomnia
• Medical contraindication (Restless Leg Syndrome/Periodic Limb Movement Disorder, Obstructive Sleep Apnea, narcolepsy, parasomnia, dementia, Parkinson's, Huntington's, stroke, traumatic brain injury, brain infection/tumor, pregnancy/breastfeeding, hyperthyroidism, cancer, severe respiratory disease, epilepsy)
• Psychiatric contraindications (mania/hypomania, alcohol or substance abuse/dependence)
• Changes to prescription medications in the past 3 months (sleep, steroid, amphetamine, other wake-promoting)
• Severe computer literacy challenges

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

SHUTi (Sleep Healthy Using the Internet)

Experimental group

Description:

Participants will be assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They will spend 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progress through the intervention, they will receive automated, tailored instructions for how to improve their sleep.

Treatment:

Behavioral: SHUTi (Sleep Healthy Using the Internet)