Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers

Not Applicable

Completed

Conditions: Family Caregivers
Insomnia
Sleep Initiation and Maintenance Disorders

Registration Number: NCT04986904

Lead Sponsor: University of Virginia

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 102

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
SHUTi Engagement	9-week Post-assessment	Level of SHUTi engagement: Core completion (i.e., nonuser \[no cores completed\], incomplete user \[1-3 Cores\], or complete user \[4-6 Cores\])

Secondary Outcome Measures

Name	Time	Method
Sleep-related Cognitions	Baseline Pre-assessment and 9-week Post-assessment	Dysfunctional Beliefs and Attitudes about Sleep; 16 items; sum scores range from 0 to 160 (higher scores indicate more dysfunctional attitudes and beliefs about sleep)
Sleep Self-efficacy	Baseline Pre-assessment and 9-week Post-assessment	Sleep Locus of Control Scale with two subscales: 1. a 5-item subscale for internal locus of control; summed scores per scale range from 5 to 30 (higher scores indicate higher belief in the locus of control measured; higher internal sleep locus of control is a better outcome) 2. a 3-item subscale for external locus of control; summed scores per scale range from 3 to 18 (higher scores indicate higher belief in the locus of control measured; lower external sleep locus of control is a better outcome)

Trial Locations

Locations (2): University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States