Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers

Study Overview
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Brief Summary
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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.

Official Title
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Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers: A Mixed Methods Approach

Conditions
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Family Caregivers, Insomnia, Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Behavioral: SHUTi (Sleep Healthy Using the Internet)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHUTi (Sleep Healthy Using the Internet)<br>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. | Behavioral: SHUTi (Sleep Healthy Using the Internet)<br>* Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program<br>* Other names: CBT-I;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SHUTi engagement | Level of SHUTi engagement: Core completion (i.e., nonuser [no cores completed], incomplete user [1-3 Cores], or complete user [4-6 Cores]) | 9-week Post-assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Open-ended feedback on SHUTi | Non-users' post-assessment will include an open-ended survey regarding barriers to SHUTi adoption, the extent to which barriers were related to caregiving, and what modifications may have increased their motivation to try SHUTi. Users' (i.e., incomplete and complete) post-assessment will include an open-ended survey assessing 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. | 9-week Post-assessment | 
| SHUTi evaluation | Items from the Internet Intervention Utility, Evaluation, and Adherence questionnaire assess users' perceived usability, acceptability, and perceived efficacy of SHUTi as well as barriers to program use | 9-week Post-assessment | 
| Sleep-related cognitions | Dysfunctional Beliefs and Attitudes about Sleep; 16 items; averaged scores range from 0 to 10 (higher scores indicate more dysfunctional attitudes and beliefs about sleep) | Baseline Pre-assessment and 9-week Post-assessment | 
| Sleep self-efficacy | Sleep Locus of Control Scale; 4-item subscales for internal and chance locus of control, respectively; averaged scores per scale range from 1 to 6 (higher scores indicate higher belief in the locus of control measured) | Baseline Pre-assessment and 9-week Post-assessment |