Single-group trial of an Internet-delivered insomnia intervention among higher-intensity family caregivers: Rationale and mixed-methods study protocol (Preprint)

BACKGROUND Family caregivers are more likely to experience insomnia relative to non-caregivers, but have significant barriers to accessing gold-standard Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment. Delivering interventions for caregivers by the Internet may help increase access to care, particularly among higher-intensity caregivers who provide assistance with multiple care tasks over many hours per week. Although there are existing Internet interventions that have been thoroughly studied and demonstrated effective in the general population, it has not been studied the extent to which these interventions may be effective for caregivers without tailoring to address this population’s unique psychosocial needs. OBJECTIVE The goal of this trial is to determine what tailoring may be necessary for which caregivers to ensure they receive optimal benefit from an existing evidence-based, Internet-delivered CBT-I program, SHUTi (Sleep Healthy Using the Internet). Specifically, we will test the association between caregivers’ engagement with SHUTi and their caregiving context characteristics (i.e., caregiving strain, self-efficacy, and guilt) and environment (i.e., proximity to care recipient; care recipient functional status, cognitive status, and problem behavior; and type of care provided). Among caregivers utilizing the program, we will also test the associations between change in known treatment mechanisms (sleep beliefs and sleep locus of control) and caregiving context factors. METHODS One-hundred higher-intensity caregivers with significant insomnia symptoms will be recruited from across the U.S. to receive access to SHUTi in an open-label trial with mixed-methods pre- and post-assessments. At post-assessment (9 weeks following pre-assessment completion), participants will be categorized according to their engagement with the program (non-users, incomplete users, or complete users). Study analyses will address three specific aims: To examine the association between caregivers’ engagement with SHUTi and their caregiving context (Aim 1a); to describe caregivers’ barriers to and motivations for SHUTi engagement will be described from open-ended survey responses (Aim 1b); and among caregivers using SHUTi, to determine whether cognitive mechanisms of change targeted by SHUTi are associated with differences in caregiving context (Aim 2). RESULTS Institutional Review Board approvals have been received and recruitment will be initiated in 2022, with data collection expected through 2023. CONCLUSIONS Findings will inform next research steps for tailoring and testing SHUTi for optimal impact and reach among caregivers. Beyond implication to the SHUTi program, findings will be translatable across intervention programs and hold significant promise to reduce inefficiencies in developing digital health interventions for caregivers, while also increasing their impact and reach for this underserved population. CLINICALTRIAL This trial is registered with ClinicalTrials.gov (NCT04986904)