Single-Group Trial of an Internet-Delivered Insomnia Intervention Among Higher-Intensity Family Caregivers: Rationale and Protocol for a Mixed Methods Study

Abstract

Background: Family caregivers are more likely to experience insomnia relative to noncaregivers but have significant barriers to accessing gold standard cognitive behavioral therapy for insomnia treatment. Delivering interventions to caregivers through 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 as effective in the general population, the extent to which these interventions may be effective for caregivers without tailoring to address this population's unique psychosocial needs has not been studied.

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 cognitive behavioral therapy for insomnia program named Sleep Healthy Using the Internet (SHUTi). Specifically, we will test the association between caregivers' engagement with SHUTi and their caregiving context characteristics (ie, caregiving strain, self-efficacy, and guilt) and environment (ie, proximity to care recipient; functional status, cognitive status, and problem behavior of care recipient; and type of care provided). Among caregivers using 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: A total of 100 higher-intensity caregivers with significant insomnia symptoms will be recruited from across the United States to receive access to SHUTi in an open-label trial with mixed methods preassessments and postassessments. At postassessment (9 weeks following preassessment completion), participants will be categorized according to their engagement with the program (nonusers, incomplete users, or complete users). Study analyses will address 3 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 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. Data collection is anticipated to begin in December 2021 and is expected to be completed in 2023.

Conclusions: Findings will inform the next research steps for tailoring and testing SHUTi for optimal impact and reach among caregivers. Beyond implication to the SHUTi program, the findings will be translatable across intervention programs and will hold significant promise to reduce inefficiencies in developing digital health interventions for caregivers while also increasing their impact and reach for this underserved population.

Trial registration: ClinicalTrials.gov; NCT04986904; https://ichgcp.net/clinical-trials-registry/NCT04986904?term=NCT04986904.

International registered report identifier (irrid): PRR1-10.2196/34792.

Keywords: cognitive behavioral therapy; eHealth; family caregiver; insomnia; mobile phone; protocol; sleep initiation and maintenance disorders.

Conflict of interest statement

Conflicts of Interest: Over the past 3 years, DJB has served as a paid consultant to the National Cancer Institute, Pear Therapeutics, Sleep Number, Idorsia, and Weight Watchers International. DJB is an author of the Pittsburgh Sleep Quality Index, Pittsburgh Sleep Quality Index Addendum for posttraumatic stress disorder, Brief Pittsburgh Sleep Quality Index, Daytime Insomnia Symptoms Scale, Pittsburgh Sleep Diary, Insomnia Symptom Questionnaire, and RU_SATED (copyrights held by the University of Pittsburgh). These instruments have been licensed to commercial entities for fees. He is also a coauthor of the Consensus Sleep Diary (copyright held by Ryerson University), which is licensed to commercial entities for a fee. LMR reports relationships with BeHealth Solutions (equity ownership and member of the board of directors) and Pear Therapeutics (consultant), which are 2 companies that develop and disseminate digital therapeutics, including licensing the therapeutic developed, based, in part, on early versions of the software used in the research reported in this paper. These companies had no role in the preparation of this manuscript. LMR is also a consultant to Mahana Therapeutics, a separate digital therapeutic company not affiliated with this research. The terms of these arrangements have been reviewed and approved by the University of Virginia in accordance with its policies.

©Kelly M Shaffer, Lee M Ritterband, Wen You, Daniel J Buysse, Meghan K Mattos, Fabian Camacho, Jillian V Glazer, Julie Klinger, Heidi Donovan. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 12.01.2022.

Figures

Figure 1

Trial procedures. SHUTi: Sleep Healthy Using the Internet.