Clinical trial NCT04986904: Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers
Official title: Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers: A Mixed Methods Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Caregivers
Insomnia
Sleep Initiation and Maintenance Disorders
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2021-08-03
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: SHUTi Engagement
timeFrame: 9-week Post-assessment
Secondary outcomes:
measure: Sleep-related Cognitions
timeFrame: Baseline Pre-assessment and 9-week Post-assessment
measure: Sleep Self-efficacy
timeFrame: Baseline Pre-assessment and 9-week Post-assessment
Other outcomes:
measure: Open-ended Feedback on SHUTi
timeFrame: 9-week Post-assessment
measure: SHUTi Evaluation
timeFrame: 9-week Post-assessment
measure: Caregiving Strain
timeFrame: Baseline Pre-assessment and 9-week Post-assessment
measure: Insomnia Symptom Severity
timeFrame: Baseline Pre-assessment and 9-week Post-assessment
measure: Sleep Onset Latency (SOL)
timeFrame: Baseline Pre-assessment and 9-week Post-assessment
measure: Wake After Sleep Onset (WASO)
timeFrame: Baseline Pre-assessment and 9-week Post-assessment
measure: Perceived Sleep Quality
timeFrame: Baseline Pre-assessment and 9-week Post-assessment
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
citation: Shaffer KM, Ritterband LM, You W, Buysse DJ, Mattos MK, Camacho F, Glazer JV, Klinger J, Donovan H. Single-Group Trial of an Internet-Delivered Insomnia Intervention Among Higher-Intensity Family Caregivers: Rationale and Protocol for a Mixed Methods Study. JMIR Res Protoc. 2022 Jan 12;11(1):e34792. doi: 10.2196/34792.
citation: Shaffer KM, Ritterband LM, You W, Mattos MK, Buysse DJ, Glazer JV, Klinger J, Donovan H. Caregivers' Internet-Delivered Insomnia Intervention Engagement and Benefit: SHUTi-CARE Trial Primary Quantitative Analysis. Ann Behav Med. 2024 Oct 16;58(10):645-657. doi: 10.1093/abm/kaae031.
citation: Shaffer KM, Perepezko K, Glazer JV, Mattos MK, Klinger J, Buysse DJ, Ritterband LM, Donovan H. Caregiver Experiences With an Internet-Delivered Insomnia Intervention: SHUTi-CARE Trial Primary Qualitative Analysis. Ann Behav Med. 2024 Oct 16;58(10):658-669. doi: 10.1093/abm/kaae041.