Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers

NCT04986904 | Completed Results

• 2 other identifiers: HSR210255R21TR003522
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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.

Conditions

Family Caregivers; Insomnia; Sleep Initiation and Maintenance Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sleep-related Cognitions

  Baseline Pre-assessment and 9-week Post-assessment

• Sleep Self-efficacy

  Baseline Pre-assessment and 9-week Post-assessment

Other Outcomes (7)

• Open-ended Feedback on SHUTi

  9-week Post-assessment

• SHUTi Evaluation

  9-week Post-assessment

• Caregiving Strain

  Baseline Pre-assessment and 9-week Post-assessment

Study Arms (1)

SHUTi (Sleep Healthy Using the Internet)

EXPERIMENTAL

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)

Interventions

SHUTi (Sleep Healthy Using the Internet) BEHAVIORAL

Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program

Also known as: Cognitive-behavioral therapy for insomnia, CBT-I

SHUTi (Sleep Healthy Using the Internet)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• University of Pittsburgh: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (2)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (3)

• 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.

  PMID: 35019846 BACKGROUND

• 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.

  PMID: 38982942 RESULT

• 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.

  PMID: 38990523 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Kelly Shaffer
• Organization: University of Virginia

kshaffer@virginia.edu

434-982-1022

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 3, 2021
• Study Start: January 11, 2022
• Primary Completion: March 6, 2023
• Study Completion: March 19, 2023
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

US (2)