Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04986904
• Other study ID #: HSR210255
• Status: Completed
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: March 19, 2023

Study information

• Verified date: October 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 19, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Family Caregivers
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• SHUTi (Sleep Healthy Using the Internet)
Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiving strain	Pearlin Stress Scale - Overload subscale; 4 items; averaged scores range from 1 to 4 (higher scores indicate greater perceived burden)	Baseline Pre-assessment and 9-week Post-assessment
Other	Insomnia symptom severity	Insomnia severity index; 2 items; summed scores range from 0 to 8 (higher scores indicate more severe insomnia symptoms)	Baseline Pre-assessment and 9-week Post-assessment
Other	Sleep onset latency (SOL)	Data collected from sleep diary: Time fell asleep - Time attempting to fall asleep	Baseline Pre-assessment and 9-week Post-assessment
Other	Wake after sleep onset (WASO)	Data collected from sleep diary: Total time awake between time feel asleep and final morning waking	Baseline Pre-assessment and 9-week Post-assessment
Other	Perceived sleep quality	Data collected from sleep diary: Nightly rating of perceived sleep quality from very poor to very good	Baseline Pre-assessment and 9-week Post-assessment
Primary	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	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
Secondary	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
Secondary	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
Secondary	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