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Completed

NCT Number: NCT04986904

Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh, Pittsburgh, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Cognitive-behavioral therapy for insomnia, CBT-I

Primary outcomes

  1. SHUTi Engagement

    Time frame: 9-week Post-assessment

    Level of SHUTi engagement: Core completion (i.e., nonuser [no cores completed], incomplete user [1-3 Cores], or complete user [4-6 Cores])

Secondary outcomes

  1. Sleep-related Cognitions

    Time frame: Baseline Pre-assessment and 9-week Post-assessment

    Dysfunctional Beliefs and Attitudes about Sleep; 16 items; sum scores range from 0 to 160 (higher scores indicate more dysfunctional attitudes and beliefs about sleep)

  2. Sleep Self-efficacy

    Time frame: Baseline Pre-assessment and 9-week Post-assessment

    Sleep Locus of Control Scale with two subscales:

    • a 5-item subscale for internal locus of control; summed scores per scale range from 5 to 30 (higher scores indicate higher belief in the locus of control measured; higher internal sleep locus of control is a better outcome)
    • a 3-item subscale for external locus of control; summed scores per scale range from 3 to 18 (higher scores indicate higher belief in the locus of control measured; lower external sleep locus of control is a better outcome)

Other outcomes

  1. Open-ended Feedback on SHUTi

    Time frame: 9-week Post-assessment

    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.

  2. SHUTi Evaluation

    Time frame: 9-week Post-assessment

    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

  3. Caregiving Strain

    Time frame: Baseline Pre-assessment and 9-week Post-assessment

    Pearlin Stress Scale - Overload subscale; 4 items; averaged scores range from 1 to 4 (higher scores indicate greater perceived burden)

  4. Insomnia Symptom Severity

    Time frame: Baseline Pre-assessment and 9-week Post-assessment

    Insomnia severity index; 2 items; summed scores range from 0 to 8 (higher scores indicate more severe insomnia symptoms)

  5. Sleep Onset Latency (SOL)

    Time frame: Baseline Pre-assessment and 9-week Post-assessment

    Data collected from sleep diary: Time fell asleep - Time attempting to fall asleep

  6. Wake After Sleep Onset (WASO)

    Time frame: Baseline Pre-assessment and 9-week Post-assessment

    Data collected from sleep diary: Total time awake between time feel asleep and final morning waking

  7. Perceived Sleep Quality

    Time frame: Baseline Pre-assessment and 9-week Post-assessment

    Data collected from sleep diary: Nightly rating of perceived sleep quality from very poor to very good

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • University of Pittsburgh

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2021
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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