Family Caregivers, Insomnia, Sleep Initiation and Maintenance Disorders
Conditions
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.
Interventions
BEHAVIORALSHUTi (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
Sponsors
University of Pittsburgh
National Center for Advancing Translational Sciences (NCATS)
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SHUTi Engagement | 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep-related Cognitions | 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) |
| Sleep Self-efficacy | Baseline Pre-assessment and 9-week Post-assessment | Sleep Locus of Control Scale with two subscales: 1. 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) 2. 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
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Symptom Severity | 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) |
| Sleep Onset Latency (SOL) | Baseline Pre-assessment and 9-week Post-assessment | Data collected from sleep diary: Time fell asleep - Time attempting to fall asleep |
| Open-ended Feedback on SHUTi | 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. |
| Perceived Sleep Quality | 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 |
| Wake After Sleep Onset (WASO) | Baseline Pre-assessment and 9-week Post-assessment | Data collected from sleep diary: Total time awake between time feel asleep and final morning waking |
| SHUTi Evaluation | 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 |
| Caregiving Strain | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SHUTi (Sleep Healthy Using the Internet) Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 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 progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.
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 | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | SHUTi (Sleep Healthy Using the Internet) |
|---|---|
| Age, Continuous | 52.82 years STANDARD_DEVIATION 13.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 94 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 79 Participants |
| Region of Enrollment United States | 100 participants |
| Sex/Gender, Customized Gender Female | 87 Participants |
| Sex/Gender, Customized Gender Male | 11 Participants |
| Sex/Gender, Customized Gender Other | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
SHUTi Engagement
Level of SHUTi engagement: Core completion (i.e., nonuser \[no cores completed\], incomplete user \[1-3 Cores\], or complete user \[4-6 Cores\])
Time frame: 9-week Post-assessment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SHUTi (Sleep Healthy Using the Internet) | SHUTi Engagement | Non-User | 18 Participants |
| SHUTi (Sleep Healthy Using the Internet) | SHUTi Engagement | Incomplete User | 22 Participants |
| SHUTi (Sleep Healthy Using the Internet) | SHUTi Engagement | Complete User | 60 Participants |
Secondary
Sleep-related Cognitions
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)
Time frame: Baseline Pre-assessment and 9-week Post-assessment
Population: SHUTi Non-Users did not complete this measure at post-assessment. There were 6 SHUTi Incomplete Users who did not complete the post-assessment. All SHUTi Complete Users completed post-assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SHUTi (Sleep Healthy Using the Internet) | Sleep-related Cognitions | Baseline | 92.61 score on a scale | Standard Deviation 31.54 |
| SHUTi Incomplete Users | Sleep-related Cognitions | Baseline | 92.68 score on a scale | Standard Deviation 18.2 |
| SHUTi Incomplete Users | Sleep-related Cognitions | Post-Assessment | 61.12 score on a scale | Standard Deviation 36.2 |
| SHUTi Complete Users | Sleep-related Cognitions | Baseline | 86.08 score on a scale | Standard Deviation 27.04 |
| SHUTi Complete Users | Sleep-related Cognitions | Post-Assessment | 54.82 score on a scale | Standard Deviation 30.08 |
Secondary
Sleep Self-efficacy
Sleep Locus of Control Scale with two subscales: 1. 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) 2. 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)
Time frame: Baseline Pre-assessment and 9-week Post-assessment
Population: SHUTi Non-Users did not complete this measure at post-assessment. There were 6 SHUTi Incomplete Users who did not complete the post-assessment. All SHUTi Complete Users completed post-assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SHUTi (Sleep Healthy Using the Internet) | Sleep Self-efficacy | Baseline Sleep Locus of Control - Internal | 17.06 score on a scale | Standard Deviation 4.49 |
| SHUTi (Sleep Healthy Using the Internet) | Sleep Self-efficacy | Baseline Sleep Locus of Control - External | 9.11 score on a scale | Standard Deviation 4.14 |
| SHUTi Incomplete Users | Sleep Self-efficacy | Baseline Sleep Locus of Control - Internal | 14.77 score on a scale | Standard Deviation 4.06 |
| SHUTi Incomplete Users | Sleep Self-efficacy | Post-Assessment Sleep Locus of Control - Internal | 15.94 score on a scale | Standard Deviation 6.39 |
| SHUTi Incomplete Users | Sleep Self-efficacy | Baseline Sleep Locus of Control - External | 8.14 score on a scale | Standard Deviation 3.17 |
| SHUTi Incomplete Users | Sleep Self-efficacy | Post-Assessment Sleep Locus of Control - External | 6.69 score on a scale | Standard Deviation 3.09 |
| SHUTi Complete Users | Sleep Self-efficacy | Baseline Sleep Locus of Control - Internal | 15.02 score on a scale | Standard Deviation 4.85 |
| SHUTi Complete Users | Sleep Self-efficacy | Baseline Sleep Locus of Control - External | 8.68 score on a scale | Standard Deviation 3.72 |
| SHUTi Complete Users | Sleep Self-efficacy | Post-Assessment Sleep Locus of Control - Internal | 16.93 score on a scale | Standard Deviation 5.12 |
| SHUTi Complete Users | Sleep Self-efficacy | Post-Assessment Sleep Locus of Control - External | 6.75 score on a scale | Standard Deviation 3 |
Other Pre-specified
Caregiving Strain
Pearlin Stress Scale - Overload subscale; 4 items; averaged scores range from 1 to 4 (higher scores indicate greater perceived burden)
Time frame: Baseline Pre-assessment and 9-week Post-assessment
Other Pre-specified
Insomnia Symptom Severity
Insomnia severity index; 2 items; summed scores range from 0 to 8 (higher scores indicate more severe insomnia symptoms)
Time frame: Baseline Pre-assessment and 9-week Post-assessment
Other Pre-specified
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.
Time frame: 9-week Post-assessment
Other Pre-specified
Perceived Sleep Quality
Data collected from sleep diary: Nightly rating of perceived sleep quality from very poor to very good
Time frame: Baseline Pre-assessment and 9-week Post-assessment
Other Pre-specified
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
Time frame: 9-week Post-assessment
Other Pre-specified
Sleep Onset Latency (SOL)
Data collected from sleep diary: Time fell asleep - Time attempting to fall asleep
Time frame: Baseline Pre-assessment and 9-week Post-assessment
Other Pre-specified
Wake After Sleep Onset (WASO)
Data collected from sleep diary: Total time awake between time feel asleep and final morning waking
Time frame: Baseline Pre-assessment and 9-week Post-assessment