Dyadic Sleep Study
Part of paid clinical trials in Coral Gables, Florida.
- Sponsor
- University of Miami
- Study ID
- NCT06569693
- Status
- Recruiting
Conditions
- Gastrointestinal Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- My Sleep Our Sleep (MSOS) Program — BEHAVIORALMSOS is a sleep intervention developed by the investigator aimed at improving sleep health for patient-sleep-partner caregiver dyads using behavioral education in sleep behaviors, sleep cognition and sleep in relationship. MSOS will be delivered over four weeks, in weekly one-hour sessions, one session per week.
- Brief Behavioral Treatment for Insomnia (BBTI) — BEHAVIORALBBTI is brief patient-focused intervention for patient-sleep-partner caregiver dyads, aimed at altering participants' sleep behaviors to improve sleep. BBTI utilizes behavioral education in sleep restriction and stimulus control. For sleep restriction, participants will be instructed to limit the time they spend in bed, which serves to increase sleep efficiency. For stimulus control, participants will be instructed to go to bed only when feeling sleepy and reserve the bed for sleep and intimacy. BBTI will be delivered over four weeks, in weekly one-hour sessions, one session per week.
Study Details
The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.
Key Dates
- Start date
- Oct 22, 2024
- Status verified
- Mar 2026
- Primary completion
- Dec 1, 2026
- Completion
- Dec 1, 2026
Study Design
- Enrollment
- 152 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: MSOS Intervention GroupParticipants (patient-sleep-partner caregiver dyads) in this group will receive the My Sleep Our Sleep (MSOS) intervention. Total participation is up to 13 weeks.
- Experimental: BBTI Intervention GroupParticipants (patient-sleep-partner caregiver dyads) in this group will receive the Brief Behavioral Treatment for Insomnia (BBTI). Total participation is up to 13 weeks.
Primary Outcome Measure
Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, Up to 13 weeks ]
Central Contacts
- Youngmee Kim, PhD305-284-5439
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami | Coral Gables | Florida | 33146 | Youngmee Kim, PhD (PRINCIPAL_INVESTIGATOR) |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | - |
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