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 — BEHAVIORAL
    MSOS 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) — BEHAVIORAL
    BBTI 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 Group
    Participants (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 Group
    Participants (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

Locations (2)

FacilityCityStateZIPSite coordinators
University of MiamiCoral GablesFlorida33146
Youngmee Kim, PhD
305-284-5439
Youngmee Kim, PhD (PRINCIPAL_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15260-

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