Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT) study is a randomized trial to determine and assess the efficacy of integrated treatment of coexisting nocturia and insomnia, as well as explore the effects of this treatment on quality of life.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:
• Age ≥ 60 years
• Average of ≥ 2 episodes per night of nocturia on the International Consultation on Incontinence Questionnaire-Overactive Bladder Module (ICIQ-OAB) questionnaire
• Insomnia Severity Index \> 7
• Able to attend weekly study visits
Locations
United States
California
VA Greater Los Angeles Healthcare System
RECRUITING
Los Angeles
Georgia
Atlanta VAHCS
RECRUITING
Atlanta
Contact Information
Primary
Taressa Sergent
Taressa.Sergent@va.gov
(404) 315-4100
Backup
Patric Campbell
Patric.Campbell@va.gov
(404) 315-4100
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2028-08
Participants
Target number of participants: 192
Treatments
Experimental: Integrated Behavioral Therapy Program
Integrated Behavioral Therapy consists of 5 weekly one-hour sessions (face-to-face either through video or in-person) + 2 telephone check-in with an interventionist. This program integrates cognitive-behavioral treatment for nocturia and insomnia. Brief telephone check-ins will be comprised of review of topics discussed during the sessions.
Placebo_comparator: Health Education Program
The Health Education Program consists of 5 weekly one-hour sessions (face-to-face either through video or in-person) + 2 telephone check-in with an interventionist. The program modules focus on brain health and includes topics such physical activity, social engagement, sleep topics (e.g., changes in sleep that occur with aging, effects of poor sleep on health), medications/medical conditions, vision and hearing impairment. Brief telephone check-ins will be comprised of review of health topics discussed during the sessions.
Related Therapeutic Areas
Sponsors
Collaborators: Emory University, University of Alabama at Birmingham, University of California, San Francisco, VA Greater Los Angeles Healthcare System, University of California, Los Angeles
Leads: Atlanta VA Medical Center