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Behavioral Intervention

Behavioral Therapy for Nocturia (MINT Trial)

N/A
Recruiting
Led By E. Camille Vaughan, MD, MS
Research Sponsored by Atlanta VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to attend weekly study visits
Age ≥ 60 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

MINT Trial Summary

This trial aims to improve sleep and reduce nighttime trips to the bathroom in older adults.

Who is the study for?
This trial is for adults aged 60 or older who have trouble sleeping due to waking up often at night to urinate (nocturia). They must be able to attend weekly visits, have moderate insomnia, and experience nocturia at least twice a night. People with other sleep disorders, recent changes in bladder medication, severe health issues, untreated sleep apnea, or those undergoing certain treatments are excluded.Check my eligibility
What is being tested?
The MINT study is testing whether an Integrated Behavioral Therapy Program can improve sleep and reduce nighttime bathroom trips compared to a Health Education Program. Participants will be randomly placed into one of these two groups to see which is more effective.See study design
What are the potential side effects?
Since the interventions involve behavioral therapy and education programs rather than medications, side effects may include discomfort from changing habits or routines but are not expected to include typical drug-related side effects.

MINT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can go to weekly appointments for the study.
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I am 60 years old or older.

MINT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Nocturia Frequency
Secondary outcome measures
Nocturia-Quality of Life
Self-Reported Insomnia Severity Index

MINT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Integrated Behavioral Therapy ProgramExperimental Treatment1 Intervention
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.
Group II: Health Education ProgramPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Emory UniversityOTHER
1,640 Previous Clinical Trials
2,560,504 Total Patients Enrolled
3 Trials studying Insomnia
3,772 Patients Enrolled for Insomnia
Atlanta VA Medical CenterLead Sponsor
26 Previous Clinical Trials
69,243 Total Patients Enrolled
VA Greater Los Angeles Healthcare SystemFED
51 Previous Clinical Trials
8,377 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it still feasible for participants to enrol in this experiment?

"This study, which was first advertised on November 1st 2023 is not presently accepting new participants. As per the information available through clinicaltrials.gov, it has been updated for the last time on October 30th 2023 and there are currently 174 other studies searching for volunteers."

Answered by AI

Who else is applying?

What site did they apply to?
Atlanta VAHCS
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Multi-center Trial to Improve Nocturia and Sleep in Older Adults
Elizabeth Camille Vaughan 2023. "Multi-center Trial to Improve Nocturia and Sleep in Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06110091.
~128 spots leftby Apr 2028
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