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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

Must not have

Prior cognitive behavioral therapy for insomnia

Sleep disturbance better explained by another sleep disorder such as restless legs syndrome, narcolepsy, insufficient sleep syndrome, or circadian rhythm sleep-wake disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have undergone cognitive behavioral therapy for insomnia.

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My sleep problems are not due to conditions like restless legs or narcolepsy.

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I currently have a urinary tract infection or blood in my urine.

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I am currently receiving treatment for cancer in my urinary or reproductive organs.

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I don't have heart failure, uncontrolled diabetes, severe kidney disease, or need dialysis soon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Nocturia Frequency

Secondary study objectives

Nocturia-Quality of Life

Self-Reported Insomnia Severity Index

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.

0 / 7Eligibility criteria met