Protocol for a multi-site randomized trial testing an integrated behavioral treatment for improving nocturia and insomnia symptoms in older adults (MINT).
Constance Fung, Courtney J Bolstad, Alison Huang...
https://pubmed.ncbi.nlm.nih.gov/41041560/Actively Recruiting
Led by Atlanta VA Medical Center · Updated on 2025-09-30
192
Participants Needed
2
Research Sites
17 weeks
Total Duration
Researchers are evaluating treatments for older adults aged 60 years and above who experience frequent nighttime urination nocturia and insomnia. This randomized trial aims to assess the effectiveness of an integrated behavioral therapy combining treatments for both conditions and explore its impact on quality of life. The study addresses a gap in current treatment options by focusing on coexisting nocturia and sleep difficulties in this population. Participants will be randomly assigned to one of two programs. The Integrated Behavioral Therapy Program includes five weekly one-hour sessions, either in-person or via video, plus two telephone check-ins focusing on managing nocturia and insomnia through education, lifestyle changes, and behavioral techniques. The Health Education Program also involves five weekly sessions and two phone calls but covers brain health topics like physical activity, social engagement, sleep changes with aging, and managing medical conditions. Both programs are delivered by an interventionist. During the study, participants will complete two baseline visits, five weekly treatment sessions, a post-intervention assessment, three monthly phone check-ins, and a final assessment four months after treatment. Assessments include questionnaires, blood and urine tests, sleep and urinary symptom diaries, and wearing a wrist actigraph for one week. The main outcome measured is the average frequency of nighttime urination at four months. Additional measures include insomnia severity and nocturia-related quality of life. The total participation lasts about four months with ongoing monitoring and support.
CONDITIONS
Multi-center Trial to Improve Nocturia and Sleep in Older Adults
T
Taressa Sergent
P
Patric Campbell
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Atlanta VA Medical Center
Lead Sponsor
VA Greater Los Angeles Healthcare System
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Integrated Behavioral Therapy Program | Health Education Program |
|---|---|---|
| What it is | A structured behavioral program integrating education, lifestyle management, cognitive strategies, relaxation, and behavioral conditioning specifically for nocturia and insomnia. | A structured health education program with sessions focused on general brain health, healthy lifestyle, effects of aging on sleep, and managing medical or sensory conditions, but without behavioral therapy components for nocturia or insomnia. |
| Role in trial | Investigational intervention tested to improve nocturia and insomnia symptoms through a targeted behavioral approach. | Active comparator arm used to match attention and provide broad health information, without targeting nocturia or insomnia behaviors. |
| Primary use or purpose | To evaluate whether integrated behavioral therapy can reduce the frequency of nighttime urination (nocturia) and improve sleep quality in older adults with both conditions. | To serve as an active control, allowing assessment of whether general health education without behavioral therapy affects nocturia or insomnia outcomes. |
| How it is given or performed | Delivered as weekly, structured group or individual sessions, incorporating education, cognitive behavioral techniques, relaxation, and lifestyle modification strategies. Participants attend regularly scheduled visits. | Delivered through weekly sessions covering topics in aging, wellness, sleep and medical management, intended as interactive group modules without specific skills training for nocturia or insomnia. |
| Evidence status / maturity | Currently being evaluated in a multi-site randomized controlled trial for efficacy in reducing nocturia and insomnia in older adults. Effectiveness not yet established; no definitive published patient outcome results as of now. | Serves as the study's active comparator; not intended or expected to achieve focused improvement in nocturia or insomnia based on existing behavioral evidence. Used to control for general education and participant engagement effects. |
| Important limitations | Long-term effectiveness, generalizability to broader older adult populations, and impact on more medically complex or diverse groups remain unproven until trial results are reported. The program requires structured weekly participation, which may not be accessible for all. | Does not target nocturia or insomnia through specific behavioral strategies, so improvements are expected to be less direct or substantial relative to focused interventions. Also requires consistent attendance for benefit and to serve as a fair comparator. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
2 visits including screening and enrollment visit
Duration - Approximately 6 weeks
Participants undergo 5 weekly one-hour sessions of either Integrated Behavioral Therapy or Health Education Program delivered face-to-face or remotely, followed by 2 telephone check-ins with an interventionist.
5 weekly sessions (in-person or remote) and 2 telephone check-ins
Duration - Approximately 3 months
After the treatment sessions, participants complete a post-intervention assessment and receive monthly phone calls until the final assessment at 4 months.
1 post-intervention visit and 3 monthly 15-minute phone calls plus 1 final assessment visit
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Constance Fung, Courtney J Bolstad, Alison Huang...
https://pubmed.ncbi.nlm.nih.gov/41041560/Constance H Fung, Courtney J Bolstad, Alison Huang...
https://pubmed.ncbi.nlm.nih.gov/41692807/Atlanta VA Medical Center
Lead Sponsor
VA Greater Los Angeles Healthcare System
Collaborating Sponsor