An interventional study of Integrated Behavioral Therapy Program and Health Education Program in Nocturia and Insomnia, sponsored by Atlanta VA Medical Center. Recruiting at 2 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Atlanta VA Medical Center · Not applicable, Interventional, and Treatment
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.
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. While prior research suggests the benefits of multicomponent behavioral treatment, there is an urgent need for treatment strategies that also address concomitant sleep factors, and this study has the potential to provide evidence needed for this shift in the recommended treatment of nocturia among older adults. The study population includes men and women aged 60 years or older who have nocturia at least twice nightly based on the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB) questionnaire and insomnia symptoms based on the Insomnia Severity Index. Participants will be identified through 5 sources: 1) Computer-based screening using the Veterans Affairs (VA) Corporate Database Warehouse to screen veterans who live close to the Medical Center, as well as data pulling real Social Security Numbers (SSNs) from VA's Information and Computing Infrastructure (VINCI); 2) a survey mailed once at the end of year 1 to individuals aged > 60 years who have received care at VA Greater Los Angeles (VAGLA) and University of California, Los Angeles (UCLA) sleep center and clinics and Atlanta VA and Emory University sleep center and clinics within the past 6 months; 3) referrals from clinic providers; 4) flyers/advertisements posted in the medical centers; and 5) social media advertisements.
Individuals who meet initial screening criteria will be invited to a face-to-face appointment, where participants will provide written informed consent (either paper or e-consent). At the initial screening appointment, participants will be screened for sleep apnea; have their medical records reviewed; be administered questionnaires; have blood and urine tests; and be provided with a wrist actigraph to wear at home for 1 week, along with a sleep and urinary symptom diary to complete while wearing the actigraph. If eligible, participants will be randomly assigned to either the intervention or the control. Participants assigned to Integrated Behavioral Therapy will receive combined cognitive behavioral therapy for insomnia and nocturia delivered by an interventionist, while those assigned to the Health Education Program will be provided with a health education curriculum delivered by the interventionist. After the final session, participants will have a post-intervention assessment and monthly phone calls until the final assessment 4 months later. The post-intervention assessment and 4-month assessment will include many of the same measures from the screening/baseline visit. Overall, participants in either group will receive 2 baseline/screening visits, 5 weekly one hour sessions either in-person or remotely, one post-intervention session, 3 monthly 15-minute phone calls, and 1 final assessment over the span of approximately 4 months.
Our intended sample size is 96 participants in each group across all sites (total of N=192 randomized participants across all sites; n=96 at Atlanta VA, with n=48 randomized to the Integrated Behavioral Therapy and n=48 randomized to the Health Education Program. The investigators expect to complete 392 baseline assessments (196 per site) to reach our intended sample size.
134 studies on the registry are indexed under Nocturia; 22 are open to participants now.
This study's planned enrollment of 192 is above the median of 71 across 108 interventional studies indexed under Nocturia.
Browse Nocturia studies →Atlanta VA Medical Center is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Integrated Behavioral Therapy 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.
Behavioral: Health Education Program
Integrated Behavioral Therapy is a behavioral program that includes education, lifestyle habits management, cognitive, relaxation, and behavioral conditioning for nocturia and insomnia
Health Education 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.
Mean Nocturia Frequency
The primary outcome of nocturia frequency will be measured as the average episodes per night at baseline, 2 months, and 4 months through the International Consultation on Incontinence Questionnaire-Overactive Bladder Module (ICIQ-OAB) questionnaire. An adapted version that asks the participant to record the number of nocturia episodes if the "4+" nocturia option is selected will be used. A linear mixed effects model will be used to evaluate the group difference over time in average nocturia frequency per night.
Time frame: 4 months
Self-Reported Insomnia Severity Index
The self-reported Insomnia Severity Index is a 7-item instrument with high internal consistency and validity for measures of fatigue, quality of life, anxiety, and depression. The total score is the sum of all seven items and ranges from 0-28 with higher scores indicating greater insomnia severity. The Insomnia Severity Index can also be used as a change score that measures perceived severity of insomnia symptoms. A 0.5 standardized mean difference between treatment and control is considered the clinical significance threshold for studies of chronic insomnia disorder. The Insomnia Severity Index will be modeled similarly with a linear mixed mode. If the distributions of the secondary outcome is skewed and no good transformation is found, the outcome will be categorized into categories based on quantiles or clinically meaningful values and then modeled with generalized linear mixed models using cumulative logit or generalized logit link for multinomial data.
Time frame: 4 months
Nocturia-Quality of Life
The Nocturia-Quality of Life (NQOL) questionnaire provides a detailed and robust measure to assess the impact of nocturia on quality of life with particular reference to the effects on persons' lives of nocturia and can be used as an outcome measure to assess impact of different treatment modalities. The NQOL score may be calculated by summing all items, giving a score from 0-58. A greater score indicates a higher impact on QOL. The NQOL will be modeled similarly with linear mixed models in their original scale or transformed scale as appropriate. If the distributions of the NQOL scores are skewed and no good transformation is found, the outcomes will be categorized into categories based on quantiles or clinically meaningful values and then modeled with generalized linear mixed models. Similar secondary analyses as those proposed in assessing mean nocturia frequency will be performed on the secondary outcomes NQOL.
Time frame: 4 months
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Started Dec 2023 (actual). Primary completion is estimated for Apr 2028, 52 months after the start.
Of 34 interventional studies with no phase under Nocturia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 52 months is above that.
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