Behavioral Therapy for Nocturia

(MINT Trial)

Recruiting at 1 trial location

Overseen By Patric Campbell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Atlanta VA Medical Center

Must not be taking: Bladder medications, Insomnia medications

Disqualifiers: Bipolar, Cognitive impairment, Unstable health, others

Compensation: Varies

Number of Visits: 9

Duration: 5 weeks

192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a combined treatment approach can assist older adults experiencing frequent nighttime bathroom trips (nocturia) and trouble sleeping (insomnia). One group will participate in a health education program, while another will try integrated behavioral therapy, which includes strategies to manage both conditions. The goal is to assess whether these treatments can improve sleep and overall quality of life. Individuals who make at least two nightly trips to the bathroom and suffer from insomnia might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to explore new treatment strategies that could enhance participants' quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot have new or recently discontinued insomnia medication within the past month, and your bladder medication doses must be stable without recent changes.

What prior data suggests that this behavioral therapy is safe for treating nocturia and insomnia?

Research has shown that combined behavioral therapy for issues like frequent nighttime urination (nocturia) and trouble sleeping (insomnia) is generally safe. These treatments often address more than just urinary problems, leading to improved sleep. Importantly, they do not involve medication, so there are no drug-related side effects.

Participants in similar studies found the therapy manageable and beneficial. No major negative effects have been reported from these treatments. Overall, this suggests that the therapy is safe and could be a good option for those seeking to improve sleep and manage nocturia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for nocturia because they focus on behavioral changes rather than medication. Unlike standard treatments that often involve drugs like desmopressin or anticholinergics, the Integrated Behavioral Therapy Program combines cognitive-behavioral techniques specifically targeting nocturia and insomnia, offering a holistic approach without the side effects associated with medications. Meanwhile, the Health Education Program emphasizes brain health and lifestyle factors, such as physical activity and sleep quality, that can influence nocturia. These approaches aim to provide sustainable, drug-free solutions to improve quality of life for individuals experiencing nocturia.

What evidence suggests that this trial's treatments could be effective for nocturia and insomnia?

This trial compares two approaches to managing nocturia. The Integrated Behavioral Therapy Program, one treatment arm, combines cognitive-behavioral techniques to address frequent nighttime urination and insomnia. Research has shown that such combined therapy can reduce nighttime bathroom visits and improve sleep quality. Specifically, participants in this arm reported better sleep and fewer nighttime interruptions. This approach aims to enhance overall health by addressing these issues together. Meanwhile, the Health Education Program, another arm of the trial, focuses on general health topics and serves as a comparator. ^{1 3 6 7 8}

Who Is on the Research Team?

E. Camille Vaughan

Principal Investigator

Atlanta VAMC & Emory University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You wake up to pee at least 2 times every night.

You have a score higher than 7 on a test that measures how severe your insomnia is.

I can go to weekly appointments for the study.

Exclusion Criteria

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

I have undergone cognitive behavioral therapy for insomnia.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person)

Treatment

Participants receive either Integrated Behavioral Therapy or Health Education Program over 5 weekly sessions

5 weeks

5 visits (in-person or virtual), 2 telephone check-ins

Post-intervention Assessment

Participants undergo a post-intervention assessment and monthly phone calls

1 week

1 visit (in-person or virtual), 3 monthly phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

1 final assessment (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Health Education Program
• Integrated Behavioral Therapy Program

Trial Overview

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.

How Is the Trial Designed?

Group I: Integrated Behavioral Therapy Program Experimental Treatment 1 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 Program Placebo Group 1 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.

Who Is Running the Clinical Trial?

Atlanta VA Medical Center

Lead Sponsor

Trials

28

Recruited

69,700+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

VA Greater Los Angeles Healthcare System

Collaborator

Trials

53

Recruited

8,700+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

The Whole Health model of care emphasizes a comprehensive approach to health that includes prevention, treatment, and both conventional and complementary methods, which can enhance patient well-being.

Integrative health coaching is an effective strategy for clinicians to help patients make significant behavior changes related to physical activity and exercise, supporting the management and prevention of chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity, Exercise, Whole Health, and Integrative Health Coaching. Malecki, HL., Gollie, JM., Scholten, J.[2021]

Blended-care behavior change interventions (BBCI) effectively promote weight loss, with participants losing an average of 6.55 kg over 12 months, based on data from 25,706 patients.

Coaching, self-monitoring, and self-management are key components that positively influence weight loss, while excessive appointments with dietitian coaches may hinder progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Intervention Elements Drive Weight Loss in Blended-Care Behavior Change Interventions? A Real-World Data Analysis with 25,706 Patients. Schirmann, F., Kanehl, P., Jones, L.[2022]

Health and wellness coaches (HWCs) have been effective in helping patients manage chronic diseases by supporting lifestyle behavior changes, leading to improved health outcomes.

The success of HWCs may be attributed not only to their behavioral modification techniques, like goal setting and self-monitoring, but also to their alignment with the current trend towards personalized and holistic healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential Contribution of Current Health Care Zeitgeists to the Success of Health and Wellness Coaches. Gray, JP., Arlinghaus, KR., Johnston, CA.[2020]

The Steps program was the CDC's first initiative to adopt a community-based approach to prevent chronic diseases by addressing major risk factors like tobacco use, poor nutrition, and physical inactivity.

The program evolved from focusing on individual health behaviors to implementing policy and environmental changes, significantly enhancing its effectiveness in chronic disease prevention and influencing other CDC programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evolution of the steps program, 2003-2010: transforming the federal public health practice of chronic disease prevention. Nichols, P., Ussery-Hall, A., Griffin-Blake, S., et al.[2021]

The Collaborative Care (CC) model was successfully implemented in a nurse-managed health center in Chicago, serving 166 patients in its first year, with 22% achieving depression treatment goals and 47% for anxiety.

This model not only improved patient outcomes by addressing both mental and physical health needs but also enhanced the collaboration between primary care providers and behavioral health specialists, boosting the confidence of family nurse practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative Care: Integrating Behavioral Health Into the Primary Care Setting. Reising, V., Diegel-Vacek, L., Dadabo, L., et al.[2023]

Structured treatment and education programs for diabetes and hypertension in Germany have shown increasing evidence of effectiveness, highlighting the importance of a systematic approach to patient care.

The success of these programs relies on essential components and specific conditions for effective implementation, emphasizing the need for careful planning and evaluation in healthcare interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evidence-based treatment and education programs--evaluation of complex interventions]. Mühlhauser, I.[2008]

The Health Coaching Program, tested by 20 family doctors over 12 months, successfully engaged 91% of invited patients, demonstrating high acceptance and feasibility among both patients and physicians.

Of the patients who participated, 37% completed all four steps of the program, and about 50% achieved a positive behavior change, indicating the program's effectiveness in promoting health behavior improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Health counseling in primary care doctors' offices: a new wind! The Health Coaching Program of the Swiss College of Primary Care Medicine]. Neuner-Jehle, S., Grüninger, U., Schmid, M.[2015]

A pilot project involving a neighborhood health center and a nursing school provided workshops for low-income Hispanic diabetics, enhancing client education and offering practical teaching experience for nursing students.

Participants in the workshops learned valuable skills in meal planning, medication management, exercise, and community involvement, leading to positive lifestyle changes for better diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaboration in action. Schwab, T., Simmons, R.[2007]

The mobile app My Wellness Coach (MWC) showed promising feasibility and acceptability among underserved populations, with 76% of participants setting health goals and significant improvements in overall wellbeing and physical health after 3 months.

Participants using MWC in a group setting had a higher goal completion rate (60%) compared to those using it individually (20%), suggesting that group support may enhance the app's effectiveness in promoting behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

My Wellness Coach: evaluation of a mobile app designed to promote integrative health among underserved populations. Yuan, NP., Brooks, AJ., Burke, MK., et al.[2023]

The comprehensive lifestyle health coaching (LHC) program has been successfully implemented in various settings, including large employers and healthcare facilities, using technology to deliver services primarily via telephone and the Internet.

Outcomes from published studies and clinical trials demonstrate that the LHC program effectively modifies multiple health risk factors in both healthy individuals and those with chronic diseases, showcasing its clinical effectiveness and integration with traditional medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of Lifestyle Health Coaching: Case Study of an Evidence-Based Program. Gordon, NF., Salmon, RD., Wright, BS., et al.[2020]

The Community Education Monitoring System (CEMS) effectively tracks various aspects of behavior change interventions, such as the number and type of activities, target audiences, and funding sources, using data from established health programs like the Stanford Five-City Project.

CEMS enhances program evaluation by providing a structured way to measure program reach and effectiveness, allowing for better comparisons across different health promotion initiatives and ensuring that theoretical frameworks are applied in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community education monitoring system: methods from the Stanford Five-City Project, the Minnesota Heart Health Program and the Pawtucket Heart Health Program. Flora, JA., Lefebvre, RC., Murray, DM., et al.[2019]

The article reviews four evidence-based models for facilitating health or lifestyle changes: the Transtheoretical Model, Brief Motivational Interviewing, Prevention Oriented Primary Care, and the ECBIS Psychotherapy Model, highlighting their systematic and integrative approaches.

These models can be effectively combined in clinical practice to assist patients in changing multiple health behaviors, demonstrating their practical application in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapy for health and lifestyle change. Feinstein, RE., Feinstein, MS.[2004]

Health education initiatives have been shown to effectively change health behaviors, contributing to improved health outcomes, although the specific mechanisms behind this success are not fully understood.

Incorporating preventive services into patient care, especially for high-risk individuals, can enhance the effectiveness of health education efforts, highlighting the growing focus on preventive care in primary healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education for health. A role for physicians and the efficacy of health education efforts. Council on Scientific Affairs. [2016]

Patient education significantly improves compliance with therapeutic regimens in chronic disease management, with an average improvement of 0.67 sigma over control groups, indicating a strong effect.

While patient education also leads to improvements in physiological progress (0.49 sigma) and health outcomes (0.02 sigma), the most effective strategies involve behaviorally-oriented programs that focus on changing the patient's environment rather than just increasing knowledge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does patient education in chronic disease have therapeutic value? Mazzuca, SA.[2019]

About half of American adults struggle with health literacy, which can lead to worse health outcomes and higher healthcare costs, highlighting the need for effective screening and support.

Implementing strategies like the teach-back method, visual aids, and patient empowerment training can significantly improve health literacy and patient self-management, ultimately enhancing health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice improvement, part II: health literacy. Roett, MA., Coleman, MT.[2013]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8844541/

Considerations for integrated cognitive behavioural ...

This integrated program addresses the common scenario of coexisting nocturia and chronic insomnia disorder. Keywords: sleep, insomnia, nocturia, ...

2.

withpower.com

withpower.com/trial/phase-nocturia-10-2023-911b7

Behavioral Therapy for Nocturia (MINT Trial)

Trial Overview The MINT study is testing whether an Integrated Behavioral Therapy Program can improve sleep and reduce nighttime bathroom trips compared to a ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41041560/

Protocol for a multi-site randomized trial testing an ...

Findingswill provide rigorous evidence of the efficacy of the integrated behavioral treatment program to reduce nocturia frequency as well as ...

4.

mdpi.com

mdpi.com/2077-0383/13/18/5629

Harnessing the Power of Integrated Behavioral Health to ...

Primary care behavioral health (PCBH) is well-equipped to address the challenges of accessing evidence-based care for insomnia.

5.

healthymindspolicy.org

healthymindspolicy.org/research/understanding-integrated-behavioral-health-care-and-the-collaborative-care-model

Understanding integrated behavioral health care and the ...

These models aim to improve overall, whole-person health outcomes through coordinated, cohesive care carried out by a multidisciplinary team.

6.

agsjournals.onlinelibrary.wiley.com

agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.19214

A multisite feasibility study of integrated cognitive‐behavioral ...

Current treatments target either nocturia or insomnia. Most treatments for nocturia focus exclusively on the lower urinary tract, and while ...

7.

researchsquare.com

researchsquare.com/article/rs-7330051/v1.pdf

Protocol for a multi-site randomized trial testing an ...

Current treatment approaches for nocturia often overlook non-lower urinary tract factors that may contribute to nighttime awakenings. Nocturia ...

8.

escholarship.org

escholarship.org/content/qt9z39w99k/qt9z39w99k_noSplash_8334c8f6623f8d39fe818dd37b7958ee.pdf

behavioral treatment for co-existing nocturia and chronic ...

Most treatments for nocturia focus exclusively on the lower urinary tract, and while some patients experience reduction in nocturia fre- quency with ...