Behavioral Therapy for Nocturia

(MINT Trial)

Recruiting at 1 trial location

Overseen By Taressa Sergent

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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Behavioral Therapy for Nocturia?

Research shows that patient education and behaviorally-oriented programs, which are part of the treatment, can successfully improve health outcomes by changing health behaviors. These programs have been effective in managing chronic diseases by enhancing patient compliance and physiological progress. ^{1 2 3 4 5}

Is behavioral therapy for nocturia safe for humans?

Behavioral therapy programs, like health coaching and wellness education, have been tested in various settings and are generally considered safe. These programs focus on lifestyle changes and have been well-received by both patients and healthcare providers, with high acceptance and feasibility. ^{6 7 8 9 10}

How is the Integrated Behavioral Therapy Program for nocturia different from other treatments?

The Integrated Behavioral Therapy Program for nocturia is unique because it focuses on behavior change through health coaching and education, rather than medication, to help manage symptoms. This approach uses personalized, holistic care to encourage lifestyle changes, such as exercise and self-care, which are not typically emphasized in standard treatments for nocturia. ^{11 12 13 14 15}

Research Team

E. Camille Vaughan

Principal Investigator

Atlanta VAMC & Emory University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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 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 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 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]

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]

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 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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

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

3. Switzerland 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Does patient education in chronic disease have therapeutic value? [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Practice improvement, part II: health literacy. [2013]

6. Switzerland 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]. [2015]

7. England pubmed.ncbi.nlm.nih.gov

My Wellness Coach: evaluation of a mobile app designed to promote integrative health among underserved populations. [2023]

8. England 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. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The evolution of the steps program, 2003-2010: transforming the federal public health practice of chronic disease prevention. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of Lifestyle Health Coaching: Case Study of an Evidence-Based Program. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Physical Activity, Exercise, Whole Health, and Integrative Health Coaching. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Collaborative Care: Integrating Behavioral Health Into the Primary Care Setting. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Collaboration in action. [2007]

14. United States pubmed.ncbi.nlm.nih.gov

Psychotherapy for health and lifestyle change. [2004]

15. United States pubmed.ncbi.nlm.nih.gov

The Potential Contribution of Current Health Care Zeitgeists to the Success of Health and Wellness Coaches. [2020]