Home-Based Behavioral Therapy for Type 2 Diabetes

(HOME DM-BAT Trial)

Recruiting at 1 trial location

Overseen By Elise A Mosley-Johnson, MPH

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Dementia, Substance abuse, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 8 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a telephone-based support program for low-income, ethnic minority seniors with poorly controlled diabetes. The program aims to improve their health by educating them about diabetes, promoting healthy behaviors, and addressing social challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on behavioral therapy and medication adherence, so it's likely you can continue your current medications, but you should confirm with the trial organizers.

How is Home-based Diabetes-Modified Behavioral Activation Treatment different from other treatments for type 2 diabetes?

Home-based Diabetes-Modified Behavioral Activation Treatment is unique because it focuses on behavioral changes that patients can implement at home, rather than relying on medication or clinical visits. This approach empowers patients to manage their diabetes through lifestyle adjustments and self-monitoring, which can be more convenient and personalized compared to traditional treatments. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Home-based Diabetes-Modified Behavioral Activation Treatment for Type 2 Diabetes?

Research shows that behavioral programs, including psychological and family-based interventions, can improve outcomes for people with type 2 diabetes. Additionally, Cognitive Behavioral Therapy (CBT) has been found to help individuals manage their diabetes better. ^{6 7 8 9 10}

Who Is on the Research Team?

Leonard Egede, MD

Principal Investigator

State University of New York at Buffalo

Are You a Good Fit for This Trial?

This trial is for low-income seniors aged 65 or older with poorly controlled Type 2 Diabetes (T2DM), specifically those who are Black/African American or Hispanic, living in Milwaukee area senior housing or communities. Participants must have an HbA1c level of at least 8% and be able to communicate in English or Spanish. Those with active psychosis, severe mental disorders, substance abuse issues, participation in other diabetes studies, significant dementia, or a life expectancy under one year cannot join.

Inclusion Criteria

Able to communicate in English or Spanish

You have been diagnosed with type 2 diabetes and have an HbA1c level of 8% or higher.

You are 65 years old or older.

Exclusion Criteria

You currently have severe mental health issues.

Your doctor thinks you may have less than a year to live.

You have severe memory problems or confusion.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 weekly sessions of Home DM-BAT delivered via telephone by trained nurse educators

8 weeks

8 visits (telephone)

Booster Sessions

Participants receive monthly booster sessions from months 3 to 12

10 months

10 visits (telephone)

Follow-up

Participants are monitored for clinical and behavioral outcomes at 3, 6, 9, and 12 months post-randomization

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Home-based Diabetes-Modified Behavioral Activation Treatment
• Supportive Therapy

Trial Overview The study tests Home DM-BAT—a culturally-tailored home and phone-based intervention by nurse educators—against supportive therapy control. It aims to improve clinical outcomes like blood sugar levels (hemoglobin A1c), blood pressure, cholesterol; behavioral aspects such as glucose monitoring, dieting habits; exercise routines; medication adherence; and overall quality of life over a period of 12 months.

How Is the Trial Designed?

Group I: Home DM-BAT Intervention Experimental Treatment 1 Intervention

A trained nurse educator will deliver the manualized Home DM-BAT intervention. Subjects will receive 8-weekly sessions of behavioral activation and monthly booster sessions from months 3-12 via telephone.

Group II: Control Group (GHE+ST) Active Control 1 Intervention

Patients randomized to the control group will receive in-home 8-weekly sessions of combined general health education (GHE) and supportive therapy (ST) and monthly booster sessions from months 3-12 via telephone.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

Behavioral programs for adults with type 2 diabetes that include at least 11 contact hours significantly improve glycemic control, with a reduction of 0.4% or more in hemoglobin A1c (HbA1c), while programs with 10 or fewer hours show little benefit.

Participants with higher baseline HbA1c levels (7.0% or greater), those under 65 years old, and minority groups experienced greater reductions in HbA1c, indicating that these subgroups may benefit more from intensive behavioral interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Programs for Type 2 Diabetes Mellitus: A Systematic Review and Network Meta-analysis. Pillay, J., Armstrong, MJ., Butalia, S., et al.[2022]

A family-based psychological intervention significantly reduced A1C levels in patients with poorly controlled type 2 diabetes, with the intervention group showing an average A1C of 8.4% compared to 8.8% in the control group after 6 months.

The intervention was particularly effective for patients with the highest baseline A1C levels (over 9.5%), leading to notable improvements in diabetes-related beliefs, psychological well-being, diet, exercise, and family support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological family intervention for poorly controlled type 2 diabetes. Keogh, KM., Smith, SM., White, P., et al.[2022]

Cognitive Behaviour Therapy (CBT) interventions can improve self-management practices in individuals with type 2 diabetes, as highlighted by a rapid review of nine studies, primarily from developing countries.

The review emphasizes the importance of tailoring CBT interventions to the socio-economic contexts of individuals, particularly in South Africa, to enhance their effectiveness in managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the role of CBT in the self-management of type 2 diabetes: A rapid review. Visagie, E., Deacon, E., Kok, R.[2023]

Citations

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

Behavioral Programs for Type 2 Diabetes Mellitus: A Systematic Review and Network Meta-analysis. [2022]

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

Psychological family intervention for poorly controlled type 2 diabetes. [2022]

3. South Africa pubmed.ncbi.nlm.nih.gov

Exploring the role of CBT in the self-management of type 2 diabetes: A rapid review. [2023]

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

Case study: feasibility of multisystemic therapy as a treatment for urban adolescents with poorly controlled type 1 diabetes. [2022]

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

Intensive behavioral Therapy for weight loss in patients with, or At-Risk of, type 2 Diabetes: Results from the PaTH to health diabetes study. [2023]

6. France pubmed.ncbi.nlm.nih.gov

[Outcomes of transcutaneous posterior tibial nerve stimulation for overactive bladder in diabetic patients]. [2018]

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

Cognitive components of behavioral therapy for overactive bladder: a systematic review. [2022]

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

Percutaneous tibial nerve stimulation for the treatment of urinary frequency, urinary urgency, and urge incontinence: results from a community-based clinic. [2010]

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

Behavioral intervention for community-dwelling individuals with urinary incontinence. [2019]

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

Hypnotherapy for treatment of overactive bladder: a randomized controlled trial pilot study. [2021]