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Cognitive Behavioral Therapy

Mind and Motion for Type 2 Diabetes and Depression (MenDIII Trial)

N/A

Waitlist Available

Led By Jaclynn Hawkins, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Ambulatory status

Must not have

Active endocarditis

Symptomatic severe aortic stenosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 10 weeks, 18 weeks, 30 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to recruit 80 Black men with type 2 diabetes and depression, who are over 18 years old and have had diabetes for at least a year. Participants must have an A1

Who is the study for?

The MenD 3 trial is for Black men over 18 with type 2 diabetes and depression living in Wayne or Washtenaw County. They must have been diagnosed with diabetes for at least a year, have an A1C of 7.0%+, be under a doctor's care, willing to attend study events, and have reliable internet and transportation.

What is being tested?

This trial tests the effects of Cognitive Behavioral Therapy (CBT), guided exercise, and group discussions on managing type 2 diabetes and depression. Participants will engage in weekly activities via Zoom including CBT sessions, exercises, group support talks, plus health assessments at four intervals.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions to exercise such as muscle soreness or fatigue. Psychological discomfort could arise from discussing personal issues during therapy or group sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can walk on my own.

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I have been diagnosed with Type 2 Diabetes for at least a year.

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I am an African American/Black male.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an ongoing heart infection.

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I have severe symptoms from a narrowed heart valve.

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I have an acute aortic dissection.

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I have had a lung clot.

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I often feel very out of breath or experience dizziness, fainting, or blackouts.

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I have had an amputation below the hip.

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I do not have numbness, tingling, or pain in my hands or feet.

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I have severe heart failure.

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I have severe COPD and need oxygen.

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I have frequent chest pain due to heart problems.

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I have inflammation of the heart muscle or the sac surrounding the heart.

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I have had a recent blood clot in my lung.

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I have had a deep vein clot.

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I recently had laser surgery for advanced retinal disease.

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I experience chest pain when I exert myself.

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My blood pressure is very high.

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I have had a stroke in the past.

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I have a physical disability that makes testing unsafe or difficult for me.

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I have a heart rhythm problem that affects my blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in A1C

Change in Blood Pressure (systolic and diastolic)

Change in Depression Symptoms (Patient Health Questionnaire 9)

+2 more

Secondary study objectives

Change in Diabetes Quality of Life (Diabetes Quality of Life Instrument)

Change in General Quality of Life (12-Item Short Form Survey (SF-12))

Other study objectives

Chance in Estimated Abdominal Subcutaneous and Visceral Fat Stores

Change in Aerobic Capacity (6 minute walk test)

Change in BMI

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment3 Interventions

Participants randomized to the intervention group will receive 8 one hour virtual sessions of individual cognitive behavioral therapy (CBT) that will take place via U-M Zoom, which is a HIPAA compliant virtual conferencing platform. Participants in this group will also receive 8 one hour virtual sessions of individual exercise. Participants in this group will also receive 8 one hour virtual group discussion sessions that will serve as on-going support. This group (4-8 participants) discussion will be facilitated by one CBT Interventionist and one Exercise Interventionist. These sessions will take place following the individual sessions of CBT and Exercise.

Group II: Control GroupActive Control1 Intervention

Participants randomized to the control group will receive enhanced usual care (EUC). The EUC group will receive 8 sessions of standard Cognitive Behavioral Therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioral Therapy

2016

Completed Phase 4

~3120

Exercise

2016

Completed Phase 1

~820