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Mind and motion: new study tests CBT and exercise for black men with diabetes

NCT ID NCT06574035

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study is testing whether combining cognitive behavioral therapy (CBT) with guided exercise can improve blood sugar control, reduce depression, and boost quality of life in Black men with type 2 diabetes. Eighty participants will receive 8 sessions of CBT, with half also getting 8 exercise sessions and group support. The study lasts 7 months and tracks health outcomes at several points.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cognitive Behavioral Therapy and guided exercise
What this could lead to
If successful, this approach could offer a practical, culturally tailored way to help Black men with type 2 diabetes better manage their blood sugar and mental health.
What could go wrong
This is a small pilot study with only 80 participants, so results may not apply to everyone. It also relies on self-reported data and internet access, which could limit accuracy and participation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * African American/Black males * age 18 years or older * ambulatory status * diagnosis of Type 2 Diabetes (T2D) for one year duration or longer * be under the care of a physician for their diabetes, self report an A1C of 7.0% or more in the last year * be willing to participate in study events (weekly physical activity, exercise and CBT sessions, group discussion sessions, and in-person health assessments) * have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet/phone/computer to complete study related tasks * live in the Wayne or Washtenaw County\\ * have reliable transportation to in-person events Exclusion Criteria: * stage 2 hypertension as defined by Joint National Committee (JNC) VIII * recent cardiac events * recent laser surgery for proliferative retinopathy * history of stroke * lower limb amputation * peripheral neuropathy * severe Chronic Obstructive Pulmonary Disease (COPD) (e.g., basal oxygen) * class III or IV heart failure * medical instability. Per American College of Sports Medicine (ACSM) guidelines, medical exclusion criteria will also include currently experiencing: * ongoing unstable angina * uncontrolled cardiac arrhythmia with hemodynamic compromise * active endocarditis * symptomatic severe aortic stenosis * acute myocarditis or pericarditis * acute aortic dissection * acute pulmonary embolism * pulmonary infarction * deep venous thrombosis * physical disability that precludes safe and adequate testing * chest discomfort with exertion * unreasonable breathlessness, or dizziness, fainting, or blackouts. As part of the screening process, the investigators will ask the participant to self-report on these conditions. Participants who are currently receiving psychotherapy services for the treatment of depression from a mental health provider will be excluded. Participants who are currently receiving only medication management from a psychiatrist will be included. If you are interested in the study, please complete our screening survey: https://redcapproduction.umms.med.umich.edu/surveys/?s=JNPPEDANX7KLPPF9. Thank you so much!

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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