Status:
WITHDRAWN
Program ACTIVE: Phase 2
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus, Type 2
Depression
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The present study seeks to tailor the original Program ACTIVE (Adults Coming Together to Increase Vital Exercise) to meet the cultural norms and needs of adult Black men with comorbid Type 2 diabetes ...
Detailed Description
Black men have a 1.5 higher incidence of type 2 diabetes (T2D) compared to non-Hispanic White men and are twice as likely to die from diabetes-related complications. Additionally, Black men are more l...
Eligibility Criteria
Inclusion
- (must include all of the following):
- age 18 or older
- male sex assigned at birth
- Black
- a diagnosis of T2D for one year duration or longer
- ambulatory status
- major depression lasting 2 weeks or longer with no current evidence of psychotic symptoms. All persons scoring \>5 on a PHQ-9 administered via a telephone screening (administered by a research assistant or project coordinator) will be invited to participate. Patients who are currently prescribed antidepressant medications for 6 weeks or longer and who meet diagnostic criteria for major depression without psychotic features will be included. Patients who are currently receiving only medication management from a psychiatrist will be included. Respondents who meet eligibility criteria will be invited to participate in the baseline screening assessment.
Exclusion
- Stage 2 hypertension as defined by JNC VIII
- recent cardiac events
- recent laser surgery for proliferative retinopathy
- history of stroke
- lower limb amputation
- asensory peripheral neuropathy
- aortic stenosis or other severe valvular heart disease
- atrial fibrillation
- severe COPD (e.g., basal oxygen)
- class III or IV heart failure or medical instability
- Patients who report the use of a current antidepressant medication for 5 weeks or less will be excluded or deferred for later screening after the 6-week period. Patients who are currently receiving psychotherapy services from a mental health provider will be excluded. Psychiatric exclusion criteria include: active suicidal ideation or a history of a suicide attempt, bipolar depression or history of psychotic disorder, current substance use or dependent disorder.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04369001
Start Date
December 1 2020
End Date
December 1 2021
Last Update
January 25 2021
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