Program ACTIVE: Phase 2
Diabetes Mellitus, Type 2, Depression
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes, Depression
Eligibility Criteria
Inclusion Criteria: (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 Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention Group
Enhanced Usual Care
(Program ACTIVE n=20) Participants randomized into the Program ACTIVE group will receive a gym membership to a local, Detroit-based community recreation facility where they will complete 150 minutes of exercise per week for 12 weeks and will receive 10 sessions (once weekly) of CBT therapy sessions. Exercise per week will be documented using exercise logs. Exercise logs will be given to research staff at the end of the 12-week timeframe; all exercise logs will be kept organized respective to the participant identification number and related documents (questionnaires and surveys). To ensure treatment fidelity, three CBT and three physical activity sessions will be selected at random and recorded and rated for fidelity to the above content by our research team.
(EUC n=20) Participants randomized to enhanced usual care will receive referrals to community mental health providers, pedometers, gym memberships to a community-based venue, and intervention patient manuals. Participants will not be required to report any use of resources offered or change their course of treatment in any way. Based on several years of experience in Detroit, providing all participants with referrals, pedometers, gym access and educational materials minimizes ethical concerns regarding assignment of underserved populations to receive a no-treatment control.