Program ACTIVE: Phase 2

University of Michigan

Status: Withdrawn

Conditions: Depression; Diabetes Mellitus, Type 2

Treatments: Behavioral: Cognitive Behavioral Therapy; Behavioral: Community-Based Exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04369001

ProgramACTIVE

P30DK092926 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 and depression by using focus groups comprised of Black men with Type 2 diabetes. The use of peer perspectives allows for an improved strategy to reach, retain, and improve outcomes in this population.

Following the tailoring of program materials, the intervention (Program ACTIVE) will be facilitated with Black men with comorbid Type 2 diabetes and depression using evidence-based cognitive behavioral therapy and community-based exercise interventions.

Full 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 likely to be diagnosed with T2D compared to non-Hispanic White men, and this disparity increases among men over the age of 55. Poor diabetes self-management dramatically increases the risk for micro and macrovascular complications. Because Black men have worsened glycemic management compared to non-Hispanic White men, their risk for these diabetes complications is higher. In addition to physical complications, patients with T2D are twice as likely to experience depressive symptoms than those without T2D. Depressive symptoms are associated with suboptimal blood glucose levels and diabetes complications. A growing body of literature also demonstrates the critical role of gender in the management of physical and mental health conditions, including T2D and depression, and shows that male gender norms may conflict with help-seeking and healthy behaviors.

Program ACTIVE (Adults Coming Together to Increase Vital Exercise) is an evidence-based, cognitive behavioral therapy (CBT) and community-based exercise (EXER) intervention that aims to improve diabetes and depression outcomes that was developed for adults with type 2 diabetes. Research suggests that Black men have more adverse life experiences than men of other racial/ethnic groups, and consequently, experience worsened mental health. Since CBT and exercise programs are the gold standard for treating comorbid T2D and depression, tailoring these existing interventions to meet the needs of Black men with T2D is critical, especially given that high rates of T2D and depression exist in low income Black communities. Additionally, there is a dearth of literature about barriers and facilitators to mental health care utilization and exercise among Black men with T2D. The proposed study seeks to:

Aim 1 (Pre-implementation): Adapt an evidence-based intervention to work with Black men with T2D and depression in a community-based clinic. Adaptation and refinement, guided by the TDF domains, will involve:

1. conducting focus groups with Black men with comorbid T2D and depression to assess barriers and facilitators to mental health care utilization and exercise and to evaluate feasibility and acceptability of intervention materials.

Aim 2: Assess the impact of the implementation intervention strategies developed in Aim 1 by:

1. conducting a pilot randomized controlled trial of Program ACTIVE to evaluate participant recruitment and retention rates, treatment and intervention satisfaction and estimate intervention effect sizes on our primary outcomes of glycemic control (HbA1c) and depression as well as on secondary outcomes such as self-management behaviors and diabetes social support at baseline, 3 and 6 months post-intervention. Data from the pilot trial will help refine recruitment strategies, training materials, and the implementation protocol to be used in a larger pilot trial.
2. conducting qualitative interviews, guided by the TDF domains, to better understand the acceptability and sustainability of M-Action as routine practice in a community-based clinic.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intervention Group

Experimental group

Description:

(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.

Treatment:

Behavioral: Community-Based Exercise

Behavioral: Cognitive Behavioral Therapy

Enhanced Usual Care

No Intervention group

Description:

(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.