NCT04369001

Program ACTIVE: Phase 2

Program ACTIVE: Implementing a Cognitive Behavioral Therapy and Physical Activity Program for Black Men With Comorbid Diabetes and Depression

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Diabetes Mellitus, Type 2
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Community-Based Exercise	Participants will complete 150 minutes of exercise per week for 12 weeks. Exercise per week will be documented using exercise logs. The exercise protocol will be a culturally-tailored community-based exercise intervention based on the aerobic exercise goals used in the Program ACTIVE study and psychoeducational materials adapted from Program ACTIVE based on feedback from Black men with T2D. Exercise in Program ACTIVE will be obtained through individualized community-based activities that participants in the focus groups indicate as feasible rather than the highly controlled laboratory environment. Exercise goals will be adapted to accommodate the physical and medical restrictions of an older-adult diabetes population.
BEHAVIORAL	Cognitive Behavioral Therapy	Participants will receive 10 sessions of CBT using a manualized approach based on Beck's model of cognitive therapy. Sessions are to be completed once weekly in conjunction with weekly exercise. The Program ACTIVE CBT intervention includes: presentation of CBT model; thought records, cognitive distortions, counterarguments, cognitive reframing, automatic thoughts, core beliefs, and relapse prevention. Session goals will be tailored to the needs of men so that the order of topics may vary. Each session will begin with the designation of session goals, review of previously assigned homework, and introduction of new concepts and skills. Individually-tailored homework assignments designed to provide practice with the concepts/skills of the session will be assigned.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-07-01
• Completion: 2021-12-01
• First posted: 2020-04-30
• Last updated: 2021-01-25