Program ACTIVE: Implementing a Cognitive Behavioral Therapy and Physical Activity Program for Black Men With Comorbid Diabetes and Depression
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change of Metabolic Control
研究概览
简要总结
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.
详细描述
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:
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •(must include all of the following):
- •age 18 or older
- •male sex assigned at birth
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention Group
(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.
干预措施: Community-Based Exercise (Behavioral)
Intervention Group
(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.
干预措施: Cognitive Behavioral Therapy (Behavioral)
Enhanced Usual Care
(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.
结局指标
主要结局
Change of Metabolic Control
时间窗: HbA1c will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post treatment assessment.
Metabolic Control will be measured via hemoglobin A1c (HbA1c). HbA1c will be collected using the DCA 2000 point-of-care testing instrument.
Change of Depression Scores
时间窗: Depression scores will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.
Depression will be measured using the PHQ-9 (score \>=10) and The BDI-II, a 21-item self-administered questionnaire used to assess symptoms of depression. Depression will be measured using the Beck Depression Inventory (BDI-II). BDI-II items have been designed to correspond with DSM-IVTR diagnostic criteria. The BDI-II has been shown to have excellent test-retest reliability and validity when used in general populations as well for use with diabetes samples.
次要结局
- Change of Weight(Weight will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.)
- Change of Diabetes Social Support(Diabetes Social Support scores will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.)
- Change of Regimen Adherence(Perceived Diabetes Self-Management scores will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.)
- Change of Body Mass Index(Body Mass Index will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.)
- Change of Adherence to Gender Norms(Male Role Norms Inventory-Short Form scores will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.)
- Change of Diabetes Quality of Life(Diabetes Quality of Life scores will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.)
- Change of Blood Pressure(Blood Pressure will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.)
- Change of Diabetes-Related Distress(Diabetes Related Distress scores will be collected once at baseline, once immediately after the completion of the exercise and behavioral interventions, 3-month post treatment assessment, and 6-months post-treatment assessment.)
研究者
Jaclynn Hawkins
Assistant Professor
University of Michigan