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Program ACTIVE: Phase 2

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ClinicalTrials.gov Identifier: NCT04369001
Recruitment Status : Withdrawn (Due to covid-19 and social distancing, this study was terminated.)
First Posted : April 30, 2020
Last Update Posted : January 25, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Jaclynn Hawkins, University of Michigan

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 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Depression Behavioral: Community-Based Exercise Behavioral: Cognitive Behavioral Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Program ACTIVE: Implementing a Cognitive Behavioral Therapy and Physical Activity Program for Black Men With Comorbid Diabetes and Depression
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.
Other Name: EXER

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.
Other Name: CBT

No Intervention: 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.



Primary Outcome Measures :
  1. Change of Metabolic Control [ Time Frame: 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.

  2. Change of Depression Scores [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change of Regimen Adherence [ Time Frame: 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. ]
    Regimen adherence will be measured using the Perceived Diabetes Self-Management Scale, a self-report questionnaire used to measure a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision. The responses for the PDSMS items range from 1 = "Strongly Disagree" to 5 = "Strongly Agree." Four of the items (#s 1, 2, 6, & 7) are worded such that high agreement signifies low self-efficacy or perceived competence. These four items are reverse scored prior to being added to the other four items. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.

  2. Change of Adherence to Gender Norms [ Time Frame: 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. ]
    Adherence to gender norms will be measured using the Male Role Norms Inventory-Short Form. The items are separated into seven subscales: Restrictive Emotionality, Self-Reliance Through Mechanical Skills, Negativity Toward Sexual Minorities, Avoidance of Femininity, Importance of Sex, Toughness, and Dominance. Response Options are on a 7-point scale ranging from strongly disagree = 1 to strongly agree = 7. Higher scores indicate more traditional gender role beliefs.

  3. Change of Body Mass Index [ Time Frame: 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. ]
    Body Mass Index will be calculated using height and weight. Height will be measured using a stadiometer.

  4. Change of Weight [ Time Frame: 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. ]
    Weight will be measured on a high quality, calibrated digital scale.

  5. Change of Blood Pressure [ Time Frame: 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. ]
    Blood Pressure will be measured using the auscultatory method assessing for both diastolic and systolic pressure.

  6. Change of Diabetes Social Support [ Time Frame: 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. ]
    Diabetes Social Support will be measured using the Diabetes Social Support Questionnaire. The questionnaire is a 5-item survey with answers ranging from 1 - "I receive none" to 5 - "I don't need help." Total scores range from a minimum of 5, indicating low social support for diabetes treatment and management, to 25, a high indication of social support for diabetes treatment and management.

  7. Change of Diabetes-Related Distress [ Time Frame: 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. ]
    Diabetes-related Distress will be measured using Diabetes Distress Scale (Short Form-12). The Diabetes Distress Scale items pertain to common emotions perceived by individuals self-managing their diabetes. The scale, ranging from 1 = not a problem to 6 = very serious problem scores the degree to which the items have distressed the individual.

  8. Change of Diabetes Quality of Life [ Time Frame: 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. ]
    Diabetes Quality of Life will be used to measure quality of life. The DQoL measure consists of 46 items ranked on a 5-point Likert scale. Total scores range from 0 (lowest possible QoL) to 100 (highest possible QoL).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligible participants must identify as male-assigned at birth and currently identify as a man.
Accepts Healthy Volunteers:   No
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.
  Study Documents (Full-Text)

Documents provided by Jaclynn Hawkins, University of Michigan:
Informed Consent Form  [PDF] February 26, 2020

Publications:
Centers for Disease Control and Prevention. Age-Adjusted Percentage of Civilian, Noninstitutionalized Population with Diagnosed Diabetes, by Race and Sex, United States, 1980-2011, 2013. http://www.cdc.gov/diabetes/statistics/prev/national/figraceethsex.htm
Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: US Department of Health and Human Services, 2014.
Hawkins, J, Kieffer EC, Sinco B et al.
Michigan Department of Community Health. Michigan Primary Care Transformation Project (MIPCT): Information for Michigan POs/PHOs and Payers 2011.
Miller, D. B., & M. D. Bennett. 2011. "Special Issue: Challenges, Disparities and Experiences of African American Males." Research on Social Work Practice 21(3): 265-68. doi:10.1177/1049731510393985.
Watkins, D. C., & D. M. Griffith. 2013. "Practical Solutions To Addressing Men's Health Disparities: Guest Editorial." International Journal of Men's Health 12(3): 187-94.
Griffith, DM, Thorpe RJ, Wong JY. (Ed); Wester, Stephen R. (Ed). (2016). Men's physical health and health behaviors. APA handbook of men and masculinities., (pp. 709-730). Washington, DC, US: American Psychological Association, xxiv, 799 pp.http://dx.doi.org/10.1037/14594-032
Beck, A.T., Rush, A.J., Shaw, B.F., Emery, G., Cognitive therapy of depression. 1979, New York, NY: The Guilford Press.

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Responsible Party: Jaclynn Hawkins, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT04369001    
Other Study ID Numbers: ProgramACTIVE
P30DK092926 ( U.S. NIH Grant/Contract )
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaclynn Hawkins, University of Michigan:
Type 2 diabetes
Depression
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Depression
Depressive Disorder
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders