Clinical trial NCT04369001: Program ACTIVE: Phase 2
Official title: Program ACTIVE: Implementing a Cognitive Behavioral Therapy and Physical Activity Program for Black Men With Comorbid Diabetes and Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Depression
Keywords: Type 2 diabetes
Depression
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-04-30
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Change of Metabolic Control
timeFrame: 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.
measure: Change of Depression Scores
timeFrame: 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.
Secondary outcomes:
measure: Change of Regimen Adherence
timeFrame: 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.
measure: Change of Adherence to Gender Norms
timeFrame: 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.
measure: Change of Body Mass Index
timeFrame: 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.
measure: Change of Weight
timeFrame: 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.
measure: Change of Blood Pressure
timeFrame: 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.
measure: Change of Diabetes Social Support
timeFrame: 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.
measure: Change of Diabetes-Related Distress
timeFrame: 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.
measure: Change of Diabetes Quality of Life
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
References:
citation: 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
citation: 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.
citation: Egede LE, Mueller M, Echols CL, Gebregziabher M. Longitudinal differences in glycemic control by race/ethnicity among veterans with type 2 diabetes. Med Care. 2010 Jun;48(6):527-33. doi: 10.1097/MLR.0b013e3181d558dc.
citation: Liburd LC, Namageyo-Funa A, Jack L Jr. Understanding "masculinity" and the challenges of managing type-2 diabetes among African-American men. J Natl Med Assoc. 2007 May;99(5):550-2, 554-8.
citation: Seawell AH, Hurt TR, Shirley MC. The Influence of Stress, Gender, and Culture on Type 2 Diabetes Prevention and Management Among Black Men: A Qualitative Analysis. Am J Mens Health. 2016 Mar;10(2):149-56. doi: 10.1177/1557988315580132. Epub 2015 Apr 9.
citation: Hawkins, J, Kieffer EC, Sinco B et al.
citation: Hawkins J, Watkins DC, Kieffer E, Spencer M, Piatt G, Nicklett EJ, Lebron A, Espitia N, Palmisano G. An Exploratory Study of the Impact of Gender on Health Behavior Among African American and Latino Men With Type 2 Diabetes. Am J Mens Health. 2017 Mar;11(2):344-356. doi: 10.1177/1557988316681125. Epub 2016 Dec 5.
citation: de Groot M, Doyle T, Kushnick M, Shubrook J, Merrill J, Rabideau E, Schwartz F. Can lifestyle interventions do more than reduce diabetes risk? Treating depression in adults with type 2 diabetes with exercise and cognitive behavioral therapy. Curr Diab Rep. 2012 Apr;12(2):157-66. doi: 10.1007/s11892-012-0261-z.
citation: Holden KB, McGregor BS, Blanks SH, Mahaffey C. Psychosocial, socio-cultural, and environmental influences on mental health help-seeking among African-American men. J Mens Health. 2012 Jun 1;9(2):63-69. doi: 10.1016/j.jomh.2012.03.002.
citation: Watkins DC, Hawkins J, Mitchell JA. The Discipline's Escalating Whisper: Social Work and Black Men's Mental Health. Res Soc Work Pract. 2015 Mar;25(2):240-250. doi: 10.1177/1049731514526621. Epub 2014 Mar 19.
citation: Watkins DC, Jefferson SO. Recommendations for the use of online social support for African American men. Psychol Serv. 2013 Aug;10(3):323-32. doi: 10.1037/a0027904. Epub 2012 Aug 27.
citation: Watkins DC. Depression over the adult life course for African American men: toward a framework for research and practice. Am J Mens Health. 2012 May;6(3):194-210. doi: 10.1177/1557988311424072. Epub 2011 Nov 21.
citation: Williams DR. The health of men: structured inequalities and opportunities. Am J Public Health. 2003 May;93(5):724-31. doi: 10.2105/ajph.93.5.724.
citation: Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012 Apr 24;7:37. doi: 10.1186/1748-5908-7-37.
citation: Michigan Department of Community Health. Michigan Primary Care Transformation Project (MIPCT): Information for Michigan POs/PHOs and Payers 2011.
citation: Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. The prevalence of comorbid depression in adults with diabetes: a meta-analysis. Diabetes Care. 2001 Jun;24(6):1069-78. doi: 10.2337/diacare.24.6.1069.
citation: Nefs G, Pouwer F, Denollet J, Pop V. The course of depressive symptoms in primary care patients with type 2 diabetes: results from the Diabetes, Depression, Type D Personality Zuidoost-Brabant (DiaDDZoB) Study. Diabetologia. 2012 Mar;55(3):608-16. doi: 10.1007/s00125-011-2411-2. Epub 2011 Dec 24.
citation: de Groot M, Doyle T, Hockman E, Wheeler C, Pinkerman B, Shubrook J, Gotfried R, Schwartz F. Depression among type 2 diabetes rural Appalachian clinic attendees. Diabetes Care. 2007 Jun;30(6):1602-4. doi: 10.2337/dc06-1599. Epub 2007 Mar 12. No abstract available.
citation: Lustman PJ, Freedland KE, Griffith LS, Clouse RE. Fluoxetine for depression in diabetes: a randomized double-blind placebo-controlled trial. Diabetes Care. 2000 May;23(5):618-23. doi: 10.2337/diacare.23.5.618.
citation: de Groot M, Anderson R, Freedland KE, Clouse RE, Lustman PJ. Association of depression and diabetes complications: a meta-analysis. Psychosom Med. 2001 Jul-Aug;63(4):619-30. doi: 10.1097/00006842-200107000-00015.
citation: Egede LE, Zheng D, Simpson K. Comorbid depression is associated with increased health care use and expenditures in individuals with diabetes. Diabetes Care. 2002 Mar;25(3):464-70. doi: 10.2337/diacare.25.3.464.
citation: Ciechanowski PS, Katon WJ, Russo JE. Depression and diabetes: impact of depressive symptoms on adherence, function, and costs. Arch Intern Med. 2000 Nov 27;160(21):3278-85. doi: 10.1001/archinte.160.21.3278.
citation: Egede LE. Major depression in individuals with chronic medical disorders: prevalence, correlates and association with health resource utilization, lost productivity and functional disability. Gen Hosp Psychiatry. 2007 Sep-Oct;29(5):409-16. doi: 10.1016/j.genhosppsych.2007.06.002.
citation: Katon W, Russo J, Von Korff M, Lin E, Simon G, Bush T, Ludman E, Walker E. Long-term effects of a collaborative care intervention in persistently depressed primary care patients. J Gen Intern Med. 2002 Oct;17(10):741-8. doi: 10.1046/j.1525-1497.2002.11051.x.
citation: Zhang X, Norris SL, Gregg EW, Cheng YJ, Beckles G, Kahn HS. Depressive symptoms and mortality among persons with and without diabetes. Am J Epidemiol. 2005 Apr 1;161(7):652-60. doi: 10.1093/aje/kwi089.
citation: Jaggi LJ, Mezuk B, Watkins DC, Jackson JS. The Relationship between Trauma, Arrest, and Incarceration History among Black Americans: Findings from the National Survey of American Life. Soc Ment Health. 2016 Nov;6(3):187-206. doi: 10.1177/2156869316641730. Epub 2016 Oct 20.
citation: 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.
citation: 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.
citation: Cornish EK, McKissic SA, Dean DAL, Griffith DM. Lessons Learned About Motivation From a Pilot Physical Activity Intervention for African American Men. Health Promot Pract. 2017 Jan;18(1):102-109. doi: 10.1177/1524839915614800. Epub 2016 Jul 10.
citation: Griffith DM, Cornish EK, McKissic SA, Dean DA. Differences in Perceptions of the Food Environment Between African American Men Who Did and Did Not Consume Recommended Levels of Fruits and Vegetables. Health Educ Behav. 2016 Dec;43(6):648-655. doi: 10.1177/1090198115626923. Epub 2016 Mar 1.
citation: 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
citation: Sherman LD, Hawkins JM, Bonner T. An Analysis of the Recruitment and Participation of African American Men in Type 2 Diabetes Self-Management Research: A Review of the Published Literature. Soc Work Public Health. 2017 Jan 2;32(1):38-48. doi: 10.1080/19371918.2016.1188742. Epub 2016 Jul 8.
citation: Beck, A.T., Rush, A.J., Shaw, B.F., Emery, G., Cognitive therapy of depression. 1979, New York, NY: The Guilford Press.
citation: Babyak M, Blumenthal JA, Herman S, Khatri P, Doraiswamy M, Moore K, Craighead WE, Baldewicz TT, Krishnan KR. Exercise treatment for major depression: maintenance of therapeutic benefit at 10 months. Psychosom Med. 2000 Sep-Oct;62(5):633-8. doi: 10.1097/00006842-200009000-00006.
citation: Mazzeo RS, Tanaka H. Exercise prescription for the elderly: current recommendations. Sports Med. 2001;31(11):809-18. doi: 10.2165/00007256-200131110-00003.
citation: Levant RF, Hall RJ, Rankin TJ. Male Role Norms Inventory-Short Form (MRNI-SF): development, confirmatory factor analytic investigation of structure, and measurement invariance across gender. J Couns Psychol. 2013 Apr;60(2):228-238. doi: 10.1037/a0031545. Epub 2013 Feb 18.
citation: Broadhead WE, Gehlbach SH, de Gruy FV, Kaplan BH. The Duke-UNC Functional Social Support Questionnaire. Measurement of social support in family medicine patients. Med Care. 1988 Jul;26(7):709-23. doi: 10.1097/00005650-198807000-00006.
citation: Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.
citation: Reliability and validity of a diabetes quality-of-life measure for the diabetes control and complications trial (DCCT). The DCCT Research Group. Diabetes Care. 1988 Oct;11(9):725-32. doi: 10.2337/diacare.11.9.725.
citation: Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.