Program ACTIVE: Phase 2

NCT04369001 | Withdrawn

• 2 other identifiers: ProgramACTIVEP30DK092926
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2; Depression

Keywords

Type 2 diabetes; Depression

Outcome Measures

Primary Outcomes (2)

• Change of Metabolic Control

  Metabolic Control will be measured via hemoglobin A1c (HbA1c). HbA1c will be collected using the DCA 2000 point-of-care testing instrument.

  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.

• Change of Depression Scores

  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.

  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 (8)

• 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 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 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 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 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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

(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; Behavioral: Cognitive Behavioral Therapy

Enhanced Usual Care

NO INTERVENTION

(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.

Interventions

Community-Based Exercise BEHAVIORAL

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.

Also known as: EXER

Intervention Group

Cognitive Behavioral Therapy BEHAVIORAL

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.

Also known as: CBT

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligible participants must identify as male-assigned at birth and currently identify as a man.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 30, 2020
• Study Start: December 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 25, 2021

Record last verified: 2021-01