Behavioral Activation Therapy for Both Depression and Diabetes Vs. Diabetes Alone Delivered Via Group Visits (BA-MEDIC)

The purpose of this study is to determine whether group visits with added behavioral activation (BA) for depression will have a greater clinical impact than our standard group visits without BA for depression in reducing the risk of future coronary events as measured by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine and depression symptoms as measured by Patient Health Questionnaire-9 (PHQ-9) after 6 months.

Study Overview

• Status: Completed
• Conditions: Depression; Diabetes
• Intervention / Treatment: Behavioral: Behavioral activation (BA)

Detailed Description

BACKGROUND Nearly 33% of the 24.5 million people in the US with diabetes mellitus (DM) have co-morbid depression. Since 65% of patients with DM die from cardiovascular disease (CVD), concomitant control of CVD risk factors along with glycemic control is crucial to prevent adverse outcomes. However, co-morbid depression makes DM and CVD risk factors harder to control. We demonstrated that a pharmacist-led group visit model consisting of: 1) pharmacotherapy management for DM, hyperlipidemia and hypertension, 2) self-management education, 3) case management and 4) behavioral strategies for DM and CVD self-care behaviors, was more efficacious in improving hyperglycemia and CVD risk factors compared to standard primary care controls in a general DM population and also for patients with DM and co-morbid depression. For participants with DM and depression there was also a non-significant trend toward improvement in depression despite the lack of depression treatment.

OBJECTIVE: Our objective is to determine whether group visits with added behavioral activation (BA) for depression (cases) will have a greater clinical impact than our standard group visits without BA for depression (active control) in reducing the risk of future coronary events as measured by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine and depression symptoms as measured by Patient Health Questionnaire-9 (PHQ-9) after 6 months.

RESEARCH PLAN/METHODS: The goal is to conduct a randomized-controlled pilot trial (n=25 in each arm) to evaluate the clinical effect of added BA to our group intervention in patients with DM and depression who have a Hemoglobin A1c>=8% and a PHQ-9 depression score >=10 and at least one additional CVD risk factor such as tobacco use, hyperlipidemia or hypertension not at American Heart Association and American Diabetes Association guideline recommended goals. The interventions in both arms will consist of 4 weekly group visits of 2-hour duration followed by monthly booster group visits for 6 months to prevent relapse.

The primary aims are:

• 1) To examine the effects of our group visit model with and without added BA therapy on the 10-year UKPDS coronary event risk, and PHQ-9 depression scores after 6 months
• 2) To examine the acceptability and adherence to our group visit model with and without added BA therapy by way of focus groups and attendance

The secondary aim is

• 1) To explore mediating factors of our group visit model with added BA therapy that are associated with improvement in CVD risk and depression

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Providence VAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of type 2 diabetes
• Clinical diagnosis of depression
• PHQ-9 score ≥10 for depressive symptoms
• >= 18 years old
• a most recent HbA1c ≥8.0% within the previous 12 months in the chart; and
• have 1 or more of the following modifiable CVD risk factors not at target goals, defined as:
• current smoker (any cigarette smoking <30 days),
• blood pressure >130/80 mm Hg, documented at least twice in the last 6 months
• LDL cholesterol >100 mg/dL within the last 12 months.

Exclusion Criteria:

• Inability to attend the group sessions
• active psychosis of any type or organic brain injury that precludes DM self- care
• type 1 diabetes as documented in the medical chart
• pregnancy
• actively suicidal and /or
• end-stage medical illness (e.g. metastatic cancer, awaiting organ transplant)
• Patients currently enrolled in DM group programs that include medication titration within the group setting would not be eligible due to co- intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group visits with behavioral activation; Group visits with behavioral activation (BA) will consist of 4 weekly group visits of 2-hour duration followed by monthly booster group visits for 6 months to prevent relapse.	Behavioral: Behavioral activation (BA); The addition of Behavioral activation (BA) to our group visits in patients with DM and depression will consist of 4 weekly group visits of 2-hour duration followed by monthly booster group visits for 6 months to prevent relapse.; Other Names: BA MEDIC
No Intervention: Standard group visits; Standard group visits will consist of 4 weekly group visits of 2-hour duration followed by monthly booster group visits for 6 months to prevent relapse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 10-year UKPDS coronary event risk and PHQ-9 depression scores.	To examine the effects of our group visit model with and without added BA therapy on the 10-year UKPDS coronary event risk, and PHQ-9 depression scores after 6 months.	Change from baseline in 10-year UKPDS coronary event risk and PHQ-9 depression scores at 6 months..

Collaborators and Investigators

• Sponsor: Providence VA Medical Center
• Investigators: Principal Investigator: Tracey H Taveira, Pharm.D., Providence VAMC

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2012
• Primary Completion (Actual): October 2, 2015
• Study Completion (Actual): October 2, 2015

Study Registration Dates

• First Submitted: November 12, 2013
• First Submitted That Met QC Criteria: January 2, 2014
• First Posted (Estimate): January 6, 2014

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Depression; Diabetes; Group
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Mood Disorders; Endocrine System Diseases; Depression; Depressive Disorder; Diabetes Mellitus
• Other Study ID Numbers: 12CRP9840018