Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-01-26 @ 1:52 PM
Study NCT ID:
NCT02027259
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2013-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Activation Therapy for Both Depression and Diabetes Vs. Diabetes Alone Delivered Via Group Visits
Sponsor:
Providence VA Medical Center
Organization:
Study Overview
Official Title:
Behavioral Activation Therapy for Both Depression and Diabetes Vs. Diabetes Alone Delivered Via Group Visits
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BA-MEDIC
Brief Summary:
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: