Behavioral Activation Therapy for Both Depression and Diabetes Vs. Diabetes Alone Delivered Via Group Visits

NCT02027259 | Completed

• 1 other identifier: 12CRP9840018
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Depression

Keywords

Diabetes; Depression; Group

Outcome Measures

Primary Outcomes (1)

• 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..

Study Arms (2)

Group visits with behavioral activation

EXPERIMENTAL

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)

Standard group visits

NO INTERVENTION

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.

Interventions

Behavioral activation (BA) BEHAVIORAL

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.

Also known as: BA MEDIC

Group visits with behavioral activation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Providence VA Medical Center: lead

Study Sites (1)

Providence VAMC

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Depression

Condition Hierarchy (Ancestors)

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

Study Officials

• Tracey H Taveira, Pharm.D.

  Providence VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tracey H. Taveira, Pharm.D., CDOE

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: January 6, 2014
• Study Start: January 19, 2012
• Primary Completion: October 2, 2015
• Study Completion: October 2, 2015
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

US (1)