Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression

Summary

This clinical trial will compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) for diabetes and depression at 6 and 12 month follow-up. The proposed study is a randomized controlled trial enrolling 242 largely rural Veterans with uncontrolled diabetes and clinically-significant depressive symptoms. Both groups will receive screening, education, and notification of clinical findings along with follow-up in usual primary care. HOPE participants will also receive behavioral coaching telephone sessions over a six month period. Patients in the control group will be screened, and providers will be notified of high risk patients' status and need for intervention. Both groups will receive only usual primary care during the subsequent 6 month maintenance period. Study measurements using self-report questionnaires will also be collected at baseline, 6 and 12 months follow-up. The investigators will also conduct chart reviews to evaluate usual care blood tests for diabetes control. Changes in measurements from baseline will be compared between groups. This intervention will reach Veterans in rural setting where community-based primary care is needed, especially care that blends treatment strategies for physical and emotional health.

Conditions

• Diabetes Mellitus
• Depression

Interventions

BEHAVIORAL

Healthy Outcomes through Patient Empowerment (HOPE)

HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period.

BEHAVIORAL

Enhanced Usual Care

All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care.

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Aanand D Naik, MD BA · Michael E. DeBakey VA Medical Center, Houston, TX

• Jeffrey Cully, PhD MEd · Michael E. DeBakey VA Medical Center, Houston, TX

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-11-01

Primary Completion

2016-06-24

Completion

2016-09-30

Countries

• United States

Study Locations