Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Depression

In brief

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.

Key facts

Study ID: NCT01572389
Run by: VA Office of Research and Development
People needed: 225
Starts: 2012-11-01
Expected to finish: 2016-09-30
Last updated by the study team: 2017-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Veterans with comorbid diabetes and depressive symptoms receiving primary care services at VA CBOCs throughout Southeast Texas
as well as MEDVAMC patients living >20 miles from the hospital who face similar distance related treatment barriers
Participants must have:
a diagnosis of diabetes mellitus
an average HbA1c level >7.5% in the prior 6 months
clinically significant symptoms of depression
Verification of diabetes mellitus diagnoses will be based on data collected from the VA data warehouse.
To verify that participants meet the depression criteria, the investigators will use participant self-report of clinically significant depressive symptoms according to the PHQ-9, where a score of greater than/equal to 10 on the PHQ-9 will signify a clinically meaningful symptom burden.

You may not qualify if…

The investigators will exclude potential participants only for clinical factors that would render a telephone-based behavioral activation intervention inappropriate.
Specific exclusion criteria are:
lack of regular access to a telephone
significant cognitive impairment (three or more errors) on an established six-item screening exam
meeting criteria for bipolar, psychotic, or substance-abuse disorders
presence of uncorrected hearing or vision impairment
their medical chart recommends not titrating therapy due to prior history of significant hypoglycemic events
they live within 20 miles of the MEDVAMC.
Patients will be secondarily excluded if their HbA1C level falls below 7.5% at baseline assessment, or if they report suicidal ideation on the PHQ-9 at baseline assessment.
Patients receiving mental health services at the time of study recruitment will not be excluded.
All mental health treatments and health service-use characteristics will be included in study analyses as covariates.

Where it is running

Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States

Full record on ClinicalTrials.gov

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