Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression

Project Background: The co-occurrence of diabetes and depressive symptoms is highly prevalent
and has dramatic consequences on the quality of life and health of affected patients. Due to
the complex interrelation between these conditions, patients often experience both
psychological and physiological difficulties. Furthermore, Veterans with diabetes and
depressive symptoms in rural settings have limited access to care. Interventions that reach
Veterans in rural / community-based primary care are needed, especially those that blend
treatment strategies for physical and emotional health.

Project Objectives: Specific (Primary) Aim (1): Compare the effectiveness of the Healthy
Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) at 6
and 12 month follow-up.

Hypothesis 1a: After 6 months (active treatment phase), HOPE will produce greater
improvements in diabetes control (measured by hemoglobin A1c levels) and depression (measured
by PHQ-9 scores) than will EUC.

Hypothesis 1b: At 12 months (6-month active phase plus 6-month maintenance phase), HOPE
participants will continue to evidence significant greater improvements in HbA1c and PHQ-9
compared with EUC participants.

Exploratory Specific Aim (2): To examine the role of moderators and mediators on intervention
effectiveness Exploratory Aim 2a. To evaluate factors that mediate or moderate effectiveness
at 6 and 12 months for all enrolled patients (regardless of intervention group assignment).
Potential mediating and moderating variables include patient-level (clinical factors-diabetes
distress and self-efficacy and sociodemographics) and facility-level factors (availability of
medical and mental health services by clinical site).

Exploratory Aim 2b. To evaluate factors that mediate or moderate effectiveness at 6 and 12
months for patients enrolled in the HOPE intervention arm. Intervention factors include
adherence (e.g. session attendance), fidelity (ratings of coach effectiveness), and treatment
implementation (e.g., goal setting quality and self-management behaviors) as well as any
significant predictors obtained from Aim 1a.

Exploratory Specific Aim (3): Evaluate the potential for embedding the HOPE intervention
processes within a VA CBOC using the REAIM framework for evaluating effectiveness of
behavioral interventions.

Exploratory Aim 3a - Reach. Compare clinical and demographic characteristics of enrolled
study participants with the characteristics of all potentially eligible patients at each
CBOC.

Exploratory Aim 3b - Adoption. Qualitatively elicit clinicians' perceptions of behavioral
coaches, patients' use of action plans, and responses to coaches' recommendations in
preparation for future implementation

Project Methods: 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 6 behavioral
coaching telephone sessions and 3 booster sessions over a six month period. Coaches will use
a standardized, theory-based process for conducting the sessions with the aim of creating
patient-centered and articulated goals and behavioral action plans. Participants' primary
care providers will be notified about session discussions and the resultant goals and action
plans. Both groups will receive only usual primary care during the subsequent 6 months
maintenance period. Hemoglobin A1c and PHQ-9 measurements along with self-report
questionnaires will also be collected at baseline, 6 and 12 months follow-up. Changes in
measurements from baseline will be compared between groups. Analytic evaluations of
intervention mediators/moderators and implementation will also be conducted at 6 and 12
months follow-up.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.