Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression

Depression Clinical Trial

Official title: Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes Mellitus

• NCT number: NCT01572389
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Completed
• Phase: N/A
• Start date: November 1, 2012
• Completion date: September 30, 2016