Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression
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|ClinicalTrials.gov Identifier: NCT01572389|
Recruitment Status : Completed
First Posted : April 6, 2012
Results First Posted : November 1, 2017
Last Update Posted : November 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Depression||Behavioral: Healthy Outcomes through Patient Empowerment (HOPE) Behavioral: Enhanced Usual Care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||225 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression|
|Actual Study Start Date :||November 1, 2012|
|Actual Primary Completion Date :||June 24, 2016|
|Actual Study Completion Date :||September 30, 2016|
Experimental: Arm 1: HOPE
The Healthy Outcomes through Patient Empowerment (HOPE) intervention group is the intervention arm which will employ behavioral health coaching telephone sessions. Tele-coaching is a theoretically grounded, structured processes guided by intervention manuals.
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.
Active Comparator: Arm 2: EUC
The Enhanced Usual Care (EUC) group will serve as a concurrent control group to compare to the intervention arm of the study. Participants are screened for diabetes self-management behaviors and control and for active depressive and anxiety symptoms. Primary care providers are alerted of the patients' status and given decision support to enhance care for these uncontrolled conditions.
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.
- Change in Hemoglobin A1C [ Time Frame: Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months. ]Measures of Hemoglobin A1C will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control. Hemoglobin A1C is a blood test taken to assess average blood glucose levels in the body. Normal range of A1C level is below 5.7. Eligible participants had an A1C of 7.5 or higher. The higher the A1C the more a person's diabetes is uncontrolled.
- Change in Patient Health Questionnaires-9 During Intervention [ Time Frame: PHQ-9 will be assessed at baseline, 6-, and 12- months. ]The Patient Health Questionnaires-9 assesses depressive symptoms during the course of the intervention. The PHQ-9 ranges in score from 0 - 27; where higher numbers represent increase levels of depression. Scores from 5 - 9 represent "minimal symptoms" of depression; 10 - 14 represent "minor depression", dysthymia, or major depression - mild; 15 - 19 represent "major depression, moderately severe"; and scores of 20 and above is considered "major depression, severe." Participants with that scored a 10 or above were eligible for the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572389
|United States, Texas|
|Michael E. DeBakey VA Medical Center, Houston, TX|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Aanand D Naik, MD BA||Michael E. DeBakey VA Medical Center, Houston, TX|
|Principal Investigator:||Jeffrey Cully, PhD MEd||Michael E. DeBakey VA Medical Center, Houston, TX|