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.
The specific objective of this study was to compare the effectiveness of the Healthy Outcomes through Patient Empowerment (HOPE) intervention to enhanced usual care (EUC) on diabetes (HbA1c) and depression (PHQ-9) outcomes at 6 and 12 month follow-up. The exploratory aims of the project included: 1) The examination of the role of moderators and mediators on intervention effectiveness; 2) the evaluation of factors that mediate or moderate effectiveness at 6 and 12 months for patients enrolled in the HOPE intervention arm; and, 3) The evaluation of the potential for embedding the HOPE intervention processes within a VA CBOC using the RE-AIM framework for evaluating effectiveness of behavioral interventions.
The HOPE study is a randomized controlled trial. We enrolled 225 Veterans from the Michael E. DeBakey VA Medical Center and surrounding community-based outpatient clinics with uncontrolled diabetes and clinically-significant depressive symptoms. One hundred thirty-six Veterans were randomized to the HOPE Intervention and 89 to Enhanced Usual Care (EUC). Eligible, veterans lived 20 miles or more from the tertiary center where they are treated or receive their primary care through one of the surrounding VA community-based clinics. Veterans had an HbA1c level above 7.5 in the last 12 months and achieved a score of 10 or greater on the PHQ-9 scale administered by the study staff. Veterans randomized to both groups received screening, education, and notification of clinical findings along with follow-up in usual primary care. Participants randomized to HOPE also received behavioral coaching telephone sessions over a six month period. Coaches used a standardized, theory-based process for conducting the sessions with the aim of creating patient-centered and articulated goals and behavioral action plans. Hemoglobin A1c and PHQ-9 measurements along with self-report questionnaires were collected at baseline, 6 and 12 months follow-up. Changes in measurements from baseline were compared between groups.
The proposed hypotheses for the study were: 1. that 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. 2. that at 12 months (6-month active phase plus 6-month maintenance phase), HOPE participants will continue to evidence significantly greater improvements in HbA1c and PHQ-9 compared with EUC participants.
Preliminary Analyses for the primary outcomes demonstrated small intervention effect sizes for change in depression (PHQ-9) of d=0.34 and diabetes-related QoL (PAID) of d=0.32; and no intervention effect for change in glycemic control (HbA1c) with d=0.06. PHQ-9 and HbA1c values did reach levels of minimally clinically significant change in the intervention group at 12-month follow-up (PHQ-9: from 15.8 +/- 4.2 to 10.1 +/- 6.9; HbA1c: 9.2 +/-1.4 to 8.7 +/-1.6); but these changes were not statistically significant compared to the usual care group in a time by treatment analyses: PHQ-9 (p=.10) and HbA1c (p=.74).
In each main area assessed, Veterans in the HOPE group had improvements in their depression symptoms (PHQ-9 change 5.7), glycemic control (A1c change 0.5), and diabetes distress (PAID change 17.4) but these changes were not statistically significant compared with the enhanced usual care group in our Intent to Treat Analyses. We are proceeding with additional analyses to explore treatment dose effects and other "treatment as received" analyses to determine if certain patients experience greater treatment related effects than others.
The HOPE Project demonstrated modest benefits on depression symptoms and diabetes related QoL for Veteran participants one-year after enrollment. There was no treatment benefits at one-year follow-up for glycemic control (HbA1c). Furthermore, the changes from 6 to 12 months were stable or even improved in the intervention group compared to some regression among usual care participants for the main outcomes.
The results of the study were not as robust as anticipated overall when comparing the HOPE intervention to enhanced usual care. Additional analyses are planned to identify characteristics of patients and potential dose-response effects that may be associated with higher likelihood of benefit from enrollment in the HOPE intervention. If present, the HOPE intervention could be targeted to this more selective at-risk population.
- Naik AD, Hundt NE, Vaughan EM, Petersen NJ, Zeno D, Kunik ME, Cully JA. Effect of Telephone-Delivered Collaborative Goal Setting and Behavioral Activation vs Enhanced Usual Care for Depression Among Adults With Uncontrolled Diabetes: A Randomized Clinical Trial. JAMA Network Open. 2019 Aug 2; 2(8):e198634.
- Hundt NE, Renn BN, Sansgiry S, Petersen NJ, Stanley MA, Kauth MR, Naik AD, Kunik ME, Cully JA. Predictors of response to brief CBT in patients with cardiopulmonary conditions. Health psychology : official journal of the Division of Health Psychology, American Psychological Association. 2018 Sep 1; 37(9):866-873.
- Renn BN, Hundt NE, Sansgiry S, Petersen NJ, Kauth MR, Kunik ME, Cully JA. Integrated Brief Cognitive Behavioral Therapy Improves Illness Intrusiveness in Veterans With Chronic Obstructive Pulmonary Disease. Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2018 Jul 13; 52(8):686-696.
- Miles SR, Khambaty T, Petersen NJ, Naik AD, Cully JA. The Role of Affect and Coping in Diabetes Self-Management in Rural Adults with Uncontrolled Diabetes and Depressive Symptoms. Journal of Clinical Psychology in Medical Settings. 2018 Mar 1; 25(1):55-65.
- Martin CE, Renn BN, Winderman KE, Hundt N, Petersen NJ, Naik AD, Cully JA. Classifying diabetes-burden: A factor analysis of the Problem Areas in Diabetes Scale. Journal of Health Psychology. 2018 May 1; 23(6):882-888.
- Tinetti ME, Naik AD, Dodson JA. Moving From Disease-Centered to Patient Goals-Directed Care for Patients With Multiple Chronic Conditions: Patient Value-Based Care. JAMA cardiology. 2016 Apr 1; 1(1):9-10.
- Naik AD, Lawrence B, Kiefer L, Ramos K, Utech A, Masozera N, Rao R, Petersen NJ, Kunik ME, Cully JA. Building a primary care/research partnership: lessons learned from a telehealth intervention for diabetes and depression. Family Practice. 2015 Apr 1; 32(2):216-23.
- Cully JA, Breland JY, Robertson S, Utech AE, Hundt N, Kunik ME, Petersen NJ, Masozera N, Rao R, Naik AD. Behavioral health coaching for rural veterans with diabetes and depression: a patient randomized effectiveness implementation trial. BMC health services research. 2014 Apr 28; 14:191.
- Naik AD, White CD, Robertson SM, Armento ME, Lawrence B, Stelljes LA, Cully JA. Behavioral health coaching for rural-living older adults with diabetes and depression: an open pilot of the HOPE Study. BMC geriatrics. 2012 Jul 24; 12(1):37.
- Naik AD, Hernandez A, Odom EA, Zeno D, Walder A, Cully J. Reliability and Validity of the Goal Evaluation Tool (GET) for Multimorbid Older Adults. Poster session presented at: American Geriatrics Society Annual Meeting; 2016 May 20; Long Beach, CA.
- Stevenson AP, Catic A, Walder A, Kunik ME, Henson HK, Naik AD. Less Maybe More when Caring for High-Risk Older Adults in Patient Centered Medical Homes. Poster session presented at: American Geriatrics Society Annual Meeting; 2016 May 20; Long Beach, CA.
- Robertson SM, Naik AN, White CD, Armento ME, Lawrence B, Stelljes LA, Cully JA. Behavioral health coaching for rural living older adults with diabetes and depression: An open pilot of the HOPE Study. Poster session presented at: Gerontological Society of America Annual Scientific Meeting; 2012 Nov 14; San Diego, CA.
Mental, Cognitive and Behavioral Disorders, Health Systems, Diabetes and Related Disorders
Treatment - Efficacy/Effectiveness Clinical Trial, Treatment - Comparative Effectiveness