Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression

NCT01572389 | Completed Results DMC

• 1 other identifier: IIR 10-135
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Depression

Keywords

Diabetes Mellitus; Depression; Affective Symptoms; Self Care; Telemedicine; Psychotherapy

Outcome Measures

Primary Outcomes (2)

• Change in Hemoglobin A1C

  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.

  Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months.

• Change in Patient Health Questionnaires-9 During Intervention

  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.

  PHQ-9 will be assessed at baseline, 6-, and 12- months.

Study Arms (2)

Arm 1: HOPE

EXPERIMENTAL

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)

Arm 2: EUC

ACTIVE COMPARATOR

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

Interventions

Healthy Outcomes through Patient Empowerment (HOPE) BEHAVIORAL

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.

Arm 1: HOPE

Enhanced Usual Care BEHAVIORAL

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.

Arm 2: EUC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (7)

• 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. J Health Psychol. 2018 May;23(6):882-888. doi: 10.1177/1359105316678667. Epub 2016 Nov 21.

  PMID: 27872390 RESULT

• 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 Cardiol. 2016 Apr 1;1(1):9-10. doi: 10.1001/jamacardio.2015.0248. No abstract available.

  PMID: 27437646 RESULT

• 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. Fam Pract. 2015 Apr;32(2):216-23. doi: 10.1093/fampra/cmu084. Epub 2014 Dec 31.

  PMID: 25552674 RESULT

• 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 Serv Res. 2014 Apr 28;14:191. doi: 10.1186/1472-6963-14-191.

  PMID: 24774351 RESULT

• 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 Geriatr. 2012 Jul 24;12:37. doi: 10.1186/1471-2318-12-37.

  PMID: 22828177 RESULT

• Vaughan EM, Cully JA, Petersen NJ, Hundt NE, Kunik ME, Zeno DD, Naik AD. Testing the Impact of a Collaborative, Goal-Setting, and Behavioral Telehealth Intervention on Diabetes Distress: A Randomized Clinical Trial. Telemed J E Health. 2022 Jan;28(1):84-92. doi: 10.1089/tmj.2020.0533. Epub 2021 Mar 15.

  PMID: 33728989 DERIVED

• 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 Netw Open. 2019 Aug 2;2(8):e198634. doi: 10.1001/jamanetworkopen.2019.8634.

  PMID: 31390035 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Depression; Affective Symptoms

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Aanand, Naik, MD
• Organization: Department of Veteran Affairs

anaik@bcm.edu

713-794-8541

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: April 6, 2012
• Study Start: November 1, 2012
• Primary Completion: June 24, 2016
• Study Completion: September 30, 2016
• Last Updated: November 1, 2017
• Results First Posted: November 1, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)