N/A
N=225
Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression
Diabetes Mellitus · Depression
Bottom Line
View on ClinicalTrials.gov: NCT01572389 ↗Enrolled (actual)
225
Serious AEs
0.4%
Results posted
Nov 2017
Primary outcome: Primary: Change in Hemoglobin A1C — 9.2; 9.3; 9.1; 8.7 percentage of glycated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Healthy Outcomes through Patient Empowerment (HOPE) (Behavioral); Enhanced Usual Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin A1C |
9.2; 9.3; 9.1; 8.7; 8.7; 8.9 | — |
| PRIMARY Change in Patient Health Questionnaires-9 During Intervention |
15.8; 16.2; 10.9; 12.4; 10.1; 12.6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01572389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.