CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 225 enrolled
Drug / intervention
Healthy Outcomes through Patient Empowerment (HOPE) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01572389
NCT01572389N/ACompleted

Behavioral Activation Therapy for Rural Veterans With Diabetes and Depression

VA Office of Research and Development·interventional·Posted Apr 6, 2012·Updated Nov 1, 2017

In Brief

A clinical study evaluating Healthy Outcomes through Patient Empowerment (HOPE) and Enhanced Usual Care for Diabetes Mellitus and Depression. Completed, enrolled 225 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2012
Enrollment StartNov 1, 2012
Primary CompletionJun 24, 2016
Study CompletionSep 30, 2016
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 14.2 years ago

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.

Enhanced Usual Carebehavioral

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.