Enhanced Collaborative Depression Treatment in Primary Care: The RESPECT-D-E Trial
Primary care physicians have emerged as the predominant mental health care providers for diagnosing and treating depression. The majority of patients with mood disorders receive treatment in the primary care setting, within which approximately 10-30% of all patients present with a depressive disorder. Comprehensive 'Collaborative Care' models of depression management significantly improve depression outcomes and health-related quality of life. Core features of these programs include use of a trained depression care manager to closely coordinate with primary care clinicians, support treatment recommendations, provide patient education, conduct patient follow-up to ensure adequate treatment, and manage as-needed access to psychiatrists for patients with more complex presentations. Evidence based Collaborative Care models do not currently weave in the use of web-based or mobile technologies. These technologies offer unique features that may make collaborative depression care more effective. The digital health coaching program for depressive symptoms enhanced during Phase I of the current project is a web-based tool featuring video, text, links and graphics which provide patients with education, self-management techniques, tailored feedback, and tools for tracking treatment progress. The RESPECT-D (Re-engineering Systems of Primary Care Treatment of Depression) intervention is a collaborative depression management model for primary care. The primary objective of this project is to compare the efficacy of an enhanced Collaborative Care model for depression (RESPECT-D-E) to the standard model (RESPECT-D) for patients with minor and major depression and dysthymic disorder. This study will be a randomized controlled trial with 150 participants who are receiving antidepressant medication treatment in the primary care setting. The primary objectives are: reduction in subject reported depressive symptoms, improvement in subject reported health related quality of life and improvement in subject adherence to treatment regimen as demonstrated by self-report measures and clinician-administered assessment. The investigators hypothesize that compared to RESPECT-D at 12 weeks, participants randomized to RESPECT-D-E will demonstrate: a greater reduction in depressive symptoms, a greater improvement in health-related quality of life and a greater satisfaction with quality of depression care received.
Depressive Disorder, Major
Depressive Disorder, Minor
Other: RESPECT-D-E (Enhanced)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Development and Evaluation of Enhanced Digital Health Coaching Program for Depressive Symptoms to Support Collaborative Depression Treatment in Primary Care: The RESPECT-D-E (Enhanced) Trial|
- Change in Score of Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]17-item assessment rated during a clinical interview
- Change in Score of Hopkins Symptom Checklist-20 (HSCL-20) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Self-report measure of depressive symptom severity
|Study Start Date:||September 2011|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Active Comparator: RESPECT-D
The RESPECT-D Model: Collaborative Care depression treatment within primary care including care manager
The RESPECT-D (Re-engineering Systems of Primary Care Treatment of Depression) intervention is a systematic approach to the assessment and management of depression within Primary Care. The essential components of the Collaborative Care model include prepared PCPs and practices, the Care Manager, and a Behavioral Health specialist all working in partnership with the patient. The trained depression care manager closely coordinates with primary care clinicians, supports treatment recommendations, patient education, appropriate follow-up to ensure adequate treatment, and coordination with a consulting psychiatrist.
Other Name: Collaborative Care Treatment for Depression in Primary Care
RESPECT-D-E: Collaborative Care depression treatment within primary care including care manager plus on-line coaching, education and symptom, side effect and, medication adherence tracking with the digital health coaching program for depressive symptoms.
Other: RESPECT-D-E (Enhanced)
The RESPECT-D-E intervention includes all of the components of the RESPECT-D model, but also incorporates the enhanced digital health coaching program for depressive symptoms tool, is an on-line program with education, coaching, self-management techniques, symptom, side effect and medication adherence tracking for depression. Depressive symptoms, medication side effects and adherence data are automatically delivered to the Care Manager for use in treatment planning. The program provides tailored feedback, provides coaching on skills related to depression treatment (such as changing negative thoughts and avoiding relapse), and offers tools for tracking behavior change.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01583400
|United States, New Hampshire|
|Family Medicine Clinics, Cheshire Medical Center (DH-Keene)|
|Keene, New Hampshire, United States, 03431|
|Principal Investigator:||Mark T. Hegel, PhD||Dartmouth-Hitchcock Medical Center|