Enhanced Collaborative Depression Treatment in Primary Care: The RESPECT-D-E Trial

Depressive Disorder, Major Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

The National Comorbidity Survey suggests a lifetime prevalence of 17% and 1-year prevalence of 10% for major depression. Within primary care, approximately 10-30% of patients present with a depressive disorder. Over the past decade, primary care physicians have emerged as the predominant mental health care providers insofar as diagnosing and treating depression, with the majority of patients with mood disorders receiving treatment in a primary care setting.

Comprehensive 'Collaborative Care' models of depression management in primary care 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, provision of specific treatment recommendations/guidelines, patient education, appropriate follow-up by the depression care manager to ensure adequate treatment, as-needed access to psychiatrists for patients with more complex presentations, and, occasionally, on-site psychotherapy. For example, the IMPACT study of primary care patients with late-life depression found that a Collaborative Care program doubled the effectiveness of depression treatment and improved functional outcomes at 3 months, 6 months and 1 year compared to usual care. The RESPECT-D phone-based Collaborative Care program similarly had increases at 3 and 6 months in depression response, remission, and satisfaction with care, compared to usual care.

Nonetheless, evidence based Collaborative Care leaves room for improvement. In both IMPACT and RESPECT-D, 40% to 50% of intervention participants failed to achieve a clinically meaningful depression treatment effect. 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 enhanced digital health coaching program for depressive symptoms is a web-based tool featuring video, text and graphics which provides patients with education, self-management techniques, tailored feedback, and tools for tracking treatment progress. Incorporating a digital health coaching program for depressive symptoms into the flow of collaborative depression care and testing its impact is an important next step for the field.

The RESPECT-D (Re-engineering Systems of Primary Care Treatment of Depression) intervention is a systematic approach to the assessment and management of depression by the primary care provider, with a centrally based care manager providing telephone support for patients. The essential components of this Collaborative Care model include prepared PCPs and practices, the Care Manager, and a Behavioral Health specialist all working in partnership with the patient.

RESPECT-D-E (Enhanced) intervention is Collaborative Care depression treatment in primary care including care manager (the elements of RESPECT-D) plus patient access to on-line coaching, education, and symptom, side effect and medication adherence tracking which is automatically fed back to the Care Manager.

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) in primary care patients with minor and major depression and dysthymic disorder .

The RESEPCT-D-E trial is a randomized, 12-week prospective 2-arm, comparative clinical effectiveness study. Primary care patients (N=150) with major or minor depressive disorder, or dysthymia and currently taking antidepressant medication will be randomly assigned to either Collaborative Care treatment for depression (RESPECT-D) or RESPECT-D plus a digital health coaching program for depressive symptoms intervention (RESPECT-D-E). Patients will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks using self-report and clinician -administered rating scales including the Hopkins Symptom Checklist and Hamilton Depression Rating Scale. Intervention participants will receive access to the online depression coach as well as the elements of standard Collaborative Care (RESPECT-D). The primary objectives are: reduction in depressive symptoms, improvement in health related quality of life and improvement in adherence to treatment regimen.

The secondary objectives of the RESPECT-D-E trial are to: Evaluate the program impact on overall health, work productivity, and medical costs; Assess the usability of the enhanced digital health coaching program for depressive symptoms tool; Assess the program's impact on overall satisfaction with care.

Hypotheses: Compared to RESPECT-D at 12 weeks, participants randomized to RESPECT-D-E will demonstrate: H1.1a: a greater reduction in depressive symptoms, as measured by the clinician administered Hamilton Depression Rating Scale (HAM-D); H1.1b: a greater reduction in depressive symptoms, as measured by the self-report Hopkins Symptom Checklist Depression Scale (HSCL-20); H1.1c: a greater improvement in health related quality of life, as measured by the Mental Component Summary score from the Medical Outcomes Study Short Form (SF-36); H1.1d: a greater satisfaction with quality of depression care received.

Hypothesis 1.2: Compared to RESPECT-D at 4, 8, and 12 weeks, participants randomized to RESPECT-D-E will demonstrate: H1.2a: more frequent contact with the depression care manager and primary care provider, as measured by depression care manager treatment logs and medical record review; H1.2b: greater adherence to their antidepressant regimen, as measured by participant self-report; H1.2c: greater exposure to depression counseling, as measured by participant self-report. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Minor
• Disease
• Dysthymic Disorder

• NCT number: NCT01583400
• Study type: Interventional
• Source: Dartmouth-Hitchcock Medical Center
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Completion date: October 2013