Enhanced Collaborative Depression Treatment in Primary Care: The RESPECT-D-E Trial
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|ClinicalTrials.gov Identifier: NCT01583400|
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : September 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder, Major Depressive Disorder, Minor Dysthymic Disorder||Other: RESPECT-D Other: RESPECT-D-E (Enhanced)||Not Applicable|
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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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
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.
- Change in Score of Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 12 weeks ]17-item assessment rated during a clinical interview
- Change in Score of Hopkins Symptom Checklist-20 (HSCL-20) [ Time Frame: 12 weeks ]Self-report measure of depressive symptom severity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|