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