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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

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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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	131 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (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
Study Start Date :	September 2011
Actual Primary Completion Date :	October 2013
Actual Study Completion Date :	October 2013

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: RESPECT-D; The RESPECT-D Model: Collaborative Care depression treatment within primary care including care manager	Other: RESPECT-D; 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
Experimental: RESPECT-D-E; 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.; Other Names: Enhanced Collaborative Care Treatment for Depression in Primary Care; Digital Health Coaching Program for Depressive Symptoms

Outcome Measures

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Primary Outcome Measures :

1. Change in Score of Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 12 weeks ]
   17-item assessment rated during a clinical interview

Secondary Outcome Measures :

1. Change in Score of Hopkins Symptom Checklist-20 (HSCL-20) [ Time Frame: 12 weeks ]
   Self-report measure of depressive symptom severity

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Males and Females, ages 18 and older who are self-reporting generally good health.
• Newly started on an antidepressant medication, switched to a different antidepressant medication or prescribed an increased dosage of antidepressant medication within the past 2 weeks.
• A Hamilton Depression Rating Scale (HAM-D) score of greater than 10.
• A Patient Health Questionnaire (PHQ-9) score of 10 or greater, with endorsement of depressed mood or anhedonia, and endorsement of impaired daily function.
• Meets diagnostic criteria for Major Depressive Disorder, persistent Minor Depressive Disorder (i.e., > 1 month duration), or Dysthymic Disorder via a structured interview with the PRIME-MD.
• Able to read, understand, and sign the Informed Consent in English.
• Willing and able to comply with study requirements.
• Well-versed in using a personal computer and the internet and must have easy access to a computer connected to the internet everyday (both weekdays and weekends).
• Enrollment in Surescripts Pharmacy benefit plan
• Currently under care with a Provider in Family Medicine at Cheshire Medical Center / Dartmouth-Hitchcock Keene

Exclusion Criteria:

• Subjects must not have a major psychiatric co-morbid condition (schizophrenia, bipolar affective disorder, obsessive-compulsive disorder, PTSD, or a depressive disorder with psychotic features, as determined from chart review and patient report).
• Subjects must not have a substance use disorder or dependence as assessed by: CAGE Alcohol Dependence Questionnaire score >3
• Subjects must not have a history of treatment -resistant depression as defined by the following: Psychiatric hospitalization within the past year; More than 2 clinically ineffective antidepressant medication trials, of adequate duration and adequate dose, within the current depressive episode; Any history of Electroconvulsive Therapy (ECT); A trial of Monoamine Oxidase inhibitor (MAO) within the past year.
• Subjects must not report being actively suicidal
• Subjects must score 4 or greater on the Callahan Six-Item Cognitive Screening assessment
• Subjects must not be diagnosed with a terminal or near terminal medical illness such that their primary care provider has estimated the patient has less than 6 months to live.
• Subjects reporting any medical condition that would make it unsafe to participate in a research study.
• Participation in any other clinical research study within the past 30 days.
• Participation in any on-line depression-related coaching or lifestyle improvement program within the past 5 years.

Contacts and Locations

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Locations

United States, New Hampshire
Family Medicine Clinics, Cheshire Medical Center (DH-Keene)
Keene, New Hampshire, United States, 03431

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Johnson & Johnson

Investigators

Principal Investigator:	Mark T. Hegel, PhD	Dartmouth-Hitchcock Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Dietrich AJ, Oxman TE, Williams JW Jr, Schulberg HC, Bruce ML, Lee PW, Barry S, Raue PJ, Lefever JJ, Heo M, Rost K, Kroenke K, Gerrity M, Nutting PA. Re-engineering systems for the treatment of depression in primary care: cluster randomised controlled trial. BMJ. 2004 Sep 11;329(7466):602. Epub 2004 Sep 2.

Hunkeler EM, Katon W, Tang L, Williams JW Jr, Kroenke K, Lin EH, Harpole LH, Arean P, Levine S, Grypma LM, Hargreaves WA, Unützer J. Long term outcomes from the IMPACT randomised trial for depressed elderly patients in primary care. BMJ. 2006 Feb 4;332(7536):259-63. Epub 2006 Jan 20.

Katon W, Von Korff M, Lin E, Walker E, Simon GE, Bush T, Robinson P, Russo J. Collaborative management to achieve treatment guidelines. Impact on depression in primary care. JAMA. 1995 Apr 5;273(13):1026-31.

Katon WJ, Von Korff M, Lin EH, Simon G, Ludman E, Russo J, Ciechanowski P, Walker E, Bush T. The Pathways Study: a randomized trial of collaborative care in patients with diabetes and depression. Arch Gen Psychiatry. 2004 Oct;61(10):1042-9.

Katon W, Von Korff M, Lin E, Simon G, Walker E, Unützer J, Bush T, Russo J, Ludman E. Stepped collaborative care for primary care patients with persistent symptoms of depression: a randomized trial. Arch Gen Psychiatry. 1999 Dec;56(12):1109-15.

Torrey WC, Drake RE. Practicing shared decision making in the outpatient psychiatric care of adults with severe mental illnesses: redesigning care for the future. Community Ment Health J. 2010 Oct;46(5):433-40. doi: 10.1007/s10597-009-9265-9. Epub 2009 Nov 8.

Unützer J, Katon W, Callahan CM, Williams JW Jr, Hunkeler E, Harpole L, Hoffing M, Della Penna RD, Noël PH, Lin EH, Areán PA, Hegel MT, Tang L, Belin TR, Oishi S, Langston C; IMPACT Investigators. Improving Mood-Promoting Access to Collaborative Treatment. Collaborative care management of late-life depression in the primary care setting: a randomized controlled trial. JAMA. 2002 Dec 11;288(22):2836-45.

Kessler RC, Nelson CB, McGonagle KA, Liu J, Swartz M, Blazer DG. Comorbidity of DSM-III-R major depressive disorder in the general population: results from the US National Comorbidity Survey. Br J Psychiatry Suppl. 1996 Jun;(30):17-30.

McQuaid JR, Stein MB, Laffaye C, McCahill ME. Depression in a primary care clinic: the prevalence and impact of an unrecognized disorder. J Affect Disord. 1999 Sep;55(1):1-10.

Norquist GS, Regier DA. The epidemiology of psychiatric disorders and the de facto mental health care system. Annu Rev Med. 1996;47:473-9. Review.

Stein MB, Kirk P, Prabhu V, Grott M, Terepa M. Mixed anxiety-depression in a primary-care clinic. J Affect Disord. 1995 May 17;34(2):79-84.

Weilburg JB, O'Leary KM, Meigs JB, Hennen J, Stafford RS. Evaluation of the adequacy of outpatient antidepressant treatment. Psychiatr Serv. 2003 Sep;54(9):1233-9.

Responsible Party:	Mark T. Hegel, Associate Professor, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT01583400 History of Changes
Other Study ID Numbers:	CPHS#22616, W&P-PCMH-01
First Posted:	April 24, 2012
Last Update Posted:	September 18, 2014
Last Verified:	September 2014

Keywords provided by Mark T. Hegel, Dartmouth-Hitchcock Medical Center:

Depressive Disorder, Major; Depressive Disorder, Minor; Dysthymic Disorder

Additional relevant MeSH terms:

Disease; Depression; Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder	Pathologic Processes; Behavioral Symptoms; Mood Disorders; Mental Disorders