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

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.

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.