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
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Condition or disease | Intervention/treatment | Phase |
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Depressive Disorder, Major Depressive Disorder, Minor Dysthymic Disorder | Other: RESPECT-D Other: RESPECT-D-E (Enhanced) | Not Applicable |

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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: RESPECT-D
The RESPECT-D Model: Collaborative Care depression treatment within primary care including care manager
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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
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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.
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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:
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- 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

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

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 |
Publications:
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 Key Record Dates |
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 |