Behavioral Medicine Intervention With Depressed Patients in a Community Health Center Setting
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Purpose
The linkage between the Massachusetts General Hospital (MGH)-Community Health Associates and the MGH-Benson Henry Institute for Mind-Body Medicine began in order to address the concern of providing affordable, easily accessible, culturally appropriate behavioral medicine interventions for low income patients served by MGH Community Health Centers, as well as the desire to demonstrate the efficacy and economics of these interventions. Since depression was such a prevalent issue among health center patients, with a significant impact on health care service utilization, it was decided to focus on offering Mind/Body services to this population first.
| Condition | Intervention |
|---|---|
|
Depression |
Behavioral: Medical Symptom Reduction Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Primary Purpose: Supportive Care |
| Official Title: | Outcomes and Cost-Effectiveness of a Behavioral Medicine Intervention With Depressed Patients in a Community Health Center Setting |
- Resulting scores on six measurement scales (these scales are listed below) [ Time Frame: 6 weeks or 8 weeks (the study design was later modified to 8 weeks in length) ] [ Designated as safety issue: No ]
- Depression severity CEDS-10
- Quality of Life: QOL-5
- Health Status (SF-12)
- Satisfaction with care (PSQ-18)
- Perceived Stress Scale (PSS-18)
- State Anxiety Scale (STAI-20)
- Resulting scores on two questionnaire forms (these questionnaires are listed below) [ Time Frame: 6 weeks or 8 weeks (the study design was later modified to 8 weeks) ] [ Designated as safety issue: No ]
- Lifestyle Profile II
- MSR-Patient Intake Questionnaire
| Enrollment: | 43 |
| Study Start Date: | September 2007 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Other
Subject progress will be measured through a comparison of scored questionnaires, distributed the pre program initiation and post program completion time points.
|
Behavioral: Medical Symptom Reduction Program
The program combines lecture, skills training, symptom monitoring, and group sharing aimed at preparing patients to take active roles in managing their own health. Elements of the program include:
Other Name: Meditation, Mind Body techniques, Cognitive Psychology
|
Detailed Description:
The application of behavioral medicine programs in community health settings is important to explore, as that application empowers the patient to apply self-care modalities that can be utilized in the long-term, for depression as well as for many other stress-related illnesses.
Behavioral and Mind/Body techniques, such as the Relaxation Response, have been reported to be useful therapeutically (often as an adjunct to medical treatment) in numerous conditions that are caused or exacerbated by stress including: mild to moderate depression/anxiety; anxiety; headache; back/neck pain; myocardial ischemia; premature ventricular contractions in stable ischemic heart disease or hypertension; osteoarthritis; stress symptoms; improved outcomes after cardiac and other surgery; pain relief and anxiety reduction in femoral arteriography and other invasive medical procedures; premenstrual syndrome; infertility; psychosomatic complaints; chronic pain; insomnia; musculoskeletal disorders; wound healing; rheumatoid arthritis; fibromyalgia and disease and treatment related symptoms of cancer. In our recent review of the literature, we suggest that the Relaxation Response may be an appropriate and relevant therapeutic state to counteract several stress-related disease processes.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients 21 years of age or older
- Diagnosis of depression
- Currently being treated for depression with medications and/or psychological counseling through onethrough one of the MGH-HealthCare Centers.
- Planning to continue using the health center as their main source of general medical services for the coming year.
Exclusion Criteria:
- History of bipolar disorder
- Active substance abuse
- History of psychosis
- Severe cognitive dysfunction (MMSE ≤ 24)
- Inability to speak English
- We will not exclude patients on the basis of their religious preferences or practices.
Contacts and Locations| United States, Massachusetts | |
| MGH Community Health Care Center | |
| Charlestown, Massachusetts, United States | |
| MGH Community Health Care Centers | |
| Revere, Massachusetts, United States | |
| Principal Investigator: | Gregory L. Fricchione, MD | Massachusetts General Hospital |
| Study Director: | Kathleen M. Miller, RN | Massachusetts General Hospital |
| Study Director: | Herbert Benson, MD | Massachusetts General Hospital |
| Study Director: | John W. Denninger, MD, PhD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Gregory Fricchione, MD, Associate Chief of Psychiatry, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01330420 History of Changes |
| Other Study ID Numbers: | 2007P001633, Center for Disease Control |
| Study First Received: | March 11, 2011 |
| Last Updated: | April 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013