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Behavioral Medicine Intervention With Depressed Patients in a Community Health Center Setting

NCT ID: NCT01330420

Last Updated: 2017-11-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Relaxation Response Resiliency Program for Depression

The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session, 1.5 hour, mind body intervention.

The 3RP-D was designed to promote resiliency by reducing the harmful effects of stress through the elicitation of the relaxation response, and through skill training to enhance positive attitudes and beliefs, nutrition, exercise, recuperative sleep, social support, and coping. Specific interventions include: cognitive behavioral therapy (CBT), enhancing social support (SS), cultivating positive attitudes and beliefs (CPE), and promoting Healthy Lifestyle Habits(HL). The 3RP-D program has been manualized for use by group facilitators and health center patients.

Group Type EXPERIMENTAL

Relaxation Response Resiliency Program for Depression

Intervention Type BEHAVIORAL

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:

* Elicitation of the relaxation response through techniques such as diaphragmatic breathing and mindfulness.
* Examination and reversal of negative thought patterns.
* Physical movement, including stretching and yoga.
* Healthy eating and other positive lifestyle behaviors.
* Goal setting.

Interventions

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Relaxation Response Resiliency Program for Depression

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:

* Elicitation of the relaxation response through techniques such as diaphragmatic breathing and mindfulness.
* Examination and reversal of negative thought patterns.
* Physical movement, including stretching and yoga.
* Healthy eating and other positive lifestyle behaviors.
* Goal setting.

Intervention Type BEHAVIORAL

Other Intervention Names

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Medical Symptom Reduction Program, Meditation, Mind Body techniques, Cognitive Psychology

Eligibility Criteria

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Inclusion Criteria

* Patients 21 years of age or older
* Diagnosis of depression
* Currently being treated for depression with medications and/or psychological counseling through 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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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John W. Denninger, MD, PhD

Director of Research at the Benson-Henry Institute for Mind Body Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregory L. Fricchione, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Kathleen M. Miller, RN

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Herbert Benson, MD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

John W. Denninger, MD, PhD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Locations

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MGH Community Health Care Center

Charlestown, Massachusetts, United States

Site Status

MGH Community Health Care Centers

Revere, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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Center for Disease Control

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2007P001633

Identifier Type: -

Identifier Source: org_study_id