Clinical trial NCT01330420: Behavioral Medicine Intervention With Depressed Patients in a Community Health Center Setting
Official title: Outcomes and Cost-Effectiveness of a Behavioral Medicine Intervention With Depressed Patients in a Community Health Center Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2011-04-07
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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 criteria: 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.

Primary outcomes:
measure: Depression Severity (CEDS-10)
timeFrame: comparison pre program initiation and post program completion time points (6 weeks)
measure: Health Status (SF-12)
timeFrame: comparison pre program initiation and post program completion time points (6 weeks)
measure: Quality of Life (QOL-5)
timeFrame: comparison pre program initiation and post program completion time points (6 weeks)
measure: Satisfaction With Care (PSQ-18)
timeFrame: comparison pre program initiation and post program completion time points (6 weeks)
Secondary outcomes:
measure: The Health Promoting Lifestyle Profile II (HPLP-II)
timeFrame: comparison pre program initiation and post program completion time points (6 weeks)
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: MGH Community Health Care Center
state: Massachusetts
city: Revere
country: United States
facility: MGH Community Health Care Centers
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Gregory L. Fricchione, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Kathleen M. Miller, RN
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: Herbert Benson, MD
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: John W. Denninger, MD, PhD
role: STUDY_DIRECTOR
References: