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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John W. Denninger, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01330420
First received: March 11, 2011
Last updated: July 31, 2013
Last verified: July 2013
  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: Relaxation Response Resiliency Program for Depression

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Outcomes and Cost-Effectiveness of a Behavioral Medicine Intervention With Depressed Patients in a Community Health Center Setting

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Depression Severity (CEDS-10) [ Time Frame: comparison pre program initiation and post program completion time points (6 weeks) ] [ Designated as safety issue: No ]
    The Center for Epidemiologic Studies Depression Scale (CES-D 10) was used to assess depression severity pre-and post-intervention. This is the shorter 10-item, modified version of the 20-item CES-D. The total score is the sum of the 10 item weights, with the lowest possible score being 0 and the highest possible score being 30, and a higher score indicating more depressive symptoms. Developed from other well-validated depression scales, this instrument measures the experience of depressive symptoms over the past week. This instrument is shown to be better than the CES-D 20 in combining data from different ethnic and cultural groups, and is available in both English and Spanish. This scale has been reported to have good internal consistency and validity.

  • Health Status (SF-12) [ Time Frame: comparison pre program initiation and post program completion time points (6 weeks) ] [ Designated as safety issue: No ]
    The SF-12 was used to assess health status. It is the shortened version of the well-validated SF-36, directed at monitoring overall physical and mental health outcomes. It is available in both English and Spanish. Scoring algorithms involve weighted-item responses, all 8 scales to use the same standardization for easy comparison. All scores range from 0-100 where higher scores indicated better QOL. The mean = 50 and the SD = 10.

  • Quality of Life (QOL-5) [ Time Frame: comparison pre program initiation and post program completion time points (6 weeks) ] [ Designated as safety issue: No ]
    The QOL-5 is a short, global, and generic quality of life (QoL) questionnaire for clinical databases. The QOL-5 item tool is used to compare various population groups using generic factors common to people everywhere irrespective of age, sex, culture, and state of health. Scores on the QOL-5 ranges from 0 = lowest quality to 100 = highest quality.

  • Satisfaction With Care (PSQ-18) [ Time Frame: comparison pre program initiation and post program completion time points (6 weeks) ] [ Designated as safety issue: No ]
    Patient Satisfaction Questionnaire Short Form (PSQ-18) takes approximately 3-4 minutes to complete, containing 18 items examining seven dimensions of satisfaction with medical care: general satisfaction (2 questions, Mean =3.58, SD =0.94), technical quality (3 questions, Mean = 3.68, SD = 0.76), interpersonal manner (2 questions, Mean = 4.09, SD = 0.69), communication (2 questions, Mean = 3.74, SD = 0.87), financial aspects (2 questions, Mean = 3.78, SD = 0.94), time spent with doctor (2 questions, Mean = 3.59, SD = 0.94), and accessibility and convenience (4 questions, Mean = 3.76, SD = 0.74). Responses to each item are given on a 5-point scale ranging from 1 - strongly agree to 5 - strong disagree, therefore higher scores correspond to less satisfaction. PSQ-18 subscale scores are substantially correlated with their full-scale counterparts and possess generally adequate internal consistency reliability.


Secondary Outcome Measures:
  • The Health Promoting Lifestyle Profile II (HPLP-II) [ Time Frame: comparison pre program initiation and post program completion time points (6 weeks) ] [ Designated as safety issue: No ]

    The Health Promoting Lifestyle Profile II (HPLP-II) was used to assess health promoting behaviors. Based on the Health Promoting Model (Pender, 1982) this 52-item instrument measures self-initiated health behaviors that serve to maintain or enhance the level of self-actualization and wellness. Included are subscales for physical activity, spiritual growth, health responsibility, interpersonal relations, nutrition, and stress management. It is self-administered and uses a 4-point response format. Both English and Spanish versions are available.

    A score for overall health-promoting lifestyle is obtained by calculating a mean of the individual's responses to all 52 items; six subscale scores are obtained similarly by calculating a mean of the responses to subscale items. Scores range from 1 = Never to 4 = Routinely, with a higher score corresponding to a more health promoting lifestyle.



Enrollment: 28
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
Experimental: 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.

Behavioral: 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.
Other Name: Medical Symptom Reduction Program, 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330420

Locations
United States, Massachusetts
MGH Community Health Care Center
Charlestown, Massachusetts, United States
MGH Community Health Care Centers
Revere, Massachusetts, United States
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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: John W. Denninger, MD, PhD, Director of Research at the Benson-Henry Institute for Mind Body Medicine, 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
Results First Received: May 28, 2013
Last Updated: July 31, 2013
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 July 20, 2014