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

NCT01330420 | Completed Results

• 2 other identifiers: 2007P001633Center for Disease Control
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (4)

• Depression Severity (CEDS-10)

  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.

  comparison pre program initiation and post program completion time points (6 weeks)

• Health Status (SF-12)

  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.

  comparison pre program initiation and post program completion time points (6 weeks)

• Quality of Life (QOL-5)

  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.

  comparison pre program initiation and post program completion time points (6 weeks)

• Satisfaction With Care (PSQ-18)

  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.

  comparison pre program initiation and post program completion time points (6 weeks)

Secondary Outcomes (1)

• The Health Promoting Lifestyle Profile II (HPLP-II)

  comparison pre program initiation and post program completion time points (6 weeks)

Study Arms (1)

Relaxation Response Resiliency Program for Depression

EXPERIMENTAL

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

Interventions

Relaxation Response Resiliency Program for Depression 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.

Also known as: Medical Symptom Reduction Program, Meditation, Mind Body techniques, Cognitive Psychology

Relaxation Response Resiliency Program for Depression

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

MGH Community Health Care Center

Charlestown, Massachusetts, United States

Location

MGH Community Health Care Centers

Revere, Massachusetts, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Meditation; Cognitive Psychology

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Psychology; Behavioral Sciences; Cognitive Science

Limitations and Caveats

4/28 didn't complete both pre/post assessments \& thus didn't contribute data for this study \& were excluded. It's possible that the 24 completers had a higher degree of motivation \& commitment, which enhanced the effectiveness of the intervention.

Results Point of Contact

• Title: Kathleen Miller, RN
• Organization: Massachusetts General Hospital

kmiller16@partners.org

781-485-6176

Study Officials

• Gregory L. Fricchione, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research at the Benson-Henry Institute for Mind Body Medicine

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: April 7, 2011
• Study Start: September 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 21, 2017
• Results First Posted: October 10, 2013

Record last verified: 2017-10

Locations

US (2)