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

Outcomes and Cost-Effectiveness of a Behavioral Medicine Intervention With Depressed Patients in a Community Health Center Setting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01330420
Enrollment
28
Registered
2011-04-07
Start date
2007-09-30
Completion date
2010-08-31
Last updated
2017-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

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.

Interventions

BEHAVIORALRelaxation 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.

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
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 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.

Design outcomes

Primary

MeasureTime frameDescription
Depression Severity (CEDS-10)comparison pre program initiation and post program completion time points (6 weeks)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)comparison pre program initiation and post program completion time points (6 weeks)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)comparison pre program initiation and post program completion time points (6 weeks)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)comparison pre program initiation and post program completion time points (6 weeks)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

MeasureTime frameDescription
The Health Promoting Lifestyle Profile II (HPLP-II)comparison pre program initiation and post program completion time points (6 weeks)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.

Countries

United States

Participant flow

Recruitment details

All participants were being treated for depression with medications or psychotherapy at the MGH-Revere or MGH-Charlestown Health Centers. Referrals came from health center primary care providers (PCP's), mental health providers, or directly from patients themselves through postcards in the waiting areas.

Pre-assignment details

Licensed independent clinical social worker (LICSW) Group Facilitators administered intake evaluations with the referred patients to obtain basic demographic and clinical information, determine if they were appropriate for the group based on the inclusion and exclusion criteria, and review their goals for group participation.

Participants by arm

ArmCount
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.
28
Total28

Baseline characteristics

CharacteristicRelaxation Response Resiliency Program for Depression
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
5 Participants
Age, Categorical
Between 18 and 65 years
23 Participants
Age, Continuous50.2 years
STANDARD_DEVIATION 13
Region of Enrollment
United States
28 participants
Sex: Female, Male
Female
25 Participants
Sex: Female, Male
Male
3 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 28
serious
Total, serious adverse events
0 / 28

Outcome results

Primary

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.

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

Population: 24 patients met completer status, defined as patients who attended all or part of the six sessions.

ArmMeasureGroupValue (MEAN)Dispersion
Relaxation Response Resiliency Program for DepressionDepression Severity (CEDS-10)CSE-D 10 Pre-Intervention18 units on a scaleStandard Deviation 5.8
Relaxation Response Resiliency Program for DepressionDepression Severity (CEDS-10)CSE-D 10 Post-Intervention12 units on a scaleStandard Deviation 5.7
Comparison: Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-interventionp-value: <0.001Wilcoxon signed-ranked test
Primary

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.

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

Population: 24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.

ArmMeasureGroupValue (MEAN)Dispersion
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 Bodily Pain Post-Intervention59 units on a scaleStandard Deviation 37
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 Vitality Pre-Intervention30 units on a scaleStandard Deviation 16
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 General Health Pre-Intervention51 units on a scaleStandard Deviation 24
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 General Health Post-Intervention49 units on a scaleStandard Deviation 28
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 Physical Functioning Pre-Intervention58 units on a scaleStandard Deviation 38
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 Physical Functioning Post-Intervention58 units on a scaleStandard Deviation 35
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 Role Physical Pre-Intervention65 units on a scaleStandard Deviation 44
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 Role Physical Post-Intervention61 units on a scaleStandard Deviation 43
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 Role Emotional Pre-Intervention17 units on a scaleStandard Deviation 39
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 Role Emotional Post-Intervention39 units on a scaleStandard Deviation 50
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 Bodily Pain Pre-Intervention62 units on a scaleStandard Deviation 34
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 Mental Health Pre-Intervention34 units on a scaleStandard Deviation 17
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 Mental Health Post-Intervention50 units on a scaleStandard Deviation 20
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 Vitality Post-Intervention39 units on a scaleStandard Deviation 24
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 Social Functioning Pre-Intervention48 units on a scaleStandard Deviation 29
Relaxation Response Resiliency Program for DepressionHealth Status (SF-12)SF-12 Social Functioning Post-Intervention59 units on a scaleStandard Deviation 25
Comparison: Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-interventionp-value: <0.001Wilcoxon signed-ranked test
Primary

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.

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

ArmMeasureGroupValue (MEAN)Dispersion
Relaxation Response Resiliency Program for DepressionQuality of Life (QOL-5)QoL-5 Pre-Intervention56 units on a scaleStandard Deviation 9.9
Relaxation Response Resiliency Program for DepressionQuality of Life (QOL-5)QoL-5 Post-Intervention62 units on a scaleStandard Deviation 12
Comparison: Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-interventionp-value: <0.01Wilcoxon signed-ranked test
Primary

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.

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

Population: 24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.

ArmMeasureGroupValue (MEAN)Dispersion
Relaxation Response Resiliency Program for DepressionSatisfaction With Care (PSQ-18)PSQ-18 General Satisfaction Pre-Intervention3.9 units on a scaleStandard Deviation 0.8
Relaxation Response Resiliency Program for DepressionSatisfaction With Care (PSQ-18)PSQ-18 General Satisfaction Post-Intervention3.8 units on a scaleStandard Deviation 0.8
Relaxation Response Resiliency Program for DepressionSatisfaction With Care (PSQ-18)PSQ-18 Technical Quality Pre-Intervention4.0 units on a scaleStandard Deviation 0.6
Relaxation Response Resiliency Program for DepressionSatisfaction With Care (PSQ-18)PSQ-18 Technical Quality Post-Intervention3.7 units on a scaleStandard Deviation 0.6
Relaxation Response Resiliency Program for DepressionSatisfaction With Care (PSQ-18)PSQ-18 Interpersonal Manner Pre-Intervention4.3 units on a scaleStandard Deviation 0.6
Relaxation Response Resiliency Program for DepressionSatisfaction With Care (PSQ-18)PSQ-18 Interpersonal Manner Post-Intervention4.1 units on a scaleStandard Deviation 0.8
Relaxation Response Resiliency Program for DepressionSatisfaction With Care (PSQ-18)PSQ-18 Communication Pre-Intervention4.0 units on a scaleStandard Deviation 0.7
Relaxation Response Resiliency Program for DepressionSatisfaction With Care (PSQ-18)PSQ-18 Communication Post-Intervention3.8 units on a scaleStandard Deviation 0.8
Relaxation Response Resiliency Program for DepressionSatisfaction With Care (PSQ-18)PSQ-18 Financial Aspects Pre-Intervention3.8 units on a scaleStandard Deviation 1.1
Relaxation Response Resiliency Program for DepressionSatisfaction With Care (PSQ-18)PSQ-18 Financial Aspects Post-Intervention3.8 units on a scaleStandard Deviation 1
Relaxation Response Resiliency Program for DepressionSatisfaction With Care (PSQ-18)PSQ-18 Time Spent with Doctor Pre-Intervention3.9 units on a scaleStandard Deviation 0.6
Relaxation Response Resiliency Program for DepressionSatisfaction With Care (PSQ-18)PSQ-18 Time Spent with Doctor Post-Intervention3.7 units on a scaleStandard Deviation 0.9
Relaxation Response Resiliency Program for DepressionSatisfaction With Care (PSQ-18)PSQ-18 Accessibility & Convenience Pre-Inter.3.4 units on a scaleStandard Deviation 0.9
Relaxation Response Resiliency Program for DepressionSatisfaction With Care (PSQ-18)PSQ-18 Accessibility & Convenience Post-Inter.3.3 units on a scaleStandard Deviation 0.7
Secondary

The Health Promoting Lifestyle Profile II (HPLP-II)

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.

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

Population: 24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.

ArmMeasureGroupValue (MEAN)Dispersion
Relaxation Response Resiliency Program for DepressionThe Health Promoting Lifestyle Profile II (HPLP-II)HPLP II - Spiritual Growth Pre-Intervention2.0 units on a scaleStandard Deviation 0.5
Relaxation Response Resiliency Program for DepressionThe Health Promoting Lifestyle Profile II (HPLP-II)HPLP II - Spiritual Growth Post-Intervention2.4 units on a scaleStandard Deviation 0.7
Relaxation Response Resiliency Program for DepressionThe Health Promoting Lifestyle Profile II (HPLP-II)HPLP II - Health Responsibility Pre-Intervention2.7 units on a scaleStandard Deviation 0.6
Relaxation Response Resiliency Program for DepressionThe Health Promoting Lifestyle Profile II (HPLP-II)HPLP II - Health Responsibility Post-Intervention2.7 units on a scaleStandard Deviation 0.5
Relaxation Response Resiliency Program for DepressionThe Health Promoting Lifestyle Profile II (HPLP-II)HPLP II - Physical Activity Pre-Intervention1.9 units on a scaleStandard Deviation 0.7
Relaxation Response Resiliency Program for DepressionThe Health Promoting Lifestyle Profile II (HPLP-II)HPLP II - Physical Activity Post-Intervention2.2 units on a scaleStandard Deviation 0.8
Relaxation Response Resiliency Program for DepressionThe Health Promoting Lifestyle Profile II (HPLP-II)HPLP II - Nutrition Pre-Intervention2.6 units on a scaleStandard Deviation 0.6
Relaxation Response Resiliency Program for DepressionThe Health Promoting Lifestyle Profile II (HPLP-II)HPLP II - Nutrition Post-Intervention2.5 units on a scaleStandard Deviation 0.6
Relaxation Response Resiliency Program for DepressionThe Health Promoting Lifestyle Profile II (HPLP-II)HPLP II - Interpersonal Relations Pre-Intervention2.7 units on a scaleStandard Deviation 0.5
Relaxation Response Resiliency Program for DepressionThe Health Promoting Lifestyle Profile II (HPLP-II)HPLP II - Interpersonal Relations Post-Inter.2.8 units on a scaleStandard Deviation 0.5
Relaxation Response Resiliency Program for DepressionThe Health Promoting Lifestyle Profile II (HPLP-II)HPLP II - Stress Management Pre-Intervention2.1 units on a scaleStandard Deviation 0.5
Relaxation Response Resiliency Program for DepressionThe Health Promoting Lifestyle Profile II (HPLP-II)HPLP II - Stress Management Post-Intervention2.5 units on a scaleStandard Deviation 0.6
Comparison: Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-interventionp-value: <0.01Wilcoxon signed-ranked test

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026