Depression
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Arm | Count |
|---|---|
| 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 |
| Total | 28 |
Baseline characteristics
| Characteristic | Relaxation 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, Continuous | 50.2 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 type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Response Resiliency Program for Depression | Depression Severity (CEDS-10) | CSE-D 10 Pre-Intervention | 18 units on a scale | Standard Deviation 5.8 |
| Relaxation Response Resiliency Program for Depression | Depression Severity (CEDS-10) | CSE-D 10 Post-Intervention | 12 units on a scale | Standard Deviation 5.7 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 Bodily Pain Post-Intervention | 59 units on a scale | Standard Deviation 37 |
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 Vitality Pre-Intervention | 30 units on a scale | Standard Deviation 16 |
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 General Health Pre-Intervention | 51 units on a scale | Standard Deviation 24 |
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 General Health Post-Intervention | 49 units on a scale | Standard Deviation 28 |
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 Physical Functioning Pre-Intervention | 58 units on a scale | Standard Deviation 38 |
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 Physical Functioning Post-Intervention | 58 units on a scale | Standard Deviation 35 |
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 Role Physical Pre-Intervention | 65 units on a scale | Standard Deviation 44 |
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 Role Physical Post-Intervention | 61 units on a scale | Standard Deviation 43 |
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 Role Emotional Pre-Intervention | 17 units on a scale | Standard Deviation 39 |
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 Role Emotional Post-Intervention | 39 units on a scale | Standard Deviation 50 |
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 Bodily Pain Pre-Intervention | 62 units on a scale | Standard Deviation 34 |
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 Mental Health Pre-Intervention | 34 units on a scale | Standard Deviation 17 |
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 Mental Health Post-Intervention | 50 units on a scale | Standard Deviation 20 |
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 Vitality Post-Intervention | 39 units on a scale | Standard Deviation 24 |
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 Social Functioning Pre-Intervention | 48 units on a scale | Standard Deviation 29 |
| Relaxation Response Resiliency Program for Depression | Health Status (SF-12) | SF-12 Social Functioning Post-Intervention | 59 units on a scale | Standard Deviation 25 |
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Response Resiliency Program for Depression | Quality of Life (QOL-5) | QoL-5 Pre-Intervention | 56 units on a scale | Standard Deviation 9.9 |
| Relaxation Response Resiliency Program for Depression | Quality of Life (QOL-5) | QoL-5 Post-Intervention | 62 units on a scale | Standard Deviation 12 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Response Resiliency Program for Depression | Satisfaction With Care (PSQ-18) | PSQ-18 General Satisfaction Pre-Intervention | 3.9 units on a scale | Standard Deviation 0.8 |
| Relaxation Response Resiliency Program for Depression | Satisfaction With Care (PSQ-18) | PSQ-18 General Satisfaction Post-Intervention | 3.8 units on a scale | Standard Deviation 0.8 |
| Relaxation Response Resiliency Program for Depression | Satisfaction With Care (PSQ-18) | PSQ-18 Technical Quality Pre-Intervention | 4.0 units on a scale | Standard Deviation 0.6 |
| Relaxation Response Resiliency Program for Depression | Satisfaction With Care (PSQ-18) | PSQ-18 Technical Quality Post-Intervention | 3.7 units on a scale | Standard Deviation 0.6 |
| Relaxation Response Resiliency Program for Depression | Satisfaction With Care (PSQ-18) | PSQ-18 Interpersonal Manner Pre-Intervention | 4.3 units on a scale | Standard Deviation 0.6 |
| Relaxation Response Resiliency Program for Depression | Satisfaction With Care (PSQ-18) | PSQ-18 Interpersonal Manner Post-Intervention | 4.1 units on a scale | Standard Deviation 0.8 |
| Relaxation Response Resiliency Program for Depression | Satisfaction With Care (PSQ-18) | PSQ-18 Communication Pre-Intervention | 4.0 units on a scale | Standard Deviation 0.7 |
| Relaxation Response Resiliency Program for Depression | Satisfaction With Care (PSQ-18) | PSQ-18 Communication Post-Intervention | 3.8 units on a scale | Standard Deviation 0.8 |
| Relaxation Response Resiliency Program for Depression | Satisfaction With Care (PSQ-18) | PSQ-18 Financial Aspects Pre-Intervention | 3.8 units on a scale | Standard Deviation 1.1 |
| Relaxation Response Resiliency Program for Depression | Satisfaction With Care (PSQ-18) | PSQ-18 Financial Aspects Post-Intervention | 3.8 units on a scale | Standard Deviation 1 |
| Relaxation Response Resiliency Program for Depression | Satisfaction With Care (PSQ-18) | PSQ-18 Time Spent with Doctor Pre-Intervention | 3.9 units on a scale | Standard Deviation 0.6 |
| Relaxation Response Resiliency Program for Depression | Satisfaction With Care (PSQ-18) | PSQ-18 Time Spent with Doctor Post-Intervention | 3.7 units on a scale | Standard Deviation 0.9 |
| Relaxation Response Resiliency Program for Depression | Satisfaction With Care (PSQ-18) | PSQ-18 Accessibility & Convenience Pre-Inter. | 3.4 units on a scale | Standard Deviation 0.9 |
| Relaxation Response Resiliency Program for Depression | Satisfaction With Care (PSQ-18) | PSQ-18 Accessibility & Convenience Post-Inter. | 3.3 units on a scale | Standard Deviation 0.7 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relaxation Response Resiliency Program for Depression | The Health Promoting Lifestyle Profile II (HPLP-II) | HPLP II - Spiritual Growth Pre-Intervention | 2.0 units on a scale | Standard Deviation 0.5 |
| Relaxation Response Resiliency Program for Depression | The Health Promoting Lifestyle Profile II (HPLP-II) | HPLP II - Spiritual Growth Post-Intervention | 2.4 units on a scale | Standard Deviation 0.7 |
| Relaxation Response Resiliency Program for Depression | The Health Promoting Lifestyle Profile II (HPLP-II) | HPLP II - Health Responsibility Pre-Intervention | 2.7 units on a scale | Standard Deviation 0.6 |
| Relaxation Response Resiliency Program for Depression | The Health Promoting Lifestyle Profile II (HPLP-II) | HPLP II - Health Responsibility Post-Intervention | 2.7 units on a scale | Standard Deviation 0.5 |
| Relaxation Response Resiliency Program for Depression | The Health Promoting Lifestyle Profile II (HPLP-II) | HPLP II - Physical Activity Pre-Intervention | 1.9 units on a scale | Standard Deviation 0.7 |
| Relaxation Response Resiliency Program for Depression | The Health Promoting Lifestyle Profile II (HPLP-II) | HPLP II - Physical Activity Post-Intervention | 2.2 units on a scale | Standard Deviation 0.8 |
| Relaxation Response Resiliency Program for Depression | The Health Promoting Lifestyle Profile II (HPLP-II) | HPLP II - Nutrition Pre-Intervention | 2.6 units on a scale | Standard Deviation 0.6 |
| Relaxation Response Resiliency Program for Depression | The Health Promoting Lifestyle Profile II (HPLP-II) | HPLP II - Nutrition Post-Intervention | 2.5 units on a scale | Standard Deviation 0.6 |
| Relaxation Response Resiliency Program for Depression | The Health Promoting Lifestyle Profile II (HPLP-II) | HPLP II - Interpersonal Relations Pre-Intervention | 2.7 units on a scale | Standard Deviation 0.5 |
| Relaxation Response Resiliency Program for Depression | The Health Promoting Lifestyle Profile II (HPLP-II) | HPLP II - Interpersonal Relations Post-Inter. | 2.8 units on a scale | Standard Deviation 0.5 |
| Relaxation Response Resiliency Program for Depression | The Health Promoting Lifestyle Profile II (HPLP-II) | HPLP II - Stress Management Pre-Intervention | 2.1 units on a scale | Standard Deviation 0.5 |
| Relaxation Response Resiliency Program for Depression | The Health Promoting Lifestyle Profile II (HPLP-II) | HPLP II - Stress Management Post-Intervention | 2.5 units on a scale | Standard Deviation 0.6 |