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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01330420
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
28
2
1
35
14
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Relaxation Response Resiliency Program for Depression
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Medical Symptom Reduction Program, Meditation, Mind Body techniques, Cognitive Psychology
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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 Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MGH Community Health Care Center Charlestown Massachusetts United States
    2 MGH Community Health Care Centers Revere Massachusetts United States

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • Centers for Disease Control and Prevention

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None 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
    Other Study ID Numbers:
    • 2007P001633
    • Center for Disease Control
    First Posted:
    Apr 7, 2011
    Last Update Posted:
    Nov 21, 2017
    Last Verified:
    Oct 1, 2017
    Additional relevant MeSH terms:

    Study Results

    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 Detail 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.
    Arm/Group Title Relaxation Response Resiliency Program for Depression
    Arm/Group Description The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.) The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL).
    Period Title: Overall Study
    STARTED 28
    COMPLETED 24
    NOT COMPLETED 4

    Baseline Characteristics

    Arm/Group Title Relaxation Response Resiliency Program for Depression
    Arm/Group Description 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.
    Overall Participants 28
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    23
    82.1%
    >=65 years
    5
    17.9%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    50.2
    (13.0)
    Sex: Female, Male (Count of Participants)
    Female
    25
    89.3%
    Male
    3
    10.7%
    Region of Enrollment (participants) [Number]
    United States
    28
    100%

    Outcome Measures

    1. Primary Outcome
    Title Depression Severity (CEDS-10)
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    24 patients met completer status, defined as patients who attended all or part of the six sessions.
    Arm/Group Title Relaxation Response Resiliency Program for Depression
    Arm/Group Description The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.) The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL).
    Measure Participants 24
    CSE-D 10 Pre-Intervention
    18
    (5.8)
    CSE-D 10 Post-Intervention
    12
    (5.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Relaxation Response Resiliency Program for Depression
    Comments 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-intervention
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.001
    Comments
    Method Wilcoxon signed-ranked test
    Comments
    2. Primary Outcome
    Title Health Status (SF-12)
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Relaxation Response Resiliency Program for Depression
    Arm/Group Description The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.) The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL).
    Measure Participants 23
    SF-12 General Health Pre-Intervention
    51
    (24)
    SF-12 General Health Post-Intervention
    49
    (28)
    SF-12 Physical Functioning Pre-Intervention
    58
    (38)
    SF-12 Physical Functioning Post-Intervention
    58
    (35)
    SF-12 Role Physical Pre-Intervention
    65
    (44)
    SF-12 Role Physical Post-Intervention
    61
    (43)
    SF-12 Role Emotional Pre-Intervention
    17
    (39)
    SF-12 Role Emotional Post-Intervention
    39
    (50)
    SF-12 Bodily Pain Pre-Intervention
    62
    (34)
    SF-12 Bodily Pain Post-Intervention
    59
    (37)
    SF-12 Mental Health Pre-Intervention
    34
    (17)
    SF-12 Mental Health Post-Intervention
    50
    (20)
    SF-12 Vitality Pre-Intervention
    30
    (16)
    SF-12 Vitality Post-Intervention
    39
    (24)
    SF-12 Social Functioning Pre-Intervention
    48
    (29)
    SF-12 Social Functioning Post-Intervention
    59
    (25)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Relaxation Response Resiliency Program for Depression
    Comments 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-intervention
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.001
    Comments
    Method Wilcoxon signed-ranked test
    Comments
    3. Primary Outcome
    Title Quality of Life (QOL-5)
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Relaxation Response Resiliency Program for Depression
    Arm/Group Description The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.) The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL).
    Measure Participants 24
    QoL-5 Pre-Intervention
    56
    (9.9)
    QoL-5 Post-Intervention
    62
    (12)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Relaxation Response Resiliency Program for Depression
    Comments 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-intervention
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.01
    Comments
    Method Wilcoxon signed-ranked test
    Comments
    4. Primary Outcome
    Title Satisfaction With Care (PSQ-18)
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Relaxation Response Resiliency Program for Depression
    Arm/Group Description The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.) The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL).
    Measure Participants 22
    PSQ-18 General Satisfaction Pre-Intervention
    3.9
    (0.8)
    PSQ-18 General Satisfaction Post-Intervention
    3.8
    (0.8)
    PSQ-18 Technical Quality Pre-Intervention
    4.0
    (0.6)
    PSQ-18 Technical Quality Post-Intervention
    3.7
    (0.6)
    PSQ-18 Interpersonal Manner Pre-Intervention
    4.3
    (0.6)
    PSQ-18 Interpersonal Manner Post-Intervention
    4.1
    (0.8)
    PSQ-18 Communication Pre-Intervention
    4.0
    (0.7)
    PSQ-18 Communication Post-Intervention
    3.8
    (0.8)
    PSQ-18 Financial Aspects Pre-Intervention
    3.8
    (1.1)
    PSQ-18 Financial Aspects Post-Intervention
    3.8
    (1.0)
    PSQ-18 Time Spent with Doctor Pre-Intervention
    3.9
    (0.6)
    PSQ-18 Time Spent with Doctor Post-Intervention
    3.7
    (0.9)
    PSQ-18 Accessibility & Convenience Pre-Inter.
    3.4
    (0.9)
    PSQ-18 Accessibility & Convenience Post-Inter.
    3.3
    (0.7)
    5. Secondary Outcome
    Title The Health Promoting Lifestyle Profile II (HPLP-II)
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Relaxation Response Resiliency Program for Depression
    Arm/Group Description The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.) The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL).
    Measure Participants 23
    HPLP II - Spiritual Growth Pre-Intervention
    2.0
    (0.5)
    HPLP II - Spiritual Growth Post-Intervention
    2.4
    (0.7)
    HPLP II - Health Responsibility Pre-Intervention
    2.7
    (0.6)
    HPLP II - Health Responsibility Post-Intervention
    2.7
    (0.5)
    HPLP II - Physical Activity Pre-Intervention
    1.9
    (0.7)
    HPLP II - Physical Activity Post-Intervention
    2.2
    (0.8)
    HPLP II - Nutrition Pre-Intervention
    2.6
    (0.6)
    HPLP II - Nutrition Post-Intervention
    2.5
    (0.6)
    HPLP II - Interpersonal Relations Pre-Intervention
    2.7
    (0.5)
    HPLP II - Interpersonal Relations Post-Inter.
    2.8
    (0.5)
    HPLP II - Stress Management Pre-Intervention
    2.1
    (0.5)
    HPLP II - Stress Management Post-Intervention
    2.5
    (0.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Relaxation Response Resiliency Program for Depression
    Comments 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-intervention
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.01
    Comments
    Method Wilcoxon signed-ranked test
    Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Relaxation Response Resiliency Program for Depression
    Arm/Group Description 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.
    All Cause Mortality
    Relaxation Response Resiliency Program for Depression
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Relaxation Response Resiliency Program for Depression
    Affected / at Risk (%) # Events
    Total 0/28 (0%)
    Other (Not Including Serious) Adverse Events
    Relaxation Response Resiliency Program for Depression
    Affected / at Risk (%) # Events
    Total 0/28 (0%)

    Limitations/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.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Kathleen Miller, RN
    Organization Massachusetts General Hospital
    Phone 781-485-6176
    Email kmiller16@partners.org
    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
    Other Study ID Numbers:
    • 2007P001633
    • Center for Disease Control
    First Posted:
    Apr 7, 2011
    Last Update Posted:
    Nov 21, 2017
    Last Verified:
    Oct 1, 2017