Trial Outcomes & Findings for Behavioral Medicine Intervention With Depressed Patients in a Community Health Center Setting (NCT NCT01330420)

Last Updated: 2017-11-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

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

Results posted on

2017-11-21

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Relaxation Response Resiliency Program for Depression 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).
Overall Study STARTED	28
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Relaxation Response Resiliency Program for Depression n=28 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	50.2 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Relaxation Response Resiliency Program for Depression n=24 Participants 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).
Depression Severity (CEDS-10) CSE-D 10 Pre-Intervention	18 units on a scale Standard Deviation 5.8
Depression Severity (CEDS-10) CSE-D 10 Post-Intervention	12 units on a scale Standard Deviation 5.7

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Relaxation Response Resiliency Program for Depression n=23 Participants 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).
Health Status (SF-12) SF-12 General Health Pre-Intervention	51 units on a scale Standard Deviation 24
Health Status (SF-12) SF-12 Role Emotional Post-Intervention	39 units on a scale Standard Deviation 50
Health Status (SF-12) SF-12 Bodily Pain Pre-Intervention	62 units on a scale Standard Deviation 34
Health Status (SF-12) SF-12 Mental Health Post-Intervention	50 units on a scale Standard Deviation 20
Health Status (SF-12) SF-12 Vitality Pre-Intervention	30 units on a scale Standard Deviation 16
Health Status (SF-12) SF-12 Vitality Post-Intervention	39 units on a scale Standard Deviation 24
Health Status (SF-12) SF-12 Social Functioning Pre-Intervention	48 units on a scale Standard Deviation 29
Health Status (SF-12) SF-12 Social Functioning Post-Intervention	59 units on a scale Standard Deviation 25
Health Status (SF-12) SF-12 General Health Post-Intervention	49 units on a scale Standard Deviation 28
Health Status (SF-12) SF-12 Physical Functioning Pre-Intervention	58 units on a scale Standard Deviation 38
Health Status (SF-12) SF-12 Physical Functioning Post-Intervention	58 units on a scale Standard Deviation 35
Health Status (SF-12) SF-12 Role Physical Pre-Intervention	65 units on a scale Standard Deviation 44
Health Status (SF-12) SF-12 Role Physical Post-Intervention	61 units on a scale Standard Deviation 43
Health Status (SF-12) SF-12 Role Emotional Pre-Intervention	17 units on a scale Standard Deviation 39
Health Status (SF-12) SF-12 Bodily Pain Post-Intervention	59 units on a scale Standard Deviation 37
Health Status (SF-12) SF-12 Mental Health Pre-Intervention	34 units on a scale Standard Deviation 17

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Relaxation Response Resiliency Program for Depression n=24 Participants 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).
Quality of Life (QOL-5) QoL-5 Pre-Intervention	56 units on a scale Standard Deviation 9.9
Quality of Life (QOL-5) QoL-5 Post-Intervention	62 units on a scale Standard Deviation 12

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Relaxation Response Resiliency Program for Depression n=22 Participants 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).
Satisfaction With Care (PSQ-18) PSQ-18 General Satisfaction Pre-Intervention	3.9 units on a scale Standard Deviation 0.8
Satisfaction With Care (PSQ-18) PSQ-18 General Satisfaction Post-Intervention	3.8 units on a scale Standard Deviation 0.8
Satisfaction With Care (PSQ-18) PSQ-18 Technical Quality Pre-Intervention	4.0 units on a scale Standard Deviation 0.6
Satisfaction With Care (PSQ-18) PSQ-18 Financial Aspects Pre-Intervention	3.8 units on a scale Standard Deviation 1.1
Satisfaction With Care (PSQ-18) PSQ-18 Financial Aspects Post-Intervention	3.8 units on a scale Standard Deviation 1.0
Satisfaction With Care (PSQ-18) PSQ-18 Time Spent with Doctor Pre-Intervention	3.9 units on a scale Standard Deviation 0.6
Satisfaction With Care (PSQ-18) PSQ-18 Accessibility & Convenience Pre-Inter.	3.4 units on a scale Standard Deviation 0.9
Satisfaction With Care (PSQ-18) PSQ-18 Accessibility & Convenience Post-Inter.	3.3 units on a scale Standard Deviation 0.7
Satisfaction With Care (PSQ-18) PSQ-18 Technical Quality Post-Intervention	3.7 units on a scale Standard Deviation 0.6
Satisfaction With Care (PSQ-18) PSQ-18 Interpersonal Manner Pre-Intervention	4.3 units on a scale Standard Deviation 0.6
Satisfaction With Care (PSQ-18) PSQ-18 Interpersonal Manner Post-Intervention	4.1 units on a scale Standard Deviation 0.8
Satisfaction With Care (PSQ-18) PSQ-18 Communication Pre-Intervention	4.0 units on a scale Standard Deviation 0.7
Satisfaction With Care (PSQ-18) PSQ-18 Communication Post-Intervention	3.8 units on a scale Standard Deviation 0.8
Satisfaction With Care (PSQ-18) PSQ-18 Time Spent with Doctor Post-Intervention	3.7 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Relaxation Response Resiliency Program for Depression n=23 Participants 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).
The Health Promoting Lifestyle Profile II (HPLP-II) HPLP II - Health Responsibility Post-Intervention	2.7 units on a scale Standard Deviation 0.5
The Health Promoting Lifestyle Profile II (HPLP-II) HPLP II - Physical Activity Pre-Intervention	1.9 units on a scale Standard Deviation 0.7
The Health Promoting Lifestyle Profile II (HPLP-II) HPLP II - Physical Activity Post-Intervention	2.2 units on a scale Standard Deviation 0.8
The Health Promoting Lifestyle Profile II (HPLP-II) HPLP II - Nutrition Pre-Intervention	2.6 units on a scale Standard Deviation 0.6
The Health Promoting Lifestyle Profile II (HPLP-II) HPLP II - Nutrition Post-Intervention	2.5 units on a scale Standard Deviation 0.6
The Health Promoting Lifestyle Profile II (HPLP-II) HPLP II - Interpersonal Relations Post-Inter.	2.8 units on a scale Standard Deviation 0.5
The Health Promoting Lifestyle Profile II (HPLP-II) HPLP II - Stress Management Post-Intervention	2.5 units on a scale Standard Deviation 0.6
The Health Promoting Lifestyle Profile II (HPLP-II) HPLP II - Spiritual Growth Pre-Intervention	2.0 units on a scale Standard Deviation 0.5
The Health Promoting Lifestyle Profile II (HPLP-II) HPLP II - Spiritual Growth Post-Intervention	2.4 units on a scale Standard Deviation 0.7
The Health Promoting Lifestyle Profile II (HPLP-II) HPLP II - Health Responsibility Pre-Intervention	2.7 units on a scale Standard Deviation 0.6
The Health Promoting Lifestyle Profile II (HPLP-II) HPLP II - Interpersonal Relations Pre-Intervention	2.7 units on a scale Standard Deviation 0.5
The Health Promoting Lifestyle Profile II (HPLP-II) HPLP II - Stress Management Pre-Intervention	2.1 units on a scale Standard Deviation 0.5

Adverse Events

Relaxation Response Resiliency Program for Depression

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathleen Miller, RN

Massachusetts General Hospital

Phone: 781-485-6176

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place