Meditation Versus Education for Improving Depression in Chronic Pain, a Randomized Controlled Trial

Summary

Participation Requirements

Description

OBJECTIVES To determine whether depressive symptoms, pain severity, function, quality of life, as well as opioid use can be affected by a lifestyle intervention program in depression and chronic pain. To evaluate the implementation of the program at Rivlin Medical Group (RMG) chronic pain clinic, an...

OBJECTIVES To determine whether depressive symptoms, pain severity, function, quality of life, as well as opioid use can be affected by a lifestyle intervention program in depression and chronic pain. To evaluate the implementation of the program at Rivlin Medical Group (RMG) chronic pain clinic, and to understand how the SSM intervention can be translated to other settings. RCT RECRUITMENT AND CONSENT Adults with chronic pain and depression will be recruited from one of five sites: 1) the Rivlin Medical Group Clinic, 2) the Sinai Health, Mount Sinai Academic Family Health Team, 3) Women's College Hospital TAPMI hub programs, 4) St. Michael's Hospital Academic Family Health Team, and 5) the Rehabilitation Pain Service, University Health Network. Patients will be introduced to the study and connected with study staff. All potential participants will be provided with a consent form and given a minimum of 24 hours to consider participation. After this time, informed consent will be obtained from those interested in participating and they will be screened for eligibility by study staff. STUDY INTERVENTIONS This study is a 12-week, randomized controlled trial seeking to recruit 160 participants with depression and chronic pain. The SSM intervention will be offered by trained and certified teachers from the Art of Living Foundation. The HEP intervention will be offered by a trained Nurse Practitioner, Social Worker, Psychologist, Occupational Therapist or other qualified healthcare professional. Raters, clinicians, and care providers will be blind to participant study condition. DATA COLLECTION Participants will be screened for eligibility using the Patient Health Questionnaire (PHQ-9) and Mini International Neuropsychiatric Interview Screen and Standard 7.0.2 (MINI). The primary outcome (depression) will be evaluated using the PHQ-9. The secondary outcome (pain severity and pain-related function) will be evaluated using the Brief Pain Inventory (BPI. Exploratory outcomes (health related quality of life, and opioid use) will be evaluated using the Short-form 36 (SF-36), and a medication log, respectively. Measures of primary and secondary outcomes will be administered at all 3 assessment sessions and are described below. At the baseline assessment the following information will be collected: i. Demographics survey that will collect information on age, partial Date of Birth (DOB), gender, ethnic background, employment status, housing type, highest level of education achieved, smoking, caffeine intake, drug and alcohol use, duration of pain and pain diagnosis. Participants will also be asked about their psychiatric history including age of first contact with services for mental illness (and which illness), history of hospital admissions and the number of episodes of depression; ii. PHQ-9; iii. BPI scale; iv. SF-36; v. Medication names, dosages, dosages per day, total daily dosage, and reason for use will be recorded, including vitamins and over-the-counter (OTC) medications; vi. Psychology Intake Form. During the 12 week and 6 month assessment the following questionnaires and measurements will be completed: i. PHQ-9; ii. BPI scale; iii. SF-36; iv. Medication names and doses will be collected and the recordings for opioids will be converted to total daily morphine equivalents using standardized conversion tables.

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