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

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

Sponsors

Lead Sponsor: Mount Sinai Hospital, Canada

Collaborator: Canadian Institutes of Health Research (CIHR)
Lunenfeld Tanenbaum Research Institute
Rivlin Medical Group
The Art of Living Foundation
Canadian Mental Health Association
University of Toronto

Source Mount Sinai Hospital, Canada
Brief Summary

In this study two possible treatment options available for depression and chronic pain will be explored. Both of these treatments will be offered in groups which could translate to cost-savings for the health care system. The two treatment options are: 1. The Health Enhancement Program (HEP). Designed to give participants information and guidance on how to lead a healthy lifestyle, which could be beneficial in treating depression. 2. Sahaj Samadhi Meditation (SSM). A unique and easy-to-learn meditation technique that reduces stress and provides deep relaxation which could be beneficial in treating depression. This study will use a hybrid type 1 evaluation design that primarily focuses on a single-site, single-blinded (investigator, and clinician), 12-week randomized controlled trial (RCT) comparing SSM (n=80) versus HEP (n=80) in 160 older adults with depression and chronic pain on opioid medication. Participants will be blinded to the treatment hypothesis while investigators, raters and treating clinicians will be additionally blinded to the intervention. Evaluations of depression (PHQ-9), pain symptoms (BPI), quality of life (SF-36), and opioid use will be collected at baseline, intervention completion (12 week), and at 24 week follow-up. An implementation evaluation will draw from four key study populations: (1) the patients discussed above whom participate in the SSM arm of the RCT; (2) the expert meditation instructors facilitating the intervention; (3) the RMG administrative staff involved in supporting the logistics of the intervention arm of the RCT; and (4) the clinical staff at RMG.

Detailed 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, and to understand how the SSM intervention can be translated to other settings. RCT RECRUITMENT AND CONSENT Older adults with chronic pain and depression will be recruited from the Rivlin Medical Group. Patients will be pre-screened by clinic staff and be given a letter of information/consent form. All potential participants will be given a minimum of 24 hours to consider participation. After this time, written informed consent will be obtained from those interested in participating and they will be screened for eligibility by a research coordinator. STUDY INTERVENTIONS This study is a 12-week, randomized controlled trial seeking to recruit 160 participants with depression and chronic pain from RMG. 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 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 Internation 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.

Overall Status Suspended
Start Date October 30, 2019
Completion Date October 2021
Primary Completion Date August 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Health and Depression Symptomology Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24)
Secondary Outcome
Measure Time Frame
Change in Pain Severity and pain-related function Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24)
Enrollment 160
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Health Enhancement Program (HEP)

Description: This is the active control group of the study, where participants will be educated on health promotion, healthy diet, music, and exercise, but do not learn breathing techniques, or meditation.

Arm Group Label: Active Control Group

Intervention Type: Behavioral

Intervention Name: Sahaj Samadhi Meditation (SSM)

Description: This is the experimental arm of the study, where participants will be trained in a form of meditation that may improve depressive symptoms.

Arm Group Label: Intervention Group

Eligibility

Criteria:

Inclusion Criteria: 1. >45 years of age; 2. Comorbid depression (PHQ-9 score ≥10); 3. Chronic pain (pain ≥3 months duration in any body region, by self-report); 4. On long term opioid therapy (LTOT) (any opioid, at any dose for ≥3 months, by self-report); 5. Be willing and able to attend all 4 training sessions of SSM/HEP and 75% of follow-up sessions; 6. Understanding of English language (spoken and written); 7. Able to sit for 20-25 minutes without significant discomfort. Exclusion Criteria: 1. Other major psychiatric conditions including substance use disorder, psychosis and cognitive impairment as excluded by the Mini-International Neuropsychiatric Interview (MINI) Screening and Standard tool; severe depression (PHQ-9 ≥20) and risk of imminent suicide as per MINI and/or PHQ-9; 2. Non-correctable, clinically significant sensory impairment; 3. Acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months; 4. A terminal medical diagnosis with prognosis of less than 12 months; 5. Currently practicing any form of mind-body intervention; 6. Inability to provide informed consent.

Gender: All

Minimum Age: 45 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: Rivlin Medical Group
Location Countries

Canada

Verification Date

September 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Mount Sinai Hospital, Canada

Investigator Full Name: Ross Upshur

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Active Control Group

Type: Active Comparator

Description: Ten to fifteen participants in the HEP arm will participate in the program for 4 consecutive days (2hrs/day) in the 1st week, followed by 75 min/week reinforcement sessions for 11 weeks. The Health-Enhancement Program (HEP) was designed and used as a manualized active control in meditation-based intervention trials. HEP controls for several non-specific factors found in a meditation groups, including: group support and morale, behavioural activation, reduction of stigma, facilitator attention, treatment duration, and time spent on at-home practice. HEP is tailored to be structurally equivalent to SSM with similar-sized groups, meeting schedule, total contact hours, amount of home practice and encouragement to keep practice logs.

Label: Intervention Group

Type: Experimental

Description: Ten to fifteen participants in the SSM arm will be trained for 4 consecutive days (2hrs/day) in the 1st week, followed by 75 min/week reinforcement sessions for 11 weeks. This standardized, manualized therapy will be delivered by certified meditation instructors. On day 1, participants will learn the nature of meditation, and then undergo personal guided meditation. Training on days 2-4 includes understanding the nature of the mind and the thoughts arising from it, guided meditations by the instructor, and a discussion of meditation processes. Weekly 75 min reinforcement sessions will include 20 minutes of guided meditation practice, and then focus on participants' experiences with meditation during the week, additional observations, and a review of relevant knowledge to support their home practice. Participants will also be encouraged to practice twice daily at home for 20 minutes per session.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov