Clinical trial NCT04039568: Meditation Versus Education for Improving Depression in Chronic Pain, a Randomized Controlled Trial
Official title: Meditation Versus Education for Improving Depression in Chronic Pain, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Depression
Keywords: Opioid Therapy
Sahaj Samadhi Meditation
Health Enhancement Program
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Lunenfeld Tanenbaum Research Institute
name: Rivlin Medical Group
name: The Art of Living Foundation
name: Canadian Mental Health Association
name: University of Toronto
First posted: 2019-07-31
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 through online group video calls, 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 adults with depression and chronic pain. 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 participants of the RCT; (2) the expert meditation instructors facilitating the intervention; (3) the site staff and investigators involved in supporting the logistics of the intervention arm of the RCT.

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 Adults with chronic pain and depression will be recruited from one of seven sites: 1) the Rivlin Medical Group Clinic, 2) Mount Sinai Academic Family Health Team, Sinai Health, 3) TAPMI hub programs at Women's College Hospital 4) Academic Family Health Team, St. Michael's Hospital, 5) the Rehabilitation Pain Service, University Health Network, 6) the Canadian Memorial Chiropractic College sites, and 6) South East Toronto Family Health Team, Michael Garron Hospita. Recruitment materials (brochure, poster, website) will also be shared at local independent non-hospital sites and in online spaces. 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.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years of age;
2. 2. Significant depressive symptomology (PHQ-9 score ≥10);
3. Chronic pain (pain ≥3 months duration in any body region, by self-report);
4. Be willing and able to attend all 4 training sessions of SSM/HEP and 75% of follow-up sessions;
5. Understanding of English language (spoken and written);
6. Able to sit for 20-25 minutes without significant discomfort;
7. Regular access to internet and ability to participate in video calls

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 practising any form of mind-body intervention;
6. Inability to provide informed consent

Primary outcomes:
measure: Change in Health and Depression Symptomology
timeFrame: Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24)
Secondary outcomes:
measure: Change in Pain Severity and pain-related function
timeFrame: Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24)
Other outcomes:
measure: Change in Medication Information
timeFrame: Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24)
measure: Change in Health-Related Quality of Life
timeFrame: Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24)
Locations:
city: Toronto
country: Canada
facility: Bridgepoint Collaboratory, Sinai Health
state: Ontario
Study officials:
affiliation: Sinai Health System
name: Ross Upshur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sinai Health System
name: Abhimanyu Sud, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sinai Health System
name: Michelle Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
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