Meditation Versus Education for Improving Depression in Chronic Pain, a Randomized Controlled Trial
CompletedNot applicableNCT04039568
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Brief summary (from the registry)
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.
Study details
- Official title
- Meditation Versus Education for Improving Depression in Chronic Pain, a Randomized Controlled Trial
- Conditions
- Interventions
- Behavioral: Health Enhancement Program (HEP)
- Behavioral: Sahaj Samadhi Meditation (SSM)
- Sponsor
- Mount Sinai Hospital, Canada
- Collaborators
- 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
- Start date
- 2019-10-30
- Primary completion
- 2023-02-28
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04039568