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Sahaj Samadhi Meditation (SSM) for Chronic Pain
N/A
Waitlist Available
Led By Michelle Nelson, PhD
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0), follow-up 1 (study completion; week 12-13), follow-up 2 (week 24)
Awards & highlights
Study Summary
This trial will compare two possible treatments for depression and chronic pain that will be offered through online group video calls. One treatment option is the Health Enhancement Program (HEP), and the other is Sahaj Samadhi Meditation (SSM). The trial 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.
Eligible Conditions
- Chronic Pain
- Depression
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 0), follow-up 1 (study completion; week 12-13), follow-up 2 (week 24)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0), follow-up 1 (study completion; week 12-13), follow-up 2 (week 24)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Health and Depression Symptomology
Secondary outcome measures
Change in Pain Severity and pain-related function
Other outcome measures
Change in Health-Related Quality of Life
Change in Medication Information
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
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.
Group II: Active Control GroupActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sahaj Samadhi Meditation (SSM)
2019
N/A
~110
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Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,309 Total Patients Enrolled
10 Trials studying Chronic Pain
7,938 Patients Enrolled for Chronic Pain
Lunenfeld Tanenbaum Research InstituteUNKNOWN
2 Previous Clinical Trials
1,272 Total Patients Enrolled
Mount Sinai Hospital, CanadaLead Sponsor
196 Previous Clinical Trials
67,500 Total Patients Enrolled
3 Trials studying Chronic Pain
451 Patients Enrolled for Chronic Pain
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