CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 108 enrolled
Drug / intervention
Health Enhancement Program (HEP) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04039568
NCT04039568N/ACompleted

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

Mount Sinai Hospital, Canada·interventional·Posted Jul 31, 2019·Updated Oct 25, 2023

In Brief

A clinical study evaluating Health Enhancement Program (HEP) and Sahaj Samadhi Meditation (SSM) for Chronic Pain and Depression. Completed, enrolled 108 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 31, 2019
Enrollment StartOct 30, 2019
Primary CompletionFeb 28, 2023
Study CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.9 years ago

Interventions

Health Enhancement Program (HEP)behavioral

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.

Sahaj Samadhi Meditation (SSM)behavioral

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