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

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.

Conditions

• Chronic Pain
• Depression

Interventions

BEHAVIORAL

Health Enhancement Program (HEP)

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.

BEHAVIORAL

Sahaj Samadhi Meditation (SSM)

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

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Lunenfeld Tanenbaum Research Institute

  collaborator OTHER

• Rivlin Medical Group

  collaborator UNKNOWN

• The Art of Living Foundation

  collaborator OTHER

• Canadian Mental Health Association

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• Mount Sinai Hospital, Canada

  lead OTHER

Principal Investigators

• Ross Upshur, MD · Sinai Health System

• Abhimanyu Sud, MD · Sinai Health System

• Michelle Nelson, PhD · Sinai Health System

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-30

Primary Completion

2023-02-28

Completion

2023-03-31

Countries

• Canada

Study Locations