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Published in: Trials 1/2020

Open Access 01-12-2020 | Affective Disorder | Study protocol

Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation

Authors: Abhimanyu Sud, Michelle L. A. Nelson, Darren K. Cheng, Alana Armas, Kirk Foat, Michelle Greiver, Fardous Hosseiny, Joel Katz, Rahim Moineddin, Benoit H. Mulsant, Ronnie I. Newman, Leon Rivlin, Akshya Vasudev, Ross Upshur

Published in: Trials | Issue 1/2020

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Abstract

Background

Despite the high prevalence of comorbid chronic pain and depression, this comorbidity remains understudied. Meditation has demonstrated efficacy for both chronic pain and depression independently, yet there have been few studies examining its effectiveness when both conditions are present concurrently. Furthermore, while meditation is generally accepted as a safe and effective health intervention, little is known about how to implement meditation programs within or alongside the health care system.

Methods

We will conduct a hybrid type 1 effectiveness–implementation evaluation. To measure effectiveness, we will conduct a randomized controlled trial comparing Sahaj Samadhi Meditation and the Health Enhancement Program in 160 people living with chronic pain, clinically significant depressive symptoms, and on long-term opioid therapy. Changes in depressive symptoms will be our primary outcome; pain severity, pain-related function, opioid use, and quality of life will be the secondary outcomes. The primary end point will be at 12 weeks with a secondary end point at 24 weeks to measure the sustainability of acute effects. Patients will be recruited from a community-based chronic pain clinic in a large urban center in Mississauga, Canada. The meditation program will be delivered in the clinical environment where patients normally receive their chronic pain care by certified meditation teachers who are not regulated health care providers. We will use a mixed-methods design using the multi-level framework to understand the implementation of this particular co-location model.

Discussion

Results of this hybrid evaluation will add important knowledge about the effectiveness of meditation for managing depressive symptoms in people with chronic pain. The implementation evaluation will inform both effectiveness outcomes and future program development, scalability, and sustainability.

Trial registration

ClinicalTrials.gov: NCT04039568. Registered on 31 July 2019.
Appendix
Available only for authorised users
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Metadata
Title
Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation
Authors
Abhimanyu Sud
Michelle L. A. Nelson
Darren K. Cheng
Alana Armas
Kirk Foat
Michelle Greiver
Fardous Hosseiny
Joel Katz
Rahim Moineddin
Benoit H. Mulsant
Ronnie I. Newman
Leon Rivlin
Akshya Vasudev
Ross Upshur
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04243-z

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