Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation
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 ar...
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| Format: | Article |
| Language: | English |
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BMC
2020-04-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-020-04243-z |
| _version_ | 1819089448886861824 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Abhimanyu Sud |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-21T22:08:06Z |
| format | Article |
| id | doaj.art-313b6cb41c564c1484594c8ace212a8a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-21T22:08:06Z |
| publishDate | 2020-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-313b6cb41c564c1484594c8ace212a8a2022-12-21T18:48:39ZengBMCTrials1745-62152020-04-0121111510.1186/s13063-020-04243-zSahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluationAbhimanyu Sud0Michelle L. A. Nelson1Darren K. Cheng2Alana Armas3Kirk FoatMichelle Greiver4Fardous Hosseiny5Joel Katz6Rahim Moineddin7Benoit H. Mulsant8Ronnie I. Newman9Leon Rivlin10Akshya Vasudev11Ross Upshur12Department of Family and Community Medicine, Faculty of Medicine, University of TorontoInstitute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of TorontoBridgepoint Collaboratory for Research and Innovation, Lunenfeld–Tanenbaum Research Institute, Sinai HealthBridgepoint Collaboratory for Research and Innovation, Lunenfeld–Tanenbaum Research Institute, Sinai HealthDepartment of Family and Community Medicine, Faculty of Medicine, University of TorontoCanadian Mental Health AssociationDepartment of Psychology, Faculty of Health, York UniversityDepartment of Family and Community Medicine, Faculty of Medicine, University of TorontoDepartment of Psychiatry, Faculty of Medicine, University of TorontoResearch and Health Promotion Department, Art of Living Foundation (North America)Rivlin Medical GroupDepartment of Psychiatry, Western UniversityBridgepoint Collaboratory for Research and Innovation, Lunenfeld–Tanenbaum Research Institute, Sinai HealthAbstract 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.http://link.springer.com/article/10.1186/s13063-020-04243-zChronic painDepressionMeditationEducationRandomized controlled trial (RCT)Implementation |
| spellingShingle | 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 Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation Trials Chronic pain Depression Meditation Education Randomized controlled trial (RCT) Implementation |
| title | Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation |
| title_full | Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation |
| title_fullStr | Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation |
| title_full_unstemmed | Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation |
| title_short | Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation |
| title_sort | sahaj samadhi meditation versus a health enhancement program for depression in chronic pain protocol for a randomized controlled trial and implementation evaluation |
| topic | Chronic pain Depression Meditation Education Randomized controlled trial (RCT) Implementation |
| url | http://link.springer.com/article/10.1186/s13063-020-04243-z |
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