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Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a Randomized Controlled Trial and Implementation Evaluation
- Source :
- Trials, Trials, Vol 21, Iss 1, Pp 1-15 (2020)
- Publication Year :
- 2020
- Publisher :
- Research Square Platform LLC, 2020.
-
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.
- Subjects :
- medicine.medical_specialty
Time Factors
media_common.quotation_subject
Medicine (miscellaneous)
Chronic pain
Health intervention
Severity of Illness Index
law.invention
Education
03 medical and health sciences
Study Protocol
0302 clinical medicine
Quality of life (healthcare)
Randomized controlled trial
law
Health care
11. Sustainability
medicine
Clinical endpoint
Humans
Pharmacology (medical)
030212 general & internal medicine
Meditation
media_common
Randomized Controlled Trials as Topic
Ontario
lcsh:R5-920
business.industry
Depression
Hybrid study
Sahaj Samadhi
medicine.disease
Comorbidity
3. Good health
Opioids
Treatment Outcome
Implementation
Physical therapy
Quality of Life
Randomized controlled trial (RCT)
lcsh:Medicine (General)
business
030217 neurology & neurosurgery
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- Trials, Trials, Vol 21, Iss 1, Pp 1-15 (2020)
- Accession number :
- edsair.doi.dedup.....4a059b95f705196190db972a3897f4a8
- Full Text :
- https://doi.org/10.21203/rs.2.20366/v1