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

NCT04039568 | Completed

• 1 other identifier: EO1-162072
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Chronic Pain; Depression

Keywords

Opioid Therapy; Sahaj Samadhi Meditation; Health Enhancement Program

Outcome Measures

Primary Outcomes (1)

• Change in Health and Depression Symptomology

  The Patient Health Questionnaire (PHQ-9) is a well-validated and widely used self-report scale used in depression and chronic pain clinical care and research. Reduction in a continuous outcome score is a more sensitive test viz a viz percent reduction in scores which has been reported in some depression studies.

  Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24)

Secondary Outcomes (1)

• Change in Pain Severity and pain-related function

  Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24)

Other Outcomes (2)

• Change in Medication Information

  Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24)

• Change in Health-Related Quality of Life

  Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24)

Study Arms (2)

Active Control Group

ACTIVE COMPARATOR

Ten to fifteen participants in the HEP arm will participate in the program for 4 consecutive days (2hrs/day) in the 1st week, followed by 75 min/week reinforcement sessions for 11 weeks. The Health-Enhancement Program (HEP) was designed and used as a manualized active control in meditation-based intervention trials. HEP controls for several non-specific factors found in a meditation groups, including: group support and morale, behavioural activation, reduction of stigma, facilitator attention, treatment duration, and time spent on at-home practice. HEP is tailored to be structurally equivalent to SSM with similar-sized groups, meeting schedule, total contact hours, amount of home practice and encouragement to keep practice logs.

Behavioral: Health Enhancement Program (HEP)

Intervention Group

EXPERIMENTAL

Ten to fifteen participants in the SSM arm will be trained for 4 consecutive days (2hrs/day) in the 1st week, followed by 75 min/week reinforcement sessions for 11 weeks. This standardized, manualized therapy will be delivered by certified meditation instructors. On day 1, participants will learn the nature of meditation, and then undergo personal guided meditation. Training on days 2-4 includes understanding the nature of the mind and the thoughts arising from it, guided meditations by the instructor, and a discussion of meditation processes. Weekly 75 min reinforcement sessions will include 20 minutes of guided meditation practice, and then focus on participants' experiences with meditation during the week, additional observations, and a review of relevant knowledge to support their home practice. Participants will also be encouraged to practice twice daily at home for 20 minutes per session.

Behavioral: Sahaj Samadhi Meditation (SSM)

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.

Active Control Group

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age;
• \. Significant depressive symptomology (PHQ-9 score ≥10);
• Chronic pain (pain ≥3 months duration in any body region, by self-report);
• Be willing and able to attend all 4 training sessions of SSM/HEP and 75% of follow-up sessions;
• Understanding of English language (spoken and written);
• Able to sit for 20-25 minutes without significant discomfort;
• Regular access to internet and ability to participate in video calls

You may not qualify if:

• Other major psychiatric conditions including substance use disorder, psychosis and cognitive impairment as excluded by the Mini-International Neuropsychiatric Interview (MINI) Screening and Standard tool; severe depression (PHQ-9 ≥20) and risk of imminent suicide as per MINI and/or PHQ-9;
• Non-correctable, clinically significant sensory impairment;
• Acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months;
• A terminal medical diagnosis with prognosis of less than 12 months;
• Currently practising any form of mind-body intervention;
• Inability to provide informed consent

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Lunenfeld Tanenbaum Research Institute: collaborator
• Rivlin Medical Group: collaborator
• The Art of Living Foundation: collaborator
• Canadian Mental Health Association: collaborator
• University of Toronto: collaborator

Study Sites (1)

Bridgepoint Collaboratory, Sinai Health

Toronto, Ontario, M4M 2B5, Canada

Location

Related Publications (12)

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  PMID: 22137364 BACKGROUND

• MacCoon DG, MacLean KA, Davidson RJ, Saron CD, Lutz A. No sustained attention differences in a longitudinal randomized trial comparing mindfulness based stress reduction versus active control. PLoS One. 2014 Jun 23;9(6):e97551. doi: 10.1371/journal.pone.0097551. eCollection 2014.

  PMID: 24955584 BACKGROUND

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  PMID: 26963849 BACKGROUND

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  PMID: 20569992 BACKGROUND

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  PMID: 22137418 BACKGROUND

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  PMID: 15621359 BACKGROUND

• Cunningham JL, Evans MM, King SM, Gehin JM, Loukianova LL. Opioid Tapering in Fibromyalgia Patients: Experience from an Interdisciplinary Pain Rehabilitation Program. Pain Med. 2016 Sep;17(9):1676-85. doi: 10.1093/pm/pnv079. Epub 2016 Jan 11.

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• Elliott TE, Renier CM, Palcher JA. Chronic pain, depression, and quality of life: correlations and predictive value of the SF-36. Pain Med. 2003 Dec;4(4):331-9. doi: 10.1111/j.1526-4637.2003.03040.x.

  PMID: 14750909 BACKGROUND

• Hilton L, Hempel S, Ewing BA, Apaydin E, Xenakis L, Newberry S, Colaiaco B, Maher AR, Shanman RM, Sorbero ME, Maglione MA. Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis. Ann Behav Med. 2017 Apr;51(2):199-213. doi: 10.1007/s12160-016-9844-2.

  PMID: 27658913 BACKGROUND

• Cheng DK, Simpson R, Moineddin R, Katz J, Mulsant BH, Vasudev A, Greiver M, Hosseiny F, Inzitari M, Newman RI, Rivlin L, Foat KD, Furlan AD, Flannery JF, Telner D, Bosma R, Naimer M, Chung C, Pinto AD, Nelson MLA, Upshur R, Sud A. A Multi-Site, Randomized, Parallel-Group, Controlled Trial of Virtually-Delivered Sahaj Samadhi Meditation for the Management of Moderate Depressive Symptoms in Chronic Pain. J Pain Res. 2025 Jun 13;18:2925-2946. doi: 10.2147/JPR.S515229. eCollection 2025.

  PMID: 40534615 DERIVED

• Sud A, Nelson MLA, Cheng DK, Armas A, Foat K, Greiver M, Hosseiny F, Katz J, Moineddin R, Mulsant BH, Newman RI, Rivlin L, Vasudev A, Upshur R. Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation. Trials. 2020 Apr 7;21(1):319. doi: 10.1186/s13063-020-04243-z.

  PMID: 32264945 DERIVED

MeSH Terms

Conditions

Chronic Pain; Depression

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Ross Upshur, MD

  Sinai Health System

  PRINCIPAL INVESTIGATOR

• Abhimanyu Sud, MD

  Sinai Health System

  PRINCIPAL INVESTIGATOR

• Michelle Nelson, PhD

  Sinai Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 31, 2019
• Study Start: October 30, 2019
• Primary Completion: February 28, 2023
• Study Completion: March 31, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

CA (1)