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Chronic PainNCT04039568

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

A study testing Health Enhancement Program (HEP) and Sahaj Samadhi Meditation (SSM) in people with Chronic Pain and Depression, run by Mount Sinai Hospital, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain, Depression
What is being tested?
Health Enhancement Program (HEP) and Sahaj Samadhi Meditation (SSM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteCanada
Study dates
30 Oct 2019to 31 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years of age;
  • 2. 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Bridgepoint Collaboratory, Sinai Health

    Toronto, Ontario, M4M 2B5

Other trials in Canada

About this study

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.

Read the detailed description

OBJECTIVES To determine whether depressive symptoms, pain severity, function, quality of life, as well as opioid use can be affected by a lifestyle intervention program in depression and chronic pain. To evaluate the implementation of the program at Rivlin Medical Group (RMG) chronic pain clinic, and to understand how the SSM intervention can be translated to other settings.

RCT RECRUITMENT AND CONSENT Adults with chronic pain and depression will be recruited from one of seven sites: 1) the Rivlin Medical Group Clinic, 2) Mount Sinai Academic Family Health Team, Sinai Health, 3) TAPMI hub programs at Women's College Hospital 4) Academic Family Health Team, St. Michael's Hospital, 5) the Rehabilitation Pain Service, University Health Network, 6) the Canadian Memorial Chiropractic College sites, and 6) South East Toronto Family Health Team, Michael Garron Hospita. Recruitment materials (brochure, poster, website) will also be shared at local independent non-hospital sites and in online spaces. Patients will be introduced to the study and connected with study staff. All potential participants will be provided with a consent form and given a minimum of 24 hours to consider participation. After this time, informed consent will be obtained from those interested in participating and they will be screened for eligibility by study staff.

STUDY INTERVENTIONS This study is a 12-week, randomized controlled trial seeking to recruit 160 participants with depression and chronic pain. The SSM intervention will be offered by trained and certified teachers from the Art of Living Foundation. The HEP intervention will be offered by a trained Nurse Practitioner, Social Worker, Psychologist, Occupational Therapist or other qualified healthcare professional. Raters, clinicians, and care providers will be blind to participant study condition.

DATA COLLECTION Participants will be screened for eligibility using the Patient Health Questionnaire (PHQ-9) and Mini International Neuropsychiatric Interview Screen and Standard 7.0.2 (MINI). The primary outcome (depression) will be evaluated using the PHQ-9. The secondary outcome (pain severity and pain-related function) will be evaluated using the Brief Pain Inventory (BPI. Exploratory outcomes (health related quality of life, and opioid use) will be evaluated using the Short-form 36 (SF-36), and a medication log, respectively. Measures of primary and secondary outcomes will be administered at all 3 assessment sessions and are described below.

At the baseline assessment the following information will be collected:

  1. Demographics survey that will collect information on age, partial Date of Birth (DOB), gender, ethnic background, employment status, housing type, highest level of education achieved, smoking, caffeine intake, drug and alcohol use, duration of pain and pain diagnosis. Participants will also be asked about their psychiatric history including age of first contact with services for mental illness (and which illness), history of hospital admissions and the number of episodes of depression; ii. PHQ-9; iii. BPI scale; iv. SF-36; v. Medication names, dosages, dosages per day, total daily dosage, and reason for use will be recorded, including vitamins and over-the-counter (OTC) medications; vi. Psychology Intake Form.

During the 12 week and 6 month assessment the following questionnaires and measurements will be completed:

  1. PHQ-9; ii. BPI scale; iii. SF-36; iv. Medication names and doses will be collected and the recordings for opioids will be converted to total daily morphine equivalents using standardized conversion tables.
Being tested
Health Enhancement Program (HEP), Sahaj Samadhi Meditation (SSM)
Keywords
Opioid Therapy, Sahaj Samadhi Meditation, Health Enhancement Program
Medical subject headings
Chronic Pain, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health Enhancement Program (HEP)Behavioural

    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.

  • Sahaj Samadhi Meditation (SSM)Behavioural

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

Study groups in NCT04039568
Study groupRoleWhat they receive
Active Control GroupActive comparatorTen 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.
Receives: Behavioral: Health Enhancement Program (HEP)
Intervention GroupExperimentalTen 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.
Receives: Behavioral: Sahaj Samadhi Meditation (SSM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)

  1. Change in Pain Severity and pain-related function

    The Brief Pain Inventory (BPI) is a validated self-report scale used in pain trials and clinical pain practice and is a core outcome measure per the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations. Two independent measures are included: pain severity and pain interference with function - both are clinically relevant outcomes.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2019
  2. Study start30 Oct 2019
  3. Primary completion28 Feb 2023
  4. Study completion31 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04039568
Sponsor's protocol ID
EO1-162072
Other IDs
EO1-162072
Status last verified
Oct 2023
First submitted
15 Jul 2019
Last updated
25 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

    PubMed 22310560

  • MacCoon DG, Imel ZE, Rosenkranz MA, Sheftel JG, Weng HY, Sullivan JC, Bonus KA, Stoney CM, Salomons TV, Davidson RJ, Lutz A. The validation of an active control intervention for Mindfulness Based Stress Reduction (MBSR). Behav Res Ther. 2012 Jan;50(1):3-12. doi: 10.1016/j.brat.2011.10.011. Epub 2011 Nov 11.

    PubMed 22137364

  • 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.

    PubMed 24955584

  • Rayner L, Hotopf M, Petkova H, Matcham F, Simpson A, McCracken LM. Depression in patients with chronic pain attending a specialised pain treatment centre: prevalence and impact on health care costs. Pain. 2016 Jul;157(7):1472-9. doi: 10.1097/j.pain.0000000000000542.

    PubMed 26963849

  • McMillan D, Gilbody S, Richards D. Defining successful treatment outcome in depression using the PHQ-9: a comparison of methods. J Affect Disord. 2010 Dec;127(1-3):122-9. doi: 10.1016/j.jad.2010.04.030. Epub 2010 May 31.

    PubMed 20569992

  • Meader N, Mitchell AJ, Chew-Graham C, Goldberg D, Rizzo M, Bird V, Kessler D, Packham J, Haddad M, Pilling S. Case identification of depression in patients with chronic physical health problems: a diagnostic accuracy meta-analysis of 113 studies. Br J Gen Pract. 2011 Dec;61(593):e808-20. doi: 10.3399/bjgp11X613151.

    PubMed 22137418

  • Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.

    PubMed 15621359

  • 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.

    PubMed 26755658

  • 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.

    PubMed 14750909

  • 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.

    PubMed 27658913

  • 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.

    PubMed 40534615

  • 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.

    PubMed 32264945

Questions about this trial

What is this clinical trial studying?

A study testing Health Enhancement Program (HEP) and Sahaj Samadhi Meditation (SSM) in people with Chronic Pain and Depression, run by Mount Sinai Hospital, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Health and Depression Symptomology (time frame: Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04039568, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.

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