Meditation Versus Education for Improving Depression in Chronic Pain, a Randomized Controlled Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04039568|
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : October 22, 2019
In this study two possible treatment options available for depression and chronic pain will be explored. Both of these treatments will be offered in groups which could translate to cost-savings for the health care system. The two treatment options are:
- 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.
- 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 older adults with depression and chronic pain on opioid medication. 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 patients discussed above whom participate in the SSM arm of the RCT; (2) the expert meditation instructors facilitating the intervention; (3) the RMG administrative staff involved in supporting the logistics of the intervention arm of the RCT; and (4) the clinical staff at RMG.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Depression||Behavioral: Health Enhancement Program (HEP) Behavioral: Sahaj Samadhi Meditation (SSM)||Not Applicable|
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 Older adults with chronic pain and depression will be recruited from the Rivlin Medical Group. Patients will be pre-screened by clinic staff and be given a letter of information/consent form. All potential participants will be given a minimum of 24 hours to consider participation. After this time, written informed consent will be obtained from those interested in participating and they will be screened for eligibility by a research coordinator.
STUDY INTERVENTIONS This study is a 12-week, randomized controlled trial seeking to recruit 160 participants with depression and chronic pain from RMG. 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 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 Internation 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:
i. 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:
i. 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Meditation Versus Education for Improving Depression in Chronic Pain, a Randomized Controlled Trial|
|Estimated Study Start Date :||November 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||October 2020|
Active Comparator: Active Control Group
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)
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.
Experimental: Intervention Group
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)
This is the experimental arm of the study, where participants will be trained in a form of meditation that may improve depressive symptoms.
- Change in Health and Depression Symptomology [ Time Frame: Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24) ]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.
- Change in Pain Severity and pain-related function [ Time Frame: Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24) ]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.
- Change in Medication Information [ Time Frame: Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24) ]Opioid dose will be collected via patient log is the most common measure of opioid use in clinical research trials as per our current review of multidisciplinary care for opioid tapering. Given that patients are on a variety of distinct opioids and that single patients may be on >1 formulation, there is a need for common reporting as provided by morphine equivalent doses.
- Change in Health-Related Quality of Life [ Time Frame: Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24) ]The SF-36 is validated as a QoL measurement in the chronic pain population and is recommended by IMMPACT. Included here as an exploratory outcome with expected positive findings from pilot data collected by co-I Vasudev (unpublished) and other meditation interventions, which demonstrate moderate to large effect sizes. This measure is well-aligned to the intervention which is designed as a means of improving overall QoL more than as a disease treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039568
|Contact: Darren K Cheng, MSc||4164618252 ext firstname.lastname@example.org|
|Contact: Alana Armas, MSc||4164618252 ext email@example.com|
|Rivlin Medical Group||Recruiting|
|Toronto, Ontario, Canada, L5B 2V2|
|Contact: Central Contact Person|
|Principal Investigator:||Ross Upshur, MD||Sinai Health System|
|Principal Investigator:||Abhimanyu Sud, MD||Sinai Health System|
|Principal Investigator:||Michelle Nelson, PhD||Sinai Health System|