Meditation Versus Education for Improving Depression in Chronic Pain, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change in Health and Depression Symptomology
研究概览
简要总结
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:
- 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 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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Health Enhancement Program (HEP) (Behavioral)
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.
干预措施: Sahaj Samadhi Meditation (SSM) (Behavioral)
结局指标
主要结局
Change in Health and Depression Symptomology
时间窗: 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.
次要结局
- Change in Pain Severity and pain-related function(Baseline (Week 0), Follow-up 1 (Study completion; Week 12-13), Follow-up 2 (Week 24))
研究者
Ross Upshur
Principal Investigator
Mount Sinai Hospital, Canada