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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.

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.

SUBMITTER: Sud A

PROVIDER: S-EPMC7140371 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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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.

Sud Abhimanyu A Nelson Michelle L A MLA Cheng Darren K DK Armas Alana A Foat Kirk K Greiver Michelle M Hosseiny Fardous F Katz Joel J Moineddin Rahim R Mulsant Benoit H BH Newman Ronnie I RI Rivlin Leon L Vasudev Akshya A Upshur Ross R

Trials 20200407 1

<h4>Background</h4>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 t ...[more]

PMID: 32264945

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Project description:BACKGROUND:Recent estimates suggest an 11% prevalence of current late-life depression (LLD) and a lifetime prevalence of 16-20%. LLD leads to cognitive disturbance as well as a nearly two to three times increased risk of dementia. We conducted a recent randomized controlled trial (RCT) which demonstrated that Sahaj Samadhi meditation (SSM), an easy-to-implement, meditation-based augmentation strategy, led to higher rates of symptom remission when compared to treatment as usual (40.0 vs 16.3%; odds ratio, 3.36; 95% CI 1.06-10.64; p?=?0.040). Here we present a protocol describing a two-site, blinded, RCT, comparing an SSM arm to an active-control arm - a Health Enhancement Program (HEP) intervention - in their ability to reduce depressive symptoms and improve executive functioning, among several other exploratory outcomes. METHODS/DESIGN:One hundred and ninety-two (n?=?192) participants with LLD will be recruited at two sites (London, ON, Canada, and Montreal, QC, Canada). Participants will undergo stratified randomization with regards to site and the presence of treatment-resistant-LLD (TR-LLD) or not, to either SSM or HEP. We will assess change in (1) depression severity using the Hamilton Depression Rating Scale (HAM-D), (2) executive functioning, and (3) other exploratory physiological and mood-based measures, at baseline (0?weeks), post intervention (12?weeks), and 26?weeks after baseline. Raters, clinicians, and care providers will be blinded to group allocation while participants will be blinded to the study hypotheses. DISCUSSION:This study should more definitively assess whether SSM can be used as an augmentation strategy in routine clinical care for patients suffering from LLD and TR-LLD. If the effects of SSM are significantly better than HEP, it will offer support for the routine use of this intervention to manage LLD/TR-LLD and comorbid declines in executive dysfunction. The results of this study could also inform whether SSM can improve/prevent cognitive decline in LLD. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03564041 . Registered on 20 June 2018.

Project description:Major depressive disorder (MDD) is the leading cause of disability in the developed world, yet broadly effective treatments remain elusive. Up to 40% of patients with depression are unresponsive to at least two trials of antidepressant medication and thus have "treatment-resistant depression" (TRD). There is an urgent need for cost-effective, non-pharmacologic, evidence-based treatments for TRD. Mindfulness-Based Cognitive Therapy (MBCT) is an effective treatment for relapse prevention and residual depression in major depression, but has not been previously studied in patients with TRD in a large randomized trial.The purpose of this study was to evaluate whether MBCT is an effective augmentation of antidepressants for adults with MDD who failed to respond to standard pharmacotherapy. MBCT was compared to an active control condition, the Health-Enhancement Program (HEP), which incorporates physical activity, functional movement, music therapy and nutritional advice. HEP was designed as a comparator condition for mindfulness-based interventions to control for non-specific effects. Originally investigated in a non-clinical sample to promote stress reduction, HEP was adapted for a depressed population for this study. Individuals age 18 and older with moderate to severe TRD, who failed to respond to at least two trials of antidepressants in the current episode, were recruited to participate. All participants were taking antidepressants (Treatment as usual; TAU) at the time of enrollment. After signing an informed consent, participants were randomly assigned to either MBCT or HEP condition. Participants were followed for 1 year and assessed at weeks 1-7, 8, 24, 36, and 52. Change in depression severity, rate of treatment response and remission after 8 weeks were the primary outcomes measured by the clinician-rated Hamilton Depression Severity Rating (HAM-D) 17-item scale. The participant-rated Quick Inventory of Depression Symptomology (QIDS-SR) 16-item scale was the secondary outcome measure of depression severity, response, and remission.Treatment-resistant depression entails significant morbidity and has few effective treatments. We studied the effect of augmenting antidepressant medication with MBCT, compared with a HEP control, for patients with TRD. Analyses will focus on clinician and patient assessment of depression, participants' clinical global impression change, employment and social functioning scores and quality of life and satisfaction ratings.ClincalTrials.gov identifier: NCT01021254.

Project description:ImportanceAlthough pain is among the most common symptoms reported by patients, primary care practitioners (PCPs) face substantial challenges identifying and assessing pain.ObjectiveTo evaluate a 2-step process for chronic pain screening and follow-up in primary care.Design, setting, and participantsA cross-sectional study of patients with a primary care visit between July 2, 2018, and June 1, 2019, was conducted at a statewide, multisite federally qualified health center. Participants included 68 PCPs and 58 medical assistants from 13 sites who implemented the screening process in primary care, and 38 866 patients aged 18 years or older with a primary care visit during that time.ExposuresSingle-question assessment of pain frequency, followed by a 3-question PEG (pain, enjoyment of life, general activity) functional assessment for patients with chronic pain.Main outcomes and measuresAdherence to a 2-step chronic pain screening and PEG process, proportion of patients with positive screening results, mean PEG pain severity greater than or equal to 7, and documented chronic painful condition diagnosis in patient's electronic health record between 1 year before and 90 days after screening.ResultsOf 38 866 patients with a primary care visit, 31 600 patients (81.3%) underwent screening. Mean (SD) age was 46.2 (15.4) years, and most were aged 35 to 54 years (12 987 [41.1%]), female (18 436 [58.3%]), Hispanic (14 809 [46.9%]), and English-speaking (22 519 [71.3%]), and had Medicaid insurance (18 442 [58.4%]). A total of 10 262 participants (32.5%) screened positive and, of these, 9701 (94.5%) completed the PEG questionnaire. PEG responses indicated severe pain interference with activities of daily living (PEG ≥7) in 5735 (59.1%) participants. A chronic painful condition had not been diagnosed in 4257 (43.9%) patients in the year before screening. A new chronic painful condition was diagnosed at screening or within 90 days in 2250 (52.9%) patients. Care teams found the workflow acceptable, but cited lengthy administration time, challenges with comprehension of the PEG questions, and limited comprehensiveness as implementation barriers.Conclusions and relevanceA systematic, 2-step process for chronic pain screening and functional assessment in primary care appeared to identify patients with previously undocumented chronic pain and was feasible to implement. Patient-provided information on the frequency of pain, pain level, and pain interference can help improve the assessment and monitoring of pain in primary care.

Project description:ObjectiveTo investigate the effect of a pain management core competency education program on surgical nurses' pain knowledge and pain management nursing practice behaviors.MethodsAn 8-h education program focused on pain management core competency was provided twice in two weeks including the multidimensional nature of pain, pain assessment, pharmacological and non-pharmacological management, and knowledge application was developed and implemented for surgical nurses by a multidisciplinary team. Multimodal teaching approaches such as didactic teaching and vignettes of cases for nurses to discuss were used. The Clinical Pain Knowledge Test (CPKT) was completed by 135 and 107 nurses from 17 surgical wards pre and post-program, respectively. Two hundred and three patients' medical records were randomly sampled according to the number of operations in each ward one week before and in the fifth week after the intervention, respectively. Documentation of patients' postoperative pain management nursing practice behaviors and pain intensity scores were collected.ResultsAfter the intervention, the CPKT scores of nurses significantly increased from 45.6% ± 12.3% to 54.2% ± 10.2% (t = 5.786, P < 0.001). Nurses' postoperative pain management nursing practice improved, with proportion of pain assessment documentation increased from 59.6% (121/203) to 74.9% (152/203) (χ 2 = 10.746, P = 0.001), those using pain intensity assessment tools increased from 81.8% (99/121) to 95.4% (145/152) (χ 2 = 13.079, P < 0.001), and intramuscular injection of nonopioids decreased from 12.6% (13/103) to 2.7% (3/111) (χ 2 = 7.598, P = 0.006). Patients' average worst pain score on the operation day significantly decreased (Z = -2.486, P = 0.013), and scores from the first to the third postoperative day also decreased (Z = -2.172, P = 0.030).ConclusionsImplementation of a pain management core competency education program for surgical nurses can increase their knowledge of core competencies of pain management, improve selected pain management practices, and decrease patients' postoperative pain intensity.

Project description:BACKGROUND:Female chronic pelvic pain (CPP) is defined as intermittent or constant pelvic or lower abdominal pain occurring in a woman for at least 6 months. Up to a quarter of women are estimated to be affected by CPP worldwide and it is responsible for one fifth of specialist gynecological referrals in the United Kingdom. Psychological interventions are commonly utilized. As waiting times and funding capacity impede access to face-to-face consultations, supported self-management (SSM) has emerged as a viable alternative. Mindfulness meditation is a potentially valuable SSM tool, and in the era of mobile technology, this can be delivered to the individual user via a smartphone app. OBJECTIVE:To assess the feasibility of conducting a trial of a mindfulness meditation intervention delivered by a mobile phone app for patients with CPP. The main feasibility objectives were to assess patient recruitment and app adherence, to obtain information to be used in the sample size estimate of a future trial, and to receive feedback on usability of the app. METHODS:Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS) is a three-arm feasibility trial, that took place in two hospitals in the United Kingdom. Eligible participants were randomized in a 1:1:1 ratio to one of three treatment arms: (1) the intervention arm, consisting of a guided, spoken mindfulness meditation app; (2) an active control arm, consisting of a progressive muscle relaxation app; and (3) usual care (no app). Participants were followed-up for 6 months. Key feasibility outcomes included the time taken to recruit all patients for the study, adherence, and estimates to be used in the sample size calculation for a subsequent full-scale trial. Upon completion of the feasibility trial we will conduct focus groups to explore app usability and reasons for noncompliance. RESULTS:Recruitment for MEMPHIS took place between May 2016 and September 2016. The study was closed March 2017 and the report was submitted to the NIHR on October 26, 2017. CONCLUSIONS:This feasibility trial will inform the design of a large multicentered trial to assess the clinical effectiveness of mindfulness meditation delivered via a smartphone app for the treatment of CPP. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02721108; https://clinicaltrials.gov/ct2/show/NCT02721108 (Archived by WebCite at http://www.webcitation.org/6wLMAkuaU); BioMed Central: ISRCTN10925965; https://www.isrctn.com/ISRCTN10925965 (Archived by WebCite at http://www.webcitation.org/6wLMVLuys).

Project description:BackgroundSubstantial investment has gone into research on the efficacy and effectiveness of pharmaceutical and nonpharmacologic interventions for chronic pain. However, synthesizing this extensive literature is challenging because of differences in the outcome measures used in studies of similar or competing interventions. The absence of a common metric makes it difficult to replicate findings, pool data from multiple studies, resolve conflicting conclusions, or reach consensus when interpreting findings.MethodsThis study has a seven-member Advisory Council of chronic pain experts. Preliminary analyses will be performed on data from several large existing datasets; intermediate analyses will be performed using primary data collected from Amazon's Mechanical Turk (MTurk); and cross-validation will use primary data collected from a nationally-representative, probability-based panel. Target sample size for both primary datasets is 1500. The three study aims are as follows: Aim 1 will develop and evaluate links between the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS®-29) and legacy measures used for chronic pain such as the Roland-Morris Disability Questionnaire (RMDQ) and the Oswestry Disability Index (ODI). We will assess the best method of score linking and create crosswalk tables. Aim 2 will evaluate and refine the Impact Stratification Score (ISS) based on 9 PROMIS-29 items and proposed by the NIH Research Task Force on chronic low back pain. We will evaluate the ISS in terms of other indicators of condition severity and patient prognosis and outcomes and identify cut-points to stratify chronic pain patients into subgroups. Aim 3 will evaluate the strengths and limitations of MTurk as a data collection platform for estimating chronic pain by comparing its data to other data sources.DiscussionThe accomplishment of Aims 1 and 2 will allow direct comparison of results across past and future studies of chronic pain. These comparisons will help us to understand different results from seemingly similar studies, and to determine the relative effectiveness of all pharmaceutical and nonpharmacologic interventions for chronic pain across different trials. Aim 3 findings will provide valuable information to researchers about the pros and cons of using the MTurk platform for research-based data collection.Trial registrationClinicalTrials.gov: NCT04426812 ; June 10, 2020.

Project description:BackgroundInternet-based self-management programs and telerehabilitation initiatives have increased and have been extensively used for delivering health care in many areas. These programs overcome common barriers that patients face with traditional face-to-face health care, such as travel expenditures, lack of time, and high demand on the public health system. During the COVID-19 pandemic, this mode of web-based health care delivery had become more popular. However, there is still a lack of studies testing this mode of delivery in low- and middle-income countries. To gain a better understanding of the context, feasibility, and factors involved in the implementation of a web-based program, pilot and implementation studies are necessary. These studies can better inform whether a strategy is feasible, acceptable, and adequate for its purposes and for optimizing resource allocation.ObjectiveThis study aims to evaluate the feasibility, usability, and implementation context of a self-management internet-based program based on exercises and pain education (ReabilitaDOR) in people with chronic musculoskeletal pain and to compare this program with a program using only a web-based self-management booklet.MethodsThe study design was a parallel pilot study of a prospectively registered, assessor-blinded, 2-arm randomized controlled trial with economic evaluation. This study was performed using waiting lists of physiotherapy and rehabilitation centers and advertisements on social media networks. The participants were 65 patients with chronic musculoskeletal pain aged between 18 and 60 years. The effects of an 8-week telerehabilitation program based on exercises and pain education (intervention group) were compared with those of a program based only on a web-based self-management booklet (control group). The main outcome measures were implementation outcomes of patients' perceptions of acceptability, appropriateness, feasibility, and usability of the program and the societal costs and feasibility of the main trial at 8-week posttreatment follow-up. Adverse events were also analyzed.ResultsIn total, 56 participants were analyzed at the 8-week follow-up. The intervention group showed responses with a mean of 4.5 (SD 0.6) points for acceptability, 4.5 (SD 0.5) points for appropriateness, and 4.5 (SD 0.6) points for feasibility measured on a 1 to 5 scale. All patients in the intervention group showed satisfactory responses to the system usability outcome. There is satisfactory evidence for the feasibility of the main trial. For costs related to the interventions, health care, patients, and loss of productivity at 8 weeks, we found a total expenditure of US $278.30 per patient in the intervention group and US $141.52 per patient in the control group. No adverse events were reported during the intervention period.ConclusionsWe found that the ReabilitaDOR program is feasible, appropriate, and acceptable from the users' implementation perspective. This system was considered usable by all the participants, and the main trial seemed feasible. Cost data were viable to be collected, and the program is likely to be safe.Trial registrationClinicalTrials.gov NCT04274439; https://clinicaltrials.gov/ct2/show/NCT04274439.

Dataset Information

Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation.

Publications

Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation.

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