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Background: Traditional Indian Ayurvedic medicine uses complex treatment approaches, including manual therapies, lifestyle and nutritional advice, dietary supplements, medication, yoga, and purification techniques. Ayurvedic strategies are often used to treat osteoarthritis (OA) of the knee; however, no systematic data are available on their effectiveness in comparison with standard care. The aim of this study is to evaluate the effectiveness of complex Ayurvedic treatment in comparison with conventional methods of treating OA symptoms in patients with knee osteoarthritis. Methods and design: In a prospective, multicenter, randomized controlled trial, 150 patients between 40 and 70 years, diagnosed with osteoarthritis of the knee, following American College of Rheumatology criteria and an average pain intensity of >= 40 mm on a 100 mm visual analog scale in the affected knee at baseline will be randomized into two groups. In the Ayurveda group, treatment will include tailored combinations of manual treatments, massages, dietary and lifestyle advice, consideration of selected foods, nutritional supplements, yoga posture advice, and knee massage. Patients in the conventional group will receive self-care advice, pain medication, weight-loss advice (if overweight), and physiotherapy following current international guidelines. Both groups will receive 15 treatment sessions over 12 weeks. Outcomes will be evaluated after 6 and 12 weeks and 6 and 12 months. The primary endpoint is a change in the score on the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after 12 weeks. Secondary outcome measurements will use WOMAC subscales, a pain disability index, a visual analog scale for pain and sleep quality, a pain experience scale, a quality-of-life index, a profile of mood states, and Likert scales for patient satisfaction, patient diaries, and safety. Using an adapted PRECIS scale, the trial was identified as lying mainly in the middle of the efficacy-effectiveness continuum. Discussion: This trial is the first to compare the effectiveness of a complex Ayurvedic intervention with a complex conventional intervention in a Western medical setting in patients with knee osteoarthritis. During the trial design, aspects of efficacy and effectiveness were discussed. The resulting design is a compromise between rigor and pragmatism.
BACKGROUND:Individuals with a history of recurrent depression have a high risk of repeated depressive relapse/recurrence. Maintenance antidepressant medication (m-ADM) for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to m-ADM. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce the risk of relapse/recurrence compared with usual care but has not yet been compared with m-ADM in a definitive trial.
OBJECTIVES:
To establish whether MBCT with support to taper and/or discontinue antidepressant medication (MBCT-TS) is superior to and more cost-effective than an approach of m-ADM in a primary care setting for patients with a history of recurrent depression followed up over a 2-year period in terms of preventing depressive relapse/recurrence. Secondary aims examined MBCT's acceptability and mechanism of action.
DESIGN:
Single-blind, parallel, individual randomised controlled trial.
SETTING:
UK general practices.
PARTICIPANTS:
Adult patients with a diagnosis of recurrent depression and who were taking m-ADM.
INTERVENTIONS:
Participants were randomised to MBCT-TS or m-ADM with stratification by centre and symptomatic status. Outcome data were collected blind to treatment allocation and the primary analysis was based on the principle of intention to treat. Process studies using quantitative and qualitative methods examined MBCT's acceptability and mechanism of action.
MAIN OUTCOMES MEASURES:
The primary outcome measure was time to relapse/recurrence of depression. At each follow-up the following secondary outcomes were recorded: number of depression-free days, residual depressive symptoms, quality of life, health-related quality of life and psychiatric and medical comorbidities.
RESULTS:
In total, 212 patients were randomised to MBCT-TS and 212 to m-ADM. The primary analysis did not find any evidence that MBCT-TS was superior to m-ADM in terms of the primary outcome of time to depressive relapse/recurrence over 24 months [hazard ratio (HR) 0.89, 95% confidence interval (CI) 0.67 to 1.18] or for any of the secondary outcomes. Cost-effectiveness analysis did not support the hypothesis that MBCT-TS is more cost-effective than m-ADM in terms of either relapse/recurrence or quality-adjusted life-years. In planned subgroup analyses, a significant interaction was found between treatment group and reported childhood abuse (HR 1.89, 95% CI 1.06 to 3.38), with delayed time to relapse/recurrence for MBCT-TS participants with a more abusive childhood compared with those with a less abusive history. Although changes in mindfulness were specific to MBCT (and not m-ADM), they did not predict outcome in terms of relapse/recurrence at 24 months. In terms of acceptability, the qualitative analyses suggest that many people have views about (dis)/continuing their ADM, which can serve as a facilitator or a barrier to taking part in a trial that requires either continuation for 2 years or discontinuation.
CONCLUSIONS:
There is no support for the hypothesis that MBCT-TS is superior to m-ADM in preventing depressive relapse/recurrence among individuals at risk for depressive relapse/recurrence. Both treatments appear to confer protection against relapse/recurrence. There is an indication that MBCT may be most indicated for individuals at greatest risk of relapse/recurrence. It is important to characterise those most at risk and carefully establish if and why MBCT may be most indicated for this group.
BACKGROUND:Individuals with a history of recurrent depression have a high risk of repeated depressive relapse/recurrence. Maintenance antidepressant medication (m-ADM) for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to m-ADM. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce the risk of relapse/recurrence compared with usual care but has not yet been compared with m-ADM in a definitive trial.
OBJECTIVES:
To establish whether MBCT with support to taper and/or discontinue antidepressant medication (MBCT-TS) is superior to and more cost-effective than an approach of m-ADM in a primary care setting for patients with a history of recurrent depression followed up over a 2-year period in terms of preventing depressive relapse/recurrence. Secondary aims examined MBCT's acceptability and mechanism of action.
DESIGN:
Single-blind, parallel, individual randomised controlled trial.
SETTING:
UK general practices.
PARTICIPANTS:
Adult patients with a diagnosis of recurrent depression and who were taking m-ADM.
INTERVENTIONS:
Participants were randomised to MBCT-TS or m-ADM with stratification by centre and symptomatic status. Outcome data were collected blind to treatment allocation and the primary analysis was based on the principle of intention to treat. Process studies using quantitative and qualitative methods examined MBCT's acceptability and mechanism of action.
MAIN OUTCOMES MEASURES:
The primary outcome measure was time to relapse/recurrence of depression. At each follow-up the following secondary outcomes were recorded: number of depression-free days, residual depressive symptoms, quality of life, health-related quality of life and psychiatric and medical comorbidities.
RESULTS:
In total, 212 patients were randomised to MBCT-TS and 212 to m-ADM. The primary analysis did not find any evidence that MBCT-TS was superior to m-ADM in terms of the primary outcome of time to depressive relapse/recurrence over 24 months [hazard ratio (HR) 0.89, 95% confidence interval (CI) 0.67 to 1.18] or for any of the secondary outcomes. Cost-effectiveness analysis did not support the hypothesis that MBCT-TS is more cost-effective than m-ADM in terms of either relapse/recurrence or quality-adjusted life-years. In planned subgroup analyses, a significant interaction was found between treatment group and reported childhood abuse (HR 1.89, 95% CI 1.06 to 3.38), with delayed time to relapse/recurrence for MBCT-TS participants with a more abusive childhood compared with those with a less abusive history. Although changes in mindfulness were specific to MBCT (and not m-ADM), they did not predict outcome in terms of relapse/recurrence at 24 months. In terms of acceptability, the qualitative analyses suggest that many people have views about (dis)/continuing their ADM, which can serve as a facilitator or a barrier to taking part in a trial that requires either continuation for 2 years or discontinuation.
CONCLUSIONS:
There is no support for the hypothesis that MBCT-TS is superior to m-ADM in preventing depressive relapse/recurrence among individuals at risk for depressive relapse/recurrence. Both treatments appear to confer protection against relapse/recurrence. There is an indication that MBCT may be most indicated for individuals at greatest risk of relapse/recurrence. It is important to characterise those most at risk and carefully establish if and why MBCT may be most indicated for this group.
TRIAL REGISTRATION:
Current Controlled Trials ISRCTN26666654.
FUNDING:
This project was funded by the NIHR Health Technology Assessment programme and the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care South West Peninsula and will be published in full in Health Technology Assessment; Vol. 19, No. 73. See the NIHR Journals Library website for further project information.
BACKGROUND:Individuals with a history of recurrent depression have a high risk of repeated depressive relapse/recurrence. Maintenance antidepressant medication (m-ADM) for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to m-ADM. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce the risk of relapse/recurrence compared with usual care but has not yet been compared with m-ADM in a definitive trial.
OBJECTIVES:
To establish whether MBCT with support to taper and/or discontinue antidepressant medication (MBCT-TS) is superior to and more cost-effective than an approach of m-ADM in a primary care setting for patients with a history of recurrent depression followed up over a 2-year period in terms of preventing depressive relapse/recurrence. Secondary aims examined MBCT's acceptability and mechanism of action.
DESIGN:
Single-blind, parallel, individual randomised controlled trial.
SETTING:
UK general practices.
PARTICIPANTS:
Adult patients with a diagnosis of recurrent depression and who were taking m-ADM.
INTERVENTIONS:
Participants were randomised to MBCT-TS or m-ADM with stratification by centre and symptomatic status. Outcome data were collected blind to treatment allocation and the primary analysis was based on the principle of intention to treat. Process studies using quantitative and qualitative methods examined MBCT's acceptability and mechanism of action.
MAIN OUTCOMES MEASURES:
The primary outcome measure was time to relapse/recurrence of depression. At each follow-up the following secondary outcomes were recorded: number of depression-free days, residual depressive symptoms, quality of life, health-related quality of life and psychiatric and medical comorbidities.
RESULTS:
In total, 212 patients were randomised to MBCT-TS and 212 to m-ADM. The primary analysis did not find any evidence that MBCT-TS was superior to m-ADM in terms of the primary outcome of time to depressive relapse/recurrence over 24 months [hazard ratio (HR) 0.89, 95% confidence interval (CI) 0.67 to 1.18] or for any of the secondary outcomes. Cost-effectiveness analysis did not support the hypothesis that MBCT-TS is more cost-effective than m-ADM in terms of either relapse/recurrence or quality-adjusted life-years. In planned subgroup analyses, a significant interaction was found between treatment group and reported childhood abuse (HR 1.89, 95% CI 1.06 to 3.38), with delayed time to relapse/recurrence for MBCT-TS participants with a more abusive childhood compared with those with a less abusive history. Although changes in mindfulness were specific to MBCT (and not m-ADM), they did not predict outcome in terms of relapse/recurrence at 24 months. In terms of acceptability, the qualitative analyses suggest that many people have views about (dis)/continuing their ADM, which can serve as a facilitator or a barrier to taking part in a trial that requires either continuation for 2 years or discontinuation.
CONCLUSIONS:
There is no support for the hypothesis that MBCT-TS is superior to m-ADM in preventing depressive relapse/recurrence among individuals at risk for depressive relapse/recurrence. Both treatments appear to confer protection against relapse/recurrence. There is an indication that MBCT may be most indicated for individuals at greatest risk of relapse/recurrence. It is important to characterise those most at risk and carefully establish if and why MBCT may be most indicated for this group.
TRIAL REGISTRATION:
Current Controlled Trials ISRCTN26666654.
FUNDING:
This project was funded by the NIHR Health Technology Assessment programme and the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care South West Peninsula and will be published in full in Health Technology Assessment; Vol. 19, No. 73. See the NIHR Journals Library website for further project information.
Patients with asthma and chronic obstructive pulmonary disease (COPD) often experience anxiety and depression in relation to their respiratory condition. Anxiety and depression in this population are associated with decreased activity. The aim of this phenomenological study was to carry out in-depth qualitative interviews with a purposive sample of patients with asthma and COPD taking part in an 8-week mindfulness-based cognitive therapy (MBCT) course to explore their experiences of MBCT. In particular, we were interested in how the mindfulness approach helped them, or not, and their awareness of any meaningful changes in relation to their breathlessness, activity levels, anxiety or low mood. Twenty-two patients were recruited from primary and secondary care to receive an 8-week course in MBCT. Two groups of MBCT were taught by qualified MBCT teachers in a community setting. Of the 22 patients who attended the MBCT course, 12 patients were purposively sampled to take part in an in-depth qualitative interview 2 months after completing the MBCT course. Interviews were digitally recorded and transcribed verbatim. Analysis was thematic. The themes that emerged included greater acceptance and reduced sense of disease-related stigma; noticing subtle bodily sensations to detect early warning signs of breathlessness; linking pulmonary rehabilitation advice with mindfulness; developing a new relationship to breathing, activity and associated thoughts; having a greater sense of control; being creative around limitations and removing psychological barriers to being more active. Findings offer, for the first time, qualitative evidence on how MBCT benefits patients with asthma and COPD who experience anxiety and depression. These data provide a useful adjunct to existing quantitative evidence in this area.
Patients with asthma and chronic obstructive pulmonary disease (COPD) often experience anxiety and depression in relation to their respiratory condition. Anxiety and depression in this population are associated with decreased activity. The aim of this phenomenological study was to carry out in-depth qualitative interviews with a purposive sample of patients with asthma and COPD taking part in an 8-week mindfulness-based cognitive therapy (MBCT) course to explore their experiences of MBCT. In particular, we were interested in how the mindfulness approach helped them, or not, and their awareness of any meaningful changes in relation to their breathlessness, activity levels, anxiety or low mood. Twenty-two patients were recruited from primary and secondary care to receive an 8-week course in MBCT. Two groups of MBCT were taught by qualified MBCT teachers in a community setting. Of the 22 patients who attended the MBCT course, 12 patients were purposively sampled to take part in an in-depth qualitative interview 2 months after completing the MBCT course. Interviews were digitally recorded and transcribed verbatim. Analysis was thematic. The themes that emerged included greater acceptance and reduced sense of disease-related stigma; noticing subtle bodily sensations to detect early warning signs of breathlessness; linking pulmonary rehabilitation advice with mindfulness; developing a new relationship to breathing, activity and associated thoughts; having a greater sense of control; being creative around limitations and removing psychological barriers to being more active. Findings offer, for the first time, qualitative evidence on how MBCT benefits patients with asthma and COPD who experience anxiety and depression. These data provide a useful adjunct to existing quantitative evidence in this area.
BackgroundDepression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating depression and maintenance anti-depressants (m-ADM) can prevent relapse. However, individuals with depression often express a wish for psychological help that can help them recover from depression in the long-term. We need to develop psychological therapies that prevent depressive relapse/recurrence. A recently developed treatment, Mindfulness-based Cognitive Therapy (MBCT, see http://www.mbct.co.uk) shows potential as a brief group programme for people with recurring depression. In two studies it has been shown to halve the rates of depression recurring compared to usual care.
This trial asks the policy research question, is MBCT superior to m-ADM in terms of: a primary outcome of preventing depressive relapse/recurrence over 24 months; and, secondary outcomes of (a) depression free days, (b) residual depressive symptoms, (c) antidepressant (ADM) usage, (d) psychiatric and medical co-morbidity, (e) quality of life, and (f) cost effectiveness? An explanatory research question asks is an increase in mindfulness skills the key mechanism of change?
Methods/Design
The design is a single blind, parallel RCT examining MBCT vs. m-ADM with an embedded process study. To answer the main policy research question the proposed trial compares MBCT plus ADM-tapering with m-ADM for patients with recurrent depression. Four hundred and twenty patients with recurrent major depressive disorder in full or partial remission will be recruited through primary care. Depressive relapse/recurrence over two years is the primary outcome variable. The explanatory question will be addressed in two mutually informative ways: quantitative measurement of potential mediating variables pre/post-treatment and a qualitative study of service users' views and experiences.
Discussion
If the results of our exploratory trial are extended to this definitive trial, MBCT will be established as an alternative approach to maintenance anti-depressants for people with a history of recurrent depression. The process studies will provide evidence about the effective components which can be used to improve MBCT and inform theory as well as other therapeutic approaches.
BACKGROUND:Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating depression and maintenance anti-depressants (m-ADM) can prevent relapse. However, individuals with depression often express a wish for psychological help that can help them recover from depression in the long-term. A recently developed treatment, mindfulness-based cognitive therapy (MBCT), shows potential as a brief group program for people with recurring depression.This trial asks the policy research question; is MBCT with support to taper/discontinue antidepressant medication (MBCT-TS) superior to m-ADM in terms of: a primary outcome of preventing depressive relapse/recurrence over 24 months; and secondary outcomes of (a) depression free days, (b) residual depressive symptoms, (c) antidepressant medication (ADM) usage, (d) psychiatric and medical co-morbidity, (e) quality of life, and (f) cost effectiveness? An explanatory research question also asks whether an increase in mindfulness skills is the key mechanism of change.The design is a single-blind, parallel randomized controlled trial examining MBCT-TS versus m-ADM with an embedded process study. To answer the main policy research question the proposed trial compares MBCT-TS with m-ADM for patients with recurrent depression. Four hundred and twenty patients with recurrent major depressive disorder in full or partial remission will be recruited through primary care.
RESULTS:
Depressive relapse/recurrence over two years is the primary outcome variable. Analyses will be conducted following CONSORT standards and overseen by the trial's Data Monitoring and Safety Committee. Initial analyses will be conducted on an intention-to-treat basis, with subsequent analyses being per protocol. The explanatory question will be addressed in two mutually informative ways: quantitative measurement of potential mediating variables pre- and post-treatment and a qualitative study of service users' views and experiences.
CONCLUSIONS:
If the results of our exploratory trial are extended to this definitive trial, MBCT-TS will be established as an alternative approach to maintenance antidepressants for people with a history of recurrent depression. The process studies will provide evidence about the effective components which can be used to improve MBCT and inform theory as well as other therapeutic approaches.
Yoga has been found effective in the treatment of chronic low back pain. We aimed to evaluate the effectiveness of lyengar yoga in chronic neck pain by means of a randomized clinical trial. Seventy-seven patients (aged 47.9 +/- 7.9, 67 female) with chronic neck pain who scored >40 mm on a 100-mm visual analog scale (VAS) were randomized to a 9-week lyengar yoga program with weekly 90-minute classes (n = 38) or to a self-care/exercise program (n = 38). Patients were examined at baseline and after 4 and 10 weeks. The primary outcome measure was change of mean pain at rest (VAS) from baseline to week 10. Secondary outcomes included pain at motion, functional disability, quality of life (QOL), and psychological outcomes. Twelve patients in the yoga group and 11 patients in the self-care/exercise group were lost to follow-up, with higher study nonadherence in the self-care group (5 versus 10 patients). Mean pain at rest was reduced from 44.3 +/- 20.1 to 13.0 +/- 11.6 at week 10 by yoga and from 41.9 +/- 21.9 to 34.4 +/- 21.1 by self-care/exercise (group difference: -20.1, 95% confidence interval: -30.0, -10.1; P < .001). Pain at motion was reduced from 53.4 18.5 to 22.4 +/- 18.7 at week 10 by yoga and from 49.4 +/- 22.8 to 39.9 +/- 21.5 by self-care/exercise (group difference: -18.7, 95% confidence interval: -29.3, -8.1; P < .001). Significant treatment effects of yoga were also found for pain-related apprehension, disability, QOL, and psychological outcomes. Sensitivity analyses suggested minimal influence of dropout rates. Both programs were well tolerated. In this preliminary trial, yoga appears to be an effective treatment in chronic neck pain with possible additional effects on psychological well-being and QOL. The effectiveness of yoga in chronic neck pain should be further tested by comparative effectiveness studies with longer observation periods. Perspective: This article presents the results of a randomized controlled trial on the clinical effects of a 9-week yoga program or self-care exercise in patients with chronic neck pain. Yoga led to superior pain relief and functional improvements and might be a useful treatment option for chronic neck pain. (C) 2012 by the American Pain Society