Search results
Found 39 matches for Mindfulness for Life
Reducing stress and promoting well-being in healthcare workers using mindfulness-based cognitive therapy for life.
Healthcare workers play a critical role in the health of a nation, yet rates of healthcare worker stress are disproportionately high. We evaluated whether mindfulness-based cognitive therapy for life (MBCT-L), could reduce stress in healthcare workers and target a range of secondary outcomes. Method: This is the first parallel randomised controlled trial of MBCT-L. Participants were NHS workers, who were randomly assigned (1:1) to receive either MBCT-L or wait-list. The primary outcome was self-reported stress at post-intervention. Secondary variables were well-being, depression, anxiety, and work-related outcomes. Mixed regressions were used. Mindfulness and self/other-compassion were explored as potential mechanisms of effects on stress and wellbeing. Results: We assigned 234 participants to MBCT-L (n = 115) or to wait-list (n = 119). 168 (72%) participants completed the primary outcome and of those who started the MBCT-L 73.40% (n = 69) attended the majority of the sessions. MBCT-L ameliorated stress compared with controls (B = 2.60, 95% CI = 1.63‒3.56; d = -0.72; p < .0001). Effects were also found for well-being, depression and anxiety, but not for work-related outcomes. Mindfulness and self-compassion mediated effects on stress and wellbeing. Conclusions: MBCT-L could be an effective and acceptable part of a wider healthcare workers well-being and mental health strategy.
Evaluation of mindfulness-based cognitive therapy for life and a cognitive behavioural therapy stress-management workshop to improve healthcare staff stress: study protocol for two randomised controlled trials.
BACKGROUND: Healthcare workers experience higher levels of work-related stress and higher rates of sickness absence than workers in other sectors. Psychological approaches have potential in providing healthcare workers with the knowledge and skills to recognise stress and to manage stress effectively. The strongest evidence for effectiveness in reducing stress in the workplace is for stress-management courses based on cognitive behavioural therapy (CBT) principles and mindfulness-based interventions (MBIs). However, research examining effects of these interventions on sickness absence (an objective indicator of stress) and compassion for others (an indicator of patient care) is limited, as is research on brief CBT stress-management courses (which may be more widely accessible) and on MBIs adapted for workplace settings. METHODS/DESIGN: This protocol is for two randomised controlled trials with participant preference between the two trials and 1:1 allocation to intervention or wait-list within the preferred choice. The first trial is examining a one-day CBT stress-management workshop and the second trial an 8-session Mindfulness-Based Cognitive Therapy for Life (MBCT-L) course, with both trials comparing intervention to wait-list. The primary outcome for both trials is stress post-intervention with secondary outcomes being sickness absence, compassion for others, depression symptoms, anxiety symptoms, wellbeing, work-related burnout, self-compassion, presenteeism, and mindfulness (MBCT-L only). Both trials aim to recruit 234 staff working in the National Health Service in the UK. DISCUSSION: This trial will examine whether a one-day CBT stress-management workshop and an 8-session MBCT-L course are effective at reducing healthcare staff stress and other mental health outcomes compared to wait-list, and, whether these interventions are effective at reducing sickness absence and presenteeism and at enhancing wellbeing, self-compassion, mindfulness and compassion for others. Findings will help inform approaches offered to reduce healthcare staff stress and other key variables. A note of caution is that individual-level approaches should only be part of the solution to reducing healthcare staff stress within a broader focus on organisational-level interventions and support. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN11723441 . Registered on 16 June 2017. Protocol Version 1: 24 April 2017. Trial Sponsor: Sussex Partnership NHS Foundation Trust (ResearchGovernance@sussexpartnership.nhs.uk).
Pathways to mental well-being for graduates of mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR): A mediation analysis of an RCT.
OBJECTIVE: To explore mediated effects of Mindfulness-Based Cognitive Therapy-"Taking it Further" (MBCT-TiF) on mental well-being through changes in mindfulness, self-compassion, and decentering. METHOD: A secondary analysis of an RCT using simple mediation, with 164 graduates of MBCT and mindfulness-based stress reduction (MBSR), was implemented whereby MBCT-TiF (vs ongoing mindfulness practice; OMP) was the independent variable; changes in mindfulness, self-compassion, and decentering during the intervention were the mediators; and mental well-being at post-intervention, whilst controlling for baseline, was the dependent variable. Secondary outcomes included psychological quality of life, depression, and anxiety. RESULTS: Compared to OMP, MBCT-TiF experienced significant improvements in mental well-being through changes in all three mediators (mindfulness: ab = 0.11 [0.03, 0.25]; decentering: ab = 0.16 [0.05, 0.33]; self-compassion: ab = 0.07 [0.01, 0.18]). A similar pattern was demonstrated for depression, but only mindfulness and decentering mediated effects on psychological quality of life and anxiety. CONCLUSION: The findings provide preliminary support for all three mediators in driving change in mental well-being in a sample of MBCT/MBSR graduates. Future work must be theory-driven and powered to test all mediators in parallel and alongside other potential mediators (e.g., equanimity) to further understand independent contributions and interacting effects.Trial registration: ClinicalTrials.gov identifier: NCT05154266.
Efficacy and acceptability of pharmacological and non-pharmacological interventions for non-specific chronic low back pain: a protocol for a systematic review and network meta-analysis.
BACKGROUND: Despite the enormous financial and humanistic burden of chronic low back pain (CLBP), there is little consensus on what constitutes the best treatment options from a multitude of competing interventions. The objective of this network meta-analysis (NMA) is to determine the relative efficacy and acceptability of primary care treatments for non-specific CLBP, with the overarching aim of providing a comprehensive evidence base for informing treatment decisions. METHODS: We will perform a systematic search to identify randomised controlled trials of interventions endorsed in primary care guidelines for the treatment of non-specific CLBP in adults. Information sources searched will include major bibliographic databases (MEDLINE, Embase, CENTRAL, CINAHL, PsycINFO and LILACS) and clinical trial registries. Our primary outcomes will be patient-reported pain ratings and treatment acceptability (all-cause discontinuation), and secondary outcomes will be functional ability, quality of life and patient/physician ratings of overall improvement. A hierarchical Bayesian class-based NMA will be performed to determine the relative effects of different classes of pharmacological (NSAIDs, opioids, paracetamol, anti-depressants, muscle relaxants) and non-pharmacological (exercise, patient education, manual therapies, psychological therapy, multidisciplinary approaches, massage, acupuncture, mindfulness) interventions and individual treatments within a class (e.g. NSAIDs: diclofenac, ibuprofen, naproxen). We will conduct risk of bias assessments and threshold analysis to assess the robustness of the findings to potential bias. We will compute the effect of different interventions relative to placebo/no treatment for both short- and long-term efficacy and acceptability. DISCUSSION: While many factors are important in selecting an appropriate intervention for an individual patient, evidence for the analgesic effects and acceptability of a treatment are key factors in guiding this selection. Thus, this NMA will provide an important source of evidence to inform treatment decisions and future clinical guidelines. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registry number: CRD42019138115.
The effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse/recurrence: results of a randomised controlled trial (the PREVENT study).
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.
A parallel-group, randomized controlled trial into the effectiveness of Mindfulness-Based Compassionate Living (MBCL) compared to treatment-as-usual in recurrent depression: Trial design and protocol.
Mindfulness Based Cognitive Therapy (MBCT) has been shown to reduce the risk of relapse in patients with recurrent depression, but relapse rates remain high. To further improve outcome for this group of patients, follow-up interventions may be needed. Compassion training focuses explicitly on developing self-compassion, one of the putative working mechanisms of MBCT. No previous research has been done on the effectiveness of compassion training following MBCT in patients with recurrent depression.To investigate the effectiveness of Mindfulness-Based Compassionate Living (MBCL) in reducing (residual) depressive symptoms in patients with recurrent depression who previously participated in MBCT.A randomized controlled trial comparing MBCL in addition to treatment as usual (TAU) with TAU only, in patients suffering from recurrent depressive episodes who completed an MBCT course in the past. Assessments will take place at baseline, post-treatment and at six months follow-up. After the control period, patients randomized to the TAU condition will be offered MBCL as well.Primary outcome measure is severity of depressive symptoms according to the Beck Depression Inventory-II (BDI-II) at post-treatment. Secondary outcome measures are presence or absence of DSM-IV depressive disorder, rumination, self-compassion, mindfulness skills, positive affect, quality of life, experiential avoidance and fear of self-compassion.Our study is the first randomized controlled trial to examine the effectiveness of compassion training following MBCT in a recurrently depressed population.ClinicalTrials.gov: NCT02059200, registered 30 January 2014.
The State- and Trait-Level Effects and Candidate Mechanisms of Four Mindfulness-Based Cognitive Therapy (MBCT) Practices: Two Exploratory Studies.
OBJECTIVES: The primary aim was to explore state- and trait-level effects and candidate mechanisms of four Mindfulness-Based Cognitive Therapy (MBCT) practices. METHOD: One hundred sixty adults self-selected from the general population were randomized to one of four mindfulness practices: body scan, mindful movement, breath and body, and befriending. Study 1 explored state-level self-compassion, mindfulness, decentering (mechanisms), and pleasantness of thoughts, emotions, and body sensations at multiple time points using two single mindfulness sessions. Study 2 explored trait-level self-compassion, mindfulness, decentering, interoceptive awareness, attentional control (mechanisms), anxiety, depression, and psychological quality of life pre-post 2 weeks of daily practice. RESULTS: In study 1, state-level effects were demonstrated in all candidate mechanisms and outcomes within the whole sample across time points (d = 0.27 to 0.86), except for state decentering. After controlling for pre-scores and additional covariates, no between-group effects were found (p = 0.050 to 0.973). In study 2, trait-level effects were demonstrated in psychological quality of life and most candidate mechanisms within the whole sample (d = 0.26 to 0.64) but no between-group effects were found (p = 0.080 to 0.805). Within the whole sample, after controlling for pre-scores, changes in mindfulness, self-compassion, decentering, and interoceptive awareness (i.e. body listening) were associated with improvements in psychological quality of life (r = 0.23 to 0.40) and self-led mindfulness practice (r = 0.18 to 0.23). CONCLUSIONS: Future research should test the generated hypotheses using well-designed, adequately powered, and theory-driven studies that address universal and specific mechanisms in different populations and contexts. PRE-REGISTRATION: This study is not pre-registered. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12671-023-02193-6.
Are People Mindful in Different Ways? Disentangling the Quantity and Quality of Mindfulness in Latent Profiles and Exploring their Links to Mental Health and Life Effectiveness
Copyright © 2017 European Association of Personality Psychology We sought to disambiguate the quantitative and qualitative components of mindfulness profiles, examine whether including ‘nonattachment’ as a subcomponent of mindfulness alters the profiles, and evaluate the extent to which the person-centred approach to understanding mindfulness adds predictive power beyond a more parsimonious variable-centred approach. Using data from a nationally representative sample of Americans (N = 7884; 52% female; Age: M = 47.9, SD = 16), we utilized bifactor exploratory structural equation modelling and latent profile analysis to separate the level and shape of previously identified profiles of mindfulness (Pearson, Lawless, Brown, & Bravo,). Consistent with past research, we identified a judgmentally observing profile and a non-judgmentally aware group, but inconsistent with past research, we did not find profiles that showed high or low levels on all specific aspects of mindfulness. Adding nonattachment did not alter the shape of the profiles. Profile membership was meaningfully related to demographic variables. In models testing the distinctive predictive utility of the profiles, the judgmentally observing profile, compared to the other profiles, showed the highest levels of mental ill-health, but also the highest levels of life satisfaction and effectiveness. We discuss the implications of our study for clinical interventions and understanding the varieties of mindfulness. Copyright © 2017 European Association of Personality Psychology.
Cognitive-behavioural therapy for insomnia (CBT-I) across the life span: Guidelines and clinical protocols for health professionals
In Cognitive-Behavioural Therapy for Insomnia (CBT-I) Across the Life Span: Guidelines and Clinical Protocols for Health Professionals, a team of distinguished medical researchers delivers a comprehensive exploration of various treatment protocols used by health professionals treating patients with insomnia from several different populations. The included treatment protocols are written by members of the European Academy for Cognitive-Behaviour Treatment for Insomnia and reflect the most current practice and theoretical models. The editors have included contributions from leading scholars throughout Europe, as well as up-and-coming researchers with new and exciting data and conclusions to share with the community of health practitioners treating patients experiencing insomnia. In the book, readers will find discussions of the presentation of insomnia in different professional populations - including healthcare workers and shift workers - as well as the presence of common comorbidities. They'll also discover: A thorough introduction to the disorder of insomnia, as well as the use of cognitive-behavioural therapy in the treatment of insomnia patients Comprehensive explorations of the influence of the lifespan and professional factors on the presentation and impact of insomnia on paediatric and adult patients In-depth discussions of frequently occurring comorbidities, including affective disorders, mental disorders, somatic disorders and chronic pain Fulsome treatments of the emotional processes associated with insomnia, including acceptance and commitment therapy and mindfulness training Perfect for psychologists, psychiatrists, social workers and other clinicians engaged in the treatment of insomnia, Cognitive-Behavioural Therapy for Insomnia (CBT-I) Across the Life Span: Guidelines and Clinical Protocols for Health Professionals will also earn a place in the libraries of medical researchers with a professional interest in CBT, insomnia and other sleep disorders.
Recovery from recurrent depression with mindfulness-based cognitive therapy and antidepressants: a qualitative study with illustrative case studies.
OBJECTIVES: This study aimed to describe the recovery journeys of people with a history of recurrent depression who took part in a psychosocial programme designed to teach skills to prevent depressive relapse (mindfulness-based cognitive therapy (MBCT)), alongside maintenance antidepressant medication (ADM). DESIGN: A qualitative study embedded within a multicentre, single blind, randomised controlled trial (the PREVENT trial). SETTING: Primary care urban and rural settings in the UK. PARTICIPANTS: 42 people who participated in the MBCT arm of the parent trial were purposively sampled to represent a range of recovery journeys. INTERVENTIONS: MBCT involves eight weekly group sessions, with four refresher sessions offered in the year following the end of the programme. It was adapted to offer bespoke support around ADM tapering and discontinuation. METHODS: Written feedback and structured in-depth interviews were collected in the 2 years after participants undertook MBCT. Data were analysed using thematic analysis and case studies constructed to illustrate the findings. RESULTS: People with recurrent depression have unique recovery journeys that shape and are shaped by their pharmacological and psychological treatment choices. Their journeys typically include several over-arching themes: (1) beliefs about the causes of depression, both biological and psychosocial; (2) personal agency, including expectations about their role in recovery and treatment; (3) acceptance, both of depression itself and the recovery journey; (4) quality of life; (5) experiences and perspectives on ADM and ADM tapering-discontinuation; and (6) the role of general practitioners, both positive and negative. CONCLUSIONS: People with recurrent depression describe unique, complex recovery journeys shaped by their experiences of depression, treatment and interactions with health professionals. Understanding how several themes coalesce for each individual can both support their recovery and treatment choices as well as health professionals in providing more accessible, collaborative, individualised and empowering care. TRIAL REGISTRATION NUMBER: Clinical trial number ISRCTN26666654; post results.
Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy
Background Mindfulness-based cognitive therapy (MBCT) is an effective group intervention for reducing rates of depression relapse. However, about one-third of graduates experience relapse within 1 year of completing the course. Objective The current study aimed to explore the need and strategies for additional support following the MBCT course. Methods We conducted 4 focus groups via videoconferencing, two with MBCT graduates (n = 9 in each group) and two with MBCT teachers (n = 9; n = 7). We explored participants’ perceived need for and interest in MBCT programming beyond the core program and ways to optimize the long-term benefits of MBCT. We conducted thematic content analysis to identify patterns in transcribed focus group sessions. Through an iterative process, multiple researchers developed a codebook, independently coded the transcripts, and derived themes. Results Participants said the MBCT course is highly valued and was, for some, “life changing.” Participants also described challenges with maintaining MBCT practices and sustaining benefits after the course despite using a range of approaches (ie, community and alumni-based meditation groups, mobile applications, taking the MBCT course a second time) to maintain mindfulness and meditative practice. One participant described finishing the MBCT course as feeling like “falling off a cliff.” Both MBCT graduates and teachers were enthusiastic about the prospect of additional support following MBCT in the form of a maintenance program. Conclusion Some MBCT graduates experienced difficulty maintaining practice of the skills they learned in the course. This is not surprising given that maintained behavior change is challenging and difficulty sustaining mindfulness practice after a mindfulness-based intervention is not specific to MBCT. Participants shared that additional support following the MBCT program is desired. Therefore, creating an MBCT maintenance program may help MBCT graduates maintain practice and sustain benefits longer-term, thereby decreasing risk for depression relapse
Functional impairment, stress, and psychosocial intervention in bipolar disorder.
The longitudinal course of bipolar disorder (BD) is highly impairing. This article reviews recent research on functional impairment in the course of BD, the roles of social and intrafamilial stress in relapse and recovery, and the role of adjunctive psychosocial interventions in reducing risk and enhancing functioning. Comparative findings in adult and childhood BD are highlighted. Life events and family-expressed emotion have emerged as significant predictors of the course of BD. Studies of social information processing suggest that impairments in the recognition of facial emotions may characterize both adult- and early-onset bipolar patients. Newly developed psychosocial interventions, particularly those that focus on family and social relationships, are associated with more rapid recovery from episodes and better psychosocial functioning. Family-based psychoeducational approaches are promising as early interventions for children with BD or children at risk of developing the disorder. For adults, interpersonal therapy, mindfulness-based strategies, and cognitive remediation may offer promise in enhancing functioning.
Review of systematic reviews of non-pharmacological interventions to improve quality of life in cancer survivors.
OBJECTIVES: Over two million people in the UK are living with and beyond cancer. A third report diminished quality of life. DESIGN: A review of published systematic reviews to identify effective non-pharmacological interventions to improve the quality of life of cancer survivors. DATA SOURCES: Databases searched until May 2017 included PubMed, Cochrane Central, EMBASE, MEDLINE, Web of Science, the Cumulative Index to Nursing and Allied Health Literature, and PsycINFO. STUDY SELECTION: Published systematic reviews of randomised trials of non-pharmacological interventions for people living with and beyond cancer were included; included reviews targeted patients aged over 18. All participants had already received a cancer diagnosis. Interventions located in any healthcare setting, home or online were included. Reviews of alternative therapies or those non-English reports were excluded. Two researchers independently assessed titles, abstracts and the full text of papers, and independently extracted the data. OUTCOMES: The primary outcome of interest was any measure of global (overall) quality of life. ANALYTICAL METHODS: Quality assessment assessing methdological quality of systematic reviews (AMSTAR) and narrative synthesis, evaluating effectiveness of non-pharmacological interventions and their components. RESULTS: Of 14 430 unique titles, 21 were included in the review of reviews. There was little overlap in the primary papers across these reviews. Thirteen reviews covered mixed tumour groups, seven focused on breast cancer and one focused on prostate cancer. Face-to-face interventions were often combined with online, telephone and paper-based reading materials. Interventions included physical, psychological or behavioural, multidimensional rehabilitation and online approaches. Yoga specifically, physical exercise more generally, cognitive behavioural therapy (CBT) and mindfulness-based stress reduction (MBSR) programmes showed benefit in terms of quality of life. CONCLUSIONS: Exercise-based interventions were effective in the short (less than 3-8 months) and long term. CBT and MBSR also showed benefits, especially in the short term. The evidence for multidisciplinary, online and educational interventions was equivocal.
Feasibility and Acceptability of Mindfulness-based Cognitive Therapy Compared with Mindfulness-based Stress Reduction and Treatment as Usual in People with Depression and Cardiovascular Disorders: a Three-Arm Randomised Controlled Trial
Depression co-occurs in 20% of people with cardiovascular disorders, can persist for years and predicts worse physical health outcomes. While psychosocial treatments have been shown to treat acute depression effectively in those with comorbid cardiovascular disorders, to date, there has been no evaluation of approaches aiming to prevent relapse and treat residual depression symptoms in this group. Consequently, the current study aimed to examine the feasibility and acceptability of a randomised controlled trial design evaluating an adapted version of mindfulness-based cognitive therapy (MBCT) designed specifically for people with comorbid depression and cardiovascular disorders. A three-arm feasibility randomised controlled trial was conducted, comparing MBCT adapted for people with cardiovascular disorders plus treatment as usual (TAU), mindfulness-based stress reduction (MBSR) plus TAU and TAU alone. Participants completed a set of self-report measures of depression severity, anxiety, quality of life, illness perceptions, mindfulness, self-compassion and affect and had their blood pressure taken immediately before, after and 3 months following the intervention. Those in the adapted-MBCT arm additionally underwent a qualitative interview to gather their views about the adapted intervention. Three thousand four hundred potentially eligible participants were approached when attending an outpatient appointment at a cardiology clinic or via a GP letter following a case note search. Two hundred forty-two (7.1%) were interested in taking part, 59 (1.7%) were screened as being suitable and 33 (< 1%) were eventually randomised to the three groups. Of 11 participants randomised to adapted-MBCT, 7 completed the full course, levels of home mindfulness practice were high and positive qualitative feedback about the intervention was given. Twenty-nine out of 33 randomised participants completed all the assessment measures at all three time points. The means Patient Health Questionnaire (PHQ)-9 scores for the MBCT-Heart and Living Mindfully (HeLM) group were lower at post-intervention and at the 3-month follow-up compared to the MBSR and TAU groups. The sample was heterogeneous in terms of whether they reported current depression or had a history of depression and the time since the onset of cardiovascular disorders (1 to 25 years). The adapted-MBCT intervention was feasible and acceptable to participants; however, certain aspects of the trial design were not. In particular, low recruitment rates were achieved and there was a high withdrawal rate between screening and randomisation. Moreover, the heterogeneity in the sample was high, meaning the adapted intervention was unlikely to be well tailored to all the participants needs. This suggests that if the decision is made to move to a definitive trial, study recruitment procedures will need to be revised to recruit a target sample that optimally matches the adapted intervention.
Update to the study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment depressive relapse/recurrence: the PREVENT trial.
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. TRIAL REGISTRATION: Trial registered 7 May 2009; ISRCTN26666654.
Preventing relapse in recurrent depression using mindfulness-based cognitive therapy, antidepressant medication or the combination: trial design and protocol of the MOMENT study.
UNLABELLED: BACKGROUND: Depression is a common psychiatric disorder characterized by a high rate of relapse and recurrence. The most commonly used strategy to prevent relapse/recurrence is maintenance treatment with antidepressant medication (mADM). Recently, it has been shown that Mindfulness-Based Cognitive Therapy (MBCT) is at least as effective as mADM in reducing the relapse/recurrence risk. However, it is not yet known whether combination treatment of MBCT and mADM is more effective than either of these treatments alone. Given the fact that most patients have a preference for either mADM or for MBCT, the aim of the present study is to answer the following questions. First, what is the effectiveness of MBCT in addition to mADM? Second, how large is the risk of relapse/recurrence in patients withdrawing from mADM after participating in MBCT, compared to those who continue to use mADM after MBCT? METHODS/DESIGN: Two parallel-group, multi-center randomized controlled trials are conducted. Adult patients with a history of depression (3 or more episodes), currently either in full or partial remission and currently treated with mADM (6 months or longer) are recruited. In the first trial, we compare mADM on its own with mADM plus MBCT. In the second trial, we compare MBCT on its own, including tapering of mADM, with mADM plus MBCT. Follow-up assessments are administered at 3-month intervals for 15 months. Primary outcome is relapse/recurrence. Secondary outcomes are time to, duration and severity of relapse/recurrence, quality of life, personality, several process variables, and incremental cost-effectiveness ratio. DISCUSSION: Taking into account patient preferences, this study will provide information about a) the clinical and cost-effectiveness of mADM only compared with mADM plus MBCT, in patients with a preference for mADM, and b) the clinical and cost-effectiveness of withdrawing from mADM after MBCT, compared with mADM plus MBCT, in patients with a preference for MBCT. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00928980.
Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of depressive relapse/recurrence: the PREVENT trial.
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. 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. TRIAL REGISTRATION NUMBER: ISRCTN26666654.
Mindfulness-based cognitive therapy to prevent relapse in recurrent depression.
For people at risk of depressive relapse, mindfulness-based cognitive therapy (MBCT) has an additive benefit to usual care (H. F. Coelho, P. H. Canter, & E. Ernst, 2007). This study asked if, among patients with recurrent depression who are treated with antidepressant medication (ADM), MBCT is comparable to treatment with maintenance ADM (m-ADM) in (a) depressive relapse prevention, (b) key secondary outcomes, and (c) cost effectiveness. The study design was a parallel 2-group randomized controlled trial comparing those on m-ADM (N = 62) with those receiving MBCT plus support to taper/discontinue antidepressants (N = 61). Relapse/recurrence rates over 15-month follow-ups in MBCT were 47%, compared with 60% in the m-ADM group (hazard ratio = 0.63; 95% confidence interval: 0.39 to 1.04). MBCT was more effective than m-ADM in reducing residual depressive symptoms and psychiatric comorbidity and in improving quality of life in the physical and psychological domains. There was no difference in average annual cost between the 2 groups. Rates of ADM usage in the MBCT group was significantly reduced, and 46 patients (75%) completely discontinued their ADM. For patients treated with ADM, MBCT may provide an alternative approach for relapse prevention.
Effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse or recurrence (PREVENT): a randomised controlled trial.
BACKGROUND: Individuals with a history of recurrent depression have a high risk of repeated depressive relapse or recurrence. Maintenance antidepressants for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to medication. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce risk of relapse or recurrence compared with usual care, but has not yet been compared with maintenance antidepressant treatment in a definitive trial. We aimed to see whether MBCT with support to taper or discontinue antidepressant treatment (MBCT-TS) was superior to maintenance antidepressants for prevention of depressive relapse or recurrence over 24 months. METHODS: In this single-blind, parallel, group randomised controlled trial (PREVENT), we recruited adult patients with three or more previous major depressive episodes and on a therapeutic dose of maintenance antidepressants, from primary care general practices in urban and rural settings in the UK. Participants were randomly assigned to either MBCT-TS or maintenance antidepressants (in a 1:1 ratio) with a computer-generated random number sequence with stratification by centre and symptomatic status. Participants were aware of treatment allocation and research assessors were masked to treatment allocation. The primary outcome was time to relapse or recurrence of depression, with patients followed up at five separate intervals during the 24-month study period. The primary analysis was based on the principle of intention to treat. The trial is registered with Current Controlled Trials, ISRCTN26666654. FINDINGS: Between March 23, 2010, and Oct 21, 2011, we assessed 2188 participants for eligibility and recruited 424 patients from 95 general practices. 212 patients were randomly assigned to MBCT-TS and 212 to maintenance antidepressants. The time to relapse or recurrence of depression did not differ between MBCT-TS and maintenance antidepressants over 24 months (hazard ratio 0·89, 95% CI 0·67-1·18; p=0·43), nor did the number of serious adverse events. Five adverse events were reported, including two deaths, in each of the MBCT-TS and maintenance antidepressants groups. No adverse events were attributable to the interventions or the trial. INTERPRETATION: We found no evidence that MBCT-TS is superior to maintenance antidepressant treatment for the prevention of depressive relapse in individuals at risk for depressive relapse or recurrence. Both treatments were associated with enduring positive outcomes in terms of relapse or recurrence, residual depressive symptoms, and quality of life. FUNDING: National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme, and NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula.
Systematic review and meta-analysis of transdiagnostic psychological treatments for anxiety and depressive disorders in adulthood.
A broad array of transdiagnostic psychological treatments for depressive and anxiety disorders have been evaluated, but existing reviews of this literature are restricted to face-to-face cognitive behavioural therapy (CBT) protocols. The current meta-analysis focused on studies evaluating clinician-guided internet/computerised or face-to-face manualised transdiagnostic treatments, to examine their effects on anxiety, depression and quality of life (QOL). Results from 50 studies showed that transdiagnostic treatments are efficacious, with large overall mean uncontrolled effects (pre- to post-treatment) for anxiety and depression (gs=.85 and .91 respectively), and medium for QOL (g=.69). Uncontrolled effect sizes were stable at follow-up. Results from 24 RCTs that met inclusion criteria showed that transdiagnostic treatments outperformed control conditions on all outcome measures (controlled ESs: gs=.65, .80, and .46 for anxiety, depression and QOL respectively), with the smallest differences found compared to treatment-as-usual (TAU) control conditions. RCT quality was generally poor, and heterogeneity was high. Examination of the high heterogeneity revealed that CBT protocols were more effective than mindfulness/acceptance protocols for anxiety (uncontrolled ESs: gs=.88 and .61 respectively), but not depression. Treatment delivery format influenced outcomes for anxiety (uncontrolled ESs: group: g=.70, individual: g=.97, computer/internet: g=.96) and depression (uncontrolled ESs: group: g=.89, individual: g=.86, computer/internet: g=.96). Preliminary evidence from 4 comparisons with disorder-specific treatments suggests that transdiagnostic treatments are as effective for reducing anxiety, and may be superior for reducing depression. These findings show that transdiagnostic psychological treatments are efficacious, but higher quality research studies are needed to explore the sources of heterogeneity amongst treatment effects.