Economic Evaluation Alongside a Randomized Controlled Trial of Mindfulness-Based Cognitive Therapy in Healthy Adults.

Purpose: This study aimed to conduct an economic evaluation of mindfulness-based cognitive therapy (MBCT) in healthy participants by performing cost-utility analysis (CUA) and cost-benefit analysis (CBA). Patients and Methods: CUA was carried out from a healthcare sector perspective and CBA was from the employer's perspective in parallel with a randomized controlled trial. Of the 90 healthy participants, 50 met the inclusion criteria and were randomized to the MBCT group (n = 25) or wait-list control group (n = 25). In the CUA, intervention costs and healthcare costs were included, while the mean difference in the change in quality-adjusted life years (QALYs) between the baseline and 16-week follow-up was used as an indicator of effect. Incremental cost-effectiveness ratio (ICER) was produced, and uncertainty was addressed using non-parametric bootstrapping with 5000 replications. In the CBA, the change in productivity losses was reflected as a benefit, while the costs included intervention and healthcare costs. The net monetary benefit was calculated, and uncertainty was handled with 5000 bootstrapping. Healthcare costs were measured with the self-report Health Service Use Inventory. The purchasing power parity in 2019 was used for currency conversion. Results: In the CUA, incremental costs and QALYs were estimated at JPY 19,700 (USD 189) and 0.011, respectively. The ICER then became JPY 1,799,435 (USD 17,252). The probability of MBCT being cost-effective was 92.2% at the threshold of 30,000 UK pounds per QALY. The CBA revealed that MBCT resulted in increased costs (JPY 24,180) and improved work productivity (JPY 130,640), with a net monetary benefit of JPY 106,460 (USD 1021). The probability of the net monetary benefit being positive was 69.6%. Conclusion: The results suggested that MBCT may be more cost-effective from a healthcare sector perspective and may be cost-beneficial from the employer's perspective.

Emotional Exhaustion of Burnout Among Medical Staff and Its Association With Mindfulness and Social Support: A Single Center Study During the COVID-19 Pandemic in Japan.

Background: Although higher rates of burnout have been reported during the COVID-19 pandemic, the contribution of the modifiable factors is lesser-known. We investigated how the risk of emotional exhaustion was associated with mindfulness skills and social support in a single medical center in Japan. Methods: We conducted a cross-sectional web survey on mental health for all staff of a national medical hospital from February to March 2021. We examined the association between self-rated emotional exhaustion and levels of mindfulness and social support using multivariate logistic regression. Results: Of the 830 participants, signs of emotional exhaustion were observed in 261 (31%) individuals. Among those highly exposed to the virus at work, individuals with low levels of mindfulness and social support had significantly higher odds of emotional exhaustion [OR 3.46 (95% CI; 1.48-8.09), OR; 3.08 (95% CI; 1.33-7.13), respectively] compared to those with high levels. However, among those not highly exposed to the virus, individuals with both low and moderate levels of mindfulness had significantly higher odds of emotional exhaustion. [OR 3.33 (95% CI; 2.22-5.00), OR; 2.61 (95% CI; 1.73-3.94), respectively]. Conclusion: We found that factors associated with emotional exhaustion differed by exposure to SARS-CoV-2. Building mindfulness skills can help reduce the high burden placed on the staff. Additionally, increasing social support may be useful especially for workers highly exposed to SARS-CoV-2.

Effectiveness and Cost-effectiveness of Online Brief Mindfulness-based Cognitive Therapy for the Improvement of Productivity in the Workplace: Study Protocol for a Randomized Controlled Trial.

BACKGROUND: Numerous studies have demonstrated the effectiveness of mindfulness-based programs (MBPs) among both clinical and nonclinical populations. These data document positive impacts in the workplace, including reducing perceived stress and burnout and increasing well-being. However, the effectiveness for productivity, which is of most interest to managers and administrators, is still unclear. In addition, MBPs in the workplace tend to be modified by reducing the number of the program sessions or delivering content online to improve accessibility. To date, however, the impact of MBPs that feature these modifications on productivity in the workplace has not been investigated. OBJECTIVE: The study aims to investigate the effectiveness and cost-effectiveness of online-delivered brief mindfulness-based cognitive therapy (bMBCT) for improving productivity and other work-related outcomes among healthy workers compared to the waitlist control. METHODS: We will conduct a 4-week randomized controlled trial (RCT) with a 6-month follow-up. Employees are included in the study if they (1) are between the ages of 20 and 65 years and (2) work longer than 30 hours weekly. Employees are randomly allocated to either the bMBCT group or the waitlist control group. The primary outcome of the study is the mean difference of productivity measured by the World Health Organization Health and Work Performance Questionnaire (WHO-HPQ) between the groups at 4, 16, and 28 weeks. Secondary outcomes include several clinical outcomes and health economics evaluation. RESULTS: We started recruiting participants in August 2021, and the intervention began in October 2021. A total of 104 participants have been enrolled in the study as of October 2021. The intervention is scheduled to be completed in December 2023. Data collection will be completed by the end of January 2024. CONCLUSIONS: The novelty of the study is that (1) it will investigate bMBCT's effectiveness on productivity, which is still unclear, and (2) samples are recruited from 3 companies in different industries. The limitations of the study are that (1) all measures assessed are in self-report format and (2) we lack an active control group. This study has the potential to provide new data on the relationship between MBPs and occupational health and productivity. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry UMIN000044721; https://tinyurl.com/4e2fh873. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/36012.

Predictors and moderators of outcomes in mindfulness-based cognitive therapy intervention for early breast cancer patients.

OBJECTIVES: To deliver mindfulness-based cognitive therapy (MBCT) efficiently, the present study aimed (1) to identify predictors and moderators of patients who benefit from MBCT for psychological distress and (2) to explore the initial treatment reaction to identify the optimal number of sessions that produce a significant clinical effect. METHODS: This is the secondary analysis of a randomized controlled trial of MBCT for breast cancer patients (N = 74). We classified the participants into remitters vs. non-remitters, and responder vs. non-responders, according to the total score of the Hospital Anxiety and Depression Scale at the end of the intervention. We conducted multivariate analyses to explore for predictors of response and remission. We adopted generalized estimating equations to explore the optimal number of sessions. RESULTS: Sociodemographic and clinical backgrounds did not have significant influence on the treatment outcomes of the MBCT. Better program adherence, which was represented as the participants' better attendance to the MBCT program, was a significant predictor of both remission and response [odds ratio (OR) = 1.90, 95% confidence interval (CI) 1.25-2.89, p = 0.003, and OR = 1.72, 95% CI 1.12-2.65, p = 0.013, respectively]. It was not until seventh session that the remission rate exceeded 50% and the response rate showed significance. SIGNIFICANCE OF RESULTS: Sociodemographic and clinical characteristics did not significantly influence the treatment outcomes, while homework minutes and class attendance had significant effects on treatment outcomes. This implies that MBCT is recommended to any cancer patient, if he/she is motivated to the program, regardless of their sociodemographic and clinical characteristics. Patients are encouraged to attend a standard MBCT program (eight sessions) and do the assigned homework as intensely as possible. Further studies with larger sample and objective measurements are desired.

Effectiveness of Mindfulness-Based Cognitive Therapy With Follow-Up Sessions for Pharmacotherapy-Refractory Anxiety Disorders: Protocol for a Feasibility Randomized Controlled Trial.

BACKGROUND: Augmented mindfulness-based cognitive therapy (MBCT) with treatment as usual (mainly pharmacotherapy) is reported to be effective after treatment for anxiety disorders. However, whether its effectiveness persists in the long term is unclear. OBJECTIVE: This study aims to examine the feasibility, acceptability, and effectiveness of a follow-up program by conducting a feasibility randomized controlled trial (RCT) that compares augmented MBCT with follow-up sessions and that without follow-up sessions in preparation for a definitive RCT. METHODS: The study involves an 8-week MBCT with a 10-month follow-up. Patients aged 20 to 65 years who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for panic disorder, agoraphobia, or social anxiety disorder, which is not remitted with usual treatment for at least 4 weeks, will be included in the study and randomly allocated to receive augmented MBCT with follow-up sessions or augmented MBCT without follow-up sessions. For this feasibility RCT, the primary outcomes are (1) study inclusion rate, (2) dropout rate, (3) attendance rate, and (4) mean and standard deviation of several clinical measures at 8 weeks and 5, 8, and 12 months. RESULTS: We started recruiting participants in January 2020, and 43 participants have been enrolled up to January 2021. The study is ongoing, and data collection will be completed by May 2022. CONCLUSIONS: This study is novel in terms of its design, which compares augmented MBCT with and without follow-up sessions. The limitations of the trial are as follows: (1) mixed participants in terms of the delivery mode of the intervention, and (2) lack of a pharmacotherapy-alone arm. Owing to its novelty and significance, this study will provide fruitful knowledge for future definitive RCTs. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000038626; https://tinyurl.com/2p9dtxzh. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33776.

A Long-Term Pilot Study of Mindfulness-Based Cognitive Therapy for Subjective Well-Being Among Healthy Individuals in Comparison with Clinical Samples.

PURPOSE: Mindfulness-based cognitive therapy (MBCT) could be an intervention for improving subjective well-being among healthy individuals (HIs). However, MBCT studies for HIs to improve their subjective well-being are rare. The aim of this study was to report the feasibility, safety and effectiveness of MBCT for HIs in comparison with clinical samples. PATIENTS AND METHODS: We conducted a single-arm, pre-post comparison pilot study offering MBCT to both HIs and people with common mental disorders. Twenty-four participants in total were included in the study. Eight weekly two-hour sessions with six monthly boosters were offered to all participants. Assessment was carried out at baseline, week 4, 8, and during follow-up. The 5-item World Health Organization Well-Being Index (WHO-5) was the primary clinical outcome measure. RESULTS: The results showed the MBCT is sufficiently safe and would be more feasible in HIs compared to in clinical samples (attendance rate: 81.5% vs 61.3%, p=0.06). Although Satisfaction with Life Scale, the other scale of subjective well-being used, improved significantly at week 20 (p=0.01), no significant improvement was seen in WHO-5. The results of the sub-group analysis revealed WHO-5 improved significantly at week 8 and 32 among the subjects whose baseline scores began in the lower half. CONCLUSION: MBCT is sufficiently safe and would be more feasible with HIs compared to the clinical samples. In designing randomized controlled trials, selecting HIs with lower subjective well-being would be reasonable to minimize the "ceiling effect" on outcomes.

Effectiveness of Mindfulness-Based Cognitive Therapy for Improving Subjective and Eudaimonic Well-Being in Healthy Individuals: A Randomized Controlled Trial.

Objectives: Better subjective and eudaimonic well-being fosters better health conditions. Several studies have confirmed that mindfulness-based interventions are effective for improving well-being; however, the samples examined in these studies have been limited to specific populations, and the studies only measured certain aspects of well-being rather than the entire construct. Additionally, few studies have examined the effect of mindfulness-based cognitive therapy on well-being. The present study examines the feasibility of mindfulness-based cognitive therapy and its effectiveness for improving subjective and eudaimonic well-being among community residents. Methods: The study design featured an 8-week randomized, waiting-list controlled, parallel-group study. 8 weekly mindfulness classes, followed by 2 monthly classes, were provided for healthy individuals aged 20-65 years who had a Satisfaction with Life Scale score of ≤ 24 indicating average to low cognitive aspect of subjective well-being. This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (ID: UMIN000031885, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036376). Results: The results showed that cognitive aspect of subjective well-being and mindfulness skills were significantly improved at 8 weeks, and this effect was enhanced up to the end of the follow-up period. Positive affective aspect of subjective and eudaimonic well-being were significantly improved at 16 weeks. Conclusions: Eight weeks of mindfulness-based cognitive therapy with a 2-month follow-up period improves cognitive and affective aspects of subjective and eudaimonic well-being in healthy individuals. The order of improvement was cognitive, positive affective, and eudaimonic well-being. To verify these findings, multi-center randomized controlled trials with active control groups and longer follow-up periods are warranted.

Effectiveness of mindfulness-based interventions for people with dementia and mild cognitive impairment: A meta-analysis and implications for future research.

OBJECTIVE: To assess the effectiveness of mindfulness-based interventions on people with dementia and mild cognitive impairment. METHODS: We searched several electronic databases, namely Cochrane Library, EMBASE, and MEDLINE with no limitations for language or document type (last search: 1 February 2020). Randomized controlled trials of mindfulness-based interventions for people with dementia and mild cognitive impairment compared to active-control interventions, waiting lists, or treatment as usual were included. Predefined outcomes were anxiety symptoms, depressive symptoms, cognitive function, quality of life, mindfulness, ADL and attrition. We used the random effects model (DerSimonian-Laird method) for meta-analysis, reporting effect sizes as Standardized Mean Difference. Heterogeneity was assessed with the I2 statistics. RESULTS: Eight randomized controlled trials, involving 276 patients, met the eligibility criteria and were included in the meta-analysis. We found no significant effects for mindfulness-based interventions in either the short-term or the medium- to long-term on any outcomes, when compared with control conditions. The number of included studies and sample sizes were too small. Additionally, the quality of evidence was low for each randomized controlled trial included in the analysis. This is primarily due to lack of intent-to-treat analysis, high risk of bias, and imprecise study results. The limited statistical power and weak body of evidence prevented us from reaching firm conclusions. CONCLUSIONS: We found no significant effects of mindfulness-based interventions on any of the outcomes when compared with control conditions. The evidence concerning the efficacy of mindfulness-based interventions in this population is scarce in terms of both quality and quantity. More well-designed, rigorous, and large-scale randomized controlled trials are needed.

Mindfulness-Based Cognitive Therapy for Improving Subjective Well-Being Among Healthy Individuals: Protocol for a Randomized Controlled Trial.

BACKGROUND: Previous studies have indicated that higher subjective well-being works as a protective factor for health. Some studies have already shown the effects of mindfulness-based interventions on improving subjective well-being. However, these studies targeted specific populations rather than the general public. Furthermore, they assessed either life evaluation or affective aspects of subjective well-being rather than the concept as a whole, including the eudemonic aspect of well-being. OBJECTIVE: This study aims to investigate the effectiveness and cost-effectiveness of mindfulness-based cognitive therapy (MBCT) for improving the wholistic aspects of subjective well-being in healthy individuals. METHODS: This study was an 8-week, randomized, parallel-group, superiority trial with a 2-month follow-up. Healthy individuals aged 20-65 years with scores lower than 25 on the Satisfaction With Life Scale (SWLS) were eligible to participate and randomly allocated to the MBCT group or the wait-list control group. The intervention program was developed by modifying an MBCT program to improve the well-being of a nonclinical population. The primary outcome was the difference between the two groups in mean change scores from the baseline on the SWLS. The secondary outcomes included scores on the Flourishing Scale and the Scale of Positive and Negative Experience as well as the incremental cost-effectiveness ratio. RESULTS: This study began recruiting participants in July 2018 and recruitment was completed at the end of September 2019. Data collection and dataset construction was completed by the end of March 2020. CONCLUSIONS: This study is unique in that it investigates MBCT's effects on the three different aspects of subjective well-being: life evaluation, affect, and eudemonia. It is limited, as the specific effect attributable to MBCT cannot be detected because of the lack of an active control group. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000031885; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036376. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15892.

Mindfulness-Based Cognitive Therapy for Psychological Distress, Fear of Cancer Recurrence, Fatigue, Spiritual Well-Being, and Quality of Life in Patients With Breast Cancer-A Randomized Controlled Trial.

CONTEXT: Mindfulness-based interventions have been receiving growing attention in cancer care. OBJECTIVES: The purpose of this randomized controlled trial is to examine the effectiveness of mindfulness-based cognitive therapy (MBCT) for psychological distress (anxiety and depression), fear of cancer recurrence (FCR), fatigue, spiritual well-being, and quality of life (QOL) in Japanese ambulatory patients with Stage I-III breast cancer. METHODS: A total of 74 patients were randomly assigned to either an eight-week MBCT intervention group (n = 38) or a wait-list control group (n = 36). The primary outcome was psychological distress, measured on Hospital Anxiety and Depression Scale. The secondary outcomes were FCR (Concerns About Recurrence Scale-overall anxiety subscale), fatigue (Brief Fatigue Inventory), spiritual well-being (Functional Assessment of Chronic Illness Therapy-Spiritual), QOL (Functional Assessment of Cancer Therapy-General), and mindfulness skills (Five Facet Mindfulness Questionnaire). The participants were assessed at baseline (T0), Week 8 (T1), and Week 12 (T2). The results were analyzed using a intention-to-treat linear mixed model. RESULTS: The participants in the MBCT group experienced significantly better outcomes in their psychological distress (Cohen's d = 1.17; P < 0.001), FCR (d = 0.43; P < 0.05), fatigue (d = 0.66; P < 0.01), spiritual well-being (d = 0.98; P < 0.001), and QOL (d = 0.79; P < 0.001) compared with the control group. The difference remained significant at T2 (four weeks after completion of the intervention). CONCLUSION: MBCT was demonstrated to improve well-being that encompasses psychological, physical, and spiritual domains in Japanese patients with nonmetastatic breast cancer. The favorable effect was maintained up to four weeks after the completion of the intervention.

Effectiveness of mindfulness-based cognitive therapy in patients with anxiety disorders in secondary-care settings: A randomized controlled trial.

AIM: The primary objective of this study was to examine the effectiveness of mindfulness-based cognitive therapy (MBCT) in secondary-care settings where the vast majority of the patients have already undergone pharmacotherapy but have not remitted. METHODS: Eligible participants were aged between 20 and 75 years and met the criteria for panic disorder/agoraphobia or social anxiety disorder specified in the DSM-IV. They were randomly assigned to either the MBCT group (n = 20) or the wait-list control group (n = 20). The primary outcome was the difference in mean change scores between pre- and post-intervention assessments on the State-Trait Anxiety Inventory (STAI). The outcome was analyzed using an intent-to-treat approach and a mixed-effect model repeated measurement. RESULTS: We observed significant differences in mean change scores for the STAI State Anxiety subscale (difference, -10.1; 95% confidence interval, -16.9 to -3.2; P < 0.005) and STAI Trait Anxiety subscale (difference, -11.7; 95% confidence interval, -17.0 to -6.4; P < 0.001) between the MBCT and control groups. CONCLUSION: MBCT is effective in patients with anxiety disorders in secondary-care settings where the vast majority of patients are treatment-resistant to pharmacotherapy.

Feasibility study of mindfulness-based cognitive therapy for anxiety disorders in a Japanese setting.

OBJECTIVE: Mindfulness-based cognitive therapy (MBCT) could be a treatment option for anxiety disorders. Although its effectiveness under conditions of low pharmacotherapy rates has been demonstrated, its effectiveness under condition of high pharmacotherapy rate is still unknown. The aim of the study was to evaluate effectiveness of MBCT under the context of high pharmacotherapy rates. RESULTS: A single arm with pre-post comparison design was adopted. Those who had any diagnosis of anxiety disorders, between the ages of 20 and 74, were included. Participants attended 8 weekly 2-hour-long sessions followed by 2 monthly boosters. Evaluation was conducted at baseline, in the middle, at end of the intervention, and at follow-up. The State-Trait Anxiety Inventory (STAI)-state was set as the primary outcome. Pre-post analyses with mixed-effect models repeated measures were conducted. Fourteen patients were involved. The mean age was 45.0, and 71.4% were female. The mean change in the STAI-state at every point showed statistically significant improvement. The STAI-trait also showed improvement at a high significance level from the very early stages. The participants showed significant improvement at least one point in some other secondary outcomes. Trial registration Retrospectively registered at the University Hospital Medical Information Network on 1st August 2013 (ID: UMIN000011347).

Mindfulness-based cognitive therapy for Japanese breast cancer patients-a feasibility study.

OBJECTIVES: Mindfulness-based intervention has been receiving growing attention in cancer care. This study aimed to examine feasibility and to preliminary explore effectiveness of mindfulness-based cognitive therapy (MBCT) in Japanese breast cancer patients, and to explore possible modification of the program so that it fits better with this population. METHODS: Twelve participants with diagnosis of Stage I-III breast cancer received an eight session, weekly MBCT intervention in a group therapy format. The participants were followed up until 3 months after the completion of the program. RESULTS: All the participants completed the program with high attendance rate (mean number of attended sessions = 7.7). Significant improvement in anxiety (Hospital Anxiety and Depression Scale (HADS) - anxiety subscale; effect size Cohen's d = 0.88, P < 0.05), trauma-related psychological symptoms (Impact of Event Scale-revised; d = 0.64, P < 0.01) and quality of life (Functional Assessment of Cancer Therapy-Breast Cancer: FACT-B; d = 0.72, P < 0.01), and trend-level improvement in depression (HADS - depression subscale; d = 0.53, P = 0.054) were observed. Qualitative analyses suggested the program may be beneficial for alleviating fear of cancer recurrence and for increasing spiritual well-being. Some recommended modification of the program was indicated from the post-intervention interviews. CONCLUSIONS: Mindfulness-based cognitive therapy was well accepted by Japanese breast cancer patients and yielded favorable effect on their psychological status and quality of life. Further effectiveness study in a randomized-control design is warranted.

Hypnosis during pregnancy, childbirth, and the postnatal period for preventing postnatal depression.

BACKGROUND: The morbidity caused by postnatal depression is enormous. Several psychological or psychosocial interventions have appeared to be effective for treating the disorder although they have not shown a clear benefit in preventing the development of PND. As yet however, the effectiveness of hypnosis has not been evaluated in relation to this. OBJECTIVES: To assess the effect of hypnosis for preventing postnatal depression compared with usual antenatal, intranatal, or postnatal care. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2011). SELECTION CRITERIA: Randomised controlled trials comparing hypnosis with usual antenatal, intranatal, or postnatal care, where the primary or secondary objective is to assess whether there is a reduced risk of developing postnatal depression. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and assessed the one included study for risk of bias. The included study did not contribute any data for analysis. MAIN RESULTS: There was one included study (involving 63 women). However, as it did not include the outcomes of interest, no data were available for analysis for this review. AUTHORS' CONCLUSIONS: There was no evidence available from randomised controlled trials to assess the effectiveness of hypnosis during pregnancy, childbirth, and the postnatal period for preventing postnatal depression. Evidence from randomised controlled trials is needed to evaluate the use and effects of hypnosis during the perinatal period to prevent postnatal depression. Two trials are currently underway which may provide further information in the future.