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.

Cost-effectiveness analyses of augmented cognitive behavioral therapy for pharmacotherapy-resistant depression at secondary mental health care settings.

AIM: Pharmacotherapy is the primary treatment strategy in major depression. However, two-thirds of patients remain depressed after the initial antidepressant treatment. Augmented cognitive behavioral therapy (CBT) for pharmacotherapy-resistant depression in primary mental health care settings proved effective and cost-effective. Although we reported the clinical effectiveness of augmented CBT in secondary mental health care, its cost-effectiveness has not been evaluated. Therefore, we aimed to compare the cost-effectiveness of augmented CBT adjunctive to treatment as usual (TAU) and TAU alone for pharmacotherapy-resistant depression at secondary mental health care settings. METHODS: We performed a cost-effectiveness analysis at 64 weeks, alongside a randomized controlled trial involving 80 patients who sought depression treatment at a university hospital and psychiatric hospital (one each). The cost-effectiveness was assessed by the incremental cost-effectiveness ratio (ICER) that compared the difference in costs and quality-adjusted life years, and other clinical scales, between the groups. RESULTS: The ICERs were JPY -15 278 322 and 2 026 865 for pharmacotherapy-resistant depression for all samples and those with moderate/severe symptoms at baseline, respectively. The acceptability curve demonstrates a 0.221 and 0.701 probability of the augmented CBT being cost-effective for all samples and moderate/severe depression, respectively, at the threshold of JPY 4.57 million (GBP 30 000). The sensitivity analysis supported the robustness of our results restricting for moderate/severe depression. CONCLUSION: Augmented CBT for pharmacotherapy-resistant depression is not cost-effective for all samples including mild depression. In contrast, it appeared to be cost-effective for the patients currently manifesting moderate/severe symptoms under secondary mental health care.

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.

Does the rapid response of an antidepressant contribute to better cost-effectiveness? Comparison between mirtazapine and SSRIs for first-line treatment of depression in Japan.

AIM: Previous studies indicate that mirtazapine is unique in its quick responsiveness compared to other antidepressants. Although some other studies have evaluated its cost-effectiveness, they have not considered its early stage remission rate. The aim of this study was to address this research gap by using precise clinical data to evaluate the cost-effectiveness of mirtazapine in Japan. METHODS: We developed a Markov model to reflect the week-by-week transition probabilities. The Markov cycle was set as 1 week. While our clinical parameters were obtained largely from existing meta-analyses, cost data were derived from government reports. Cost-effectiveness was evaluated by incremental cost-effectiveness ratios (ICERs) per quality-adjusted life year estimated based on the probability sensitivity analyses. The ICERs were estimated at 2, 8, 26, and 52 weeks. RESULTS: In severe depression, the ICERs ranged between JPY 872 153 and 1 772 723. The probability of mirtazapine being cost-effective ranged from 0.75 to 0.99 when the ICER threshold was JPY 5 000 000. In moderate depression, the ICERs ranged between JPY 2 356 499 and 4 770 145. The probability of mirtazapine being cost-effective ranged from 0.55 to 0.83 when the ICER threshold was JPY 5 000 000. CONCLUSION: When considering the early stage efficacy of mirtazapine, it appeared to be cost-effective compared to selective serotonin reuptake inhibitors, especially for severe depression and in the early stage treatment in the Japanese setting. However, our study has some limitations. First, mirtazapine is compared with batched selective serotonin reuptake inhibitors rather than individual ones. Second, we did not consider antidepressant combination therapy as treatment options.

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.

Predictive factors associated with psychological distress of caregivers of people with dementia in Japan: a cross-sectional study.

ABSTRACTBackground:Caregivers of people with dementia are likely to have psychological distress that sometimes results in mental health problems, such as depression. The objective of this study was to examine some predictive factors that are thought to be associated with psychological distress of caregivers of people with dementia in Japan. METHODS: Design: A cross-sectional study. SAMPLE: As part of a study to estimate the cost of dementia in Japan, 1,437 people with dementia-caregiver dyads were enrolled in the current informal care time study. The measurements in the study included were the basic characteristics of the caregivers and the people with dementia, and the informal care time during a week. ANALYSIS: Factors that predict caregivers' psychological distress, which was measured by Kessler's Psychological Distress scale (K6) score, were evaluated using univariate and multivariate regression analyses. RESULTS: Approximately 69% of the caregivers recorded a K6 score higher than 4, while 18% scored higher than 12. According to the results of the logistic regression analysis (cut-off 4/5), the K6 score was associated with mental and comorbid diseases of people with dementia, informal care time, its lower number of caregivers, and the level of nursing care. According to the results of logistic regression analysis (cut-off 12/13), the K6 score was associated with mental symptoms and comorbid disease of people with dementia, sex of caregivers, informal care time, and its lower number of caregivers. CONCLUSION: Our findings indicated that the psychological distress of the caregivers is quite high and that informal care time and behavioral and psychological symptoms of dementia are associated with it. These results corroborate with previous findings.

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.

Impact of continued mindfulness practice on resilience and well-being in mindfulness-based intervention graduates during the COVID-19 pandemic: A cross-sectional study.

Aim: The coronavirus disease 2019 (COVID-19) pandemic has caused unprecedented stress. Mindfulness-based interventions (MBIs) are known to be effective in reducing stress. However, it is unclear how long-term outcomes differ between those who continue mindfulness practice after MBIs and those who do not. In this study, we hypothesized that those who continued mindfulness practice would have higher stress tolerance, and we examined this hypothesis through a survey of MBI graduates. In this study, we examined the association between the continuation of mindfulness practice among MBI completers and individual stress during the COVID-19 epidemic. Methods: A cross-sectional survey of MBI graduates was conducted. The physical and mental health states were compared between those who established a habit of mindfulness practice (practice group) and those who did not (no practice group). Results: The data were collected from 95 participants (response rate: 53.7%). Of the total respondents, 66 (69.5%) practiced mindfulness. Although the degree of perceived stress due to the COVID-19 pandemic was not statistically different between the practice and no practice groups, the practice group showed significantly lower levels of depression (p = 0.007), higher levels of resilience (p = 0.006), higher levels of overall health (p = 0.006), and higher levels of mental health (p = 0.039). The effect of mindfulness practice on reducing depression was fully mediated by resilience. Conclusion: Among MBI graduates, those who regularly practiced mindfulness had lower levels of depression and higher levels of physical and mental health. Thus, the continuation of mindfulness practice increases resilience, buffers against new stressors such as the COVID-19 pandemic, and has the potential to prevent depression.

Formulation of a Mapping Formula to Estimate Well-Being Utility from Clinical Subjective Well-Being Scales.

Purpose: Cost-effective analysis is one of the most useful analyses for political decision-making in medicine under a limited budget. Although the data of the ICEpop CAPability measure for Adults (ICECAP-A) is sometimes essential for the measurement of cost effectiveness, such data are often lacking in most clinical trials. Therefore, a conversion formula (ie mapping) derived from the values of clinical assessment scales into utility is required. Patients and Methods: We used an internet survey where 500 general residents were asked to fill in four kinds of self-reported questionnaires [ICECAP-A, the Satisfaction with Life Scale (SWLS), Flourishing Scale (FS), and the Scale of Positive and Negative Experience (SPANE)]. A beta regression was conducted with the utility assessed by ICECAP-A as a dependent variable. Results: We developed several mapping formulae depending on available questionnaires. These mapping formulae were well-validated in our validation sample. The models using a greater number of questionnaires tended to show better mapping. Conclusion: The mapping function of our formula was within the range of other reported mapping studies. We believe this formula is useful for cost effective analyses of several trials where utility data are lacking.

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.

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.

A comparison of cost-effectiveness between offering antidepressant-CBT combinations first or second, for moderate to severe depression in Japan.

BACKGROUND: It is not clear which method is more cost-effective: To initially provide all depressed patients with combination therapy (COMB; i.e. cognitive behavioural therapy plus pharmacotherapy), followed by antidepressant treatment (AD) for those still in depression; or, to first provide AD for all patients, followed by COMB for non-remission patients. The aim is to investigate whether a COMB-first strategy would be more cost-effective than an AD-first strategy, in treating depression. METHODS: A Markov model was developed to perform the analysis. The primary outcome was the incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) at 104 weeks. Probabilistic sensitivity analysis and scenario analysis were performed, to investigate the uncertainty associated with the clinical parameters and the impact of CBT's cost on the results, respectively. RESULTS: The ICER per QALY at 104 week, was JPY 591,822 (USD 5,725) for moderate depression and JPY 499,487 (USD 4,832) for severe one. The scenario analysis revealed the ICER became JPY 1,147,518 (USD 11,101) for moderate and JPY 968,484 (USD 9,369) for severe when the CBT cost was set as JPY 14,400 (USD 139)(i.e. GBP 96: the unit cost of CBT in UK), which is well below the threshold recommended by NICE (i.e. GBP 20,000-30,000). LIMITATIONS: This is a model-based analysis which was conducted from the health insurance perspective. Then, the analysis from the societal perspective would generate different results. CONCLUSIONS: The results suggest that a COMB-first strategy would be more cost effective than an AD-first strategy.

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.

Does the Combination of the Cognitive Interventions Improve the Function of Daily Living and Save the Long-Term Care Cost? A Pilot Study of Effectiveness and Cost Saving Analysis of "Learning Therapy" for People with Dementia.

BACKGROUND: Although the effects of various types of cognitive interventions have been evaluated, effectiveness and cost-saving effect of the combination of the different cognitive interventions is unknown. OBJECTIVE: This study aimed to evaluate the feasibility of conducting a definitive trial to assess the effectiveness of combined cognitive intervention. METHODS: A matched controlled trial of learning therapy (LT), a combination of cognitive training and stimulation, was conducted. The samples were recruited from the nursing homes. Inclusion criteria were as follows: age 65 years or older, clinical diagnosis of dementia, level of activities of daily living at II or above, Mini-Mental State Examination score between 10 and 26, receiving long-term-care services without history of LT, and provision of written consent. The primary outcomes were safety, validity of eligibility, retention rate, and effect on the functions of daily living represented by Criterion Time for Certification of Needed Long-Term-Care (CT for CNLTC) at 12 months. Cost-benefit analysis was also conducted to assess the cost saving effect of LT. RESULTS: No serious adverse events were detected. The exclusion rate at the screening phase was 5% and the retention rate was 77% at 12 months. LT demonstrated statistically significant improvement in CT for CNLTC at 12 months (Δ=18.8, almost equivalent to "one" degree of the care needed level) and saved the long-term-care cost by JPY 200,000 (USD 1,618). CONCLUSIONS: LT is effective for improving care recipients' level of care needed and has a cost saving effect. A randomized controlled trial is required to verify these findings. CLINICAL TRIAL REGISTRATION: This study was approved by the ethics committee at Keio University School of Medicine (ID: 20150061). This trial was registered at University hospital Medical Information Network Clinical Trial Registry (UMIN-CTR ID: UMIN000018223).

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.

Predictive factors of the duration of sick leave due to mental disorders.

BACKGROUND: This study aimed to examine potential predictors of duration of sick leave due to mental disorders in Japan. METHODS: A total of 207 employees at a manufacturing company in Japan with a past history of sick leave due to mental disorders participated in this study. Mental disorders were defined as those listed in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). All of the participants used the mental health program that the company provided. The predictive power of the variables was tested using a Cox proportional hazard analysis. The hazard ratios in the final model were used to identify the predictor variables of the duration of sick leave. We included socio-demographic (age, sex, tenure), clinical (diagnosis and number of previous sick leave), and work-related factors (employment rank) as possible predictors. Data on these variables were obtained through the psychiatrists and psychologists in the company's mental health program. RESULTS: The results of the univariate analyses showed that the number of previous sick leave episodes, diagnosis and employee rank were significant predictors of the duration of sick leave due to mental disorders. A multivariate analysis indicated that age, number of previous sick leave and employee rank were statistically significant predictors of return to work. CONCLUSIONS: Diagnosis, number of previous sick leave episodes, and employee rank are predictors of the duration of sick leave due to mental disorders. This study's findings have implications in the development of effective interventions to prevent protracted sick leave.

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).