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.

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.

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.

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.

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.