Introduction: This study examined the efficacy of an 8-week occupational therapy program incorporating mindfulness (MOT) as a form of psychiatric rehabilitation to ameliorate residual social and occupational impairment in patients with anxiety disorders and depression. The objective was to evaluate the effects of MOT on their personal well-being and to assess the impact of MOT on brain function using quantitative electroencephalography (qEEG). Methods: This study was a randomized, wait-list control trial with assessments performed at baseline, post-intervention (9 weeks), and follow-up (18 weeks) in outpatients with anxiety disorders and depression. The MOT was conducted in small groups, comprising eight weekly 1.5-h sessions. The primary outcome was the mean score change between the pre- and post-interventions with Questionnaire about the Process of Recovery (QPR) scale. Other clinical assessments and qEEG served as secondary and biological outcomes, respectively. Results: A total of 25 patients (mean age: 44.1) were included in the analysis. The MOT group demonstrated a significantly improved QPR compared to the control group after adjusting for baseline covariates (p < 0.01). This improvement was sustained for 9 weeks after the 8-week intervention. In the qEEG analysis, a significant increase in current source density in the β2 band of the left dorsolateral prefrontal cortex was observed in the MOT group compared to the control group (p < 0.02). Conclusion: This study demonstrates that MOT improves subjective well-being and potentially, global function. This suggests that MOT may serve as a viable option for those whose symptoms have abated but who still struggle with social and occupational functioning.

Anxiety and depression are global public health concerns. The global mean prevalence of anxiety disorders and depression is 21.7% and 10.8%, respectively [1], and results in personal suffering and socioeconomic loss [2, 3]. Although many treatment options, including pharmacotherapy, are currently available, many patients have residual impairments in social and occupational roles [4, 5]. Moreover, the rates of anxiety disorders and depression increased in 2020 with the outbreak of the COVID-19 pandemic [6]. Therefore, there is a growing need for more adequate therapeutic interventions that complement these unmet medical needs.

In recent years, personal recovery has gained importance as a treatment goal for mental health [7]. The concept of recovery is subdivided nowadays, with the definition of “clinical recovery” proposed for the improvement of symptoms and functional recovery, and “personal recovery” for the process of finding new meaning and purpose in life and living a fulfilling life despite illness or disability [8‒10]. Even among patients who achieve clinical recovery, there is a certain number for whom personal recovery remains insufficient.

Research on the therapeutic effects of standardized mindfulness-based interventions, such as mindfulness-based stress reduction (MBSR) [11] and mindfulness-based cognitive therapy [12] for anxiety disorders and major depressive disorder (MDD) in clinical populations has been accumulating and has demonstrated efficacy in reducing symptom severity of anxiety disorders and depression and has shown consistent and positive results in improving many biopsychosocial conditions [13‒22]. Mindfulness has also been suggested as a way to cultivate personal qualities that are highly relevant to the recovery of people with mental illness [23]. This, however, has not been extensively researched to date. Despite the potential benefits of these programs for patients, several factors may impede participation: first, they are often run separately from the psychiatric treatment environment that patients commute to; second, few facilities offer them; and third, the length of the 2–2.5-h session [24, 25] may be burdensome for the patients to take part in the program. Fourth, financial barriers, such as self-paying participation fees, are often not covered by insurance or national healthcare systems [26].

Meanwhile, because occupational therapy (OT) is covered by public medical insurance systems or health insurance companies in many countries [27, 28] and is provided at many facilities, we believe that incorporating mindfulness elements into OT will make it easier for patients to make use of it. Patients will have a sense of security if it is provided at their hospital, which will also reduce their financial and time burdens.

OT is a client-centered rehabilitation program that promotes health and well-being through occupation. The primary goal of OT is to enable individuals to participate in everyday life [29]. Mindfulness has a natural fit with occupation; its informal practice of awareness cultivation facilitates heightened engagement in and attunement to activities, while the formal practice of mindfulness through meditation is itself an occupation [30]. Thus, mindfulness and OT are psychoeducational treatments with a great affinity for patients’ goals and ways to achieve them. McVeigh [31] proposes that occupational therapists can play a key role in assisting people in incorporating mindfulness into their daily lives, suggesting that mindfulness could involve “helping clients identify occupations during which they would benefit from greater presence” and which they can use as meditation practices.

Mindfulness-based interventions in healthcare continue to grow in scope with the description of novel protocols, the application of mindfulness to new populations, and the targeting of diverse symptoms [32, 33]. However, few randomized controlled trials (RCTs) have verified their effectiveness, and the lack of evidence indicates the need for further research. Currently, the number of facilities implementing OT programs that incorporate mindfulness meditation is limited [34]. This study refers to an OT program that incorporates mindfulness as mindfulness occupational therapy (MOT).

Regarding brain function, an imbalance between the left and right dorsolateral prefrontal cortex (dlPFC) in MDD [35], brain changes in activity with recovery from depression in response to medication or psychotherapy [36], a relationship between rumination and decreased activation of the left dlPFC [37], and functional changes in the dlPFC after mindfulness meditation [38] have been reported in previous functional imaging studies. However, there have been no reports on the relationship between the effects of MOT and these brain functions. Irrespective of the various methodologies used to investigate the pathology of depression, quantitative electroencephalography (qEEG) studies have demonstrated their potential in delineating the neurophysiological characteristics of individuals suffering from depression [39, 40]. qEEG analysis contributed to the diagnosis and/or furthered patient’s treatment [41], and it may serve as a sensitive indicator of electrophysiological anomalies in patients afflicted with neurological and psychiatric disorders [42]. Within the scope of qEEG, current source density (CSD) analysis evaluates current sources in the extracellular space, which constitute localized sources of field potentials engendered by neuronal activation, and renders a more granular representation of where activity is occurring in the brain [43]. This is particularly useful while identifying the specific cerebral regions involved in a particular task or state. Consequently, we adopted the CSD analysis of qEEG as an objective method to quantify the impact of MOT on the bilateral dlPFC.

To the best of our knowledge, there has been little verification of the effectiveness of MOT. A study [44] verified the effectiveness of MOT in reducing the incidence of impulsive behavior in patients with borderline personality disorders, showing an effect comparable to that of mindfulness meditation. However, the effectiveness of the MOT in patients with anxiety disorders and depression has not yet been verified. We believe that the validation of the effectiveness of the MOT will help increase the number of treatment options for psychiatric patients.

Therefore, this study aimed to evaluate the effect of MOT on personal recovery in patients with anxiety disorders or depression. Furthermore, this study also aimed to evaluate the impact of MOT on brain function through the objective assessment of CSD from qEEG before and after the intervention.

Study Design

This was a randomized wait-list control trial (Fig. 1). Participants were stratified based on sex and randomly assigned to either the intervention group (MOT group) or the control group (wait-list group) using computer-generated randomization. After 8 weeks of intervention, the MOT group was subjected to usual care, whereas the wait-list group underwent an 8-week MOT intervention. The levels of patient functioning and symptom severity were assessed at baseline, at 9 and 18 weeks. Owing to the nature of the intervention, neither the patients nor the instructor were blinded to the randomization status, except for the rater of the objective evaluations. To complete the MOT, patients were required to attend a minimum of five of the eight MOT sessions. This study was conducted at the Kansai Medical University Medical Center. To ascertain the inter-rater reliability, the raters underwent senior rater education and training sessions before starting the study.

Fig. 1.

Study design: a randomized, wait-list control trial with assessments at 0 weeks, 9 weeks, and during the follow-up phase, at 18 weeks. OT program incorporating mindfulness (MOT), treatment as usual (TAU), Questionnaire on the Process of Recovery (QPR), Hamilton Rating Scale for Depression (HAM-D), Clinical Global Impressions-Severity Illness Scale (CGI-S), State-Trait Anxiety Inventory (STAI), Social Adaptation Self-evaluation Scale (SASS), Five Facet Mindfulness Questionnaire (FFMQ), Continuous Performance Test (CPT), Digit Symbol Substitution Test (DSST), and quantitative electroencephalography (qEEG).

Fig. 1.

Study design: a randomized, wait-list control trial with assessments at 0 weeks, 9 weeks, and during the follow-up phase, at 18 weeks. OT program incorporating mindfulness (MOT), treatment as usual (TAU), Questionnaire on the Process of Recovery (QPR), Hamilton Rating Scale for Depression (HAM-D), Clinical Global Impressions-Severity Illness Scale (CGI-S), State-Trait Anxiety Inventory (STAI), Social Adaptation Self-evaluation Scale (SASS), Five Facet Mindfulness Questionnaire (FFMQ), Continuous Performance Test (CPT), Digit Symbol Substitution Test (DSST), and quantitative electroencephalography (qEEG).

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Participants

The participants were recruited between August 2020 and July 2021 at the General Outpatient Clinic of the Department of Neuropsychiatry at Kansai Medical University Medical Center. The eligibility criteria were as follows: (i) age between 20 and 65 years; (ii) fulfillment of the DSM-5 criteria for anxiety disorders and MDD; (iii) not changing psychotropic medications within 1 month prior to entry; (iv) being an outpatient for at least 3 months; (v) understanding that weekly participation and home practice of 10–30 min per day during the 8-week program are expected; and (vi) being able to provide written informed consent. Patients were excluded if they (i) had previous experience with mindfulness-based interventions, (ii) had severe physical problems, (iii) had treatment-resistant depression, (iv) had undergone electroconvulsive therapy, (v) had other psychiatric comorbidities, or (vi) were deemed inappropriate research participants by the principal investigator.

Intervention

The program was conducted once a week for 90 min for 8 weeks in the OT room at the Neuropsychiatry Department of Kansai Medical University Medical Center. To prevent COVID-19 infection, each group consisted of no more than 8 patients at the same time. The MOT is a slightly modified version of the MBSR that consists of sitting meditation (paying attention to one’s breathing), walking meditation (paying attention to physical sensations while walking), raisin exercise (paying attention to sensations while eating raisins), and a body scan (paying attention to the whole body). In addition, the unique part of MOT is to meditate on one’s breathing and physical sensations while performing work activities using clay work, finger paintings, and paper collages. These activities were chosen because they are characterized by the use of sensory-sensitive areas such as the fingers and upper limbs and because they are commonly used in psychiatric OT programs [44]. During the activity, patients are informed that the purpose is not to complete the work but simply to engage in the activity. We encourage them to pay attention to the smell, flexibility, temperature, color, and other characteristics of the materials, as well as to the physical sensations they are experiencing while working, to be aware of the thoughts and feelings that came up, including those thatfloated to the surface, and to notice them. The program includes sharing, in which patients have the opportunity to talk about their own experiences and speak in front of all participants, with the option of not speaking. The program content is listed in Table 1. Besides the program, 10–30 min of daily home practice will be encouraged, which they find easy to work with. The program was administered by the first author, who completed a course on MBSR foundations.

Table 1.

Content of each MOT session

Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8
Introduction (5) Body scan (40) Sitting meditation (20) Sitting meditation (10) Sitting meditation (10) Sitting meditation (10) Sitting meditation (10) Sitting meditation (5) 
Sitting meditation (15) Sharing (10) Sharing (5) Paper collage (20) Learning stress reactivity (20) Mindful yoga (40) Body scan (40) Mindful yoga (30) 
Sharing (5) Clay work (20) Mindful yoga (30) Body scan (25) Mindful yoga (30) Sharing (5) Sharing (5) Mindful yoga (30) 
Raisin exercise (15) Sharing (5) Sharing (10) Awareness of unpleasant events and learning stress (30) Sharing (5) Walking meditation in the garden (15) Finger paintings (15) Sharing (5) 
Mindful yoga (30) Sitting meditation (10) Awareness of pleasant events (20) Sum up (5) Walking meditation (10) Sharing (10) Sharing (5) Review of the program (20) 
Sharing (10) Sum up (5) Sum up (5)  Sharing (50) Communication (5) Awareness of stressful communication (15)  
Sum up (10)    Sum up (10) Sum up (5)   
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8
Introduction (5) Body scan (40) Sitting meditation (20) Sitting meditation (10) Sitting meditation (10) Sitting meditation (10) Sitting meditation (10) Sitting meditation (5) 
Sitting meditation (15) Sharing (10) Sharing (5) Paper collage (20) Learning stress reactivity (20) Mindful yoga (40) Body scan (40) Mindful yoga (30) 
Sharing (5) Clay work (20) Mindful yoga (30) Body scan (25) Mindful yoga (30) Sharing (5) Sharing (5) Mindful yoga (30) 
Raisin exercise (15) Sharing (5) Sharing (10) Awareness of unpleasant events and learning stress (30) Sharing (5) Walking meditation in the garden (15) Finger paintings (15) Sharing (5) 
Mindful yoga (30) Sitting meditation (10) Awareness of pleasant events (20) Sum up (5) Walking meditation (10) Sharing (10) Sharing (5) Review of the program (20) 
Sharing (10) Sum up (5) Sum up (5)  Sharing (50) Communication (5) Awareness of stressful communication (15)  
Sum up (10)    Sum up (10) Sum up (5)   

Bold letters represent meditation with handcrafts.

Parentheses indicate the time (in minutes) required for the program.

Assessments

As declared in the protocol enrolled prior to study entry, the primary outcome was personal recovery, which is considered an important treatment goal for anxiety disorders and depression with stable symptoms and was assessed by the score of change in the Questionnaire about the Process of Recovery (QPR) [45]. Higher scores indicate increased recovery. We used the Japanese version of the QPR, which is a reliable and valid scale for examination [42]. Data on demographics, mental health history, medications, and OT experience were collected at baseline. The time spent practicing at home was recorded after the completion of the intervention. Secondary outcomes were differences in mean score changes between pre- and post-intervention assessments using the Clinical Global Impressions-Severity Illness Scale (CGI-S), Hamilton Rating Scale for Depression (HAM-D), State-Trait Anxiety Inventory (STAI), Social Adaptation Self-evaluation Scale (SASS), Five Facet Mindfulness Questionnaire (FFMQ), Continuous Performance Test (CPT), and Digit Symbol Substitution Test (DSST).

The CGI-S [46] is a measure of symptom severity, treatment response, and treatment efficacy in treatment studies of patients with mental disorders. The HAM-D [47] is a test used by professionals to objectively quantify the state of depression. The HAM-D is widely used not only to evaluate the severity of depression at diagnosis but also to determine the degree of recovery from depression. Higher scores indicated higher levels of depression. The STAI [48] is a commonly used measure of state and trait anxiety. It comprises 20 items that assess state anxiety and 20 items that assess trait anxiety. Higher scores indicated higher levels of anxiety. The SASS [49] is a 20-item scale that measures social motivation and behavior. It covers various areas of social functioning, including work, spare time, family, environmental organization, and coping abilities. Higher scores indicated higher levels of subjective evaluation of social adjustment status. The FFMQ [50] is a 39-item self-report inventory used to assess multiple mindfulness skill constructs. Higher scores indicated higher levels of mindfulness. The reliability and validity of the Japanese version of FFMQ [51] were also evaluated. The CPT [52] measures a person’s sustained and selective attention. After watching the computer screen, the participants had to respond only when the same number appeared in succession. The numbers were 2-digit, 3-digit, and 4-digit. The DSST [53, 54] is a cognitive test that matches symbols to numbers according to a key located at the top of a page. The number of correct symbols constituted the score, and the response time was set to 120 s. Higher scores indicated higher levels of cognition.

An EEG was performed to assess the functional brain changes using an EEG-1100 Nihon Kohden system (Nihon Kohden, Tokyo, Japan) at baseline and, at 9 and 18 weeks. EEG electrodes were placed at 19 locations on the scalp (Fp1/2, F3/4, C3/4, P3/4, O1/2, F7/8, T3/4, T5/6, Fz, Cz, and Pz) according to the international 10/20 system, and the reference electrodes were placed on both earlobes. Resting and eye-closed data were recorded in this study. A qEEG was performed at a sampling rate of 500 Hz for approximately 20 min with the eyes closed at rest. A bandpass filter was applied in the range of 0.3–30 Hz. EEG fragments contaminated with muscle artifacts and eyeblink noise were excluded via visual inspection. After removing the contaminated fragments, we used an artifact detector in the LORETA-KEY software (http://www.uzh.ch/keyinst/loreta.htm) [55] to autonomously distinguish possible artifacts. Finally, 3 min of EEG recording data were obtained from each session for each patient. The CSD was calculated from the EEG data using exact low-resolution brain electromagnetic tomography [52]. The region of interest for the right dlPFC (x = 48, y = 17, z = 38.5) and the left dlPFC (x = −48, y = 17, z = 38.5) in the Montreal Neurological Institute space (Fig. 2) was selected based on a previous study investigating neural targets for enhancing emotion regulation in clinical populations [56]. The four frequency bands used in the analysis were the theta (4–8 Hz), alpha (8.5–13 Hz), beta 1 (13.5–20 Hz), and beta 2 bands (20.5–30 Hz).

Fig. 2.

Location of the regions of interest. The right dlPFC (x = 48, y = 17, z = 38.5) and the left dlPFC (x = −48, y = 17, z = 38.5) in the Montreal Neurological Institute space, based on a previous study (shown in green).

Fig. 2.

Location of the regions of interest. The right dlPFC (x = 48, y = 17, z = 38.5) and the left dlPFC (x = −48, y = 17, z = 38.5) in the Montreal Neurological Institute space, based on a previous study (shown in green).

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Statistical Analyses

Based on the full analysis set principles, only those with pre- and post-intervention data were included in the analyses. All statistical tests were 2-tailed, and statistical significance was set at p <0.05. Differences between the MOT and wait-list groups in terms of demographic and baseline characteristics were assessed using independent t tests and Pearson’s χ2 tests for categorical variables. An analysis of covariance (ANCOVA) was used to assess the change in each outcome measure from baseline to 9 weeks in both groups using the baseline scores of each assessment as a covariate. For the factors significantly associated with primary or secondary outcomes, a multiple regression analysis was added to the statistical model, factoring in the independent variables of the differential diagnoses and concomitant drug-equivalent dose. As for the sub-analysis, to verify whether the effect of MOT was maintained at 18 weeks, a one-way repeated measures analysis of variance (ANOVA) was run on the MOT group. Data were normalized by logarithmic transformation for all analyses in exact low-resolution brain electromagnetic tomography. Statistical analyses were performed using SPSS Statistics 21 for Windows (IBM Corp., Armonk, NY, USA).

Demographic and Clinical Characteristics

Figure 3 shows the flow of the participants from screening to analysis. Of the 35 participants assessed for eligibility, six were excluded (four did not meet the inclusion criteria, and two refused to participate after being informed about the study protocol). The remaining 29 patients were randomly assigned to either the MOT group (n = 15) or the wait-list group (n = 14). In the MOT group, 2 patients dropped out due to the refusal of frequent hospital visits due to concerns about the COVID-19 outbreak. Of the wait-list group, 1 patient withdrew before undergoing the intervention, and one participated in another intervention while waiting; the remaining 13 and 12 patients from each group were included in the analysis.

Fig. 3.

CONSORT flow chart. Participants were randomly assigned to an OT program incorporating mindfulness (MOT) group or wait-list group.

Fig. 3.

CONSORT flow chart. Participants were randomly assigned to an OT program incorporating mindfulness (MOT) group or wait-list group.

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There were no significant differences between the two groups in baseline demographic features, including age, sex, diagnosis, OT experience, duration from the onset, medication use (imipramine-equivalent dose, benzodiazepine-equivalent dose, chlorpromazine-equivalent dose) (Table 2), and clinical measurement scores (Table 3). For qEEG, 1 patient in the wait-list group was excluded for quality control. Therefore, data from the 13 MOT and 11 wait-list groups were used to analyze the qEEG. At the baseline, there were significant differences in the CSD of the left dlPFC in the β1 and β2 bands between groups (Table 4).

Table 2.

Baseline clinical and demographic features

CharacteristicsMOT (n = 13)Wait-list (n = 12)p value
Age, mean ± SD, years 41.9±8.3 46.6±14.1 0.31 
Female, n (%) 7 (47) 8 (53) 0.51 
Diagnosis, n (%) 
 Depression 6 (46) 7 (58) 0.54 
 Anxiety disorder 7 (54) 5 (42) 
OT experience, n (%) 3 (23) 4 (33) 0.57 
Duration from onset, mean ± SD, months 122.2±88.7 123.3±90.7 0.98 
Medication 
 Antidepressanta, mean dose ±SD 42.8±54.3 66.9±62.0 0.31 
 BZDRAsb, dose±SD 6.0±14.3 3.4±4.5 0.56 
 Antipsychotic drugsc, n (mean dose ±SD) 2 (151±107.5) 4 (77.2±52.0) 0.29 
 Other sleep medication, n (%) 9 (69) 9 (75) N.S. 
CharacteristicsMOT (n = 13)Wait-list (n = 12)p value
Age, mean ± SD, years 41.9±8.3 46.6±14.1 0.31 
Female, n (%) 7 (47) 8 (53) 0.51 
Diagnosis, n (%) 
 Depression 6 (46) 7 (58) 0.54 
 Anxiety disorder 7 (54) 5 (42) 
OT experience, n (%) 3 (23) 4 (33) 0.57 
Duration from onset, mean ± SD, months 122.2±88.7 123.3±90.7 0.98 
Medication 
 Antidepressanta, mean dose ±SD 42.8±54.3 66.9±62.0 0.31 
 BZDRAsb, dose±SD 6.0±14.3 3.4±4.5 0.56 
 Antipsychotic drugsc, n (mean dose ±SD) 2 (151±107.5) 4 (77.2±52.0) 0.29 
 Other sleep medication, n (%) 9 (69) 9 (75) N.S. 

OT, occupational therapy; BZDRAs, benzodiazepine receptor agonists.

(ex. suvorexant, ramelteon, lemborexant).

Independent t test and χ2 tests were performed. *p < 0.05 **p < 0.01.

aImipramine-equivalent dose.

bBenzodiazepine-equivalent dose.

cChlorpromazine-equivalent dose.

Table 3.

Changes in outcome measures from baseline to the endpoint in the MOT and wait-list groups

Baseline (mean±SD)p valueAmount of change (mean±SD)Fp valueη2
MOT (n = 13)wait-list (n = 12)MOT (n = 13)wait-list (n = 12)
QPR 45.3±9.0 49.4±15.2 0.42 7.6±5.8 −0.8±6.6 10.2 0.004** 0.32 
HAM-D 15.0±4.8 12.1±8.2 0.28 −5.2±5.2 −1.8 ± 5.2 1.42 0.25 0.06 
CGI-S 4.0±0.6 3.7±1.1 0.34 −1.0±0.9 −0.2±0.6 6.70 0.02* 0.23 
STAI-State 51.0±8.8 50.3±12.3 0.86 −0.8±9.3 −1.8±6.6 0.14 0.71 0.01 
STAI-Trait 60.3±9.0 55.3±11.7 0.24 −3.3±4.6 −2.1±5.5 0.30 0.59 0.01 
SASS 26.1±4.0 29.3±6.8 0.15 1.3±3.6 −1.1±4.4 2.57 0.12 0.10 
FFMQ 108.2±16.5 108.8±17.2 0.92 3.8±8.9 3.8±7.0 0.01 0.94 0.00 
CPT 50.5±9.7 54.3±8.3 0.32 1.5±5.8 −1.6±4.2 2.92 0.10 0.12 
DSST 76.5±12.6 81.2±15.5 0.42 3.3±6.4 1.3±12.9 0.03 0.87 0.00 
Baseline (mean±SD)p valueAmount of change (mean±SD)Fp valueη2
MOT (n = 13)wait-list (n = 12)MOT (n = 13)wait-list (n = 12)
QPR 45.3±9.0 49.4±15.2 0.42 7.6±5.8 −0.8±6.6 10.2 0.004** 0.32 
HAM-D 15.0±4.8 12.1±8.2 0.28 −5.2±5.2 −1.8 ± 5.2 1.42 0.25 0.06 
CGI-S 4.0±0.6 3.7±1.1 0.34 −1.0±0.9 −0.2±0.6 6.70 0.02* 0.23 
STAI-State 51.0±8.8 50.3±12.3 0.86 −0.8±9.3 −1.8±6.6 0.14 0.71 0.01 
STAI-Trait 60.3±9.0 55.3±11.7 0.24 −3.3±4.6 −2.1±5.5 0.30 0.59 0.01 
SASS 26.1±4.0 29.3±6.8 0.15 1.3±3.6 −1.1±4.4 2.57 0.12 0.10 
FFMQ 108.2±16.5 108.8±17.2 0.92 3.8±8.9 3.8±7.0 0.01 0.94 0.00 
CPT 50.5±9.7 54.3±8.3 0.32 1.5±5.8 −1.6±4.2 2.92 0.10 0.12 
DSST 76.5±12.6 81.2±15.5 0.42 3.3±6.4 1.3±12.9 0.03 0.87 0.00 

QPR, Questionnaire about the Process of Recovery; HAM-D, Hamilton Rating Scale for Depression; CGI-S, Clinical Global Impressions-severity Illness Scale; STAI, State-Trait Anxiety Inventory; SASS, Social Adaptation Self-evaluation Scale; FFMQ, Five Facet Mindfulness Questionnaire; CPT, Continuous Performance Test; DSST, Digit Symbol Substitution Test.

An ANCOVA was performed for each score, with baseline data as covariance. *p < 0.05, **p < 0.01.

Table 4.

Changes in EEG from baseline to the endpoint in the MOT and wait-list groups

Baseline (mean±SD)p valueAmount of change (mean±SD)Fp value
MOT (n = 13)wait-list (n = 11)MOT (n = 13)wait-list (n = 11)
Left dlPFC 
 θ −0.26±0.34 −0.22±0.41 0.76 −0.01±0.25 −0.12±0.46 0.5 0.49 
 α −1.06±0.43 −0.89±0.35 0.30 0.03±0.30 −0.01±0.41 0.1 0.77 
 β1 −0.68±0.35 −0.34±0.06 0.009* 0.17±0.24 0.04±0.17 2.1 0.16 
 β2 −0.47±0.32 −0.08±0.22 0.002* 0.20±0.19 0.02±0.14 7.2 0.013* 
Right dlPFC 
 θ −0.23±0.53 −0.12±0.42 0.58 0.06±0.52 0.02±0.45 0.0 0.88 
 α −0.87±0.54 −0.66±0.38 0.29 0.06±0.50 0.09±0.44 0.0 0.88 
 β1 −0.34±0.36 −0.23±0.13 0.35 −0.03±0.38 0.15±0.32 1.5 0.24 
 β2 −0.13±0.38 0.03±0.15 0.20 0.00±0.40 0.09±0.30 0.4 0.56 
Baseline (mean±SD)p valueAmount of change (mean±SD)Fp value
MOT (n = 13)wait-list (n = 11)MOT (n = 13)wait-list (n = 11)
Left dlPFC 
 θ −0.26±0.34 −0.22±0.41 0.76 −0.01±0.25 −0.12±0.46 0.5 0.49 
 α −1.06±0.43 −0.89±0.35 0.30 0.03±0.30 −0.01±0.41 0.1 0.77 
 β1 −0.68±0.35 −0.34±0.06 0.009* 0.17±0.24 0.04±0.17 2.1 0.16 
 β2 −0.47±0.32 −0.08±0.22 0.002* 0.20±0.19 0.02±0.14 7.2 0.013* 
Right dlPFC 
 θ −0.23±0.53 −0.12±0.42 0.58 0.06±0.52 0.02±0.45 0.0 0.88 
 α −0.87±0.54 −0.66±0.38 0.29 0.06±0.50 0.09±0.44 0.0 0.88 
 β1 −0.34±0.36 −0.23±0.13 0.35 −0.03±0.38 0.15±0.32 1.5 0.24 
 β2 −0.13±0.38 0.03±0.15 0.20 0.00±0.40 0.09±0.30 0.4 0.56 

dlPFC, dorsolateral prefrontal cortex; F, F value; p, p value; MOT, OT program incorporating mindfulness; θ, α, β1, β2, bands of the dlPFC regions.

The numbers are represented on a logarithmic scale (except for p and F values).

Independent t test was performed for baseline comparison. *p < 0.05 **p < 0.01.

Analysis of variance was performed for each score. *p < 0.05 **p < 0.01.

Primary Outcome

Table 3 shows the changes in the outcome measures from baseline to endpoint in the two groups. The QPR score for the MOT group increased by 7.6 points, while the wait-list group decreased by 0.8 points from baseline to 9 weeks, with a statistically significant difference (Fig. 4, F = 10.2, p = 0.004). The differences in diagnosis (depression, anxiety) and the equivalent dose of each drug did not influence the results.

Fig. 4.

The QPR score change for the MOT and the wait-list group. Evaluation of the effects of an OT program incorporating mindfulness (MOT) with a Questionnaire about the Process of Recovery (QPR) based on post-pre differences that are subjected to independent t tests to qualify for significance (**p < 0.01).

Fig. 4.

The QPR score change for the MOT and the wait-list group. Evaluation of the effects of an OT program incorporating mindfulness (MOT) with a Questionnaire about the Process of Recovery (QPR) based on post-pre differences that are subjected to independent t tests to qualify for significance (**p < 0.01).

Close modal

Secondary Outcome

The changes in CGI-S showed a significant difference between the two groups, with a score change of −1.0 in the MOT group and −0.2 in the wait-list group (F = 6.7, p = 0.02). For the other scales, no significant differences were observed between the two groups (Table 3). Differences in diagnosis (depression, anxiety) and the equivalent dose of each drug did not influence the results.

EEG Results

The CSD in the β2 band of the left dlPFC after the intervention was +0.2 in the MOT group and +0.02 in the wait-list control group, demonstrating a statistically significant increase in the MOT group compared to the control group (F = 7.2, p = 0.013) (Fig. 5). No significant differences in the pre- and post-intervention changes were observed in the other frequency bands of the left dlPFC or any frequency bands of the right dlPFC between the two groups (Table 4). Consequently, we analyzed the association between the changes in the β2 band of the left dlPFC and the changes in clinical assessment measures before and after MOT intervention. When analyzed the number by total number, changes in the β2 band of the left dlPFC moderately correlated with changes in QPR (r = 0.44, p < 0.05). Conversely, analyzed by group, there is little correlation between the two variables, r = −0.07, in the MOT intervention group. The loss of correlation might have been associated with the decrease in the number of participants, but an association might have existed between QPR and changes in the β2 activity at the dlPFC region, regardless of the MOT intervention.

Fig. 5.

Amount of change in CSD in the beta 2 band of the left dorsolateral prefrontal cortex (ldlPFC). A significant increase in the CSD was seen in the OT program incorporating MOT group compared with the wait-list group (*p < 0.05).

Fig. 5.

Amount of change in CSD in the beta 2 band of the left dorsolateral prefrontal cortex (ldlPFC). A significant increase in the CSD was seen in the OT program incorporating MOT group compared with the wait-list group (*p < 0.05).

Close modal

Sub-Analysis for the Follow-Up Phase

The QPR mean score was 45.3 at baseline, 52.9 at 9 weeks, and 52.5 at 18 weeks (Fig. 6). A repeated measures ANOVA was performed to compare the effect of MOT on the QPR score. Compared with the QPR score before the intervention, there was a significant improvement at 9 weeks (p = 0.001) after the MOT intervention and at 18 weeks (9 weeks after MOT treatment was discontinued) (p = 0.007), confirming that the effect of MOT for 9 weeks remained after the program ended.

Fig. 6.

The QPR mean score at baseline, 9 weeks, and 18 weeks of the OT program incorporating mindfulness (MOT) group. Compared with the QPR score before the intervention, there was a significant improvement at 9 weeks (p = 0.001) after the MOT intervention and at 18 weeks (9 weeks after MOT treatment was discontinued) (p = 0.007).

Fig. 6.

The QPR mean score at baseline, 9 weeks, and 18 weeks of the OT program incorporating mindfulness (MOT) group. Compared with the QPR score before the intervention, there was a significant improvement at 9 weeks (p = 0.001) after the MOT intervention and at 18 weeks (9 weeks after MOT treatment was discontinued) (p = 0.007).

Close modal

Attendance Rate and Practice Time at Home

The average number of times the MOT group participated in the 8-week program was 6.7, and most absences were due to physical illness. The average time for practice at home was 50.5 ± 39.8 min per week.

Adverse Events

No worsening of symptoms or other adverse events were observed as a result of participation in the program, while no change in medication was observed.

This study showed that MOT improved subjective well-being and potentially, the global function; however, no significant effects were observed on specific measures in outpatients with anxiety disorders and MDD in clinical settings. Moreover, the low dropout rate indicates that MOT is a safe and promising intervention. The results of the main analysis revealed significant differences in the QPR questionnaire scores between the two groups. Personal recovery has been conceptualized as a complement to clinical recovery, with the key elements of connectedness, hope and optimism, identity, meaning in life, and empowerment [10, 57], as well as coping with difficulties in life and living [58]. A previous study [59] suggested that mindfulness may be a vital component in promoting personal recovery among people with mental illnesses. We observed that MOT appears to be an effective intervention to promote personal recovery in patients with anxiety disorders and MDD who have difficulties in life and living despite a certain degree of clinical recovery that is difficult to improve with pharmacotherapy alone. Furthermore, the results of the sub-analysis showed that the recovery process was maintained 9 weeks after the end of the program, suggesting that the effects of MOT may persist even after the intervention has ended. The significant improvement in the CGI with the MOT indicated that the severity of the patient’s symptoms also improved objectively. Personal recovery has been defined as a deeply personal, unique process of changing one’s attitudes, values, feelings, goals, skills, and/or roles. It is a way of living a satisfying, hopeful, and contributing life even with the limitations caused by the illness [8]. We believe that the blinded examiner sensed a change and improvement in the patient’s personal recovery by observing their faces and attitudes.

In contrast, no significant differences were found in the symptom rating scales HAM-D and STAI, the social function scale SASS, the mindfulness scale FFMQ, or the cognitive function tests CPT and DSST. This may be partly due to the relatively mild depressive symptoms and cognitive function prior to the intervention, as indicated by the HAM-D score of 15 and the DSST score of 76.5 points. Given the moderate effect sizes observed with HAM-D (η2 = 0.06), SASS (η2 = 0.10), and CPT (η2 = 0.12), MOT might have had some benefit on depressive symptoms, social function, and cognitive function. Moreover, increasing the number of participants may make significant differences. The FFMQ captures five facets of mindfulness, namely, observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Further, higher mindfulness traits (as measured using the FFMQ) are associated with lower levels of depression, anxiety, and stress, and improve levels of well-being [60]. The reason that the MOT interventions did not correlate with the FFMQ in this study may indicate that our program was insufficient to cultivate higher mindfulness traits, or that mindfulness is usually considered to be trait-like and therefore slow to change [61]. As a whole, 8 weeks may not be long enough to evaluate the intervention at this degree of severity in clinical settings. Previous RCTs of vortioxetine that evaluated improvements in cognitive function found significant differences from placebo in participants with poor pre-intervention DSST scores but no differences from placebo in the group with better pre-intervention DSST scores [62, 63].

Another reason could be the time spent practicing it. MOT is a brief intervention compared to MBSR and mindfulness-based cognitive therapy and has demonstrated efficacy in reducing anxiety and depression symptom severity and improving social functioning, mindfulness, and cognitive function. MOT reduced the total program time to less than half that of MBSR and only encouraged home practice to the extent that it was not pressured [64], such as “as much as possible.” This result was only about 1/4 of the expected practice time for MBSR. Regarding the length of the intervention, prior research has found that time spent practicing at home is significantly associated with improvements in mindfulness, symptoms, and measures of well-being [64]. For future interventions, it would be valuable to clarify and confirm the role and importance of home practices in achieving the potential benefits of the program.

As for qEEG, there was a significant difference in the CSD of the left dlPFC in the β2 band between the two groups, suggesting that MOT intervention caused the change in dlPFC function. Previous qEEG studies have correlated high beta activity with anxiety [65, 66] and average low beta relative power wave activity with improvements in anxiety and depression [67]. Thus, the results of the qEEG study, which did not specify brain regions and used a simple method, reported a correlation between excessive high beta activity and symptoms of anxiety and depression, which is not consistent with the results of our current study. Nevertheless, to our knowledge, no study using CSD has mentioned beta waves in these pathologies. Although those findings are not directly comparable to those of the present study due to the lack of information of the brain region, the present results suggest that elevated beta activity in the dlPFC does not seem to be associated with anxiety and depression. Previous fMRI studies analyzing brain function in patients with MDD have shown hypoactivity in the left dlPFC [35], which is associated with cognitive decline and ruminative symptoms of depression [68]. Other studies reported a significant association between well-being and the left dlPFC [69], and that a positive reappraisal technique improved the sense of well-being and showed an increase in metabolic activity in the left dlPFC [70]. Therefore, we consider that the increase in the CSD of the left dlPFC in the MOT group may be related to the improvement of depression and well-being. In a future study, to enhance the sensitivity of the biomarkers, they should include a larger number of participants with a unified diagnosis, severity, and concomitant drug therapy. Biomarkers may become more clinically useful with studies that can assess genuine EEG changes associated with interventions such as MOT for psychiatric disorders.

What Is the Significance of Combining Mindfulness and OT?

First, some patients with anxiety and depression have difficulty participating in long-term silent meditation and paying attention to their breath and bodily sensations because they are easily anxious in silence and are not physically strong. Shorter versions of meditation and some MOT activities help patients pay attention to sensations during activities that involve movement. Thus, it was easier for some patients to adopt the program.

Second, by meditating while performing work activities, we can become aware of the tendency in our daily lives to switch unconsciously to the doing mode and become goal-oriented. People spend their lives almost constantly engaged in purposeful “doing” even when free of obligation or necessity [71]. It is a good exercise to realize this tendency by kneading clay, tearing paper, and applying colors to the fingers. The third is to realize that the experience of accepting “here and now, just as it is,” during goal-oriented activities can reduce the appearance of ruminative thoughts.

Fourth, dropouts were negligible. This may be related to the ease of participation in the program despite the risk of COVID-19 infection and the fact that it was part of the hospital rehabilitation program. Additionally, there was no worsening of symptoms after the end of the program; therefore, we believe that the program can be safely implemented.

Limitations

First, the sample size was small. Many patients were interested in participating in the clinical trial but were reluctant to participate in regular group meetings on site due to the COVID-19 pandemic. Despite the random assignment, some between-group factors differed at baseline, owing to the small sample size. The wide range of standard deviations that occurred as a result of the small sample size suggests that smaller effects may have been missed. Second, the period of 8 weeks might have been insufficient to evaluate mindfulness, as there was no association observed between the MOT intervention group and the FFMQ. Therefore, future studies should implement longer term evaluation. Third, this study was conducted at a single site. Caution should be exercised when generalizing these results. However, there is the advantage of uniform intervention. Fourth, the control group was a wait-list group, not an active control group. It is well known that relationships with others and participation in group activities may influence results. However, as none of the groups changed their medication, we believe that a large bias was adjusted. Fifth, anxiety disorders and MDD were analyzed together. Although differences in the diagnosis did not statistically affect the results, it is necessary to increase the number of participants and analyze the disease for a more uniform analysis. Nevertheless, the QPR is not a disease-specific measure, and it is assumed that the MOT’s main target groups are anxiety disorders and MDD; therefore, we consider the data useful in that sense. Sixth, variations in the concomitant medications for each patient could not be factored out. We confirmed that each drug did not affect the results, but further attempts to single out the concomitant medications may lead to useful results. Seventh, the severity of the patient’s depressive symptoms was moderate or mild in this study. This study included outpatients who were able to continuously visit the hospital for a certain period of time, which resulted in the inclusion of patients with relatively low severity of illness. In the future, similar studies should include inpatients with more severe depressive symptoms to verify the effectiveness of MOT.

Strengths of this Study Encompass

First, as an inaugural RCT evaluating the efficacy of MOT in enhancing personal recovery for anxiety disorders and MDD, although with a limited sample size, the results indicate that MOT elicited improvement in personal recovery. Second, EEG data confirmed functional alterations in the dlPFC as the underlying mechanism. Third, the positive impact of the MOT was sustained post-intervention.

The present findings suggest that MOT can be a practical option for patients whose symptoms have resolved but who are unable to lead a desired social life. Although there are many points to improve, we believe that it makes sense to conduct this intervention within the OT framework, as it has nevertheless shown a certain level of effectiveness.

The Institutional Review Board of Kansai Medical University Medical Center approved this trial on August 4, 2020 (number 2020052). Written informed consent was obtained from all patients. The study protocol was submitted to the University Hospital Medical Information (UMIN) on July 1, 2020, and accepted on August 4, 2020 (UMIN000041874).

The authors have had the following interests over the past 3 years: S. M. received grant funding from the Japan Society for the Promotion of Science and speaker’s honoraria from Meiji Seika Pharma, Sumitomo Pharma, Janssen Pharmaceutical, Otsuka, Takeda Pharmaceutical, and Lundbeck Japan. M.N. received honoraria from Eisai. Y.K. received grant funding from the Japan Society for the Promotion of Science and speaker’s honoraria from Meiji Seika Pharma, Otsuka, Takeda Pharmaceutical, and Sanofi. T.F. received speaker honoraria from Meiji Seika Pharma, Sumitomo Pharma, Janssen Pharmaceutical, Otsuka, Eisai, Pfizer, Takeda Pharmaceutical, and Lundbeck Japan. H.O. received speaker honoraria from Janssen Pharmaceuticals. Y.T. received grant funding from the Japan Society for the Promotion of Science and speaker honoraria from Meiji Seika Pharma, Sumitomo Pharma, Janssen Pharmaceutical, Otsuka, Eisai, Daiichi Sankyo, Pfizer, UCB Japan, Takeda Pharmaceutical, Lundbeck Japan KK, Novartis, Teijin Pharma, and Ono Pharmaceuticals. K.N. received honoraria from the Japan Society for the Promotion of Science and the speaker’s honoraria from Sumitomo Pharma, Janssen Pharmaceutical, and Otsuka. S.I. received grant funding from the Japan Society for the Promotion of Science and speaker’s honoraria from Meiji Seika Pharma, Sumitomo Pharma, Janssen Pharmaceutical, Otsuka, Eisai, Daiichi Sankyo, Pfizer, UCB Japan, Takeda Pharmaceutical, and Lundbeck Japan. T.K. received grant funding from the Japan Society for the Promotion of Science and speaker honoraria from Meiji Seika Pharma, Sumitomo Pharma, Janssen Pharmaceutical, Otsuka, Eisai, UCB Japan, Takeda Pharmaceutical, Lundbeck Japan KK, and Ono Pharmaceutical. M.K. has received grant funding from the Japanese Ministry of Health, Labor and Welfare, the Japan Society for the Promotion of Science, the SENSHIN Medical Research Foundation, the Japan Research Foundation for Clinical Pharmacology, and the Japanese Society of Clinical Neuropsychopharmacology; received speaker’s honoraria from Sumitomo Pharma, Otsuka, Meiji Seika Pharma, Eli Lilly, MSD K.K., Pfizer, Janssen Pharmaceutical, Shionogi, Mitsubishi Tanabe Pharma, Takeda Pharmaceutical, Lundbeck Viatris Inc., Eisai Co., Ltd., and Ono Pharmaceutical; and participated in an advisory/review board for Otsuka, Sumitomo Pharma, Shionogi, and Boehringer Ingelheim.

This study was supported by a grant from the Mental Health Okamoto Memorial Foundation. This agency had no role in data or manuscript preparation.

Atsuko Yamamoto designed the study, performed the clinical assessments, collected the samples, conducted the analyses, contributed to the interpretation of the data, and wrote the first draft of the manuscript. Masaki Kato supervised the study; conducted the analyses; contributed to data interpretation; and wrote, reviewed, and edited the manuscript. Banri Tsukuda, Keiichiro Nishida, and Shunichiro Ikeda conducted the analyses, contributed to data interpretation, and wrote and edited the manuscript. Shota Minami, Seina Hayamizu, Minami Naito, Yosuke Koshikawa, Toshiya Funatsuki, Chikashi Takano, Haruhiko Ogata, Yoshiteru Takekita, and Toshihiko Kinoshita contributed to data acquisition. All authors revised and approved the final version of the manuscript.

All the data generated or analyzed during this study are included in this article. Further inquiries can be directed to the corresponding authors.

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