A Randomized Controlled Trial on the Comparative Effectiveness of Mindfulness-Based Cognitive Therapy and Health Qigong-Based Cognitive Therapy Among Chinese People With Mood Disorders

Background: The goal of this study was to investigate treatment outcome and related intervention processes of mindfulness-based cognitive therapy (MBCT) versus health qigong-based cognitive therapy (HQCT) versus waitlist control (WC) among individuals with mood disorders. Methods: A total of 187 individuals with mood disorders were randomized and allocated into MBCT, HQCT, or WC groups. All participants were assessed at three time points with regard to mood symptoms, physical and mental health status, perceived stress, sleep quality, and self-ecacy. Linear mixed models analysis was used to test the individual growth model by studying the longitudinal data. Results: MBCT and HQCT both produced greater improvements on most outcome measures as compared with WC. Relatively, more reductions of mood symptoms were observed in the HQCT group as compared with the MBCT group. HQCT is more conducive to physical health status whereas MBCT has more favorable mental health outcomes. Individual growth curve models indicated that alternations in perceived stress was the common predictor of mood changes in both intervention groups. Conclusions: The predominant emphasis on physical health in HQCT makes it more acceptable and effective than MBCT as applied in Chinese individuals with mood disorders. The inuence of Chinese culture is discussed.


Background
Mood disorders such as depression and anxiety are very prevalent in China [1], with both of them are among the top 10 causes of disease burden worldwide [2]. Thus, it has prompted the necessity to nd ways for better treatment and planning of care. Individuals may consider psychotherapy instead of pharmaceutical treatment due to possible side effects and potential dependence on medication.
Cognitive behavioral therapy (CBT) has been substantially proven to be an effective psychosocial treatment in managing depression and anxiety [3,4]. However, some reviews showed that the effect sizes of CBT for depression have steadily decreased since its inception four decades ago [5][6][7]. Thus, merely employing CBT might not be su cient in managing mood disorders.
In view of the limitations of mainstream treatments, much attention shifted to alternative forms of therapy. There is a growing interest in studying mind-body interventions (MBIs) for treating depression and anxiety [8,9]. Mindfulness meditation (MM) is one of the prominent examples of MBIs. Review research and meta-analyses have demonstrated its effectiveness in treating depression and anxiety [10,11]. An integration of MM with CBT was suggested to be an effective approach for psychological health and mood symptoms [12,13]. However, MM should only represent the static form of MBIs. Traditionally, there is another dynamic form of MBI with a focus on body movement, which is called health qigong [HQ; 14]. HQ can be viewed as a kind of physical movement with introspective focus of breathing and energy in the body [15]. HQ should be able to reduce depression or anxiety in people with physical or mental illness [16,17]. The combination of HQ with CBT could be considered as one of the major behavioral strategies in countering mood symptoms [18]. There was an attempt to apply the combined form on elderly people [19], but the application on people with mood disorders is still lacking.
Taken together, MM and HQ are both perceived as MBIs and share the common features of a focus on breathing, but they represent two distinct approaches with the emphasis on mind-based practice and body-based movement practice, respectively. The integration of the former with CBT has been proven to be effective in improving mood symptoms. However, the integration of HQ and CBT still requires further research. Moreover, the above-reviewed studies of either MM or HQ seldom used a comparable mind-body intervention for control which may limit the utility in informing clinical practice. In addition, originating as a traditional Chinese health and tness exercise [14], HQ appears to be a preferred form of nonpharmacological therapy for Chinese adults [20]. Thus, it is worthwhile to ll the research gaps by comparing two different forms of MBIs, when integrated with CBT, in a Chinese population. Furthermore, studies suggested that MM is more conducive to mental health condition [21,22] whereas HQ would be more effective in treating physical health outcome [23,24]. Besides, research also demonstrated that both MM and HQ showed certain effects on stress reduction, improvement of sleep quality, and enhancement of self-e cacy [14,22,25,26]. The evidence of alternative health outcomes brought about by combining CBT with these two different forms of MBIs is thus worthy of further investigation. Further investigation is warranted to ll these research gaps.
The overarching objective of the present study was to assess and compare the relative therapeutic effects of mindfulness-based cognitive therapy (MBCT) and health qigong-based cognitive therapy (HQCT) in treating depression and anxiety with a waitlist control (WC) group in a Chinese context. We hypothesized that MBCT and HQCT would lead to improvements in primary and secondary outcomes as compared with the WC group. Speci cally, MBCT should be more favorable to mental health outcomes whereas HQCT should be more promising for physical health effects. Moreover, participants in the HQCT group would have a greater improvement in mood symptoms than counterparts in the MBCT group in a Chinese context.

Method Participants
The present study adopted a three-arm randomized controlled trial (RCT) with waitlist control design. Participants were recruited from a psychiatric outpatient clinic in Hong Kong. Inclusion criteria included: (i) a diagnosis of depression or anxiety disorder based on Diagnostic and Statistical Manual of Mental Disorders [DSM-IV; 27]; (ii) age between 18 and 70 years; (iii) regular psychiatric follow-up; (iv) primary education level or above; (v) no previous experience with cognitive therapy, mindfulness-based intervention, or health qigong. Individuals with comorbid diagnoses of schizophrenia, schizoaffective disorder, substance misuse, organic brain syndrome, or intellectual disabilities were excluded.
A total of 227 individuals showed interest to join the research. They were assessed for eligibility and 40 of them were excluded as they did not meet the inclusion criteria or were unavailable in the scheduled time. Finally, informed consent was obtained from 187 eligible and available participants. After the initial baseline assessment, participants were randomly assigned to one of the study arms using a list of computer-generated random numbers. The generation of random numbers and their assignment was performed by a statistician who is unaware of the research project's aims. Another research assistant, who assisted with the outcome assessment and data analysis, was kept unaware of the group allocation results. Through simple randomization, participants were assigned to one of the study arms in a ratio 1:1:1, namely, (a) MBCT; (b) HQCT; and (c) WC group. The WC group would continue with routine care and could join either MBCT or HQCT after 16 weeks (post nal assessment). During the entire research follow-up, a total of four participants dropped out of the study (2.14% attrition rate). The ow chart of the study is depicted in Fig. 1. Ethical approval was obtained from the Institutional Review Board of the University of Hong Kong/Hong Kong West Cluster of the Hospital Authority (UW18-458). The study adheres to CONSORT guidelines.

Interventions
MBCT is a manualised eight-week group program incorporating various mindfulness and cognitive restructuring techniques [28]. The intervention consists of eight weekly sessions of about two hours each. Quali ed therapists with basic professional training in mindfulness-based interventions, in addition to at least two years' experience conducting mindfulness-based programs, were invited to implement the MBCT group. HQCT is a program of eight weekly sessions with a combination of teaching CBT and HQ techniques. CBT materials were adapted from a Changeways core program [29] which is a psychoeducational group therapy protocol designed for people with mood disorders. Baduanjin was chosen as the HQ practice because it has been perceived as less complicated and without restrictions on time and space [30,31]. Baduanjin is characterized by eight sequential forms of movements which is also perceived as the major behavioral strategy when delivering CBT. Quali ed therapists with basic professional training in CBT and HQ were invited to implement the HQCT group. Participants in the WC group received treatment as usual without any additional intervention.

Measures
Assessments took place at three time points according to the following time schedule: (i) baseline (T0); self-e cacy as tested by the Chinese General Self-e cacy Scale [CGSS; 37]. Other socio-demographic data including age, gender, and educational level were obtained from medical records.

Data analysis
We analyzed the data using SPSS version 24.0. A MANOVA will be conducted for the continuous variables and a chi-square test will be used for the categorical variables, to compare the differences between the primary and secondary outcomes of the three groups. We used the intention-to-treat principle and linear mixed models (LMM) with restricted maximum likelihood estimation. Both intra-and interindividual differences in the growth parameters, including intercepts and slopes, were further We started the analysis with the unconditional mean model that did not contain any predictors, and then we tted the linear and the quadratic growth models to see the change in outcome measures over time. At Level 1, we used the autoregressive covariance structure (AR1) with homogeneous variances [39,40]. At Level 2, we chose a better model based on a smaller value of the Akaike information criterion (AIC). In addition, for comparison of group differences, we also reported effect sizes as Cohen's d [41]. Finally, individual growth model with time invariant and time variant predictors was conducted for both intervention groups.

Demographic characteristics and clinical outcome variables
Recruitment and follow-ups took place over 12 months from November 2018 to November 2019. The demographic characteristics of the participants are summarized by group in Table 1. The mean age was 50.5 years (standard deviation = 10.9). The majority of the participants were female (70.6%) and had a secondary education level (55.1%). The descriptive statistics of the outcome variables at the three time points by group are also shown in Table 1. There were no signi cant differences in the demographic data and outcome variables at baseline when comparing groups. The growth trajectories of different outcome variables among three groups are depicted in Figs. 2 to 7.

Unconditional mean model
The results of the null model suggested that the development of a multilevel model is warranted because intercepts varied signi cantly across individuals (Wald Z = 8.778, p < .001), and the intraclass correlation suggested that about 77.3% of the total variability in DASS-21 lies between individuals. Thus, we could further develop multilevel models to explain the variability in intercepts within and between individuals.
Linear and quadratic growth model The individual variations of the growth rates of different outcome measures in respective groups are presented in Table 2. The results of the parameter estimates of xed effects of Group × time interaction are presented in Table 3.
Regarding the intervention effect of MBCT compared with WC, participants in the former group showed signi cant time effect and time × group interaction effects on DASS-21, SF12 (Mental), CPSS, and PSQI.
In terms of the primary outcome, individuals in the MBCT group revealed signi cant decrease (β = -6.19, t = -4.03, p < .001) of mood disturbance and signi cant increase in the rate of change (β = 1.52, t = 2.12, p < .05). With regard to secondary outcomes, participants in the MBCT group indicated signi cant improvement of mental health status (β = 1.87, t = 3.62, p < .001), sleep quality (β = -1.27, t = -2.50, p < .05), and perceived stress level (β = -3.32, t = -3.68, p < .001). Effect size statistics also indicated that the MBCT group had small to moderate effects (d = 0.25 to 0.56) on the above outcome variables at posttreatment and follow-up assessments compared with the WC group. More speci cally, participants in the HQCT group with increasing physical health status, enhancing self-e cacy level, and lowering perceived stress level tended to report a reduction of mood symptoms over time.

Discussion
This study compared the intervention effects of MBCT and HQCT with the WC group in treating depression and anxiety within a Chinese context. Our hypotheses were supported. Signi cant individual reductions of mood symptoms after completion in both the MBCT and HQCT groups were indicated. Our ndings were consistent with previous research on the bene cial impacts of MM and HQ on depression and anxiety [11,17]. Previous research only showed small-to-moderate e cacy for reducing mood symptoms [42] or without reliably effects being shown at follow-up assessments [10]. However, ndings of the present study indicated a sustained moderate effect size during follow-up for both MBCT and HQCT. The enhanced effect of integrating CBT into different forms of MBI is implied.
Apart from the mood symptoms, both intervention groups also demonstrated signi cant improvements on health statues as compared with the WC group. More speci cally, MBCT is more conducive to improving mental health status whereas HQCT is more bene cial to physical health outcomes. According to the individual growth models, enhanced mental health status lead to attenuation of mood symptoms in the MBCT group. As such, the essence of mindful awareness and cognitive restructuring of thoughts in In addition, participants in the HQCT group showed slightly greater reduction of mood symptoms than those in the MBCT group, albeit with small effect size being indicated. It appears that more bene ts can be derived from movement-based MBI intervention as compared with mind-based MBI for this population. The predominant emphasis on physical health in HQCT may shed light on its applicability on people with a Chinese cultural background. As HQ is always perceived as mind-body exercises or meditative movement [23,50], people from a Chinese cultural background consider such exercise as a healthpreserving activity which is a crucial indicator of health status [51]. Moreover, compared with conventional exercise, HQ is a form of exercise that uses movement in conjunction with moving vital energy (or qi) throughout the entire body. Thus, it should lead to additional neurophysiological or biological effects on mood symptoms [14].
Moreover, the somatization tendency [52] as espoused in Chinese culture may also explain the greater effect of HQCT on mood change. Essentially, there is strong "holism" ideation in Chinese culture. A person is usually conceived "holistically" as a psychosomatic process [53], thus there is no dichotomy of mind versus physical body as both are perceived as the same substance [54]. Therefore, such holistic conception may lead people to link physical and mental health easily under the in uence of Chinese culture. This could be explained by the signi cant effects on both physical health and mental health statuses after participating in HQCT. Therefore, movement-oriented meditation like HQCT should be much more effective than the static form like MBCT in improving depression and anxiety [55].
Attenuation in perceived stress is the common predictor of mood changes in both MBCT and HQCT, which can further support the stress reduction effect of both interventions. Perceived stress reactivity could operate in speci c pathways toward the development of anxious or depressive symptoms [56,57]. Thus, echoing with previous ndings [16,58], it is no wonder perceived stress is one of the core elements causing the mood changes in MBCT and HQCT. Self-e cacy is another predictor of mood changes in HQCT but not in MBCT. Perhaps within HQCT, people gained a sense of accomplishment by learning a new skill set which is perceived as less physically or cognitively demanding [30]. Thus, enhancement of self-e cacy over time due to performance accomplishments [59] can eventually lead to mood symptom improvement [60]. On the other hand, signi cant sleep improvement was only observed in MBCT but not in HQCT. Perhaps merely the core principles of mindfulness, involving experiential awareness, attentional control, and acceptance, can directly target different vulnerabilities associated with sleep disturbances [61].

Limitations And Conclusions
First, despite the fact that a comparison of MBCT and HQCT in this study can provide useful information for appraising the effects of these two integrated interventions, the lack of a CBT-only control group may undermine the conclusion to be made regarding the additional effect of two forms of MBIs on top of CBT. Second, there was no breakdown of the mood disorders into different subtypes in this study. Considering MM or HQ can have distinct mechanisms of action on the effects of depression versus anxiety [24,62], it is suggested that speci c interpretations can be made regarding different modes of intervention as applied to depression and anxiety, respectively. Besides, meta-analysis suggested that although there are positive signs of the value of transdiagnostic CBT for anxiety and depression, there is as yet insu cient evidence to recommend its use in place of disorder-speci c CBT [63]. Thus, comparison of transdiagnostic-based versus disorder-speci c HQCT and MBCT is worthy of further investigation. Third, only a small sample was recruited in this study, consisting of a group of motivated participants from a single clinic, so they cannot be representative of a wider spectrum of individuals with mood disorders.
Lastly, regarding the elements involved in the intervention, Baduanjin was chosen in this study as the HQ practice in HQCT. However, there are different forms of HQ practice at present, such as "The Five-Animal Play" or Tai Chi Chuan [14], with lots of research having been done regarding the latter's effects on depression and anxiety [64]. Thus, further research could be considered to compare different forms of HQ practice. Despite the aforesaid limitations, this study can make a contribution by proving the bene cial effects of HQCT and MBCT over WC in bringing about mood changes. More speci cally, the physical health emphasis of HQCT can even make it more acceptable and effective in a Chinese population.  (UW18-458). An information sheet and a written consent form which has been formally approved by the ethics committee was distributed to participants when they were invited to take part in the research project. In obtaining informed consent from the participants, no undue pressure was applied. In addition, the principal investigator would answer any questions the potential participants may have. Participants were free to decide whether to participate in this study, and they could revoke their consent and withdraw from the study at any time during the study, without any reason. This decision would not affect their medical care, nor would it cause any unpleasant results. Participation in this study would not make excessive discomfort or other injuries. Observation of mental state and any potential of self-harm behaviors was closely taken throughout the processes of respective interventions or assessments. When necessary, participants would be advised to consult a professional. Regarding data monitoring, any information obtained in this study was remain very strictly con dential, will be known to no-one, and was used for research purposes only. Codes, not names, were used on all test instruments to protect con dentiality. Data were stored in encrypted le in the computer and they were locked in cabinets for keeping participants' con dential information.

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Competing interests
The authors declare that they have no competing interests Funding This research did not receive any speci c grant from funding agencies in the public, commercial, or notfor-pro t sectors.
Authors' contributions SHWC is the principal investigator of this study. He was responsible for the conceptualization, methodology, formal analysis, and writing the original draft; WWKC contributed to investigation and project administration; JYWC and PKLC contributed to resources and reviews of the writing. All authors have approved the submitted version. All authors also agreed both to be personally accountable for the author's own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature.
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