The psychophysiological effects of Tai-chi and exercise in residential schizophrenic patients: a 3-arm randomized controlled trial.

BACKGROUND: Patients with schizophrenia are characterized by high prevalence rates and chronicity that often leads to long-term institutionalization. Under the traditional medical model, treatment usually emphasizes the management of psychotic symptoms through medication, even though anti-psychotic drugs are associated with severe side effects, which can diminish patients' physical and psychological well-being. Tai-chi, a mind-body exercise rooted in Eastern health philosophy, emphasizes the motor coordination and relaxation. With these potential benefits, a randomized controlled trial (RCT) is planned to investigate the effects of Tai-chi intervention on the cognitive and motor deficits characteristic of patients with schizophrenia. METHODS/DESIGN: A 3-arm RCT with waitlist control design will be used in this study. One hundred and fifty three participants will be randomized into (i) Tai-chi, (ii) exercise or (iii) waitlist control groups. Participants in both the Tai-chi and exercise groups will receive 12-weeks of specific intervention, in addition to the standard medication and care received by the waitlist control group. The exercise group will serve as a comparison, to delineate any unique benefits of Tai-chi that are independent of moderate aerobic exercise. All three groups will undergo three assessment phases: (i) at baseline, (ii) at 12 weeks (post-intervention), and (iii) at 24 weeks (maintenance). All participants will be assessed in terms of symptom management, motor coordination, memory, daily living function, and stress levels based on self-perceived responses and a physiological marker. DISCUSSION: Based on a promising pilot study conducted prior to this RCT, subjects in the Tai-chi intervention group are expected to be protected against deterioration of motor coordination and interpersonal functioning. They are also expected to have better symptoms management and lower stress level than the other treatment groups. TRIAL REGISTRATION: The trail has been registered in the Clinical Trials Center of the University of Hong Kong (HKCTR-1453).

Protocol for a mixed-methods randomised controlled trial evaluating the effectiveness of a dyadic expressive arts-based intervention in improving the psychosocial well-being of children with intellectual disability in special schools and their mothers.

INTRODUCTION: Mothers of children with intellectual disability (ID) are often distressed because of intensive workloads and difficulties in communicating with their children. Given the interdependence between the psychosocial well-being of such dyads, interventions that promote parent-child relationships and mutual communication would be beneficial. Arts provide alternative avenues for expression and offer an imaginative and playful environment for discovering new communication strategies. Given the lack of studies on arts-based dyadic interventions, this study aims to examine the effectiveness of dyadic expressive arts-based intervention (EXAT) in improving the psychosocial outcomes of children with ID and their mothers and the mother-child relationships. METHODS AND ANALYSIS: This study will adopt a mixed-methods randomised controlled trial design, wherein 154 dyads of children with ID and their mothers will be randomised into either the dyadic EXAT group or the treatment-as-usual waitlist control group. Quantitative data will be collected at four time points: baseline (T0), postintervention (T1), 3-month postintervention (T2) and 6-month postintervention (T3). Qualitative data will be collected from a subset of 30 mothers in the intervention group at T1 and T3 to document their experiences and perceived changes after the intervention. Mixed-effects models and path analysis will be adopted to analyse the quantitative data, whereas thematic analysis will be applied to the qualitative data. Both sets of data will be triangulated for an integrated view of the effectiveness and mechanism of the intervention. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Human Research Ethics Committee of the University of Hong Kong (Ref. no.: EA200329). Written consent forms will be obtained from all recruited participants (mothers, children with ID and teachers/social workers) before data collection. The study findings will be disseminated in international conferences and peer-reviewed academic journals. TRIAL REGISTRATION NUMBER: NCT05214859.

A randomised controlled trial of expressive arts-based intervention for young stroke survivors.

BACKGROUND: Stroke causes lasting brain damage that has numerous impacts on the survivor's physical, psychosocial, and spiritual well-being. Young survivors (< 65 years old) tend to suffer more because of their longer overall survival time. Expressive arts-based intervention is considered a holistic approach for stroke rehabilitation because it allows participants to express their thoughts and emotions through the arts. The group environment also promotes mutual support among participants. The creative art-making process helps expand participants' creativity and imagination as well as promote a sense of aesthetic appreciation. Previous studies have shown the effectiveness of the arts-based intervention in managing stroke and its psychosocial-spiritual comorbidities. Nevertheless, a systematic study has not been conducted, including in young survivors. This trial plans to investigate the effectiveness of an expressive arts-based intervention on bio-psychosocial-spiritual outcomes in young Chinese stroke survivors. METHODS/DESIGN: A single-blind, two-arm cluster randomised control trial with a waitlist control design will be adopted. One hundred and fifty-four stroke survivors, aged 18-64 years with modified Rankin Scale scores of 1-4, will be screened and randomised to either an expressive arts-based intervention group or a treatment-as-usual waitlist control group. The intervention group will receive a 90-min session once a week for a total of 8 weeks. All participants will be assessed three times: at baseline, 8 weeks, and 8 months after the baseline. Study outcomes include measures of depression and anxiety, perceived stress, perceived social support, hope, spiritual well-being, quality of life, salivary cortisol, blood pressure, and heart rate. DISCUSSION: This study is expected to contribute to the current knowledge on the effectiveness of an arts-based intervention on the holistic wellness of young stroke survivors. The findings will help stroke survivors and healthcare professionals make better choices in selecting practices that will yield maximum benefits, satisfaction, adherence, and sustainability. In addition, the examination of the relationships between bio-psychosocial-spiritual variables will help contribute to the development of holistic care for the survivors. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03729648 . Registered 31 October 2018 - Retrospectively registered, (329 words).