Body-Mind-Spirit Intervention for Women With Early Psychosis

Study Overview
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Brief Summary
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This is an open-labelled randomised controlled trial (RCT) that aims to examine the effectiveness of exercise coaching approach in improving the physical activity engagement in patients with psychosis.

Detailed Description
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Patients with psychosis will be recruited from the out-patient department (OPD) of the Kwai Chung Hospital (KCH). The patient with informed consent will be randomly assigned to exercise coaching or psychoeducation group to prevent decline in cognitive and functional outcomes known to be common in this group. This comprises locally-tested evidence-based intervention strategies such as exercise and Yoga intervention, combined with exercise coaching to consolidate the exercise habit. Each of the intervention includes 28 sessions spanning for16-week.

Official Title
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Body-Mind-Spirit Intervention for Women With Early Psychosis: a Randomized Controlled Trial

Conditions
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Psychosis

Intervention / Treatment
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* Behavioral: Exercise Coaching
* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age from 18-64 Based on the Fifth version of the Diagnostic and Statistical Manual of Mental Disorders diagnosis to have schizophrenia and related psychotic disorders Have the ability to understand Chinese Able to give informed consent Physically fit for participating in our study assessed by using the Physical Activity Readiness Questionnaire (PAR-Q) Exclusion Criteria: Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders. Comorbid substance dependence Unstable psychotic symptoms Any history of brain trauma or organic brain disease Known history of intellectual disability or special school attendance Other mental conditions that requires other treatment priorities, e.g., suicidal risk. Other medical conditions that severely limits participation, comprehension, or adherence to the treatment or assessment e.g., epilepsy, dementia, terminal medical illness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise coaching group<br>This intervention is an integration of aerobic exercise, yoga, mindfulness and exercise coaching. Exercise class and coaching will be provided weekly in the first 8 weeks. In the next 8 week, exercise class will be provided weekly while exercise coaching will be provided bi-weekly. The exercise class includes aerobic exercise coached by a well-trained intervention officer, and the yoga and mindfulness coached by a certified yoga instructor. The exercise coaching session followed by some stretching and aerobic exercise session. Both motivational coaching and aerobic exercise will be coached by a well-trained intervention officer. | Behavioral: Exercise Coaching<br>* 28 classes in 16 weeks<br>|
| Active Comparator: Psychoeducation group<br>This group is similar with the exercise coaching group while exercise coaching session will be substituted by psychoeducation session. | Behavioral: Psychoeducation<br>* 28 classes in 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity Engagement | Measured by the Chinese Version of International Physical Activity Questionnaire (IPAQ-C) | Change from baseline to 6-month post-intervention |