Body-Mind-Spirit Intervention for Women With Early Psychosis

Not Applicable

• Conditions: Psychosis
• Interventions: Behavioral: Psychoeducation; Behavioral: Exercise Coaching

• Registration Number: NCT03751852
• Lead Sponsor: The University of Hong Kong

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-06-14
• Study Start: 2018-11-15
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-23
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-10
• Last Update Posted: 2021-04-14
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 57

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychoeducation group	Psychoeducation	This group is similar with the exercise coaching group while exercise coaching session will be substituted by psychoeducation session.
Exercise coaching group	Exercise Coaching	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.

Primary Outcome Measures

Name	Time	Method
Physical Activity Engagement	Change from baseline to 6-month post-intervention	Measured by the Chinese Version of International Physical Activity Questionnaire (IPAQ-C)

Trial Locations

Locations (1)

University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong