Body-Mind-Spirit Intervention for Women With Early Psychosis

NCT ID: NCT03751852

Last Updated: 2021-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2021-09-30

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.

Conditions

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Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise coaching group

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.

Group Type EXPERIMENTAL

Exercise Coaching

Intervention Type BEHAVIORAL

28 classes in 16 weeks

Psychoeducation group

This group is similar with the exercise coaching group while exercise coaching session will be substituted by psychoeducation session.

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

28 classes in 16 weeks

Interventions

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Exercise Coaching

28 classes in 16 weeks

Intervention Type BEHAVIORAL

Psychoeducation

28 classes in 16 weeks

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Professor Eric Y.H. Chen

Chi-li Pao Foundation Professor of Psychiatry; Chair Professor in Psychiatry; Head, Department of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Yu Hai Chen, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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124-01

Identifier Type: OTHER

Identifier Source: secondary_id

JCWowExercise

Identifier Type: -

Identifier Source: org_study_id

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