Body-Mind-Spirit Intervention for Women With Early Psychosis

NCT03751852 | Unknown DMC

• 2 other identifiers: JCWowExercise124-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis

Outcome Measures

Primary Outcomes (1)

• Physical Activity Engagement

  Measured by the Chinese Version of International Physical Activity Questionnaire (IPAQ-C)

  Change from baseline to 6-month post-intervention

Study Arms (2)

Exercise coaching group

EXPERIMENTAL

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

Psychoeducation group

ACTIVE COMPARATOR

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

Behavioral: Psychoeducation

Interventions

Exercise Coaching BEHAVIORAL

28 classes in 16 weeks

Exercise coaching group

Psychoeducation BEHAVIORAL

28 classes in 16 weeks

Psychoeducation group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: As agreement with funder
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

University of Hong Kong

Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Eric Yu Hai Chen, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chi-li Pao Foundation Professor of Psychiatry; Chair Professor in Psychiatry; Head, Department of Psychiatry

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: November 23, 2018
• Study Start: November 15, 2018
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)