Body-Mind-Spirit Intervention for Women With Early Psychosis

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Psychosis
• Intervention / Treatment: Behavioral: Exercise Coaching; Behavioral: Psychoeducation

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 Type: Interventional
• Enrollment (Anticipated): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 0000
    • University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Exercise Coaching; 28 classes in 16 weeks
Active Comparator: Psychoeducation group; This group is similar with the exercise coaching group while exercise coaching session will be substituted by psychoeducation session.	Behavioral: Psychoeducation; 28 classes in 16 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Eric Yu Hai Chen, MD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: June 14, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 10, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: JCWowExercise; 124-01 (KWC IRB / REC No.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No