Body-Mind-Spirit Intervention for Women With Early Psychosis

Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03751852
• Other study ID #: JCWowExercise
• Secondary ID: 124-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2021
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• Exercise Coaching
28 classes in 16 weeks
• Psychoeducation
28 classes in 16 weeks

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Engagement	Measured by the Chinese Version of International Physical Activity Questionnaire (IPAQ-C)	Change from baseline to 6-month post-intervention