Back to resultsBody-Mind-Spirit Intervention for Women With Early Psychosis
Primary Purpose
Psychosis
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Exercise Coaching
Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis
Eligibility Criteria
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.
Sites / Locations
- University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise coaching group
Psychoeducation group
Arm Description
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.
This group is similar with the exercise coaching group while exercise coaching session will be substituted by psychoeducation session.
Outcomes
Primary Outcome Measures
Physical Activity Engagement
Measured by the Chinese Version of International Physical Activity Questionnaire (IPAQ-C)
Secondary Outcome Measures
Full Information
NCT ID
NCT03751852
First Posted
June 14, 2018
Last Updated
April 10, 2021
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03751852
Brief Title
Body-Mind-Spirit Intervention for Women With Early Psychosis
Official Title
Body-Mind-Spirit Intervention for Women With Early Psychosis: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise coaching group
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychoeducation group
Arm Type
Active Comparator
Arm Description
This group is similar with the exercise coaching group while exercise coaching session will be substituted by psychoeducation session.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Coaching
Intervention Description
28 classes in 16 weeks
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
28 classes in 16 weeks
Primary Outcome Measure Information:
Title
Physical Activity Engagement
Description
Measured by the Chinese Version of International Physical Activity Questionnaire (IPAQ-C)
Time Frame
Change from baseline to 6-month post-intervention
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
As agreement with funder
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Yu Hai Chen, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
ZIP/Postal Code
0000
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Body-Mind-Spirit Intervention for Women With Early Psychosis
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