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Trial record 12 of 5138 for:    Recruiting, Not yet recruiting, Available Studies | "Psychotic Disorders"

Body-Mind-Spirit Intervention for Women With Early Psychosis

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ClinicalTrials.gov Identifier: NCT03751852
Recruitment Status : Not yet recruiting
First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Professor Eric Y.H. Chen, The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Psychosis Behavioral: Exercise Coaching Behavioral: Psychoeducation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Body-Mind-Spirit Intervention for Women With Early Psychosis: a Randomized Controlled Trial
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Physical Activity Engagement [ Time Frame: Change from baseline to 6-month post-intervention ]
    Measured by the Chinese Version of International Physical Activity Questionnaire (IPAQ-C)

  2. Physical Activity Engagement [ Time Frame: Change from baseline to 12-month post-intervention ]
    Measured by the Chinese Version of International Physical Activity Questionnaire (IPAQ-C)


Secondary Outcome Measures :
  1. Working Memory [ Time Frame: At 6- and 12- month ]
    Measured by Digit Span backwards test. In this test, the subject was asked to recall a series of numbers in reverse order. The correctly recalled series were scored as 1, and the test contains 14 sequences of numbers. The range of working memory score is from 0 to 14, with higher values representing better outcome.

  2. Attention and Concentration [ Time Frame: At 6- and 12-month ]
    Measured by Letter Cancellation test Q score. The basic version of the task consists of six 52-character rows in which the target character is randomly interspersed approximately 18 times in each row. Subjects were asked to cancel the letter "C" and "E" as quickly as possible. The time to completion, number of error and omission items were recorded. A "quality of search" index (Q), developed by Geldmacher et al., was applied for the analysis. Q is the ratio of correct number to total number of targets multiplied by the ratio of correct number per second. Higher Q scores represent more efficient performance and better attention and concentration. Q scores could range from 0 (worst possible outcome) to 1 (best possible outcome)



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   As agreement with funder
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751852


Contacts
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Contact: Yi Nam Suen, PhD 3917 9579 suenyn@hku.hk
Contact: Lik Hang Lincoln Lo, PhD 2831 5342 linclo@hku.hk

Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Eric Yu Hai Chen, MD The University of Hong Kong

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Responsible Party: Professor Eric Y.H. Chen, Chi-li Pao Foundation Professor of Psychiatry; Chair Professor in Psychiatry; Head, Department of Psychiatry, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03751852     History of Changes
Other Study ID Numbers: JCWowExercise
124-01 ( Other Identifier: KWC IRB / REC No. )
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders