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
|Condition or disease||Intervention/treatment||Phase|
|Psychosis||Behavioral: Exercise Coaching Behavioral: Psychoeducation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
28 classes in 16 weeks
- 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)
- 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)
- 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.
- 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)
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
|Contact: Yi Nam Suen, PhD||3917 firstname.lastname@example.org|
|Contact: Lik Hang Lincoln Lo, PhD||2831 email@example.com|
|Principal Investigator:||Eric Yu Hai Chen, MD||The University of Hong Kong|