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NCT04430868 Clinical Trial

Lifestyle Redesign For Schizophrenia

Schizophrenia Clinical Trial

Official title:
The Impact of Lifestyle Redesign Program in Schizophrenia

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04430868
Other study ID # B20190705
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date November 30, 2020

Study information
Verified date June 2020
Source Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to investigate the effects of lifestyle redesign program plus treatment as usual versus treatment as usual on cognition, psychiatric symptoms, quality of life, and occupational engagement for schizophrenia.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date November 30, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- diagnosis of schizophrenia, based on the ICD-10 diagnostic criteria for research (World Health Organization, 1992)

- age from 20 to 65

- attending day care center regularly for at least 1 month and taking stable dose of medication

Exclusion Criteria:

- comorbid other mental disorder (e.g. depression, anxiety, ADHD...etc.)

- comorbid mental retardation

- lacking the reading and writing skills

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• lifestyle redesign program
In this group, it starts with health education, the participants then change their opinions and experience health activities, and it ends with discussion and sharing their experience.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan

Outcome
Type Measure Description Time frame Safety issue
Primary Change scores of Brief Psychiatric Symptom Rating Scale (BSRS) The Chinese version of BSRS with 50 items is administered to measure psychiatric symptoms. BSRS items were evaluated on a five-point Likert scale from 0 (not present) to 4 (extremely severe). The total score ranged from 0 to 200, with higher scores reflecting more severe of psychiatric symptoms. 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
Primary Change scores of Occupational Self Assessment (OSA) The OSA with 29 items is administered to measure occupational engagement. 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
Primary Change scores of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) The Chinese version of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) was administered to measure subjective quality of life. The total scores ranged from 33-165, with higher scores indicating comparatively lower quality of life. 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
Primary Change scores of Montreal Cognitive Assessment (MoCA) The Chinese version of MoCA was administered to measure cognition, with higher scores indicating better cognition. 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
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