Lifestyle Redesign For Schizophrenia
Primary Purpose
Schizophrenia, Rehabilitation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lifestyle redesign program
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
LRP group
TAU group
Arm Description
The participants in LRP group receive lifestyle redesign program plus treatment as usual. The LRP intervention consisted of one 90-minute session each week for 10 weeks
The participants in TAU group received usual treatment at the same time as LRP group.
Outcomes
Primary Outcome Measures
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.
Change scores of Occupational Self Assessment (OSA)
The OSA with 29 items is administered to measure occupational engagement.
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.
Change scores of Montreal Cognitive Assessment (MoCA)
The Chinese version of MoCA was administered to measure cognition, with higher scores indicating better cognition.
Secondary Outcome Measures
Full Information
NCT ID
NCT04430868
First Posted
June 11, 2020
Last Updated
June 11, 2020
Sponsor
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04430868
Brief Title
Lifestyle Redesign For Schizophrenia
Official Title
The Impact of Lifestyle Redesign Program in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LRP group
Arm Type
Experimental
Arm Description
The participants in LRP group receive lifestyle redesign program plus treatment as usual. The LRP intervention consisted of one 90-minute session each week for 10 weeks
Arm Title
TAU group
Arm Type
No Intervention
Arm Description
The participants in TAU group received usual treatment at the same time as LRP group.
Intervention Type
Behavioral
Intervention Name(s)
lifestyle redesign program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change scores of Brief Psychiatric Symptom Rating Scale (BSRS)
Description
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.
Time Frame
3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
Title
Change scores of Occupational Self Assessment (OSA)
Description
The OSA with 29 items is administered to measure occupational engagement.
Time Frame
3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
Title
Change scores of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
Description
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.
Time Frame
3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
Title
Change scores of Montreal Cognitive Assessment (MoCA)
Description
The Chinese version of MoCA was administered to measure cognition, with higher scores indicating better cognition.
Time Frame
3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Lifestyle Redesign For Schizophrenia
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