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Lifestyle Redesign For Schizophrenia

Primary Purpose

Schizophrenia, Rehabilitation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lifestyle redesign program
Sponsored by
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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