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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable schizophrenia

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 11, 2020

Last Update Submit

June 11, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

LRP group

EXPERIMENTAL

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

Behavioral: lifestyle redesign program

TAU group

NO INTERVENTION

The participants in TAU group received usual treatment at the same time as LRP group.

Interventions

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.

LRP group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • comorbid other mental disorder (e.g. depression, anxiety, ADHD...etc.)
  • comorbid mental retardation
  • lacking the reading and writing skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational Therapist

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 12, 2020

Study Start

July 1, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

June 12, 2020

Record last verified: 2020-06