Lifestyle Redesign For Schizophrenia

The Impact of Lifestyle Redesign Program in Schizophrenia

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Rehabilitation
• Intervention / Treatment: Behavioral: lifestyle redesign program

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LRP group; 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; 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.
No Intervention: TAU group; The participants in TAU group received usual treatment at the same time as LRP group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: B20190705

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No