SchizophreniaNCT04430868
Lifestyle Redesign For Schizophrenia
A study testing lifestyle redesign program in people with Schizophrenia and Rehabilitation, run by Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia, Rehabilitation
- What is being tested?
- lifestyle redesign program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- comorbid other mental disorder (e.g. depression, anxiety, ADHD...etc.)
- comorbid mental retardation
- lacking the reading and writing skills
About this study
Official title: 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.
- Conditions
- Schizophrenia, Rehabilitation
- Being tested
- lifestyle redesign program
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle redesign programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: lifestyle redesign program |
| TAU group | No intervention | The participants in TAU group received usual treatment at the same time as LRP group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, YU SHIUAN LIAW, Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430868
- Sponsor's protocol ID
- B20190705
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Lifestyle Redesign Program in Schizophrenia
- ClinicalTrials.gov ID
- NCT04430868
- Acronym / sponsor ID
- B20190705
- Conditions
- Schizophrenia, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. TaiwanOther government
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LRP group | Experimental | Behavioral: lifestyle redesign programThe 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 |
| TAU group | No intervention | –The participants in TAU group received usual treatment at the same time as LRP group. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- comorbid other mental disorder (e.g. depression, anxiety, ADHD...etc.)
- comorbid mental retardation
- lacking the reading and writing skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle redesign programIn 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. | Behavioural | LRP group |
Primary outcome
Change scores of Brief Psychiatric Symptom Rating Scale (BSRS)
Time frame: 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
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)
Time frame: 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
The OSA with 29 items is administered to measure occupational engagement.
Change scores of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
Time frame: 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
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)
Time frame: 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention
The Chinese version of MoCA was administered to measure cognition, with higher scores indicating better cognition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle redesign program in people with Schizophrenia and Rehabilitation, run by Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores of Brief Psychiatric Symptom Rating Scale (BSRS) (time frame: 3 times: 1 to 2 weeks before intervention, 1 to 5 days after intervention and at 1 month after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.