SchizophreniaNCT04040998
Compensatory Cognitive Training For Schizophrenia
A study testing Compensatory Cognitive Training in people with Schizophrenia, run by Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan at 1 site in Taiwan.
Trial summary
This study aimed to investigate the effects of compensatory cognitive training plus treatment as usual (CCT+TAU) versus treatment as usual (TAU) on on self-esteem, self-efficacy, quality of life, and self-stigma for schizophrenia. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Compensatory Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jan 2018to 31 May 2018
- 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
- Women only
- 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 3 months
- taking stable dose of medication for at least 3 months
Who cannot join
- comorbid autism spectrum disorder
- comorbid mental retardation
- lacking the reading and writing skills
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taoyuan Psychiatric Center Ministry of Health and Welfare
Taoyuan, 330
About this study
Official title: Compensatory Cognitive Training for Psychosocial Correlates and Self-stigma in Persons With Schizophrenia
This study aimed to investigate the effects of compensatory cognitive training plus treatment as usual (CCT+TAU) versus treatment as usual (TAU) on on self-esteem, self-efficacy, quality of life, and self-stigma for schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Compensatory Cognitive Training
- Keywords
- schizophrenia, compensatory cognitive training, generalized estimating equation, psychosocial correlates, self-stigma
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compensatory Cognitive TrainingBehavioural
Teach the participants compensatory cognitive skills and strategies
| Study group | Role | What they receive |
|---|---|---|
| CCT+TAU group | Experimental | The participants in CCT+TAU group received compensatory cognitive training plus treatment as usual. The CCT intervention consisted of two 50-minute sessions each week for 10 weeks Receives: Behavioral: Compensatory Cognitive Training |
| TAU group | No intervention | The participants in TAU group received usual treatment at the same time as CCT+TAU group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of Rosenberg Self-Esteem Scale (RSES)
The Chinese version of Rosenberg Self-Esteem Scale (RSES) was implemented as self-esteem measures. The total score ranged from 10 to 40, with higher scores reflecting higher levels of self-esteem.
Measured: 3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
Change scores of General Self-Efficacy Scale (GSES)
The Chinese version of General Self-Efficacy Scale (GSES) consisted of 10 items, assessing optimistic self-beliefs to cope with a variety of difficult demands in life. The total score ranged from 10 to 40, with higher scores indicating more self-efficacy.
Measured: 3 times: 1 to 2 weeks before intervention, 1 day 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 day after intervention and at 1 month after intervention
Change scores of Internalized Stigma of Mental Illness (ISMIS)
The Chinese version of Internalized Stigma of Mental Illness (ISMIS) consists of 29 items incorporated in five domains: alienation, stereotype endorsement, discrimination experience, social withdrawal, and stigma resistance. The total scores range from 29-116. The higher scores on the ISMIS indicates more severe internalized stigmatization.
Measured: 3 times: 1 to 2 weeks before intervention, 1 day 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 posted1 Aug 2019
- Study start5 Jan 2018
- Primary completion31 May 2018
- Study completion31 May 2018
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
- 46 participants (actual)
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
- NCT04040998
- Sponsor's protocol ID
- TaoyuanMH
- Status last verified
- Jul 2019
- First submitted
- 26 Jul 2019
- Last updated
- 1 Aug 2019
- 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 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compensatory Cognitive Training for Psychosocial Correlates and Self-stigma in Persons With Schizophrenia
- ClinicalTrials.gov ID
- NCT04040998
- Acronym / sponsor ID
- TaoyuanMH
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, compensatory cognitive training, generalized estimating equation, psychosocial correlates, self-stigma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. TaiwanOther government
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 1 Aug 2019 (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 compensatory cognitive training plus treatment as usual (CCT+TAU) versus treatment as usual (TAU) on on self-esteem, self-efficacy, quality of life, and self-stigma for schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCT+TAU group | Experimental | Behavioral: Compensatory Cognitive TrainingThe participants in CCT+TAU group received compensatory cognitive training plus treatment as usual. The CCT intervention consisted of two 50-minute sessions each week for 10 weeks |
| TAU group | No intervention | –The participants in TAU group received usual treatment at the same time as CCT+TAU group. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 3 months
- taking stable dose of medication for at least 3 months
Key exclusion criteria (3 listed)
- comorbid autism spectrum disorder
- 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 |
|---|---|---|
| Compensatory Cognitive TrainingTeach the participants compensatory cognitive skills and strategies | Behavioural | CCT+TAU group |
Primary outcome
Change scores of Rosenberg Self-Esteem Scale (RSES)
Time frame: 3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
The Chinese version of Rosenberg Self-Esteem Scale (RSES) was implemented as self-esteem measures. The total score ranged from 10 to 40, with higher scores reflecting higher levels of self-esteem.
Change scores of General Self-Efficacy Scale (GSES)
Time frame: 3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
The Chinese version of General Self-Efficacy Scale (GSES) consisted of 10 items, assessing optimistic self-beliefs to cope with a variety of difficult demands in life. The total score ranged from 10 to 40, with higher scores indicating more self-efficacy.
Change scores of Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
Time frame: 3 times: 1 to 2 weeks before intervention, 1 day 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 Internalized Stigma of Mental Illness (ISMIS)
Time frame: 3 times: 1 to 2 weeks before intervention, 1 day after intervention and at 1 month after intervention
The Chinese version of Internalized Stigma of Mental Illness (ISMIS) consists of 29 items incorporated in five domains: alienation, stereotype endorsement, discrimination experience, social withdrawal, and stigma resistance. The total scores range from 29-116. The higher scores on the ISMIS indicates more severe internalized stigmatization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compensatory Cognitive Training in people with Schizophrenia, run by Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan at 1 site in 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 4 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: finished, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Rosenberg Self-Esteem Scale (RSES) (time frame: 3 times: 1 to 2 weeks before intervention, 1 day 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 1 Aug 2019.