- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01139099
The Evaluation of Therapeutic Efficacy on the Integrated Group Psychotherapy for Patients With Schizophrenia
December 26, 2012 updated by: National Taiwan University Hospital
Department of Psychiatry of NTUH Yun-Lin Branch
Although the patients with schizophrenia can be treated with new generation of antipsychotics medication, additional approaches are necessary to improve schizophrenics' cognitive functions, interpersonal relationships as well as social adjustment.
When some of patients return to community, they expose to practical pressure that contribute to worsen and relapse of disease.
That further damages patient's cognitive functions.
Integrated Psychological Therapy(IPT) on treating schizophrenia has dramatic improvement in recent years; it has formed structured treatment gradually on relieving illusion, hallucination as well as negative symptoms.
This study aims at conducting 12-week structured IPT group therapy.
The intended subjects are patients, met with DSM-Ⅳ-TR diagnosis of schizophrenia, from community, outpatient and inpatient service.
The overall treatments are designed to provide 1-2 hours weekly group therapy which focuses on relieving illusions, hallucination, and negative symptoms.
Patients' cognitive functions, ability of emotional adjustment and interpersonal relationship would be evaluated in pre-test and post-test to indicate whether the significant difference exists.
There is a controlled group, in which patients who still receive treatment as usual (TAU).
The study also compares the evaluation results between IPT group and TAU group, hoping to develop the therapeutic framework for Taiwan people with schizophrenia.
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Yun-lin, Taiwan, 64001
- National Taiwan University Hospital Yun-Lin Branch
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- schizophrenia,
- can concentrate in group for 30 minutes.
Exclusion Criteria:
- substance abuse (alcohol, illegal medication),
- self harm history.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Arm
There is no arm in this study.
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integrated group psychotherapy, including the interpersonal and cognitive group therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
re-hospitalization rate
Time Frame: after 3 months of the group psychotherapy
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acute symptom relapse and needed to be admitted to the acute ward
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after 3 months of the group psychotherapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive functions, ability of emotional adjustment, and interpersonal relationship
Time Frame: 12 months of the group tpsychotherapy
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The tests of psychiatric symptoms, cognitive test, anxiety, depression, interpsersonal skill, and emotional adjustment Add Secondary Outcome Measure:The Positive and Negative Syndrome Scale, Beck depression scale, Beck anxiety scale, Beck suicial ideation scale, Cognitive tests (visual spatial test), CPT-IP for attention test
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12 months of the group tpsychotherapy
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The Positive and Negative Syndrome Scale, Beck depression scale, Beck anxiety scale, Beck suicial ideation scale, Cognitive tests (visual spatial test), CPT-IP for attention test
Time Frame: 12 months of the group psychotherapy
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The Positive and Negative Syndrome Scale for psychiatric symptoms, Beck depression scale for depression symptoms, Beck anxiety scale for anxiety symptoms, Beck suicial ideation scale for suicidal ideation evalution Cognitive tests (visual spatial test), CPT-IP for attention test for cognitive function
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12 months of the group psychotherapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Li-Ren Chang, MD, Department of Psychiatry in National Taiwan University Hospital Yun-Lin Branch
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
June 7, 2010
First Submitted That Met QC Criteria
June 7, 2010
First Posted (Estimate)
June 8, 2010
Study Record Updates
Last Update Posted (Estimate)
December 27, 2012
Last Update Submitted That Met QC Criteria
December 26, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201003068R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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