The Evaluation of Therapeutic Efficacy on the Integrated Group Psychotherapy for Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Group Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- schizophrenia,
- can concentrate in group for 30 minutes.
Exclusion Criteria:
- substance abuse (alcohol, illegal medication),
- self harm history.
Sites / Locations
- National Taiwan University Hospital Yun-Lin Branch
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm
Arm Description
There is no arm in this study.
Outcomes
Primary Outcome Measures
re-hospitalization rate
acute symptom relapse and needed to be admitted to the acute ward
Secondary Outcome Measures
Cognitive functions, ability of emotional adjustment, and interpersonal relationship
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
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
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
Full Information
NCT ID
NCT01139099
First Posted
June 7, 2010
Last Updated
December 26, 2012
Sponsor
National Taiwan University Hospital
Collaborators
Kaohsiung Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01139099
Brief Title
The Evaluation of Therapeutic Efficacy on the Integrated Group Psychotherapy for Patients With Schizophrenia
Official Title
Department of Psychiatry of NTUH Yun-Lin Branch
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Kaohsiung Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm
Arm Type
Other
Arm Description
There is no arm in this study.
Intervention Type
Behavioral
Intervention Name(s)
Group Psychotherapy
Intervention Description
integrated group psychotherapy, including the interpersonal and cognitive group therapy
Primary Outcome Measure Information:
Title
re-hospitalization rate
Description
acute symptom relapse and needed to be admitted to the acute ward
Time Frame
after 3 months of the group psychotherapy
Secondary Outcome Measure Information:
Title
Cognitive functions, ability of emotional adjustment, and interpersonal relationship
Description
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
Time Frame
12 months of the group tpsychotherapy
Title
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
Description
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
Time Frame
12 months of the group psychotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
schizophrenia,
can concentrate in group for 30 minutes.
Exclusion Criteria:
substance abuse (alcohol, illegal medication),
self harm history.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Ren Chang, MD
Organizational Affiliation
Department of Psychiatry in National Taiwan University Hospital Yun-Lin Branch
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital Yun-Lin Branch
City
Yun-lin
ZIP/Postal Code
64001
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Evaluation of Therapeutic Efficacy on the Integrated Group Psychotherapy for Patients With Schizophrenia
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