The Evaluation of Therapeutic Efficacy on the Integrated Group Psychotherapy for Patients With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Kaohsiung Medical University
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01139099
First received: June 7, 2010
Last updated: December 26, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Schizophrenia
Behavioral: Group Psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Department of Psychiatry of NTUH Yun-Lin Branch

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • re-hospitalization rate [ Time Frame: after 3 months of the group psychotherapy ] [ Designated as safety issue: No ]
    acute symptom relapse and needed to be admitted to the acute ward


Secondary Outcome Measures:
  • Cognitive functions, ability of emotional adjustment, and interpersonal relationship [ Time Frame: 12 months of the group tpsychotherapy ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months of the group psychotherapy ] [ Designated as safety issue: No ]
    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


Enrollment: 50
Study Start Date: May 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm
There is no arm in this study.
Behavioral: Group Psychotherapy
integrated group psychotherapy, including the interpersonal and cognitive group therapy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • schizophrenia,
  • can concentrate in group for 30 minutes.

Exclusion Criteria:

  • substance abuse (alcohol, illegal medication),
  • self harm history.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139099

Locations
Taiwan
National Taiwan University Hospital Yun-Lin Branch
Yun-lin, Taiwan, 64001
Sponsors and Collaborators
National Taiwan University Hospital
Kaohsiung Medical University
Investigators
Study Director: Li-Ren Chang, MD Department of Psychiatry in National Taiwan University Hospital Yun-Lin Branch
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01139099     History of Changes
Other Study ID Numbers: 201003068R
Study First Received: June 7, 2010
Last Updated: December 26, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014