NCT01139099

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

December 27, 2012

Status Verified

November 1, 2012

Enrollment Period

1 year

First QC Date

June 7, 2010

Last Update Submit

December 26, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • re-hospitalization rate

    acute symptom relapse and needed to be admitted to the acute ward

    after 3 months of the group psychotherapy

Secondary Outcomes (2)

  • Cognitive functions, ability of emotional adjustment, and interpersonal relationship

    12 months of the group tpsychotherapy

  • 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

    12 months of the group psychotherapy

Study Arms (1)

Arm

OTHER

There is no arm in this study.

Behavioral: Group Psychotherapy

Interventions

integrated group psychotherapy, including the interpersonal and cognitive group therapy

Arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • substance abuse (alcohol, illegal medication),
  • self harm history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Yun-Lin Branch

Douliu, Taiwan, 64001, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Li-Ren Chang, MD

    Department of Psychiatry in National Taiwan University Hospital Yun-Lin Branch

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2010

First Posted

June 8, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

December 27, 2012

Record last verified: 2012-11

Locations