NCT02715349

Brief Summary

Families with a patient with schizophrenia and the patient are randomly assigned to receive either a 3 session psychoeducation program, or no psychoeducation. Other treatment for schizophrenia and other mental illness are provided as usual.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Sep 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

March 3, 2016

Last Update Submit

March 16, 2016

Conditions

Schizophrenia

Keywords

schizophreniapsychoeducationVietnam

Outcome Measures

Primary Outcomes (2)

  • Change from baseline (pre-treatment) to 6 months post-baseline in patient-report of quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire.

    Change in quality of life using an Analysis of Covariance with the baseline quality of life score as the covariate, the 6 month quality of life assessment as the dependent variable, and treatment group as the independent variable. The Quality of Life Enjoyment and Satisfaction Questionnaire with patient-report is used at both timepoints.

    baseline (pre-treatment). six months post-baseline.

  • Change from baseline (pre-treatment) at 6 months post-baseline in family-report of quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire.

    Change in quality of life using an Analysis of Covariance with the baseline quality of life score as the covariate, the 6 month quality of life assessment as the dependent variable, and treatment group as the independent variable. The Quality of Life Enjoyment and Satisfaction Questionnaire with family-report is used at both timepoints.

    baseline (pre-treatment). six months post-baseline.

Secondary Outcomes (3)

  • Change from baseline (pre-treatment) to 6 months post-baseline in patient-report of stigma towards schizophrenia using the Stigma Towards Schizophrenia questionnaire.

    baseline (pre-treatment). six months post-baseline.

  • Change from baseline (pre-treatment) to 6 months post-baseline in family-report of stigma towards schizophrenia using the Stigma Towards Schizophrenia questionnaire.

    baseline (pre-treatment). six months post-baseline.

  • Patient-report for schizophrenia medication compliance, at 6 months post-baseline

    6 months post-baseline

Other Outcomes (2)

  • Patient-report satisfaction with hospital services, at 6 months post-baseline

    6 months post-baseline

  • Family-report satisfaction with hospital services, at 6 months post-baseline

    6 months post-baseline

Study Arms (2)

Psychoeducation

EXPERIMENTAL

3 session psychoeducation program with the family, and 3 session psychoeducation program with the patient, after psychosis is controlled. Psychoeducation focuses on explaining schizophrenia as a medical illness, the prognosis, and how the patient and family can increase the likelihood of better outcome.

Behavioral: Psychoeducation

Control

NO INTERVENTION

Family and patient do not receive psychoeducation, but still receive standard hospital services for schizophrenia.

Interventions

PsychoeducationBEHAVIORAL

3 session psychoeducation program with the family, and 3 session psychoeducation program with the patient, after psychosis is controlled. Psychoeducation focuses on explaining schizophrenia as a medical illness, the prognosis, and how the patient and family can increase the likelihood of better outcome.

Psychoeducation

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of schizophrenia, based on ICD-10
  • Receive in-patient treatment at hospital
  • Length of schizophrenia less than 3 years.
  • Treated 3 or less times for schizophrenia.

You may not qualify if:

  • Mental retardation, or other diagnoses that could affect the ability to answer questionnaires, after the acute schizophrenia psychosis is controlled.
  • Suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danang Psychiatric Hospital

Da Nang, Vietnam

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Ngoc Tran, MD

    Danang Psychiatric Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 22, 2016

Study Start

September 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 22, 2016

Record last verified: 2016-03

Locations

VN(1)