NCT00046085

Brief Summary

This study evaluated the benefits of providing relatives of patients diagnosed with schizophrenia the opportunity to interact with each other using the Internet. It was hypothesized that patients whose relatives had access to the internet intervention would have reduced symptoms and greater community tenure, compared to their counterparts who did not have relative access to the internet education and support program. We also collected information on how frequently the relatives used the website and how well they liked its features.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2001

Longer than P75 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

March 1, 2001

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2002

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

4.8 years

First QC Date

September 19, 2002

Last Update Submit

September 8, 2016

Conditions

Schizophrenia

Keywords

SchizophreniaFamilyPsychoeducationInternet

Outcome Measures

Primary Outcomes (2)

  • Patient BPRS Total Score

    Mean total of Brief Psychiatric Rating Scale Score ( BPRS; adapted in Ventura et al, 1993) rated through patient interview. Range is 1-7, with high scores indicating more psychopathology.

    baseline, 6 month, 12 month

  • Patient Hospitalization

    Yes/No classification of hospitalization using all sources of data collected in the year

    12 months of study

Secondary Outcomes (2)

  • BPRS Psychosis Subscale Score

    baseline, 6 month, 12 month

  • Relative Anxiety on the BSI

    baseline, 6 months, 12 months

Study Arms (2)

Patient customary care

ACTIVE COMPARATOR

12 months of patient customary care

Behavioral: Customary care

Online family education

EXPERIMENTAL

12 months of patient customary care and relative access to online education and support program

Behavioral: Online Family EducationBehavioral: Customary care

Interventions

Online Family EducationBEHAVIORAL

Families were provided with private, secure access to the website, which features family-to-family chat capabilities, video lectures on the management of schizophrenia, written materials on important issues in schizophrenia management, professionally facilitated online discussions of the material, and additional resource links.

Online family education
Customary careBEHAVIORAL

Participants received care as usual.

Online family educationPatient customary care

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnostic and Statistical Manual (DSM-IV) research diagnosis of schizophrenia or schizoaffective disorder
  • Stable antipsychotic medication regimen for at least 1 month
  • Willing to participate in in-person assessments
  • At least 4 hours of weekly contact with patient
  • Willing to participate in in-person assessments
  • Interested in a family education program for schizophrenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

Related Publications (1)

  • Glynn SM, Randolph ET, Garrick T, Lui A. A proof of concept trial of an online psychoeducational program for relatives of both veterans and civilians living with schizophrenia. Psychiatr Rehabil J. 2010 Spring;33(4):278-87. doi: 10.2975/33.4.2010.278.287.

    PMID: 20374986RESULT

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Shirley M Glynn, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 19, 2002

First Posted

September 23, 2002

Study Start

March 1, 2001

Primary Completion

December 1, 2005

Study Completion

November 1, 2006

Last Updated

September 9, 2016

Record last verified: 2016-09

Locations

US(1)