Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Online Family Support and Education for Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00046085
First received: September 19, 2002
Last updated: September 8, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Schizophrenia
Behavioral: Online Family Education
Behavioral: Customary care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Online Family Support and Education for Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Patient BPRS Total Score [ Time Frame: baseline, 6 month, 12 month ] [ Designated as safety issue: No ]
    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.

  • Patient Hospitalization [ Time Frame: 12 months of study ] [ Designated as safety issue: No ]
    Yes/No classification of hospitalization using all sources of data collected in the year


Secondary Outcome Measures:
  • BPRS Psychosis Subscale Score [ Time Frame: baseline, 6 month, 12 month ] [ Designated as safety issue: No ]
    Mean total of Brief Psychiatric Rating Scale psychosis subscale Score ( BPRS; adapted in Ventura et al, 1993) rated through patient interview. Range is 1-7, with high scores indicating more psychopathology.

  • Relative Anxiety on the BSI [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Relative self-report on the anxiety subscale of the Brief Symptom Inventory (BSI; Derogatis, 1993). Range is 1-5, with high scores indicating more anxiety.


Enrollment: 42
Study Start Date: March 2001
Study Completion Date: November 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Patient customary care
12 months of patient customary care
Behavioral: Customary care
Participants received care as usual.
Experimental: Online family education
12 months of patient customary care and relative access to online education and support program
Behavioral: Online Family Education
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.
Behavioral: Customary care
Participants received care as usual.

Detailed Description:

Although psychoeducational programs for schizophrenia can reduce patient relapse rates and reduce family distress, participation rates are often low. This study evaluated an online model to provide the families of schizophrenia patients with knowledge of illness management to reduce family burden and increase perceived social support.

Relatives of patients with schizophrenia who received 12 months of customary care with access to the educational website for the first year were compared to matched group of relatives of individuals diagnosed with schizophrenia who were receiving customary care and who consented to participate in a family education program. In the education condition, relatives 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.

Relatives were assessed using 90-minute interviews at the beginning of the project and every 6 months for 12 months. The interviews were used to assess the family member's perception of the patient's symptoms, his or her knowledge of the illness, the illness's impact on the family member, and his or her perception of the website intervention.

Patients with schizophrenia or schizoaffective disorder were also asked to complete interviews and assessments at the beginning of the project and every 6 months for 12 months. The assessments include questions about symptoms, medication compliance and side effects, hospitalizations, and social functioning.

The major hypotheses were that relative participation in the online program would be associated with lower symptoms rates and hospitalizations in the patients.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Patients:

  • 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

Inclusion Criteria for Relatives:

  • At least 4 hours of weekly contact with patient
  • Willing to participate in in-person assessments
  • -Interested in a family education program for schizophrenia
  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: NCT00046085

Locations
United States, California
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Shirley M Glynn, Ph.D. University of California, Los Angeles
  More Information

Publications:
Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00046085     History of Changes
Other Study ID Numbers: R21MH062135  DSIR AT-SP 
Study First Received: September 19, 2002
Last Updated: September 8, 2016
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
Schizophrenia
Family
Psychoeducation
Internet

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 23, 2016