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Clinical Trials/NCT00046085
NCT00046085CompletedNot Applicable

Online Family Support and Education for Schizophrenia

University of California, Los Angeles1 site in 1 country42 target enrollmentStarted: March 1, 2001Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
1
Primary Endpoint
Patient BPRS Total Score

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Patient customary care

Active Comparator

12 months of patient customary care

Intervention: Customary care (Behavioral)

Online family education

Experimental

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

Intervention: Online Family Education (Behavioral)

Online family education

Experimental

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

Intervention: Customary care (Behavioral)

Outcomes

Primary Outcomes

Patient BPRS Total Score

Time Frame: baseline, 6 month, 12 month

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

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

Secondary Outcomes

  • Relative Anxiety on the BSI(baseline, 6 months, 12 months)
  • BPRS Psychosis Subscale Score(baseline, 6 month, 12 month)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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