- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00046085
Online Family Support and Education for Schizophrenia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90073
- VA Greater Los Angeles Healthcare System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Patient customary care
12 months of patient 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
|
Participants received care as usual.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline, 6 month, 12 month
|
|
Patient Hospitalization
Time Frame: 12 months of study
|
Yes/No classification of hospitalization using all sources of data collected in the year
|
12 months of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BPRS Psychosis Subscale Score
Time Frame: baseline, 6 month, 12 month
|
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.
|
baseline, 6 month, 12 month
|
|
Relative Anxiety on the BSI
Time Frame: baseline, 6 months, 12 months
|
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.
|
baseline, 6 months, 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Shirley M Glynn, Ph.D., University of California, Los Angeles
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21MH062135 (U.S. NIH Grant/Contract)
- DSIR AT-SP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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