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Online Family Support and Education for Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Family Education
Customary care
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Family, Psychoeducation, Internet

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Greater Los Angeles Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Patient customary care

Online family education

Arm Description

12 months of patient customary care

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

BPRS Psychosis Subscale Score
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
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.

Full Information

First Posted
September 19, 2002
Last Updated
September 8, 2016
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00046085
Brief Title
Online Family Support and Education for Schizophrenia
Official Title
Online Family Support and Education for Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Family, Psychoeducation, Internet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient customary care
Arm Type
Active Comparator
Arm Description
12 months of patient customary care
Arm Title
Online family education
Arm Type
Experimental
Arm Description
12 months of patient customary care and relative access to online education and support program
Intervention Type
Behavioral
Intervention Name(s)
Online Family Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Customary care
Intervention Description
Participants received care as usual.
Primary Outcome Measure Information:
Title
Patient BPRS Total Score
Description
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.
Time Frame
baseline, 6 month, 12 month
Title
Patient Hospitalization
Description
Yes/No classification of hospitalization using all sources of data collected in the year
Time Frame
12 months of study
Secondary Outcome Measure Information:
Title
BPRS Psychosis Subscale Score
Description
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.
Time Frame
baseline, 6 month, 12 month
Title
Relative Anxiety on the BSI
Description
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.
Time Frame
baseline, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley M Glynn, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20374986
Citation
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.
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Online Family Support and Education for Schizophrenia

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