SchizophreniaNCT00046085
Online Family Support and Education for Schizophrenia
A study testing Online Family Education and Customary care in people with Schizophrenia, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Online Family Education and Customary care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Nov 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
About this study
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Online Family Education, Customary care
- Keywords
- Schizophrenia, Family, Psychoeducation, Internet
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Family EducationBehavioural
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.
Customary careBehavioural
Participants received care as usual.
| Study group | Role | What they receive |
|---|---|---|
| Patient customary care | Active comparator | 12 months of patient customary care Receives: Behavioral: Customary care |
| Online family education | Experimental | 12 months of patient customary care and relative access to online education and support program Receives: Behavioral: Online Family Education; Behavioral: Customary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 month, 12 month
Patient Hospitalization
Yes/No classification of hospitalization using all sources of data collected in the year
Measured: 12 months of study
Secondary outcomes (2)
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.
Measured: baseline, 6 month, 12 month
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.
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2002 (estimated)
- Study startMar 2001
- Primary completionDec 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Shirley M Glynn, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046085
- Sponsor's protocol ID
- R21MH062135
- Other IDs
- R21MH062135, DSIR AT-SP
- Status last verified
- Sep 2016
- First submitted
- 19 Sep 2002
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20374986
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Family Support and Education for Schizophrenia
- ClinicalTrials.gov ID
- NCT00046085
- Acronym / sponsor ID
- R21MH062135
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Family, Psychoeducation, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2001
- Primary completion
- Dec 2005 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 23 Sep 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient customary care | Active comparator | Behavioral: Customary care12 months of patient customary care |
| Online family education | Experimental | Behavioral: Online Family Education, Behavioral: Customary care12 months of patient customary care and relative access to online education and support program |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Family EducationFamilies 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. | Behavioural | Online family education |
| Customary careParticipants received care as usual. | Behavioural | Online family education, Patient customary care |
Primary outcome
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
2 secondary outcomes
BPRS Psychosis Subscale Score
Time frame: baseline, 6 month, 12 month
Relative Anxiety on the BSI
Time frame: baseline, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Results publication: PubMed 20374986Glynn 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley M Glynn, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Family Education and Customary care in people with Schizophrenia, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient BPRS Total Score (time frame: baseline, 6 month, 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00046085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.