SchizophreniaPhase 2NCT00051233
Treatment of Schizophrenia Through Internet-Based Psychoeducation
A Phase 2 study testing World Wide Web-Based Psychoeducation in people with Schizophrenia and Schizoaffective Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness of a Web-based psychoeducational program in helping people with schizophrenia and their families manage the disease. Read more about this study
- Who is it for?
- Ages 14 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- World Wide Web-Based Psychoeducation
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jan 2005
- Phase
- Phase 2
- 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 14 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- At least 4 hours/week in-person contact with a family member
- Primary caregiver with a telephone
- Patient and primary caregiver speak and read English
Who cannot join
- Enrolled in another clinical trial
- Evidence of organic brain syndrome
- Current alcohol or substance abuse that could explain the presenting index psychotic episode
- DSM-IV diagnosis of psychoactive substance dependency
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Schizophrenia Patient and Family Continuity of Care
The purpose of this study is to assess the effectiveness of a Web-based psychoeducational program in helping people with schizophrenia and their families manage the disease.
Read the detailed description
This study will provide a comprehensive psychoeducational program which includes education, social support, information, coping strategies, and guidance from mental health, social services, and medical professionals. This study will work to reduce relapse, facilitate patient rehabilitation, decrease family distress, and improve family well being.
Patients and their families participate in an in-person Psychoeducational Survival Skills Workshop that is designed to provide patients and their families with basic information about schizophrenia and its treatment. After the workshop, participants are provided with 6 Web-based modules that are designed to increase mental health and schizophrenia knowledge. Patient relapse, family distress, family knowledge of schizophrenia, and data on user's acceptance and utilization are measured to determine the intervention's effectiveness.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- World Wide Web-Based Psychoeducation
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
World Wide Web-Based PsychoeducationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2003 (estimated)
- Study startJan 2003
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Armando J Rotondi, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051233
- Sponsor's protocol ID
- R01MH063484
- Other IDs
- R01MH063484, DSIR SE-DR
- Status last verified
- Jun 2014
- First submitted
- 7 Jan 2003
- Last updated
- 30 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schizophrenia Patient and Family Continuity of Care
- ClinicalTrials.gov ID
- NCT00051233
- Acronym / sponsor ID
- R01MH063484
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2003
- Study completion
- Jan 2005
- First posted
- 8 Jan 2003 (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.
The purpose of this study is to assess the effectiveness of a Web-based psychoeducational program in helping people with schizophrenia and their families manage the disease.
Detailed description
This study will provide a comprehensive psychoeducational program which includes education, social support, information, coping strategies, and guidance from mental health, social services, and medical professionals. This study will work to reduce relapse, facilitate patient rehabilitation, decrease family distress, and improve family well being.
Patients and their families participate in an in-person Psychoeducational Survival Skills Workshop that is designed to provide patients and their families with basic information about schizophrenia and its treatment. After the workshop, participants are provided with 6 Web-based modules that are designed to increase mental health and schizophrenia knowledge. Patient relapse, family distress, family knowledge of schizophrenia, and data on user's acceptance and utilization are measured to determine the intervention's effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- At least 4 hours/week in-person contact with a family member
- Primary caregiver with a telephone
- Patient and primary caregiver speak and read English
Key exclusion criteria (4 listed)
- Enrolled in another clinical trial
- Evidence of organic brain syndrome
- Current alcohol or substance abuse that could explain the presenting index psychotic episode
- DSM-IV diagnosis of psychoactive substance dependency
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 |
|---|---|---|
| World Wide Web-Based Psychoeducation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 30 Jun 2014.
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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.
Armando J Rotondi principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing World Wide Web-Based Psychoeducation in people with Schizophrenia and Schizoaffective Disorder, run by University of Pittsburgh 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 4 inclusion and 4 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 30 Jun 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
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 30 Jun 2014.