SchizophreniaPhase 3NCT00358709
Treating Psychotic Symptoms of Young Individuals Presenting a First Episode of Schizophrenia: Comparison of Two State-of-the-Art Interventions
A Phase 3 study testing Cognitive-Behavioral therapy and Symptom Management in people with Schizophrenia, run by University of British Columbia at 1 site in Canada.
Trial summary
To verify the efficacy of a group cognitive-behavioral therapy approach to lessening psychotic symptoms of individuals with a first episode of psychosis, and to compare its effects to a known skills training approach and a control group. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cognitive-Behavioral therapy and Symptom Management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 129 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2002to Dec 2006
- Phase
- Phase 3
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1) less than two years since their first consultation in psychiatry for psychotic symptoms, 2) a DSM-IV diagnosis in the schizophrenia spectrum (or a psychotic episode suggesting a non-mood related psychosis), 3) ability to read and write in English, 4) aged between 18 and 35, 5) no organic disorder, and 6) consenting to participate
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treating Psychotic Symptoms of Young Individuals Presenting a First Episode of Schizophrenia: Comparison of Cognitive-Behavioral Therapy and Skills Training Symptom Management on Measures of Symptoms and on Other Indices of Well-Being
To verify the efficacy of a group cognitive-behavioral therapy approach to lessening psychotic symptoms of individuals with a first episode of psychosis, and to compare its effects to a known skills training approach and a control group. Our primary hypotheses were that CBT would do better than the control group at all points in time, and better than the skills training approach, though only at follow-ups
Read the detailed description
The study's protocol has the following objectives: to verify the efficacy of a group CBT approach; to compare the effects of CBT to those of the symptom management module and to a control group on psychotic symptoms and subjective experiences (e.g., depression, anxiety, self-esteem, social support, insight, and coping); and to assess what the effects are related to, via measuring client variables, therapist variables, and intervention variables that might explain the results. This study follows a randomized controlled trial design where participants are randomly assigned to one of the three groups at each recruiting wave. Both treatment modalities hold the same number of group meetings as well as similar formats, lengths of treatment and operational structures, each operationalized in detailed manuals. Interviewers are blind to group allocation. Symptoms, both psychotic and otherwise, depression, self-esteem, social adaptation, anxiety, insight, social support, and coping are all measured before the beginning of treatment, three months follow-up, nine-months follow-up, and 15-months follow-up
- Conditions
- Schizophrenia
- Being tested
- Cognitive-Behavioral therapy and Symptom Management
- Keywords
- Cognitive-behavioral therapy, symptom management, first psychotic episode
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral therapy and Symptom ManagementBehavioural
A group cognitive-behavioral therapy approach to lessening psychotic symptoms of individuals with a first episode of psychosis, and comparison its effects to a known skills training approach and a control group.
What is being measured
The primary outcome is the main question the study is designed to answer.
Expected effects on symptoms, measured before beginning of treatment, three months, nine-months, and 15-months follow-ups
Measured: 15 months
Secondary outcomes (1)
Self-esteem, social adaptation, coping, insight, substance abuse, measured before beginning treatment, three months, nine-months, and 15-months follow-ups
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startJun 2002
- Primary completionDec 2006
- Study completionDec 2006
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 British ColumbiaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Tania Lecomte, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358709
- Sponsor's protocol ID
- B02-0769
- Status last verified
- Jun 2008
- First submitted
- 28 Jul 2006
- Last updated
- 19 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Psychotic Symptoms of Young Individuals Presenting a First Episode of Schizophrenia: Comparison of Cognitive-Behavioral Therapy and Skills Training Symptom Management on Measures of Symptoms and on Other Indices of Well-Being
- ClinicalTrials.gov ID
- NCT00358709
- Acronym / sponsor ID
- B02-0769
- Conditions
- Schizophrenia
- Keywords
- Cognitive-behavioral therapy, symptom management, first psychotic episode
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 1 Aug 2006 (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.
To verify the efficacy of a group cognitive-behavioral therapy approach to lessening psychotic symptoms of individuals with a first episode of psychosis, and to compare its effects to a known skills training approach and a control group. Our primary hypotheses were that CBT would do better than the control group at all points in time, and better than the skills training approach, though only at follow-ups
Detailed description
The study's protocol has the following objectives: to verify the efficacy of a group CBT approach; to compare the effects of CBT to those of the symptom management module and to a control group on psychotic symptoms and subjective experiences (e.g., depression, anxiety, self-esteem, social support, insight, and coping); and to assess what the effects are related to, via measuring client variables, therapist variables, and intervention variables that might explain the results. This study follows a randomized controlled trial design where participants are randomly assigned to one of the three groups at each recruiting wave. Both treatment modalities hold the same number of group meetings as well as similar formats, lengths of treatment and operational structures, each operationalized in detailed manuals. Interviewers are blind to group allocation. Symptoms, both psychotic and otherwise, depression, self-esteem, social adaptation, anxiety, insight, social support, and coping are all measured before the beginning of treatment, three months follow-up, nine-months follow-up, and 15-months follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1) less than two years since their first consultation in psychiatry for psychotic symptoms, 2) a DSM-IV diagnosis in the schizophrenia spectrum (or a psychotic episode suggesting a non-mood related psychosis), 3) ability to read and write in English, 4) aged between 18 and 35, 5) no organic disorder, and 6) consenting to participate
Key exclusion criteria (1 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 |
|---|---|---|
| Cognitive-Behavioral therapy and Symptom ManagementA group cognitive-behavioral therapy approach to lessening psychotic symptoms of individuals with a first episode of psychosis, and comparison its effects to a known skills training approach and a control group. | Behavioural | – |
Primary outcome
Expected effects on symptoms, measured before beginning of treatment, three months, nine-months, and 15-months follow-ups
Time frame: 15 months
1 secondary outcome
Self-esteem, social adaptation, coping, insight, substance abuse, measured before beginning treatment, three months, nine-months, and 15-months follow-ups
Time frame: 15 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 19 Jun 2008.
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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.
Tania Lecomte principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive-Behavioral therapy and Symptom Management in people with Schizophrenia, run by University of British Columbia at 1 site in Canada.
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 1 inclusion and 1 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 19 Jun 2008. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Expected effects on symptoms, measured before beginning of treatment, three months, nine-months, and 15-months follow-ups (time frame: 15 months). It is what the study was designed to measure, not a finding.
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 19 Jun 2008.