| NCT ID | NCT01980147 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nova Scotia Health Authority |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2014-03-22 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2014-03-22 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Severe mental illness such as schizophrenia and mood disorders typically develops at a young age and can cause life-long disability. Currently available treatments cannot cure severe mental illness. This makes it important to find ways to prevent severe mental illness in young people before it has a chance to develop. This research study will pilot a new preventive intervention for young people who are at high risk of developing severe mental illness. The investigators will target early preceding factors (the 'antecedents') to severe mental illness which includes anxiety, unusual hearing and visual experiences, the loss of previously acquired abilities, and sudden and unpredictable changes in mood. These antecedents strongly predict an increased risk of developing severe mental illness. They are often impairing and distressing to the individual but can be improved with self-management skills and parent training, and they are present in the individual years before the onset of severe mental illness which makes them an ideal target for early intervention. The goal is to intervene early enough in the young person's life that severe mental illness can be prevented, hopefully leading to a happy, healthy and productive adulthood. The investigators want to test the acceptability and short-term efficacy of this new preventive intervention.
Eligibility Criteria
Inclusion Criteria: * FORBOW (Families Overcoming Risks and Building Opportunities for Well-Being) participant between 9-21 years old * Meet criteria for one or more antecedents (psychotic like experience, basic symptoms, anxiety or affective lability) Exclusion Criteria: * Diagnosis of severe mental illness (schizophrenia, other psychotic disorder, bipolar disorder, severe major depressive disorder) * More than 3 sessions of structured psychological therapy in the past 12 months * Insufficient understanding of the English language to benefit from the intervention
Contact & Investigator
Rudolf Uher, MD PhD
PRINCIPAL INVESTIGATOR
Nova Scotia Health Authority
Frequently Asked Questions
Who can join the NCT01980147 clinical trial?
This trial is open to participants of all sexes, aged 9 Years or older, up to 21 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01980147 currently recruiting?
Yes, NCT01980147 is actively recruiting participants. Visit ClinicalTrials.gov or contact Nova Scotia Health Authority to inquire about joining.
Where is the NCT01980147 trial being conducted?
This trial is being conducted at Halifax, Canada, Halifax, Canada.
Who is sponsoring the NCT01980147 clinical trial?
NCT01980147 is sponsored by Nova Scotia Health Authority. The principal investigator is Rudolf Uher, MD PhD at Nova Scotia Health Authority. The trial plans to enroll 360 participants.
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