Preventive intervention for young people at risk of severe mental illness
Skills for Wellness: Cognitive-behavioural Skills Training for Psychotic-like Experiences, Basic Symptoms, Affective Lability and Anxiety in Youth
This study is testing a new program to help young people aged 9-21 who are at risk of serious mental illnesses by teaching them skills to manage early warning signs like anxiety and unusual experiences.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 9 Years to 21 Years |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 2 sites (Halifax, Nova Scotia and 1 other locations) |
| Trial ID | NCT01980147 on ClinicalTrials.gov |
What this trial studies
This research focuses on a new preventive intervention aimed at young individuals aged 9-21 who are at high risk of developing severe mental illnesses such as schizophrenia, bipolar disorder, and major depression. The study will evaluate the acceptability and efficacy of a cognitive-behavioral intervention that targets early warning signs, or antecedents, of severe mental illness, including anxiety and unusual sensory experiences. Participants will be compared to a non-intervention group to assess the impact of the intervention on emotional distress and social functioning, with the ultimate goal of reducing the risk of developing severe mental illness in the long term.
Who should consider this trial
Good fit: Ideal candidates are young individuals aged 9-21 who exhibit early signs of mental health issues but do not yet have a diagnosis of severe mental illness.
Not a fit: Patients who have already been diagnosed with severe mental illnesses such as schizophrenia or bipolar disorder will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of severe mental illness in at-risk youth.
How similar studies have performed: Other studies have shown promise in using cognitive-behavioral approaches for early intervention in mental health, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Halifax, Nova Scotia and 1 other locations
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Enrolling_by_invitation)
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Principal investigator: Rudolf Uher, MD PhD — Nova Scotia Health Authority
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.