Recruiting

Observational Study

Sponsor:

Nova Scotia Health Authority

Code:

NCT01980147

Conditions

Schizophrenia

Bipolar Disorder

Major Depression

Eligibility Criteria

Sex: All

Age: 9 - 21

Healthy Volunteers: Not accepted

Interventions

maCBT

Study Details

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.

Conditions

Schizophrenia

Bipolar Disorder

Major Depression

Study ID

NCT01980147

Start date

Mar 22, 2014

Status verified date

May, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: maCBT

Multimodal Antecedent-focussed Cognitive-behavioural Training (maCBT). This integrated model focuses on normalisation of the unusual experiences, their re-appraisal, exploring helpfulness of current coping, and developing a repertoire of strategies to decrease the impact of these experiences on the young person's life. The maCBT follows a manual describing obligatory and optional therapeutic elements, proposed list of modules, outline of a therapeutic session, and the integrated cognitive model. The model and techniques are adapted to an age range of 9 to 17 years, with more visual material and child friendly language options for the younger part of the age range (9-12) and more teen-relevant and interpersonal content options for the older part of the age range (13-17). The intervention will be delivered in 8 to 16 one-hour sessions in an individual format. Sessions will be initially weekly, and then spaced out to once every two weeks in the latter stages of the intervention.

no intervention: Comparison

Naturalistic comparison arm: No intervention offered, no intervention prohibited.

Interventions

maCBT

Multimodal Antecedent-focussed Cognitive-behavioural Training (maCBT) is an individual manualized psychological intervention. It follows an integrated model focussed on normalisation of the unusual experiences, their re-appraisal, exploring helpfulness of current coping, and developing a repertoire of strategies to decrease the impact of these experiences on the young person's life. The maCBT follows a manual describing obligatory and optional therapeutic elements, proposed list of modules, outline of a therapeutic session, and the integrated cognitive model. The intervention will be delivered in 8 to 16 one-hour sessions in an individual format. Sessions will be initially weekly, and then spaced out to once every two weeks in the latter stages of the intervention.

Primary outcome measure

  • Early antecedents to severe mental illness [ Time Frame: 4-6 months after the end of the intervention ]

Central Contacts and Locations

Locations

Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada, B3H 2E2

Contacts

Rudolf Uher, MD PhD

uher@dal.ca

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

May 14, 2025

Last verified

May, 2025

Keywords

  • Severe Mental Illness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2025-05-14.