Skills for Wellness

NCT01980147 | Recruiting

• 1 other identifier: SFW-2013
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

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

Keywords

Severe Mental Illness

Outcome Measures

Primary Outcomes (1)

• Early antecedents to severe mental illness

  Presence of any one (or more) of four early antecedents that may indicate risk for developing severe mental illness (psychotic-like experiences, basic symptoms, anxiety and affective lability). psychotic-like experiences - presence of one or more definite clinician-confirmed psychotic symptoms on Funny Feelings instrument. basic symptoms = presence of COGDIS (Cognitive Disturbances) or COPER (Cognitive-perceptive basic symptoms) high risk profile on the Schizophrenia Proneness Instrument - Child and Youth version (SPI-CY) anxiety = diagnosis of an anxiety disorder on K-SADS (Kiddie-Schedule for Affective Disorders and Schizophrenia) interview or score above the high specificity cutoff (30 or higher) on the SCARED (Screen for Child Anxiety Related Disorders) questionnaire (self or parent report) affective lability = score of 1 standard deviation or more above general population on the affective lability scales (self- or parent report)

  4-6 months after the end of the intervention

Secondary Outcomes (9)

• Severe mental illness (long-term outcome)

  Annual follow-ups over 3, 5, 7 and 10 years

• Distress associated with unusual experiences

  4-6 months, 1, 2, 3, and 5 years post intervention

• Functioning

  4-6 months, 1, 2, 3, 5 , 7 and 10 years post intervention.

• psychotic-like experiences

  4-6 months, 1, 2, 3, and 5 years post intervention

• basic symptoms

  4-6 months, 1, 2, 3, and 5 years post intervention

Study Arms (2)

maCBT

EXPERIMENTAL

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.

Behavioral: maCBT

Comparison

NO INTERVENTION

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

Interventions

maCBT BEHAVIORAL

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.

Also known as: Multimodal Antecedent-focussed Cognitive-behavioural Training

maCBT

Eligibility Criteria

• Age: 9 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Nova Scotia Health Research Foundation: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2E2, Canada

ENROLLING BY INVITATION

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2E2, Canada

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Depressive Disorder, Major; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder

Study Officials

• Rudolf Uher, MD PhD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 8, 2013
• Study Start: March 22, 2014
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)