- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01980147
Skills for Wellness (SWELL)
Skills for Wellness: Cognitive-behavioural Skills Training for Psychotic-like Experiences, Basic Symptoms, Affective Lability and Anxiety in Youth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The proposed research will test the acceptability and efficacy of an early preventive intervention for the antecedents to severe mental illness with the following hypotheses:
- Do young people at risk for severe mental illness accept a cognitive-behavioural intervention that targets early antecedents to severe mental illness?
- Does a cognitive-behavioural intervention targeting antecedents to severe mental illness reduce the rate of unusual auditory and visual experiences, the loss of previously acquired abilities, anxiety, and unstable mood?
- Does a cognitive-behavioural intervention focused on antecedents reduce emotional distress in young people at risk for severe mental illness?
- Is social functioning improved in young people at risk for severe mental illness through antecedent-focused cognitive-behavioural intervention?
- (Long-term) Does early cognitive-behavioural intervention targeting antecedents reduce the risk of developing severe mental illness?
Design: the investigators are proposing to test a new preventive intervention for antecedent conditions for which most individuals would currently receive no intervention at all. Therefore, the best comparison for the proposed intervention is a group of individuals who do not differ from the intervention group at baseline but who are neither offered a specific intervention nor discouraged from seeking any treatment that they may normally receive. Such a non-intervention comparison group is best achieved using the recently-developed cohort-multiple randomized controlled design (cmRCT; Relton et al., 2010) In a cmRCT, eligible participants are identified within a cohort study, which follows up all participants and measures outcomes of interest. A proportion of eligible participants within the cohort is randomly selected and approached to be offered the intervention of interest, while the other eligible participants in the cohort are not so approached (i.e., controls). All participants continue to be followed up as part of the cohort irrespective of whether they accept the offered intervention or not. This enables a more realistic, fair and complete evaluation of the intervention effects. Those randomly selected to be offered maCBT will be approached, given full information about the planned intervention and asked to provide a separate written consent for the intervention study.
Intervention: 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 2E2
- Recruiting
- Nova Scotia Health Authority
-
Halifax, Nova Scotia, Canada, B3H 2E2
- Enrolling by invitation
- Nova Scotia Health Authority
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
Other Names:
|
NO_INTERVENTION: Comparison
Naturalistic comparison arm: No intervention offered, no intervention prohibited.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early antecedents to severe mental illness
Time Frame: 4-6 months after the end of the intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severe mental illness (long-term outcome)
Time Frame: Annual follow-ups over 3, 5, 7 and 10 years
|
Diagnosis of major mood (major depressive disorder, bipolar disorder) or psychotic disorder (schizophrenia, schizoaffective, schizophreniform, or delusional disorder)on K-SADS or SCID (Structured Clinical Interview for DSM) diagnostic interviews on any follow-up visit.
|
Annual follow-ups over 3, 5, 7 and 10 years
|
Distress associated with unusual experiences
Time Frame: 4-6 months, 1, 2, 3, and 5 years post intervention
|
Distress ratings of the Funny Feelings questionnaire.
|
4-6 months, 1, 2, 3, and 5 years post intervention
|
Functioning
Time Frame: 4-6 months, 1, 2, 3, 5 , 7 and 10 years post intervention.
|
General, social and role functioning scales; employment status.
|
4-6 months, 1, 2, 3, 5 , 7 and 10 years post intervention.
|
psychotic-like experiences
Time Frame: 4-6 months, 1, 2, 3, and 5 years post intervention
|
presence of one or more definite clinician-confirmed psychotic symptoms on the Funny Feelings instrument
|
4-6 months, 1, 2, 3, and 5 years post intervention
|
basic symptoms
Time Frame: 4-6 months, 1, 2, 3, and 5 years post intervention
|
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)
|
4-6 months, 1, 2, 3, and 5 years post intervention
|
Anxiety
Time Frame: 4-6 months, 1, 2, 3, and 5 years post intervention
|
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)
|
4-6 months, 1, 2, 3, and 5 years post intervention
|
Affective lability - continuous
Time Frame: 4-6 months, 1, 2, 3, and 5 years post intervention
|
Total score on the Affective Lability Scales.
Continuous.
|
4-6 months, 1, 2, 3, and 5 years post intervention
|
Affective lability
Time Frame: 4-6 months, 1, 2, 3, and 5 years post intervention
|
Score of 1 standard deviation or more above general population on the affective lability scales (self- or parent report)
|
4-6 months, 1, 2, 3, and 5 years post intervention
|
Anxiety - continuous
Time Frame: 4-6 months, 1, 2, 3, and 5 years post intervention
|
Total score on the SCARED (Screen for Child Anxiety Related Disorders) questionnaire.
|
4-6 months, 1, 2, 3, and 5 years post intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rudolf Uher, MD PhD, Nova Scotia Health Authority
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFW-2013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Peking UniversityNot yet recruitingTreatment-resistant Schizophrenia
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
-
NYU Langone HealthNot yet recruitingTreatment-resistant SchizophreniaUnited States