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Skills for Wellness (SWELL)

Primary Purpose

Schizophrenia, Bipolar Disorder, Major Depression

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
maCBT
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring Severe Mental Illness

Eligibility Criteria

9 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nova Scotia Health Authority
  • Nova Scotia Health AuthorityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

maCBT

Comparison

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Severe mental illness (long-term outcome)
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.
Distress associated with unusual experiences
Distress ratings of the Funny Feelings questionnaire.
Functioning
General, social and role functioning scales; employment status.
psychotic-like experiences
presence of one or more definite clinician-confirmed psychotic symptoms on the 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 - continuous
Total score on the Affective Lability Scales. Continuous.
Affective lability
Score of 1 standard deviation or more above general population on the affective lability scales (self- or parent report)
Anxiety - continuous
Total score on the SCARED (Screen for Child Anxiety Related Disorders) questionnaire.

Full Information

First Posted
October 29, 2013
Last Updated
February 6, 2023
Sponsor
Nova Scotia Health Authority
Collaborators
Nova Scotia Health Research Foundation, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01980147
Brief Title
Skills for Wellness
Acronym
SWELL
Official Title
Skills for Wellness: Cognitive-behavioural Skills Training for Psychotic-like Experiences, Basic Symptoms, Affective Lability and Anxiety in Youth
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2014 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Nova Scotia Health Research Foundation, Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder, Major Depression
Keywords
Severe Mental Illness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
maCBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
Naturalistic comparison arm: No intervention offered, no intervention prohibited.
Intervention Type
Behavioral
Intervention Name(s)
maCBT
Other Intervention Name(s)
Multimodal Antecedent-focussed Cognitive-behavioural Training
Intervention Description
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 Information:
Title
Early antecedents to severe mental illness
Description
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)
Time Frame
4-6 months after the end of the intervention
Secondary Outcome Measure Information:
Title
Severe mental illness (long-term outcome)
Description
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.
Time Frame
Annual follow-ups over 3, 5, 7 and 10 years
Title
Distress associated with unusual experiences
Description
Distress ratings of the Funny Feelings questionnaire.
Time Frame
4-6 months, 1, 2, 3, and 5 years post intervention
Title
Functioning
Description
General, social and role functioning scales; employment status.
Time Frame
4-6 months, 1, 2, 3, 5 , 7 and 10 years post intervention.
Title
psychotic-like experiences
Description
presence of one or more definite clinician-confirmed psychotic symptoms on the Funny Feelings instrument
Time Frame
4-6 months, 1, 2, 3, and 5 years post intervention
Title
basic symptoms
Description
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)
Time Frame
4-6 months, 1, 2, 3, and 5 years post intervention
Title
Anxiety
Description
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)
Time Frame
4-6 months, 1, 2, 3, and 5 years post intervention
Title
Affective lability - continuous
Description
Total score on the Affective Lability Scales. Continuous.
Time Frame
4-6 months, 1, 2, 3, and 5 years post intervention
Title
Affective lability
Description
Score of 1 standard deviation or more above general population on the affective lability scales (self- or parent report)
Time Frame
4-6 months, 1, 2, 3, and 5 years post intervention
Title
Anxiety - continuous
Description
Total score on the SCARED (Screen for Child Anxiety Related Disorders) questionnaire.
Time Frame
4-6 months, 1, 2, 3, and 5 years post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf Uher, MD PhD
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2E2
Country
Canada
Individual Site Status
Enrolling by invitation
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rudolf Uher, MD PhD
Email
uher@dal.ca
First Name & Middle Initial & Last Name & Degree
Jill Cumby, RN
Email
jill.cumby@nshealth.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Skills for Wellness

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