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Skills for Wellness (SWELL)

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ClinicalTrials.gov Identifier: NCT01980147
Recruitment Status : Recruiting
First Posted : November 8, 2013
Last Update Posted : July 17, 2018
Sponsor:
Collaborators:
Nova Scotia Health Research Foundation
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Rudolf Uher, Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar Disorder Major Depression Behavioral: maCBT Not Applicable

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:

  1. Do young people at risk for severe mental illness accept a cognitive-behavioural intervention that targets early antecedents to severe mental illness?
  2. 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?
  3. Does a cognitive-behavioural intervention focused on antecedents reduce emotional distress in young people at risk for severe mental illness?
  4. Is social functioning improved in young people at risk for severe mental illness through antecedent-focused cognitive-behavioural intervention?
  5. (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 : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Skills for Wellness: Cognitive-behavioural Skills Training for Psychotic-like Experiences, Basic Symptoms, Affective Lability and Anxiety in Youth
Actual Study Start Date : March 22, 2014
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


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.
Behavioral: 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.
Other Name: Multimodal Antecedent-focussed Cognitive-behavioural Training

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



Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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. 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

  5. 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)

  6. 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)

  7. Affective lability - continuous [ Time Frame: 4-6 months, 1, 2, 3, and 5 years post intervention ]
    Total score on the Affective Lability Scales. Continuous.

  8. 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)

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980147


Locations
Canada, Nova Scotia
Capital District Health Authority Enrolling by invitation
Halifax, Nova Scotia, Canada, B3H 2E2
Nova Scotia Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 2E2
Contact: Rudolf Uher, MD PhD       uher@dal.ca   
Contact: Jill Cumby, RN       jill.cumby@nshealth.ca   
Sponsors and Collaborators
Nova Scotia Health Authority
Nova Scotia Health Research Foundation
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Rudolf Uher, MD, PhD, MRCPsych Nova Scotia Health Authority

Responsible Party: Rudolf Uher, Professor, Staff Psychiatrist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01980147     History of Changes
Other Study ID Numbers: SFW-2013
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rudolf Uher, Nova Scotia Health Authority:
Severe Mental Illness

Additional relevant MeSH terms:
Schizophrenia
Bipolar Disorder
Depressive Disorder, Major
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Depressive Disorder
Mood Disorders