SchizophreniaSWELLNCT01980147
Skills for Wellness
A study testing maCBT in people with Schizophrenia and Bipolar Disorder, run by Nova Scotia Health Authority at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 21 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Major Depression
- What is being tested?
- maCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesCanada
- Study dates
- 22 Mar 2014to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Enrolling by invitation
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2E2
- Recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2E2
Rudolf Uher, MD PhD, uher@dal.ca
Jill Cumby, RN, jill.cumby@nshealth.ca
About this study
Official title: Skills for Wellness: Cognitive-behavioural Skills Training for Psychotic-like Experiences, Basic Symptoms, Affective Lability and Anxiety in Youth
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.
Read the 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.
- Conditions
- Schizophrenia, Bipolar Disorder, Major Depression
- Being tested
- maCBT
- Keywords
- Severe Mental Illness
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Depressive Disorder, Major, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maCBTBehavioural
Also called Multimodal Antecedent-focussed Cognitive-behavioural Training
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: maCBT |
| Comparison | No intervention | Naturalistic comparison arm: No intervention offered, no intervention prohibited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4-6 months after the end of the intervention
Secondary outcomes (9)
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.
Measured: Annual follow-ups over 3, 5, 7 and 10 years
Distress associated with unusual experiences
Distress ratings of the Funny Feelings questionnaire.
Measured: 4-6 months, 1, 2, 3, and 5 years post intervention
Functioning
General, social and role functioning scales; employment status.
Measured: 4-6 months, 1, 2, 3, 5 , 7 and 10 years post intervention.
psychotic-like experiences
presence of one or more definite clinician-confirmed psychotic symptoms on the Funny Feelings instrument
Measured: 4-6 months, 1, 2, 3, and 5 years post intervention
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)
Measured: 4-6 months, 1, 2, 3, and 5 years post intervention
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)
Measured: 4-6 months, 1, 2, 3, and 5 years post intervention
Affective lability - continuous
Total score on the Affective Lability Scales. Continuous.
Measured: 4-6 months, 1, 2, 3, and 5 years post intervention
Affective lability
Score of 1 standard deviation or more above general population on the affective lability scales (self- or parent report)
Measured: 4-6 months, 1, 2, 3, and 5 years post intervention
Anxiety - continuous
Total score on the SCARED (Screen for Child Anxiety Related Disorders) questionnaire.
Measured: 4-6 months, 1, 2, 3, and 5 years post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study start22 Mar 2014
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Research Foundation, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Rudolf Uher, MD PhD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980147
- Sponsor's protocol ID
- SFW-2013
- Acronym
- SWELL
- Status last verified
- May 2025
- First submitted
- 29 Oct 2013
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skills for Wellness: Cognitive-behavioural Skills Training for Psychotic-like Experiences, Basic Symptoms, Affective Lability and Anxiety in Youth
- ClinicalTrials.gov ID
- NCT01980147
- Acronym / sponsor ID
- SWELL / SFW-2013
- Conditions
- Schizophrenia, Bipolar Disorder, Major Depression
- Keywords
- Severe Mental Illness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Nova Scotia Health Research Foundation, Canadian Institutes of Health Research (CIHR)
- Study start
- 22 Mar 2014 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| maCBT | Experimental | Behavioral: maCBTMultimodal 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. |
| Comparison | No intervention | –Naturalistic comparison arm: No intervention offered, no intervention prohibited. |
Who may qualify
- Ages
- 9 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maCBTAlso: Multimodal Antecedent-focussed Cognitive-behavioural TrainingMultimodal 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. | Behavioural | maCBT |
Primary outcome
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)
9 secondary outcomes
Severe mental illness (long-term outcome)
Time frame: 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
Functioning
Time frame: 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
basic symptoms
Time frame: 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
Affective lability - continuous
Time frame: 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
Anxiety - continuous
Time frame: 4-6 months, 1, 2, 3, and 5 years post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rudolf Uher, MD PhD principal investigator
Nova Scotia Health Authority
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maCBT in people with Schizophrenia and Bipolar Disorder, run by Nova Scotia Health Authority at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early antecedents to severe mental illness (time frame: 4-6 months after the end of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.