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Mindfulness and CBT for Preventing Severe Mental Illness in Youth (SWELL Trial)

N/A

Recruiting

Led By Rudolf Uher, MD PhD

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

FORBOW (Families Overcoming Risks and Building Opportunities for Well-Being) participant between 9-21 years old

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up annual follow-ups over 3, 5, 7 and 10 years

Awards & highlights

SWELL Trial Summary

This trial will test a new intervention to prevent severe mental illness in young people who are at high risk. The intervention will target early preceding factors to severe mental illness, which are often impairing and distressing to the individual but can be improved with self-management skills and parent training. The goal is to intervene early enough in the young person's life that severe mental illness can be prevented.

Who is the study for?

This trial is for young individuals aged 9-21 who are part of the FORBOW study, showing early signs that may predict severe mental illness, like anxiety or mood swings. It's not for those with a severe mental illness diagnosis or who've had significant therapy recently.Check my eligibility

What is being tested?

The trial tests a new preventive intervention called maCBT aimed at improving self-management skills to prevent the development of severe mental illnesses in high-risk youths by addressing early symptoms.See study design

What are the potential side effects?

Since this is a psychological intervention focusing on cognitive behavioral techniques, there might be no direct physical side effects; however, participants could experience emotional discomfort while discussing personal issues.

SWELL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a FORBOW participant aged between 9 and 21.

SWELL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ annual follow-ups over 3, 5, 7 and 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~annual follow-ups over 3, 5, 7 and 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and annual follow-ups over 3, 5, 7 and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mental disorders

Secondary outcome measures

Affective lability

Affective lability - continuous

Anxiety

+6 more

SWELL Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: maCBTExperimental Treatment1 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.

Group II: ComparisonActive Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nova Scotia Health AuthorityLead Sponsor

258 Previous Clinical Trials

83,494 Total Patients Enrolled

3 Trials studying Schizophrenia

251 Patients Enrolled for Schizophrenia

Nova Scotia Health Research FoundationOTHER_GOV

14 Previous Clinical Trials

33,692 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,207 Total Patients Enrolled

13 Trials studying Schizophrenia

727,212 Patients Enrolled for Schizophrenia

Media Library

maCBT Clinical Trial Eligibility Overview. Trial Name: NCT01980147 — N/A

Schizophrenia Research Study Groups: maCBT, Comparison

Schizophrenia Clinical Trial 2023: maCBT Highlights & Side Effects. Trial Name: NCT01980147 — N/A

maCBT 2023 Treatment Timeline for Medical Study. Trial Name: NCT01980147 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a way for me to be involved in this research project?

"To be included in this medical trial, subjects must have a diagnosis of bipolar disorder and fall between the ages of 9 and 21. The research team is looking to recruit 360 participants."

Answered by AI

Does this trial restrict participation to individuals of a certain age range?

"This clinical trial is exclusively for those aged 9 to 21. As such, there are 91 trials specifically targeting minors and 449 studies recruiting adults over the age of 65."

Answered by AI

Are participants currently being sought for this experiment?

"Affirmative. According to the details on clinicaltrials.gov, this medical trial was initially announced on March 22nd 2014 and has recently been updated on February 6th 2023 with 360 participants sought from one site only."

Answered by AI

What is the participant enrollment size for this experiment?

"Affirmative. Information posted on clinicaltrials.gov indicates that this medical research is actively seeking participants, with 360 individuals being targeted across one site since it was first published in March 2014 and last modified in February 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Skills for Wellness

Rudolf Uher 2014. "Skills for Wellness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01980147.

All > Schizophrenia > Bipolar Disorder