← Back to Search

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

Must not have

More than 3 sessions of structured psychological therapy in the past 12 months

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had more than 3 therapy sessions in the last year.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mental disorders

Secondary study objectives

Affective lability

Affective lability - continuous

Anxiety

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 2Eligibility criteria met