Mindfulness and CBT for Preventing Severe Mental Illness in Youth

(SWELL Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8-16 weeks

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a new approach called maCBT to prevent severe mental illnesses like schizophrenia or mood disorders in young people. MaCBT, which stands for Multimodal Antecedent-focused Cognitive-behavioral Training, targets early warning signs such as anxiety, unusual sensory experiences, and mood swings. The goal is to help young individuals manage these symptoms early, potentially preventing severe mental illness later in life. This trial may suit young people aged 9-21 who have experienced anxiety, mood swings, or other early signs of mental health issues but have not been diagnosed with a severe mental illness. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could transform early mental health interventions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention is safe for young people?

Research shows that Mindfulness and Cognitive Behavioral Therapy (CBT) are generally safe and well-tolerated. Studies have found that CBT helps people change unhelpful behaviors, improving mental health. When combined with CBT, mindfulness practices effectively prevent depression recurrence and enhance overall mental well-being.

Mindfulness-based cognitive therapies have increased life satisfaction and improved family relationships in teens. These therapies help individuals become more aware of their thoughts and feelings in the present moment, leading to better coping strategies.

While every treatment can have side effects, mindfulness and CBT are known for having few, if any, serious negative effects. They are widely used and accepted in mental health treatment, making them a safe option for young people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about maCBT because it offers a fresh approach to preventing severe mental illness in youth by integrating mindfulness with cognitive-behavioral techniques. Unlike traditional treatments that often focus on managing symptoms after they appear, maCBT aims to normalize unusual experiences and equip young people with proactive strategies to reduce their impact. This treatment is tailored to be age-appropriate, using visual materials and relatable language, making it particularly engaging for children and teens. Additionally, maCBT is delivered in a flexible format, with sessions that initially occur weekly and then shift to bi-weekly, allowing for personalized pacing and sustained support.

What evidence suggests that maCBT might be an effective treatment for preventing severe mental illness in youth?

Research has shown that Mindfulness and Acceptance-based Cognitive Behavioral Therapy (maCBT), which participants in this trial may receive, can help prevent serious mental health issues in young people. Studies have found that mindfulness-based therapy can improve life satisfaction and family relationships for teenagers. This therapy manages anxiety and unusual experiences by teaching self-management skills. maCBT helps young people understand and rethink unusual experiences, enabling them to develop coping strategies. These strategies aim to reduce the impact of early signs of mental health issues, such as anxiety and mood changes, before they worsen. Overall, maCBT appears promising in helping at-risk youth avoid severe mental health problems later in life. ^{1 3 6 7 8}

Who Is on the Research Team?

Rudolf Uher, MD

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have experienced symptoms like hallucinations, mood swings, or severe anxiety.

I am a FORBOW participant aged between 9 and 21.

Exclusion Criteria

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

Diagnosis of severe mental illness (schizophrenia, other psychotic disorder, bipolar disorder, severe major depressive disorder)

Insufficient understanding of the English language to benefit from the intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Multimodal Antecedent-focussed Cognitive-behavioural Training (maCBT) in 8 to 16 one-hour sessions, initially weekly, then bi-weekly.

8-16 weeks

8-16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 4-6 months, 1, 2, 3, and 5 years post intervention.

5 years

Long-term follow-up

Annual follow-ups to assess long-term outcomes such as severe mental illness diagnosis and functioning.

10 years

What Are the Treatments Tested in This Trial?

Interventions

• maCBT

Trial Overview 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.

How Is the Trial Designed?

Group I: maCBT Experimental Treatment 1 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: Comparison Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Nova Scotia Health Research Foundation

Collaborator

Trials

15

Recruited

34,100+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

Acceptance and Commitment Therapy (ACT) in a community camp setting significantly improved psychological flexibility and mindful awareness in children, as shown by self-report measures from the Avoidance and Fusion Questionnaire for Youth (AFQ-Y) and the Child Acceptance and Mindfulness Measure (CAMM).

The experimental group demonstrated substantial improvements compared to the control group, with significant differences in posttest scores, indicating that ACT is an effective and easily implemented intervention for enhancing mindfulness in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuro-Typical Children Outcomes from an Acceptance and Commitment Therapy Summer Camp. Enoch, MR., Dixon, MR.[2020]

The study explored the feasibility of an Acceptance and Commitment Therapy (ACT)-based prevention program for anxiety and depression among 48 high school students, showing that the program was acceptable and could be effectively implemented in a school setting.

While no statistically significant differences were found between the ACT intervention and usual classes, the effect sizes indicated potential benefits of the ACT program, suggesting it could be a promising approach for preventing anxiety and depression in young people and warrants further research with a larger sample.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy universal prevention program for adolescents: a feasibility study. Burckhardt, R., Manicavasagar, V., Batterham, PJ., et al.[2020]

Mindfulness-Based Interventions (MBIs) showed small but significant treatment effects in youth, with a meta-analysis of 76 studies involving 6121 participants indicating an effect size of g=0.305 for pre-post designs and g=0.322 for controlled designs.

The effectiveness of MBIs appeared to increase over time, with follow-up assessments showing larger effects (g=0.462 for pre-post and g=0.402 for controlled designs), suggesting that the benefits of mindfulness practices may continue to grow after the intervention ends.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions with youth: A comprehensive meta-analysis of group-design studies. Klingbeil, DA., Renshaw, TL., Willenbrink, JB., et al.[2018]

Mindfulness training led to significant improvements in psychological symptoms and quality of life for a diverse group of 143 psychiatric outpatients, indicating its overall efficacy as a therapeutic intervention.

However, patients with bipolar disorder did not show significant improvement, which may be linked to their longer illness duration and lower baseline severity compared to other diagnostic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness training in a heterogeneous psychiatric sample: outcome evaluation and comparison of different diagnostic groups. Bos, EH., Merea, R., van den Brink, E., et al.[2019]

Acceptance is a crucial mechanism in mindfulness interventions, as it enhances the effectiveness of attention monitoring skills in improving mental and physical health outcomes.

Experimental studies indicate that mindfulness interventions that lack acceptance training are less effective in reducing stress and enhancing positive emotions and social relationships, highlighting the importance of incorporating acceptance into these practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness, acceptance, and emotion regulation: perspectives from Monitor and Acceptance Theory (MAT). Lindsay, EK., Creswell, JD.[2023]

A pilot study involving 56 adolescents (average age 14.5 years) showed that an 8-session online mindfulness-based intervention significantly reduced psychiatric symptoms and improved coping strategies, especially in those categorized as moderate-risk.

The study found that specific facets of mindfulness were associated with reductions in anxiety, depression, and somatic symptoms, indicating that certain components of mindfulness training may be more effective in alleviating mental health issues in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes From an Online Pilot Mindfulness Based Intervention with Adolescents: A Comparison by Categories of Risk. Hutchison, M., Russell, BS., Starkweather, AR., et al.[2023]

Mindfulness-based cognitive therapy (MBCT) is effective in helping individuals manage psychological symptoms like depression and anxiety by teaching them to regulate their attention through meditation.

Empirical studies support the use of MBCT for youth, particularly those struggling with negative thought patterns like rumination, indicating its potential as a valuable treatment option for adolescents facing emotional challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving self-regulation in adolescents: current evidence for the role of mindfulness-based cognitive therapy. Perry-Parrish, C., Copeland-Linder, N., Webb, L., et al.[2020]

A 5-week mindfulness-based intervention for adolescents with psychiatric disorders led to significant decreases in psychological distress and increases in mindfulness and self-esteem, indicating its potential effectiveness.

Both adolescents and their parents reported improvements in functioning, suggesting that the intervention is not only feasible and acceptable but also beneficial for mental health, warranting further research in a randomized controlled study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taming the adolescent mind: preliminary report of a mindfulness-based psychological intervention for adolescents with clinical heterogeneous mental health diagnoses. Tan, L., Martin, G.[2022]

Mindfulness-Based Cognitive Therapy for Children (MBCT-C) showed significant improvements in overall clinical severity for 24 youth with anxiety disorders at-risk for bipolar disorder compared to a waitlist control period.

While MBCT-C did not significantly improve clinician- and child-rated anxiety or emotion regulation, increases in mindfulness during the therapy were linked to better anxiety and emotion regulation outcomes, suggesting a potential mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for children and adolescents with anxiety disorders at-risk for bipolar disorder: A psychoeducation waitlist controlled pilot trial. Cotton, S., Kraemer, KM., Sears, RW., et al.[2021]

The iMatter program, which teaches mindfulness and relaxation strategies to adolescents in a psychiatric hospital, showed positive effects, with participants reporting improved mood after sessions.

Physiological measures indicated that participants experienced a significant decrease in heart rate following mindfulness group sessions, suggesting a calming effect of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based group therapy: Impact on psychiatrically hospitalized adolescents. Sams, DP., Handley, ED., Alpert-Gillis, LJ.[2019]

Citations

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Mindfulness and CBT for Preventing Severe Mental Illness ... The SWELL medical study, being run by Nova Scotia Health Authority, is evaluating whether maCBT will have tolerable side effects & efficacy for patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10157071/

Efficacy of mindfulness- and acceptance-based cognitive ... The primary outcome was somatic symptom severity. Secondary outcomes were degrees of depression and of anxiety, health anxiety, perceived health ...

3. psycnet.apa.org psycnet.apa.org/record/2015-53617-011

Mindfulness- and acceptance-based cognitive ... Mindfulness-based cognitive therapy for hypochondriasis, or severe health anxiety: A pilot study. Journal of Anxiety Disorders, 24(8), 931–935. http://dx ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876201818311304

Effectiveness of mindfulness based cognitive behavior ... Mindfulness based cognitive behaviour therapy improves life satisfaction, life orientation and family functioning of adolescents.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05010317

Mindfulness and Acceptance Based Therapy for ... The study proposes to explore acceptability of an adapted mindfulness and acceptance-based psychosocial intervention (acceptance and commitment therapy: ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489050/

Cognitive–behavioral therapy for management of mental ... Cognitive–behavioral therapy (CBT) helps individuals to eliminate avoidant and safety-seeking behaviors that prevent self-correction of faulty beliefs.

7. mdpi.com mdpi.com/2077-0383/14/5/1703

Mindfulness-Based Cognitive Therapy in Clinical Practice MBCT is a clinical intervention that integrates cognitive therapy with mindfulness practices to prevent depression relapses and improve mental health.

8. researchprotocols.org researchprotocols.org/2022/1/e33776/

Effectiveness of Mindfulness-Based Cognitive Therapy ... Methods: The study involves an 8-week MBCT with a 10-month follow-up. Patients aged 20 to 65 years who meet the Diagnostic and Statistical ...