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

Trial Summary

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 data supports the effectiveness of the treatment maCBT, Mindfulness and Acceptance-based Cognitive Behavioral Therapy, for preventing severe mental illness in youth?

Research shows that mindfulness-based interventions can help reduce psychological symptoms and improve emotion regulation in young people. Studies have found that these interventions lead to small but positive effects on mental health, with some evidence suggesting that acceptance skills are crucial for their success. ^{1 2 3 4 5}

Is Mindfulness and Acceptance-based Cognitive Behavioral Therapy safe for young people?

Research on mindfulness-based therapies, including Mindfulness-Based Cognitive Therapy (MBCT) and Acceptance and Commitment Therapy (ACT), suggests they are generally safe for children and adolescents. These therapies have been used in various settings and have shown promise in improving mental health without significant safety concerns. ^{6 7 8 9 10}

How is the treatment maCBT different from other treatments for preventing severe mental illness in youth?

maCBT is unique because it combines mindfulness (being present and aware without judgment) with cognitive behavioral therapy (CBT), focusing on acceptance and emotion regulation to prevent severe mental illness in youth. This approach is different from traditional treatments as it emphasizes mindfulness and acceptance as key components to improve mental health outcomes. ^{1 5 6 9 10}

What is the purpose of this trial?

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.

Research Team

Rudolf Uher, MD

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions with youth: A comprehensive meta-analysis of group-design studies. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes From an Online Pilot Mindfulness Based Intervention with Adolescents: A Comparison by Categories of Risk. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Mindfulness training in a heterogeneous psychiatric sample: outcome evaluation and comparison of different diagnostic groups. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based group therapy: Impact on psychiatrically hospitalized adolescents. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. New Zealand pubmed.ncbi.nlm.nih.gov

Improving self-regulation in adolescents: current evidence for the role of mindfulness-based cognitive therapy. [2020]

7. Australia 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. [2021]

8. England 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy universal prevention program for adolescents: a feasibility study. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

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