Harry Potter-Themed Cognitive Behavioral Therapy for Suicidal Thoughts and Behaviors

Overseen By Mark Sinyor, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

3204 Participants Needed

Trial Summary

What is the purpose of this trial?

School-based mental health literacy interventions have been shown to reduce and/or prevent suicidal ideation and attempts. Most programs to date include an adapted version of Cognitive Behavioural Therapy (CBT) - the gold standard treatment for youth and adult mood and anxiety disorders. CBT teaches youth about the relationship between their thoughts, feelings, and behaviours, and provides strategies for managing distress. However, there is no established standard mental health literacy curriculum in Ontario. The investigators developed a school-based mental health literacy program that uses the third book in the Harry Potter series ('Harry Potter and the Prisoner of Azkaban') to teach students how to cope with distress through CBT skills. This study will determine whether the Harry Potter-based mental health literacy curriculum diminishes suicidality in students. The study will also determine whether the curriculum decreases depression and anxiety symptoms and improves well-being. The 3-month intervention is a manual-based curriculum which teaches CBT skills in English class. The website includes video and text-based onboarding to train teachers on all the lessons. Youth complete online exercises for each unit and teachers follow a manual with checklists to preserve high fidelity and standardization of core learning. Participating classes will be randomized in 1:1 fashion to receive the curriculum in the fall (\~Oct-Dec) or the winter (\~Feb-Apr). The study will use a stepped-wedge design to introduce the curriculum to classes sequentially testing whether students who receive it in fall will improve at mid-year and those in winter will catch up by year-end. The winter group is included as a "maturational" control to account for changes over the school year that are independent of the intervention and so that order effects of curriculum delivery can be tested. For this design, questionnaires will be administered four times throughout the school year (once before and after each semester), and once more the following year to measure duration of response. At each timepoint, subjects will complete validated questionnaires about suicide attempts and self-harm, anxiety, depression, well-being, and health services usage. Students may also choose to participate in focus groups to collect qualitative data on their experience with the curriculum. With additional consent (Ontario youth only), we will also collect aggregate lists of the Ontario Health Insurance Plan (OHIP) numbers for participating students. These will be provided to the Institute of Clinical Evaluative Sciences (ICES) who will identify sex, age and pre-existing healthcare utilization matched controls from regions that do not adopt the curriculum.

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 seems to focus on a school-based curriculum rather than medication changes.

What data supports the effectiveness of the treatment Harry Potter-based Mental Health Literacy Curriculum for suicidal thoughts and behaviors?

The Harry Potter-based Cognitive-Behavioral Therapy Skills Curriculum has been shown to improve well-being and reduce suicidal thoughts in middle schoolers. Additionally, school-based mental health literacy interventions, like this one, have been effective in helping young people recognize mental health issues and seek help, which can prevent the worsening of mental health problems. ^{1 2 3 4 5}

Is the Harry Potter-themed cognitive behavioral therapy safe for humans?

The Harry Potter-based cognitive behavioral therapy curriculum has been tested in middle schoolers and showed no safety concerns, suggesting it is generally safe for use in humans. ^{3 4 6 7 8}

How is the Harry Potter-based Mental Health Literacy Curriculum treatment different from other treatments for suicidal thoughts and behaviors?

This treatment is unique because it uses the Harry Potter series to teach Cognitive Behavioral Therapy (CBT) concepts, combining elements of bibliotherapy (using literature for therapy) with traditional CBT techniques, which is not common in other treatments for suicidal thoughts and behaviors. ^{1 9 10 11 12}

Eligibility Criteria

This trial is for Grade 7 and 8 students who can speak and read English fluently. They must be willing to fill out questionnaires about their mental health before the intervention, during, and after it ends. High school students in Grades 9-12 may also participate if allowed.

Inclusion Criteria

My school offers Grade 7 and 8, and possibly high school grades if needed.

Participants must be willing to complete demographic and clinical self-report questionnaires on anxiety, depression, and general well-being before the intervention and at each timepoint.

Participants must be able to speak and read fluent English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

3-month manual-based curriculum teaching CBT skills using 'Harry Potter and the Prisoner of Azkaban' in English class

12 weeks

4 visits (in-person) for questionnaire administration

Follow-up

Participants are monitored for changes in suicidality, depression, anxiety, and well-being through questionnaires

Approximately 1 year

5 visits (in-person) for questionnaire administration

Extension

Additional follow-up to measure long-term effects of the curriculum

6 months

Treatment Details

Interventions

• Harry Potter-based Mental Health Literacy Curriculum

Trial Overview The study tests a Harry Potter-themed CBT curriculum aimed at improving mental wellness in children. Classes are randomly chosen to start the program either in fall or winter, with assessments throughout the year to measure its effectiveness on reducing suicidal thoughts and behaviors.

Participant Groups

Group I: CBT Curriculum - Second Cohort (Waitlist Controls) Experimental Treatment 1 Intervention

Students will receive the current school board curriculum as usual for the first half of the academic year, serving as wait-list controls. Since this is a stepped wedge trial, the winter cohort will receive the identical intervention as the fall cohort in the second half of academic year.

Group II: CBT Curriculum - First Cohort Experimental Treatment 1 Intervention

Students will receive the 3-month cognitive behavioral therapy curriculum in the first half of the academic year.

Harry Potter-based Mental Health Literacy Curriculum is already approved in Canada for the following indications:

Approved in Canada as Harry Potter-based Mental Health Literacy Curriculum for:

• Suicidality prevention
• Depression
• Anxiety symptoms
• Improvement of well-being

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Findings from Research

Bibliotherapy, which involves reading and discussing literature, has been shown to help patients develop new perspectives and enhance their sense of purpose, making it a valuable non-pharmaceutical intervention for mental health issues, especially during the COVID-19 pandemic.

The systematic review identified 13 relevant studies and highlighted the need for more structured research on bibliotherapy, suggesting that it can positively impact mental health by promoting values like autonomy and justice, and providing a framework for healthcare professionals to implement effective bibliotherapy interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bibliotherapy as a Non-pharmaceutical Intervention to Enhance Mental Health in Response to the COVID-19 Pandemic: A Mixed-Methods Systematic Review and Bioethical Meta-Analysis. Monroy-Fraustro, D., Maldonado-Castellanos, I., Aboites-Molina, M., et al.[2021]

Rational emotive behaviour therapy (REBT) significantly reduced symptoms of anxiety and depression in high school students, with lasting effects observed at a six-month follow-up, compared to a control group.

REBT also effectively decreased dysfunctional thinking and increased self-esteem and hope, highlighting its potential as a valuable mental health intervention in school settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rational emotive behaviour therapy in high schools to educate in mental health and empower youth health. A randomized controlled study of a brief intervention. Sælid, GA., Nordahl, HM.[2019]

A Harry Potter-based mental health curriculum significantly reduced suicidality and improved emotional regulation and self-concept among middle-schoolers, with 200 students participating in the intervention compared to 230 in a control group.

The intervention showed particularly strong benefits for girls, with significant improvements in measures of depression and anxiety, indicating that creative, relatable approaches to mental health education can be effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of a Harry Potter-Based Cognitive-Behavioral Therapy Skills Curriculum on Suicidality and Well-being in Middle Schoolers: A Randomized Controlled Trial. Klim-Conforti, P., Zaheer, R., Levitt, AJ., et al.[2022]

A study involving interviews with 11 school staff in England revealed that adaptations to a Canadian mental health literacy curriculum were made to better fit local contexts, including changes in content emphasis and teaching methods to be more interactive.

Logistical and philosophical reasons drove these adaptations, highlighting the need for flexibility in mental health interventions to reduce stigma and empower students while ensuring effective implementation in diverse educational settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of a school-based mental health literacy curriculum: from Canadian to English classrooms. Mansfield, R., Humphrey, N., Patalay, P., et al.[2022]

A review of 11 studies involving 7066 participants from 66 secondary schools found no strong evidence that school-based mental health literacy interventions effectively improve help-seeking outcomes among children and young people.

The lack of standardized measures and comprehensive approaches to mental health literacy and stigma has limited the evidence on the effectiveness of these interventions, highlighting the need for better measurement tools and economic evaluations in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: School-based mental health literacy interventions to promote help-seeking - a systematic review. Ma, KKY., Burn, AM., Anderson, JK.[2023]

The Short Mental Health Literacy Program (SMHLP), a 50-minute teacher-led session, significantly improved mental health literacy among 975 high school first graders in Japan, with lasting effects observed at a 2-month follow-up.

Students who participated in the SMHLP showed increased knowledge about mental health, recognition of the need to seek help, and intentions to help peers, indicating that brief educational interventions can effectively enhance mental health understanding in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quasi-cluster randomized controlled trial of a classroom-based mental health literacy educational intervention to promote knowledge and help-seeking/helping behavior in adolescents. Yamaguchi, S., Ojio, Y., Foo, JC., et al.[2021]

A high-school mental health curriculum called The Guide significantly improved students' mental health knowledge and attitudes, with 265 students showing marked gains in understanding after the course (p < 0.001).

The improvements in knowledge were maintained at a 2-month follow-up, indicating that the curriculum has lasting effects on mental health literacy among students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained improvements in students' mental health literacy with use of a mental health curriculum in Canadian schools. Mcluckie, A., Kutcher, S., Wei, Y., et al.[2023]

A study involving 332 grade 9 students showed that using an evidence-based mental health literacy curriculum significantly improved students' knowledge and reduced stigma about mental health, with lasting effects observed one year later.

Both students and educators experienced substantial improvements in mental health knowledge and stigma reduction, indicating that the curriculum is effective for enhancing mental health literacy outcomes in a school setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term impact of a mental health literacy resource applied by regular classroom teachers in a Canadian school cohort. Wei, Y., Church, J., Kutcher, S.[2023]

Cognitive-behavioral therapy (CBT) is recognized as an effective treatment for depression in children and adolescents, but there is limited evidence specifically addressing its efficacy for adolescents experiencing suicidality.

The article discusses various CBT techniques aimed at reducing suicidal thoughts and behaviors in depressed adolescents, highlighting the need for more targeted treatment trials in this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for adolescent depression and suicidality. Spirito, A., Esposito-Smythers, C., Wolff, J., et al.[2022]

A brief cognitive behavioral (CB) group intervention significantly reduced the risk of major depressive disorder (MDD) onset in adolescents, with only 0.8% of participants developing MDD compared to 6.3% in the bibliotherapy group and 6.5% in the brochure control group.

While the CB group showed lower depressive symptom severity immediately after the intervention compared to the brochure control, the effects on long-term outcomes were small and not significant, suggesting that while the intervention is effective, its impact may vary based on initial depression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indicated cognitive behavioral group depression prevention compared to bibliotherapy and brochure control: acute effects of an effectiveness trial with adolescents. Rohde, P., Stice, E., Shaw, H., et al.[2021]

A pilot study involving 232 middle school students tested a Harry Potter-based curriculum aimed at teaching Cognitive Behavioral Therapy (CBT) skills, but found no significant differences in well-being scores compared to a control group of 362 students.

The study highlighted the feasibility of implementing the intervention but indicated that the current assessment tools may not effectively measure its impact, suggesting the need for a revised curriculum and validated measures in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Investigation of a Novel Cognitive Behavioural Therapy Curriculum on the Wellbeing of Middle Schoolers. Sinyor, M., Hawes, D., Rector, NA., et al.[2022]

Cognitive-Behavioral Therapy (CBT) significantly reduced suicidal ideation and hopelessness in depressed adolescents aged 12 to 18 who had attempted suicide, with a 54% to 77% decrease in scores after 12 weeks of treatment.

In a clinical trial involving 30 participants, those receiving CBT showed marked improvements compared to a control group that did not receive the intervention, highlighting the efficacy of CBT in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive-behavioral therapy in decreasing suicidal ideation and hopelessness of the adolescents with previous suicidal attempts. Alavi, A., Sharifi, B., Ghanizadeh, A., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Bibliotherapy as a Non-pharmaceutical Intervention to Enhance Mental Health in Response to the COVID-19 Pandemic: A Mixed-Methods Systematic Review and Bioethical Meta-Analysis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Rational emotive behaviour therapy in high schools to educate in mental health and empower youth health. A randomized controlled study of a brief intervention. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The Impact of a Harry Potter-Based Cognitive-Behavioral Therapy Skills Curriculum on Suicidality and Well-being in Middle Schoolers: A Randomized Controlled Trial. [2022]

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

Adaptation of a school-based mental health literacy curriculum: from Canadian to English classrooms. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Review: School-based mental health literacy interventions to promote help-seeking - a systematic review. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A quasi-cluster randomized controlled trial of a classroom-based mental health literacy educational intervention to promote knowledge and help-seeking/helping behavior in adolescents. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Sustained improvements in students' mental health literacy with use of a mental health curriculum in Canadian schools. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Long-term impact of a mental health literacy resource applied by regular classroom teachers in a Canadian school cohort. [2023]

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

Cognitive-behavioral therapy for adolescent depression and suicidality. [2022]

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

Indicated cognitive behavioral group depression prevention compared to bibliotherapy and brochure control: acute effects of an effectiveness trial with adolescents. [2021]

11. Canada pubmed.ncbi.nlm.nih.gov

Preliminary Investigation of a Novel Cognitive Behavioural Therapy Curriculum on the Wellbeing of Middle Schoolers. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive-behavioral therapy in decreasing suicidal ideation and hopelessness of the adolescents with previous suicidal attempts. [2022]