Cognitive Behavioural Therapy for Mood and Anxiety Disorders

(I-CARE Trial)

Overseen By Prudence Chan, HBSc

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Active psychosis, mania, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special type of talk therapy, called CBT-MyOWL, is effective and appealing to young people with mood or anxiety disorders. It combines regular cognitive behavioral therapy (CBT), which helps change negative thinking patterns, with reading a Harry Potter novel to teach coping skills. Participants will try either CBT-MyOWL or regular CBT (CBT-as-usual) over 12 sessions. The trial seeks teens aged 14 to 19 who have a mood or anxiety disorder and can read a novel. As an unphased trial, this study provides a unique opportunity to explore an innovative therapy approach that could enhance coping skills and improve mental health.

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 CBT-MyOWL and CBT-as-usual are safe for youth with mood and anxiety disorders?

Research has shown that Cognitive Behavioral Therapy (CBT) is safe and well-tolerated for treating mood and anxiety disorders. CBT, including versions with added features like CBT-MyOWL, typically has few side effects. This is because CBT is a type of talk therapy, focusing on conversations rather than medications or physical treatments.

Studies have found that CBT reduces symptoms of depression and anxiety without causing significant problems. For example, individuals often manage stress better and respond more calmly to difficult situations. Reports of negative effects are rare, making CBT a popular choice recommended by healthcare providers.

CBT-MyOWL is a new version of traditional CBT. It combines regular therapy with reading activities from a popular book series to help teach coping skills. This method is designed to be engaging and is expected to be as safe as regular CBT.

Overall, both CBT-MyOWL and traditional CBT are considered safe and effective for young people with mood and anxiety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CBT-MyOWL because it combines traditional cognitive behavioral therapy (CBT) with an engaging twist: using the story and themes of "Harry Potter and the Prisoner of Azkaban" to teach coping skills and emotional resilience. Unlike standard CBT treatments, which typically rely on workbooks and direct cognitive exercises, CBT-MyOWL incorporates experiential learning through literature, which may help participants connect with the material on a deeper emotional level. This innovative approach aims to make therapy more relatable and enjoyable, potentially enhancing its effectiveness for mood and anxiety disorders.

What evidence suggests that this trial's treatments could be effective for mood and anxiety disorders?

Research shows that cognitive behavioral therapies (CBTs) effectively treat mood and anxiety disorders. Studies have found that they significantly improve symptoms like depression and anxiety. In this trial, participants will join one of two treatment arms. One arm will receive CBT-MyOWL, a new method combining traditional CBT with literature to teach coping skills. Early results suggest that using books like the Harry Potter series can make therapy more engaging and help build emotional strength. The other arm will receive CBT-as-usual, which focuses on recognizing and reevaluating cognitive distortions and developing problem-solving skills. Overall, evidence supports CBT, including new versions like CBT-MyOWL, as a top treatment choice for mood issues. ^{1 2 3 4 6}

Who Is on the Research Team?

Mark Sinyor, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for English-speaking teens aged 14-19 with a primary diagnosis of mood or anxiety disorder, who are considered by their physician to be suitable candidates for Cognitive Behavioural Therapy (CBT).

Inclusion Criteria

I am between 14 and 19 years old.

I can understand and speak English, and I can read a novel.

My doctor recommends cognitive behavioral therapy for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 sessions of either CBT-MyOWL or CBT-as-usual, with questionnaires completed at sessions 3, 6, 9, and 12

12 weeks

12 sessions (in-person)

Follow-up

Participants are monitored for retention, anxiety, depression, coping, and self-harm outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CBT-as-usual
• CBT-MyOWL

Trial Overview The study compares two types of CBT: 'CBT-MyOWL', which includes literature-based therapy, and standard 'CBT-as-usual'. It checks if the new method keeps patients engaged longer and is well-received. Teens will attend 12 sessions and complete questionnaires.

How Is the Trial Designed?

Group I: CBT-MyOWL Experimental Treatment 1 Intervention

A novel talk therapy model where we incorporate the standard CBT model with experiential learning while reading the third novel in the Harry Potter series to teach coping skills and emotional resiliency. The 12 sessions of CBT-MyOWL will follow a modestly adapted version of the intervention offered on www.myowl.org. The therapist will cover topics such as risk and protective factors for distress and mental health problems, cognitive distortions, cognitive reframing, fear hierarchies, behavioural activation and core beliefs while reading Harry Potter and the Prisoner of Azkaban.

Group II: CBT-as-usual Active Control 1 Intervention

A talk therapy where participants will be encouraged to recognize distortions in thinking and then to reevaluate them in light of the evidence, gain a better understanding of how their behaviour contributes to wellbeing, learn to use problem-solving skills to cope with difficult situations, and learn to develop a greater sense of confidence in one's own abilities. This is the control group, and they will be utilizing the 'Mind over Mood' and/or the 'Anxiety and Phobia Workbook' according to the primary diagnosis.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

Computerized cognitive behavior therapy (cCBT) has been shown to be effective in treating mild to moderate depression, as supported by a meta-review of twelve systematic reviews published between 1999 and February 2011.

While cCBT is effective, there is a lack of information on the cost-effectiveness of different cCBT approaches, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-review of the effectiveness of computerised CBT in treating depression. Foroushani, PS., Schneider, J., Assareh, N.[2021]

An 8-week community-based cognitive-behavioral therapy (CBT) self-help program significantly reduced symptoms of depression, with a mean improvement in Patient Health Questionnaire-9 (PHQ-9) scores of -3.64 compared to a delayed access group.

The immediate access group showed a 43.8% reduction in PHQ-9 scores by 50% or more, while the delayed group had only 17.9%, indicating that timely access to CBT can lead to better mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based group guided self-help intervention for low mood and stress: randomised controlled trial. Williams, C., McClay, CA., Matthews, L., et al.[2022]

A survey of 42 general practitioners in rural Victoria revealed that most GPs either occasionally or regularly use cognitive behavioural therapy (CBT) to manage depression and anxiety, recognizing its usefulness in enhancing doctor-patient communication.

Despite acknowledging the benefits of CBT, GPs expressed concerns that it might lengthen their consultations, highlighting the need for further research on effectively integrating CBT into rural general practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy: a study of rural general practitioners' understanding and expectations. Pierce, D., Pearce, C.[2019]

Automated, internet-delivered cognitive behavior therapy (iCBT) has shown substantial benefits for treating anxiety disorders, with an effect size of 1.0, comparable to traditional face-to-face CBT.

In large effectiveness trials, 60% of patients who completed iCBT courses in primary care no longer met the diagnostic criteria for anxiety, highlighting its efficacy and convenience for most individuals with primary anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered cognitive behavior therapy for anxiety disorders is here to stay. Andrews, G., Newby, JM., Williams, AD.[2022]

Both Group and Individual Cognitive Behavioral Therapy (CBT) showed similar effectiveness in reducing depressive symptoms, with no significant differences in outcomes at post-treatment or follow-up.

Group CBT was found to be more cost-effective, being 1.5 times less expensive than Individual CBT, despite patients initially preferring individual treatment; this suggests that clinicians might consider offering Group CBT more often.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome, costs and patient engagement for group and individual CBT for depression: a naturalistic clinical study. Brown, JS., Sellwood, K., Beecham, JK., et al.[2022]

In a study of 143 depressed patients undergoing cognitive-behavioral therapy (CBT), their expectations for positive outcomes increased steadily from the start of treatment to the end, indicating that therapy can enhance patients' hopes for improvement.

Factors such as having previous depressive episodes negatively impacted initial outcome expectations, while higher well-being was linked to more positive expectations; additionally, differences between therapists influenced how patients' expectations changed over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient characteristics and the therapist as predictors of depressed patients' outcome expectation over time: A multilevel analysis. Vîslă, A., Flückiger, C., Constantino, MJ., et al.[2020]

In a study involving 246 patients with generalized anxiety disorder (GAD), metacognitive therapy (MCT) was found to be more effective than cognitive-behavioral therapy (CBT), with a significant mean difference in treatment outcomes and higher recovery rates (65% for MCT vs. 38% for CBT).

Both therapies were assessed at pre-treatment, post-treatment, and a 2-year follow-up, showing that the superior effects of MCT were maintained over time, indicating its potential as a more effective long-term treatment option for GAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metacognitive therapy versus cognitive-behavioural therapy in adults with generalised anxiety disorder. Nordahl, HM., Borkovec, TD., Hagen, R., et al.[2022]

A randomized controlled trial involving 167 adults showed that the interactive multimedia program 'Beating the Blues' (BtB) significantly improved symptoms of anxiety and depression compared to standard treatment after 2 months and maintained these improvements at 6 months.

The effectiveness of BtB was independent of the severity of depression at the start of treatment, suggesting that this program can be beneficial for a wide range of patients, regardless of their initial condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized, interactive, multimedia cognitive-behavioural program for anxiety and depression in general practice. Proudfoot, J., Goldberg, D., Mann, A., et al.[2022]

Cognitive Behaviour Therapy (CBT) and counselling showed comparable effectiveness in treating moderate to severe depression, with pre-post effect sizes of 1.59 for CBT and 1.55 for counselling, indicating both can be effective options.

Patients receiving counselling attended fewer sessions on average (7.5 sessions) compared to those receiving CBT (8.9 sessions), and counselling was found to be more effective at the two-session mark, suggesting that session length and type of therapy may influence outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparative effectiveness and efficiency of cognitive behaviour therapy and generic counselling in the treatment of depression: evidence from the 2nd UK National Audit of psychological therapies. Pybis, J., Saxon, D., Hill, A., et al.[2020]

Computerized cognitive behavior therapy (CCBT) has shown effectiveness comparable to therapist-led cognitive behavior therapy (TCBT) for treating anxiety and depression, while also being more effective than standard treatment methods.

CCBT, particularly the 'Beating the Blues' program, has been found to be cost-effective, with a cost per quality-adjusted life-year (QALY) of £1801, suggesting it could be a valuable option for mental health treatment, although further research is needed to confirm long-term outcomes and patient preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised cognitive behaviour therapy for depression and anxiety update: a systematic review and economic evaluation. Kaltenthaler, E., Brazier, J., De Nigris, E., et al.[2022]

The new individually tailored internet-based cognitive-behavioral therapy (ICBT) program, TAIL, was found to be as effective as traditional disorder-specific ICBT for treating depression, with a large effect size (d = 1.33) based on a study of 284 participants.

However, TAIL did not perform as well as disorder-specific ICBT for social anxiety and panic disorder, indicating that while it is a strong alternative for depression, it may not be as effective for these other conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing individually tailored to disorder-specific internet-based cognitive-behavioural therapy: benchmarking study. Kraepelien, M., Forsell, E., Karin, E., et al.[2022]

A study involving 688 undergraduates found that cognitive behavioral therapy (CBT) that incorporates safety behaviors is significantly more acceptable to participants than traditional CBT that discourages such behaviors.

Cognitively based CBT was preferred over extinction-based CBT, and factors like previous treatment and higher anxiety levels were linked to lower acceptability ratings, highlighting the importance of tailoring CBT approaches to enhance their acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Further Support for the Acceptability-Enhancing Roles of Safety Behavior and a Cognitive Rationale in Cognitive Behavioral Therapy for Anxiety Disorders. Levy, HC., Senn, JM., Radomsky, AS.[2020]

The computerized CBT program MoodGYM was found to significantly reduce symptoms of general psychological distress and stress in a randomized controlled trial with 149 participants, although the study faced high dropout rates.

While MoodGYM showed effectiveness for some outcomes, it did not significantly reduce symptoms of depression, anxiety, or impaired daily functioning, suggesting it may be better suited as an additional treatment option rather than a primary intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the computerized CBT programme, MoodGYM, for public mental health service users waiting for interventions. Twomey, C., O'Reilly, G., Byrne, M., et al.[2018]

In a trial with 197 participants over 10 weeks, clients who selected their own treatment modules in internet-delivered cognitive behavior therapy (ICBT) showed a small but significant improvement in depression compared to those with clinician-tailored modules, indicating that personalized treatment can enhance efficacy.

The study found that while support on demand (initiated by clients) was generally effective, it resulted in a higher dropout rate, suggesting that while flexibility in support may be beneficial, it needs careful management to ensure client retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free choice of treatment content, support on demand and supervision in internet-delivered CBT for adults with depression: A randomized factorial design trial. Andersson, G., Käll, A., Juhlin, S., et al.[2023]

A review of 13 studies found that the competence of therapists significantly contributes to the effectiveness of cognitive behavior therapy (CBT), with a small overall effect size of 0.24 and a moderate effect size of 0.38 specifically for patients with major depression.

In contrast, adherence to CBT protocols alone did not show a significant impact on patient outcomes, suggesting that the quality of therapist performance is more crucial for therapeutic improvement than strictly following treatment manuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The relationship between therapist's competence and adherence to outcome in cognitive-behavioural therapy - results of a metaanalysis]. Zarafonitis-Müller, S., Kuhr, K., Bechdolf, A.[2018]

Citations

1. withpower.com withpower.com/trial/cognitive-behavioural-therapy-for-mood-and-anxiety-disorders-0d9ac

Cognitive Behavioural Therapy for Mood and Anxiety ... CBT-MyOWL is unique because it combines traditional cognitive behavioral therapy (CBT) with literature-based strategies to optimize wellness, offering a novel ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11134235/

Protocol for a Randomized Controlled Trial - PMC This study aims to establish predictive features that forecast responses to transdiagnostic CBT in anxiety disorders and to investigate key mechanisms ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0165032725012339

Cognitive behavioral therapies are evidence-based – ... CBTs currently hold status as research-supported or evidence-based treatments for depressive disorders (APA, 2021; NICE, 2022) and are suggested as first-line ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12046258/

Optimization of Internet-Delivered Cognitive Behavioral ... Treatment outcomes are promising with clinically significant symptom improvement (eg, anxiety, depression, and posttraumatic stress) and ...

5. mdpi.com mdpi.com/1648-9144/61/3/431

Next-Generation Cognitive-Behavioral Therapy for ... CBT is now the dominant therapy for depressive disorders and is also generally recommended in treatment guidelines for patients with major depression [20,21].

6. researchgate.net researchgate.net/publication/303845063_Motivational_Interviewing_as_an_Adjunct_to_Cognitive_Behavior_Therapy_for_Anxiety_Disorders_A_Critical_Review_of_the_Literature

Motivational Interviewing as an Adjunct to Cognitive ... Cognitive behavior therapy (CBT) is efficaciously and effectively used in the treatment of anxiety disorders; however, as CBT for anxiety routinely utilizes ...