Cognitive Behavioural Therapy for Mood and Anxiety Disorders

(I-CARE Trial)

Overseen By Prudence Chan, HBSc

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Active psychosis, mania, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if CBT(Cognitive Behavioural Therapy)-MyOWL(Optimizing Wellness through Literature) is feasible, leads to better patient retention, and has high acceptability by youth psychiatric outpatients with mood and/or anxiety disorder aged 14-19. The main questions it aims to answer are: Primary Objective (feasibility): To determine whether a clinically meaningful proportion of youth complete a full course of CBT-MyOWL / CBT-as-usual. Primary Objective (acceptability): To determine whether the CBT-MyOWL and CBT-as-usual interventions delivered are acceptable to youth participants. Secondary Objectives: 1. To determine whether CBT-MyOWL enhances time of retention compared to CBT-as-usual. 2. To determine whether youth who receive CBT-MyOWL have improved scores on all of the following over the course of treatment and endpoint compared to youth who receive CBT-as usual: i) depression and anxiety ii) suicidal ideation, iii) self-harm, and iv) coping and emotional resiliency. Participants will: Participate in 12 sessions of either CBT-MyOWL or CBT-as-usual (active control) Completes 4-5 questionnaires at sessions 3,6,9,12 Complete the acceptability and exit interview at session 12

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 Cognitive Behavioural Therapy for Mood and Anxiety Disorders?

Research shows that Cognitive Behavioural Therapy (CBT) is effective for reducing symptoms of depression and anxiety, with studies indicating significant improvements in psychological distress and daily functioning. Additionally, internet-delivered CBT has shown large positive effects, and the competence of the therapist plays a crucial role in patient improvement. ^{1 2 3 4 5}

Is Cognitive Behavioural Therapy (CBT) safe for humans?

Cognitive Behavioural Therapy (CBT) is generally considered safe for humans, as it is a widely used treatment for anxiety and mood disorders. It is often preferred due to its structured approach and has been shown to be effective in many cases without significant safety concerns. ^{6 7 8 9 10}

How is CBT-MyOWL different from other treatments for mood and anxiety disorders?

CBT-MyOWL is unique because it combines traditional cognitive behavioral therapy (CBT) with literature-based strategies to optimize wellness, offering a novel approach compared to standard CBT treatments. ^{11 12 13 14 15}

Research Team

Mark Sinyor, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• CBT-as-usual (Behavioral Intervention)
• CBT-MyOWL (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Outcome, costs and patient engagement for group and individual CBT for depression: a naturalistic clinical study. [2022]

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

A randomized controlled trial of the computerized CBT programme, MoodGYM, for public mental health service users waiting for interventions. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Patient characteristics and the therapist as predictors of depressed patients' outcome expectation over time: A multilevel analysis. [2020]

4. England 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. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

[The relationship between therapist's competence and adherence to outcome in cognitive-behavioural therapy - results of a metaanalysis]. [2018]

6. United States 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. [2020]

7. England 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. [2020]

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

Metacognitive therapy versus cognitive-behavioural therapy in adults with generalised anxiety disorder. [2022]

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

Computerised cognitive behaviour therapy for depression and anxiety update: a systematic review and economic evaluation. [2022]

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

Internet-delivered cognitive behavior therapy for anxiety disorders is here to stay. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Meta-review of the effectiveness of computerised CBT in treating depression. [2021]

12. Australia pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy: a study of rural general practitioners' understanding and expectations. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Computerized, interactive, multimedia cognitive-behavioural program for anxiety and depression in general practice. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Comparing individually tailored to disorder-specific internet-based cognitive-behavioural therapy: benchmarking study. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Community-based group guided self-help intervention for low mood and stress: randomised controlled trial. [2022]