Online Cognitive Behavioural Therapy for Anxiety

Overseen By Heather D Hadjistavropoulos, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Regina

Disqualifiers: Age, Non-public safety personnel, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

164 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores an online therapy course designed to help public safety personnel manage anxiety. The researchers aim to determine which of the four delivery methods works best. Some participants will progress through the course at their own pace, while others will follow a set order. Additionally, some will receive extra social learning materials, such as case stories and motivational videos. This trial suits current or former public safety workers living in Canada who can regularly access the internet. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance mental health support for public safety personnel.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Internet-delivered Cognitive Behaviour Therapy is safe?

Research has shown that Internet-delivered Cognitive Behavioral Therapy (iCBT) is generally safe. Several studies suggest that iCBT for anxiety is as effective as traditional face-to-face CBT. Users of iCBT often report satisfaction comparable to those attending in-person sessions.

In one study, 82 participants who used iCBT tailored to their needs reported positive experiences. They completed their courses and noticed symptom improvement.

Public safety personnel who used iCBT also reported satisfaction and symptom improvement. This group completed their courses and felt better afterward.

Overall, iCBT appears well-received, with users reporting improvements during and after treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these online Cognitive Behavioural Therapy (CBT) treatments for anxiety because they offer flexible and personalized approaches compared to traditional in-person therapy sessions. Unlike standard CBT, these treatments allow participants to navigate course modules at their own pace, whether they choose a personalized or tunneled delivery. Additionally, the enhanced social learning resources provide supplementary materials like motivational videos and real client quotes, which could enhance engagement and effectiveness. This innovative digital approach could broaden access to therapy, making it more convenient and potentially more effective for users.

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

Research shows that online Cognitive Behavioural Therapy (iCBT) effectively treats anxiety. Studies have found it to be as effective as traditional, face-to-face CBT, a popular anxiety treatment. iCBT successfully reduces anxiety symptoms in both adults and young people. It is cost-effective and accessible from anywhere, making it a convenient choice. Although iCBT requires commitment from participants, it offers flexibility and access to proven therapy methods. This trial will explore different delivery methods of iCBT, including personalized and tunneled delivery with either standard or enhanced social learning resources. Overall, iCBT is a promising option for managing anxiety. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for public safety personnel struggling with PTSD, depression, or anxiety. Participants should be comfortable using the internet for therapy and willing to try self-help cognitive behavior therapy (CBT). Specific eligibility details are not provided.

Inclusion Criteria

Current or former public safety personnel (or public safety personnel trainee)

Residing in Canada at time of enrollment

Has regular access to the internet

Exclusion Criteria

Not a current or former public safety personnel (or public safety personnel trainee)

Not residing in Canada at time of enrollment

Does not have regular access to the internet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Online screening questionnaire

Treatment

Participants receive the Self-Guided PSP Wellbeing Course, a transdiagnostic internet intervention, over a period of 8 weeks with access to course materials for up to 26 weeks.

8 weeks

Online course access

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 8 weeks and 20 weeks post-treatment.

18 weeks

Online questionnaires at 8 and 20 weeks post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Internet-delivered Cognitive Behaviour Therapy

Trial Overview

The study tests unguided internet-delivered CBT tailored for public safety workers. It compares different delivery methods: tunneled vs personalized, and the addition of social learning resources.

How Is the Trial Designed?

Group I: Tunneled Delivery/Standard Resources Experimental Treatment 3 Interventions

In this arm, participants will be guided through the Self-Guided PSP Wellbeing Course in a predetermined order and using predetermined timing. Future lessons will "unlock" as previous lessons are completed. Participants receiving the standard resources will be presented with resources that are typically presented in PSPNET courses. This includes lesson slides case stories, do-it yourself guides, and frequently asked questions pages.

Group II: Tunneled Delivery/Enhanced Social Learning Resources Experimental Treatment 3 Interventions

In this arm, participants will be guided through the Self-Guided PSP Wellbeing Course in a predetermined order and using predetermined timing. Future lessons will "unlock" as previous lessons are completed. Participants receiving the enhanced social learning resources will receive the same resources offered in the standard conditions (i.e., lesson slides, case stories, do-it-yourself guides, and frequently asked questions pages) and will also receive additional resources. Additional resources will include homework records to accompany the case stories, de-identified quotations from previous clients for each lesson, and a motivational video encouraging them to engage with the course.

Group III: Personalized Delivery/Standard Resources Experimental Treatment 3 Interventions

In this arm, participants will be able to navigate through the course modules in whichever order and at whatever pace they like. Participants will not have to complete one lesson in order to gain access to the following lesson. Participants receiving the standard resources will be presented with resources that are typically presented in the course. This includes lesson slides, case stories, do-it yourself guides, and frequently asked questions pages.

Group IV: Personalized Delivery/Enhanced Social Learning Resources Experimental Treatment 3 Interventions

In this arm, participants will be able to navigate through the course modules in whichever order and at whatever pace they like. Participants will not have to complete one lesson in order to gain access to the following lesson. Participants receiving the enhanced social learning resources will receive the same resources offered in the standard conditions (i.e., lesson slides, case stories, do-it-yourself guides, and frequently asked questions pages) and will also receive additional resources. Additional resources will include homework records to accompany the case stories, de-identified quotations from previous clients for each lesson, and a motivational video encouraging them to engage with the course.

Internet-delivered Cognitive Behaviour Therapy is already approved in Canada, European Union, United States for the following indications:

Approved in Canada as ICBT for:

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Post-Traumatic Stress Disorder

Approved in European Union as ICBT for:

• Depression
• Anxiety Disorders
• PTSD

Approved in United States as ICBT for:

• Depression
• Anxiety Disorders
• PTSD

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

Government of Canada

Collaborator

Trials

13

Recruited

2,400+

Published Research Related to This Trial

A randomized controlled trial involving 93 children aged 8-12 with anxiety disorders showed that internet-delivered cognitive behavior therapy (ICBT) significantly reduced anxiety symptoms, with a large effect size (Cohen's d = 1.66) reported by clinicians after 10 weeks of treatment.

At the three-month follow-up, 50% of children in the ICBT group no longer met the criteria for their principal anxiety diagnosis, indicating that ICBT can lead to lasting improvements in anxiety management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered cognitive behavioural therapy for children with anxiety disorders: A randomised controlled trial. Vigerland, S., Ljótsson, B., Thulin, U., et al.[2022]

The BIP OCD Junior program, an internet-delivered cognitive behavioral therapy (ICBT) for children aged 7-11 with OCD, showed significant improvement in symptoms after 12 weeks, with a large effect size (Cohen's d = 1.86).

Both children and parents found the treatment credible and were highly satisfied, suggesting that ICBT could be a feasible option for young children with OCD, although further randomized controlled trials are needed to confirm its efficacy compared to traditional face-to-face therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered cognitive behavioural therapy for young children with obsessive-compulsive disorder: development and initial evaluation of the BIP OCD Junior programme. Aspvall, K., Andrén, P., Lenhard, F., et al.[2022]

The Overall Anxiety Severity and Impairment Scale (OASIS) shows a strong positive relationship with various disorder-specific anxiety scales, indicating it can effectively measure anxiety symptoms across different disorders in internet-delivered cognitive behavioral therapy (iCBT) programs.

OASIS may serve as a useful outcome measurement tool in both disorder-specific and transdiagnostic iCBT programs, as it demonstrated stable associations with anxiety symptoms from the first to the last session in a study involving multiple anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Overall Anxiety Severity and Impairment Scale as an Outcome Measure in Internet-Delivered Cognitive Behavioral Therapy for Anxiety Disorders: Observational Study. Karpov, B., Lipsanen, JO., Ritola, V., et al.[2023]

A study involving 175 young people aged 7-18 with anxiety disorders showed that Internet-delivered cognitive behavior therapy (iCBT) effectively reduced anxiety symptoms, bringing most children to within the normal range after treatment.

Factors such as poor couple relationship quality and older maternal age were associated with less improvement in anxiety symptoms, indicating that while iCBT is generally effective, certain family dynamics may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered cognitive behavior therapy with minimal therapist support for anxious children and adolescents: predictors of response. Spence, SH., Prosser, SJ., March, S., et al.[2021]

The pilot study involving 94 adolescents aged 13 to 17 showed that the Internet-based cognitive behavioral therapy program, Breathe, was moderately satisfactory, with 90% of participants finding it easy to use and understand.

However, retention rates were low, with only 28% of the Breathe group completing the program, indicating that adjustments are needed to improve participant engagement and reduce barriers to completing the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial. O'Connor, K., Bagnell, A., McGrath, P., et al.[2020]

A systematic review of 76 randomized controlled trials involving 11,704 participants found that behavioral activation in internet cognitive behavioral therapy (iCBT) may significantly reduce depression severity, while relaxation techniques could potentially be harmful.

Combining human and automated encouragement in iCBT programs was shown to decrease dropout rates, suggesting that support mechanisms are crucial for maintaining engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dismantling, optimising, and personalising internet cognitive behavioural therapy for depression: a systematic review and component network meta-analysis using individual participant data. Furukawa, TA., Suganuma, A., Ostinelli, EG., et al.[2022]

The iCBT program Tranquility demonstrated a high fidelity to cognitive behavioral therapy principles, with a mean rating of 91% from CBT experts, indicating it effectively follows established therapeutic guidelines.

Usability ratings for Tranquility were also high, with 88% of participants recommending the program, suggesting it is user-friendly and has potential for broader adoption in treating anxiety and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Based Cognitive Behavioral Therapy Program for Anxiety and Depression (Tranquility): Adaptation Co-design and Fidelity Evaluation Study. Patterson, VC., Rossi, MA., Pencer, A., 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]

In a study analyzing 490 emails from therapists supporting 44 patients in internet-delivered cognitive behavior therapy (iCBT) for generalized anxiety disorder, specific therapist behaviors like task reinforcement and empathetic communication were found to positively influence treatment outcomes, including module completion.

Conversely, deadline flexibility was negatively associated with treatment outcomes, suggesting that how therapists interact with patients in iCBT can significantly affect symptom improvement and engagement with the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapist behaviours in internet-delivered cognitive behaviour therapy: analyses of e-mail correspondence in the treatment of generalized anxiety disorder. Paxling, B., Lundgren, S., Norman, A., et al.[2022]

In an 8-week internet-delivered cognitive behavior therapy (ICBT) program for anxiety and depression involving 80 clients, the average client asked less than two questions per treatment session, indicating limited engagement with the material.

The types of questions asked primarily focused on understanding the treatment content (46.72%), but the number of questions did not correlate with treatment outcomes, suggesting that simply asking more questions may not lead to better results in ICBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are Clients Asking Their Therapist During Therapist-Assisted Internet-Delivered Cognitive Behaviour Therapy? A Content Analysis of Client Questions. Soucy, JN., Hadjistavropoulos, HD., Pugh, NE., et al.[2019]

A systematic review of 44 documents on 10 internet-based cognitive behavioral therapy (iCBT) programs for children and adolescents with anxiety identified key design features that enhance program use, including tailoring, personalization, and social support elements.

Programs that included adjunct support, such as face-to-face or online communication, showed higher engagement and completion rates, suggesting that combining multiple persuasive system design features can significantly improve the effectiveness of iCBT interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Delivery Features That May Improve the Use of Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Anxiety: A Realist Literature Synthesis With a Persuasive Systems Design Perspective. Radomski, AD., Wozney, L., McGrath, P., et al.[2020]

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