Therapist-guided Internet-delivered Cognitive Behavioural Therapy

Study Overview
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Brief Summary
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Depression and anxiety are prevalent and disabling conditions that often go untreated. Internet-delivered Cognitive Behaviour Therapy (ICBT) is a relatively new approach to treatment that is a convenient way for patients to access care. ICBT is typically highly standardized and involves patients reviewing weekly lessons over the Internet. Patients also receive brief weekly support from a therapist via secure emails or phone calls. Past research shows that  75% of patients complete ICBT and report large symptom improvements. Although these results are very promising, research also suggests that ICBT could potentially be improved by being more personalized in terms of amount of therapist contact, especially for clients with more severe symptoms. The current trial will involve therapists who work in a clinic that specializes in ICBT. Over one year, 440 patients with depression and/or anxiety will be randomized to either receive standardized (5 lessons completed in 8 weeks; once week therapist contact) or personalized ICBT (5 lessons completed in 8 weeks; personalized therapist contact depending on needs of patient). Psychosocial outcomes of patients in the two treatment arms will be compared post-treatment and at 3-month, 6-month, and 1-year follow-up from enrollment. Data on intervention usage, satisfaction measures, and costs will also be assessed.

Official Title
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Advancing Mental Health Care by Improving the Delivery of Therapist-guided, Internet-delivered Cognitive Behavioural Therapy in Clinical Practice

Conditions
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Anxiety, Depression

Intervention / Treatment
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* Behavioral: Personalized ICBT
* Behavioral: Standard ICBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older residing in Saskatchewan, Canada endorsing symptoms of anxiety or depression able to access a computer and internet service willing to provide a physician as emergency contact Exclusion Criteria: high suicide risk suicide attempt or hospitalization in the last year primary problems with psychosis, alcohol or drug problems, mania currently receiving active psychological treatment for anxiety or depression not present in province during treatment; concerns about online therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized ICBT<br>An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support within one business day of client emails. Amount of contact will be personalized to patients' needs. | Behavioral: Personalized ICBT<br>* An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support within one business day of client emails. Amount of contact will be personalized to patients' needs.<br>|
| Active Comparator: Standard ICBT<br>An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support by email only once a week. Therapist will spend approximately 15 minutes per week/per client. | Behavioral: Standard ICBT<br>* An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support by email only once a week. Therapist will spend approximately 15 minutes per week/per client.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression | Measured by Patient Health Questionnaire - 9 Item (PHQ-9) | baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up | 
| Change in anxiety | Measured by Generalize Anxiety Disorder - 7 Item (GAD7) | baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in psychological distress | Measured by Kessler 10-Item Scale | baseline, 8 weeks, 3 months, 6 months, and 1 year follow up | 
| Change in disability | Measure by Sheehan Disability Scale-3 Item | baseline, 8 weeks, 3 months, 6 months, and 1 year follow up | 
| Change in panic symptoms | Measured by Panic Disorder Severity Scale-Self Report | baseline, 8 weeks, 3 months, 6 months, and 1 year follow up | 
| Change in social anxiety symptoms | Measured by Social Interaction Anxiety Scale | baseline, 8 weeks, 3 months, 6 months, and 1 year follow up | 
| Change in social phobia symptoms | Measured by Social Phobia Scale-Short form | baseline, 8 weeks, 3 months, 6 months, and 1 year follow up | 
| Change in post-traumatic symptoms | Measured by PTSD Checklist 5 | Administered to only those participants meeting criteria for post-traumatic stress based on the modified brief Life Events Checklist for DSM 5 (LEC-5) at each time point: baseline, 3 months, 6 months, and 1 year follow up | 
| Change in quality of life symptoms | Measured by EQ-5D-5L | baseline, 8 weeks, 3 months, 6 months, and 1 year follow up | 
| Change in treatment costs | Measured by Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada | Part 1 and 2: baseline, 3 months, 6 months, and 1 year follow up; Part 3: baseline and 1 year follow up | 
| Therapeutic alliance | Measured by Working Alliance Inventory-Short Form | 8 weeks | 
| Treatment credibility | Measured by Credibility Questionnaire | baseline and 8 weeks | 
| Treatment satisfaction | Measured by Internet-CBT Treatment Satisfaction Measure | 8 weeks | 
| Engagement | Measured by: number of lessons completed, number of days of access, number of emails sent to therapist, number of phone calls with therapist, number of emails from therapist to client, total words emailed to therapist, total words emailed from therapist to patient | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, depression, internet-delivered cognitive behaviour therapy, randomized controlled trial, patient-centered, knowledge implementation, mental health system, therapist-assistance