An interventional study of Personalized ICBT and Standard ICBT in Anxiety and Depression, sponsored by University of Regina. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by University of Regina · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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
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
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.
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.
Change in depression
Measured by Patient Health Questionnaire - 9 Item (PHQ-9)
Time frame: 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)
Time frame: baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up
Change in psychological distress
Measured by Kessler 10-Item Scale
Time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Change in disability
Measure by Sheehan Disability Scale-3 Item
Time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Change in panic symptoms
Measured by Panic Disorder Severity Scale-Self Report
Time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Change in social anxiety symptoms
Measured by Social Interaction Anxiety Scale
Time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Change in social phobia symptoms
Measured by Social Phobia Scale-Short form
Time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Change in post-traumatic symptoms
Measured by PTSD Checklist 5
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 8 weeks
Treatment credibility
Measured by Credibility Questionnaire
Time frame: baseline and 8 weeks
Treatment satisfaction
Measured by Internet-CBT Treatment Satisfaction Measure
Time frame: 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
Time frame: 8 weeks
Plan to share: No
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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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University of Regina