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
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Among 33 studies in Depression by University of Regina — 12 open to participants now, 12 under way, none of them phase 3. Depression · University of Regina.
Among the 33 studies in Depression by University of Regina, this one is the 4th largest by enrollment of the 31 interventional ones that give a count, is one of 2 that started in 2017, is one of 29 with no phase, and was the 1st registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →12 of the 33 studies in Depression by University of Regina are open now, in 1 country. Recruiting first, the newest first:
University of Regina · Sites in Canada
Ages 18+
University of Regina · Sites in Canada
Ages 18+
University of Regina · Sites in Canada
Ages 18+
University of Regina · Sites in Canada
Ages 18+ · Healthy volunteers
University of Regina · Sites in Canada
Ages 18+
By country, each count listing its studies:
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 2 started in 2017.
This study's enrollment of 449 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 158 across the 31 interventional studies, 141 across the 2 observational. Of the 20 that completed or were terminated, 0 (0%) have results posted.
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University of Regina is the lead sponsor of 58 studies on the registry; 23 are open to participants now.
5 of the studies in Depression by University of Regina that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06745349University of ReginaThe Sleep Course: An Online Sleep Intervention for Adults With Self-reported Sleep Difficulties | 2026-12 |
| NCT07095582University of ReginaEnhancing Internet-Delivered Cognitive Behaviour Therapy With Additional Content | 2026-12 |
| NCT05333627University of ReginaInternet-delivered Cognitive Behaviour Therapy for Students: Duration Preference Trial | 2027-04-30 |
| NCT06298279University of ReginaAssessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel | 2027-04-30 |
| NCT06881693University of ReginaInternet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety in Perinatal Parents | 2027-06-30 |
Add all 5 to your calendar (.ics) → With an account.
Among the 33 studies in Depression by University of Regina, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
This study's enrollment of 449 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Browse Depression studies →University of Regina is the lead sponsor of 58 studies on the registry; 23 are open to participants now.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Oct 2019, 24 months.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 24 months is above that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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