Online Therapy Unit, University of Regina
Regina, Saskatchewan, S4S 0A2, Canada
NCT Number: NCT03304392
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Regina, Saskatchewan, S4S 0A2, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
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.
Time frame: baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up
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
Measured by Generalize Anxiety Disorder - 7 Item (GAD7)
Time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Measured by Kessler 10-Item Scale
Time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Measure by Sheehan Disability Scale-3 Item
Time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Measured by Panic Disorder Severity Scale-Self Report
Time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Measured by Social Interaction Anxiety Scale
Time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Measured by Social Phobia Scale-Short form
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
Measured by PTSD Checklist 5
Time frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Measured by EQ-5D-5L
Time frame: Part 1 and 2: baseline, 3 months, 6 months, and 1 year follow up; Part 3: baseline and 1 year follow up
Measured by Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada
Time frame: 8 weeks
Measured by Working Alliance Inventory-Short Form
Time frame: baseline and 8 weeks
Measured by Credibility Questionnaire
Time frame: 8 weeks
Measured by Internet-CBT Treatment Satisfaction Measure
Time frame: 8 weeks
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
University of Regina
Other
Advancing Mental Health Care by Improving the Delivery of Therapist-guided, Internet-delivered Cognitive Behavioural Therapy in Clinical Practice
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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