Advancing Mental Health Care by Improving the Delivery of Therapist-guided, Internet-delivered Cognitive Behavioural Therapy in Clinical Practice
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Anxiety
- Sponsor
- University of Regina
- Enrollment
- 449
- Locations
- 1
- Primary Endpoint
- Change in depression
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in depression
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)
Change in anxiety
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)
Secondary Outcomes
- Treatment satisfaction(8 weeks)
- Change in psychological distress(baseline, 8 weeks, 3 months, 6 months, and 1 year follow up)
- Change in post-traumatic symptoms(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(baseline, 8 weeks, 3 months, 6 months, and 1 year follow up)
- Change in social phobia symptoms(baseline, 8 weeks, 3 months, 6 months, and 1 year follow up)
- Change in treatment costs(Part 1 and 2: baseline, 3 months, 6 months, and 1 year follow up; Part 3: baseline and 1 year follow up)
- Therapeutic alliance(8 weeks)
- Treatment credibility(baseline and 8 weeks)
- Change in panic symptoms(baseline, 8 weeks, 3 months, 6 months, and 1 year follow up)
- Change in social anxiety symptoms(baseline, 8 weeks, 3 months, 6 months, and 1 year follow up)
- Engagement(8 weeks)
- Change in disability(baseline, 8 weeks, 3 months, 6 months, and 1 year follow up)