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Clinical Trials/NCT03304392
NCT03304392
Completed
N/A

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

University of Regina1 site in 1 country449 target enrollmentOctober 11, 2017

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.

Registry
clinicaltrials.gov
Start Date
October 11, 2017
End Date
October 15, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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