Clinical trial NCT03304392: Therapist-guided Internet-delivered Cognitive Behavioural Therapy
Official title: Advancing Mental Health Care by Improving the Delivery of Therapist-guided, Internet-delivered Cognitive Behavioural Therapy in Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Keywords: anxiety
depression
internet-delivered cognitive behaviour therapy
randomized controlled trial
patient-centered
knowledge implementation
mental health system
therapist-assistance
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-10-09
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in depression
timeFrame: baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up
measure: Change in anxiety
timeFrame: baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up
Secondary outcomes:
measure: Change in psychological distress
timeFrame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
measure: Change in disability
timeFrame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
measure: Change in panic symptoms
timeFrame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
measure: Change in social anxiety symptoms
timeFrame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
measure: Change in social phobia symptoms
timeFrame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
measure: Change in post-traumatic symptoms
timeFrame: 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
measure: Change in quality of life symptoms
timeFrame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
measure: Change in treatment costs
timeFrame: Part 1 and 2: baseline, 3 months, 6 months, and 1 year follow up; Part 3: baseline and 1 year follow up
measure: Therapeutic alliance
timeFrame: 8 weeks
measure: Treatment credibility
timeFrame: baseline and 8 weeks
measure: Treatment satisfaction
timeFrame: 8 weeks
measure: Engagement
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Online Therapy Unit, University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Heather D Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References: