- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03304392
Therapist-guided Internet-delivered Cognitive Behavioural Therapy
February 18, 2020 updated by: University of Regina
Advancing Mental Health Care by Improving the Delivery of Therapist-guided, Internet-delivered Cognitive Behavioural Therapy in Clinical Practice
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
449
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4S 0A2
- Online Therapy Unit, University of Regina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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 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 within one business day of client emails.
Amount of contact will be personalized to patients' needs.
|
ACTIVE_COMPARATOR: 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 by email only once a week.
Therapist will spend approximately 15 minutes per week/per client.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up
|
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)
|
baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in psychological distress
Time Frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
|
Measured by Kessler 10-Item Scale
|
baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
|
Change in disability
Time Frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
|
Measure by Sheehan Disability Scale-3 Item
|
baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
|
Change in panic symptoms
Time Frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
|
Measured by Panic Disorder Severity Scale-Self Report
|
baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
|
Change in social anxiety symptoms
Time Frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
|
Measured by Social Interaction Anxiety Scale
|
baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
|
Change in social phobia symptoms
Time Frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
|
Measured by Social Phobia Scale-Short form
|
baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
|
Change in post-traumatic symptoms
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
|
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
Time Frame: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
|
Measured by EQ-5D-5L
|
baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
|
Change in treatment costs
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
|
Part 1 and 2: baseline, 3 months, 6 months, and 1 year follow up; Part 3: baseline and 1 year follow up
|
Therapeutic alliance
Time Frame: 8 weeks
|
Measured by Working Alliance Inventory-Short Form
|
8 weeks
|
Treatment credibility
Time Frame: baseline and 8 weeks
|
Measured by Credibility Questionnaire
|
baseline and 8 weeks
|
Treatment satisfaction
Time Frame: 8 weeks
|
Measured by Internet-CBT Treatment Satisfaction Measure
|
8 weeks
|
Engagement
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
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 11, 2017
Primary Completion (ACTUAL)
October 15, 2019
Study Completion (ACTUAL)
October 15, 2019
Study Registration Dates
First Submitted
September 29, 2017
First Submitted That Met QC Criteria
October 5, 2017
First Posted (ACTUAL)
October 9, 2017
Study Record Updates
Last Update Posted (ACTUAL)
February 20, 2020
Last Update Submitted That Met QC Criteria
February 18, 2020
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 375860
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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