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

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.

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

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.

Clinical Trials on Depression

Clinical Trials on Personalized ICBT

3
Subscribe