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Therapist-guided Internet-delivered Cognitive Behavioural Therapy

Primary Purpose

Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Personalized ICBT
Standard ICBT
Sponsored by
University of Regina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring anxiety, depression, internet-delivered cognitive behaviour therapy, randomized controlled trial, patient-centered, knowledge implementation, mental health system, therapist-assistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Online Therapy Unit, University of Regina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personalized ICBT

Standard ICBT

Arm Description

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 by email only once a week. Therapist will spend approximately 15 minutes per week/per client.

Outcomes

Primary Outcome Measures

Change in depression
Measured by Patient Health Questionnaire - 9 Item (PHQ-9)
Change in anxiety
Measured by Generalize Anxiety Disorder - 7 Item (GAD7)

Secondary Outcome Measures

Change in psychological distress
Measured by Kessler 10-Item Scale
Change in disability
Measure by Sheehan Disability Scale-3 Item
Change in panic symptoms
Measured by Panic Disorder Severity Scale-Self Report
Change in social anxiety symptoms
Measured by Social Interaction Anxiety Scale
Change in social phobia symptoms
Measured by Social Phobia Scale-Short form
Change in post-traumatic symptoms
Measured by PTSD Checklist 5
Change in quality of life symptoms
Measured by EQ-5D-5L
Change in treatment costs
Measured by Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada
Therapeutic alliance
Measured by Working Alliance Inventory-Short Form
Treatment credibility
Measured by Credibility Questionnaire
Treatment satisfaction
Measured by Internet-CBT Treatment Satisfaction Measure
Engagement
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

Full Information

First Posted
September 29, 2017
Last Updated
February 18, 2020
Sponsor
University of Regina
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03304392
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
October 15, 2019 (Actual)
Study Completion Date
October 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Regina
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression
Keywords
anxiety, depression, internet-delivered cognitive behaviour therapy, randomized controlled trial, patient-centered, knowledge implementation, mental health system, therapist-assistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
449 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized ICBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard ICBT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Personalized ICBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard ICBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in depression
Description
Measured by Patient Health Questionnaire - 9 Item (PHQ-9)
Time Frame
baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up
Title
Change in anxiety
Description
Measured by Generalize Anxiety Disorder - 7 Item (GAD7)
Time Frame
baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up
Secondary Outcome Measure Information:
Title
Change in psychological distress
Description
Measured by Kessler 10-Item Scale
Time Frame
baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Title
Change in disability
Description
Measure by Sheehan Disability Scale-3 Item
Time Frame
baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Title
Change in panic symptoms
Description
Measured by Panic Disorder Severity Scale-Self Report
Time Frame
baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Title
Change in social anxiety symptoms
Description
Measured by Social Interaction Anxiety Scale
Time Frame
baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Title
Change in social phobia symptoms
Description
Measured by Social Phobia Scale-Short form
Time Frame
baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Title
Change in post-traumatic symptoms
Description
Measured by PTSD Checklist 5
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
Title
Change in quality of life symptoms
Description
Measured by EQ-5D-5L
Time Frame
baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Title
Change in treatment costs
Description
Measured by Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada
Time Frame
Part 1 and 2: baseline, 3 months, 6 months, and 1 year follow up; Part 3: baseline and 1 year follow up
Title
Therapeutic alliance
Description
Measured by Working Alliance Inventory-Short Form
Time Frame
8 weeks
Title
Treatment credibility
Description
Measured by Credibility Questionnaire
Time Frame
baseline and 8 weeks
Title
Treatment satisfaction
Description
Measured by Internet-CBT Treatment Satisfaction Measure
Time Frame
8 weeks
Title
Engagement
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather D Hadjistavropoulos, PhD
Organizational Affiliation
University of Regina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Online Therapy Unit, University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Therapist-guided Internet-delivered Cognitive Behavioural Therapy

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