Back to resultsOptimizing Duration of Therapist-guided Internet-delivered Cognitive Behaviour Therapy
Primary Purpose
Anxiety, Depression
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Internet-delivered cognitive behaviour therapy
Sponsored by
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-centred, personalized therapy, knowledge implementation, mental health system, therapist-assistance, booster session, factorial design
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- Endorse symptoms of anxiety or depression
- Resident of Saskatchewan
- Access to a computer and the Internet
Exclusion Criteria:
- Have a severe psychiatric illness (e.g. psychosis)
- Assessed as being at high risk of suicide
- Report severe problems with alcohol or drugs
- Report severe cognitive impairment
Sites / Locations
- Online Therapy Unit, University of Regina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Extended Contact
8 Week ICBT no Booster
Extended Contact with Booster
8 week ICBT with Booster
Arm Description
Clients in the Extended Contact condition will be asked at the 6 week mark if they like they can extend their treatment and receive up to 12 weeks of support. They will be informed that this may be helpful if they feel they have fallen behind in reviewing of the materials, if they would like to receive support while they work on supplementary resources or if they would like extended support while they work on core lessons. If they would like additional support, participants will answer questions presented on the website about their desire for this additional support what they would like to focus on during this time. Those clients who indicate that they would like this extended support will automatically have their therapists check-in with them for up to 12 weeks. Those that do not request the additional support will end treatment as planned at the end of 8 weeks.
In the standard condition, clients will receive 8 weeks of therapist support. They will not be given the option to extend their treatment and support to 12 weeks. The booster course will not be offered in this condition.
Clients in the Extended Contact condition will receive an email at the 6 week mark letting them know that they if they like they can extend their treatment and receive up to 12 weeks of support. At week 6, clients will answer questions on the website about whether they would like this additional support or not and what they would like to focus on during this time. Clients who indicate they would like this extended support will automatically have their therapists check-in with them for up to 12 weeks. They will also be told that at 16 weeks they will have access to a booster session (online materials that go over core skills such as thought challenging, deep breathing, behavioural activation, and graded exposure). At 16 weeks, they will be sent an email reminder to log in for the booster course. The therapist will send a supportive email to the client offering to assist with any challenges the client reports in the check-in questionnaire by email or phone call over the next 2 weeks.
Clients in the booster condition will be told that at 16 weeks they will have access to a booster session (online materials that go over core skills such as thought challenging, deep breathing, behavioural activation, and graded exposure). At 16 weeks, they will be sent an email reminder to log in for the booster course. The therapist will send a supportive email to the client offering to assist with any challenges the client reports in the check-in questionnaire by email or phone call over the next 2 weeks.
Outcomes
Primary Outcome Measures
Patient Health Questionnaire 9-item (PHQ-9)
Change in depression symptoms. 9 items are summed into a total score, with scores ranging from 0 to 27. Higher scores are associated with higher depression severity.
Generalized Anxiety Disorder 7-item (GAD-7)
Change in anxiety symptoms. 7 items are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.
Secondary Outcome Measures
Panic Disorder Severity Scale Self-report
Change in panic symptoms. Items are summed into a total score. Total scores range between 0 and 28, with higher scores representing more severe self-reported symptoms of panic.
Social Interaction Anxiety Scale (6 items)
Change in social anxiety symptoms. Items from the two measures are summed into a total score. Total scores range between 0 and 24, with higher scores representing more severe self-reported symptoms of social phobia
Social Phobia Scale-Short form (6 items)
Change in social anxiety symptoms. Items from the two measures are summed into a total score. Total scores range between 0 and 24, with higher scores representing more severe self-reported symptoms of social phobia
Quality of Life (EQ-ED-5L)
Change in quality of life. Items are summed into six sub-total scores. The first five sub-total scores respectively assess various domains of quality of life (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
Each of the five sub-total scores range between 1 and 5, with higher scores representing greater self-reported severity and impairment in these various domains. The last sub-total score provides an overall index of health and can range between 0 and 100, with higher scores representing better self-reported health.
Mental Health Service Use, Medication, and Employment
This measure is 19 items and measures direct and indirect cost of mental health symptoms. Frequency of visits to health specialists (e.g., family doctor, walk-in clinic, psychiatrist, psychologist, social worker, nurse/community nurse/psychiatric nurse) or use of health services (e.g. psychiatric day-patient/part-time treatment, alcohol or drug treatment program, self-help group, ambulance/paramedics, crisis service, hospital admission) in the previous 3 months for mental health reasons are collected. Medication use/changes in previous 3 months for mental health concerns. Questions about occupation, hours in contract, and time off work in previous 3 months for mental health concerns.
Treatment Satisfaction
Measure includes 19 questions assessing satisfaction with various aspects of Internet-CBT and also negative effects of treatment
Insomnia Severity Index (ISI)
Measure includes 7 questions rated on a 0-4 point scale with higher scores indicative of higher levels of insomnia.
Sheehan Disability Scale (SDS)
Higher total scores indicate a greater degree of impairment. Total scores range from 0 to 30. Scores in each of 3 specific life domains range from 0 to 10.
Life Events Checklist for DSM-5 (LEC-5)
Life Events Checklist for DSM-5 (LEC-5). A checklist of common traumatic events used to establish the nature of the traumatic events a respondent has experienced. This questionnaire is not intended to be scored but is used for descriptive purposes.
PTSD Checklist for DSM-5 (PCL-5)
Higher total scores indicate greater severity of posttraumatic stress. Scores range from 0 to 80.
Full Information
NCT ID
NCT04228575
First Posted
January 9, 2020
Last Updated
December 15, 2021
Sponsor
University of Regina
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT04228575
Brief Title
Optimizing Duration of Therapist-guided Internet-delivered Cognitive Behaviour Therapy
Official Title
Optimizing Duration of Therapist-guided Internet-delivered Cognitive Behaviour Therapy for Anxiety and Depression
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (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 common and prevalent conditions that are frequently under treated. In an attempt to increase timely and accessible psychological treatment, Internet-delivered Cognitive Behaviour Therapy (ICBT) has emerged. ICBT involves delivering therapeutic content to manage depression and or anxiety via structured online lessons. This is often combined with brief therapist guidance, for example once per week for 8 weeks via secure messaging or phone calls. Although outcomes of ICBT are very impressive, there is room for improvement in terms of completion rates and outcomes. Feedback from patients suggest that some patients would prefer longer term support or follow-up care.
In this two-factorial randomized controlled trial, the investigators aim to contribute to the literature by examining whether the efficacy of ICBT is improved by offering an extended period of support to clients (from 8 weeks to 12 weeks) and being offered a booster session at 16 weeks after treatment enrollment (yes vs no). Follow-up assessments will be conducted at 8, 16 and 26 weeks after treatment enrollment. Primary outcomes are reduced anxiety and depression. Secondary outcomes include reduced panic, social anxiety, trauma, quality of life, disability, work productivity, and healthcare use.
Detailed Description
Past research of ICBT offered in routine care has found that patients and therapists often recommend "personalizing" the delivery of ICBT, for example, by increasing the length of time therapist support is available or offering booster sessions after treatment has ended. To date, in terms of ICBT, there has been limited research on the impact of extending support after treatment materials have been delivered or offering a booster session.
In this trial, the investigators will examine if the efficacy of ICBT is improved by offering an extended period of support to clients (from 8 weeks to 12 weeks) or by being offered a booster session at 16 weeks after treatment enrollment (yes vs no). Follow-up assessments will be conducted at 8, 16 and 26 weeks after treatment enrollment. Primary outcomes are reduced anxiety and depression. Secondary outcomes include reduced panic, social anxiety, trauma, quality of life, disability, work productivity, and healthcare use. The impact of these factors on intervention usage (e.g., completion rates, log-ins, emails sent) and treatment satisfaction will also be examined.
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-centred, personalized therapy, knowledge implementation, mental health system, therapist-assistance, booster session, factorial design
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
410 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Extended Contact
Arm Type
Experimental
Arm Description
Clients in the Extended Contact condition will be asked at the 6 week mark if they like they can extend their treatment and receive up to 12 weeks of support. They will be informed that this may be helpful if they feel they have fallen behind in reviewing of the materials, if they would like to receive support while they work on supplementary resources or if they would like extended support while they work on core lessons. If they would like additional support, participants will answer questions presented on the website about their desire for this additional support what they would like to focus on during this time. Those clients who indicate that they would like this extended support will automatically have their therapists check-in with them for up to 12 weeks. Those that do not request the additional support will end treatment as planned at the end of 8 weeks.
Arm Title
8 Week ICBT no Booster
Arm Type
Experimental
Arm Description
In the standard condition, clients will receive 8 weeks of therapist support. They will not be given the option to extend their treatment and support to 12 weeks. The booster course will not be offered in this condition.
Arm Title
Extended Contact with Booster
Arm Type
Experimental
Arm Description
Clients in the Extended Contact condition will receive an email at the 6 week mark letting them know that they if they like they can extend their treatment and receive up to 12 weeks of support. At week 6, clients will answer questions on the website about whether they would like this additional support or not and what they would like to focus on during this time. Clients who indicate they would like this extended support will automatically have their therapists check-in with them for up to 12 weeks.
They will also be told that at 16 weeks they will have access to a booster session (online materials that go over core skills such as thought challenging, deep breathing, behavioural activation, and graded exposure). At 16 weeks, they will be sent an email reminder to log in for the booster course. The therapist will send a supportive email to the client offering to assist with any challenges the client reports in the check-in questionnaire by email or phone call over the next 2 weeks.
Arm Title
8 week ICBT with Booster
Arm Type
Experimental
Arm Description
Clients in the booster condition will be told that at 16 weeks they will have access to a booster session (online materials that go over core skills such as thought challenging, deep breathing, behavioural activation, and graded exposure). At 16 weeks, they will be sent an email reminder to log in for the booster course. The therapist will send a supportive email to the client offering to assist with any challenges the client reports in the check-in questionnaire by email or phone call over the next 2 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered cognitive behaviour therapy
Intervention Description
All clients will receive the Wellbeing Course developed at Macquarie University, Australia. The Wellbeing Course is a transdiagnostic Internet-delivered cognitive behaviour intervention targeting symptoms of depressive and anxiety disorders. It comprises 5 online lessons targeting: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure; and 5) relapse prevention. Materials are presented in a didactic (i.e., text-based with visual images) and case-enhanced learning format (i.e., educational stories demonstrate the application of skills) and include homework activities. Lessons are released gradually in a standardized order over 8 weeks. Phone calls will only be made if there is a significant clinical issue requiring therapist attention that cannot be addressed over email (e.g., sudden increase in symptoms). Therapists will spend ~15 mins. per week/per client.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire 9-item (PHQ-9)
Description
Change in depression symptoms. 9 items are summed into a total score, with scores ranging from 0 to 27. Higher scores are associated with higher depression severity.
Time Frame
Baseline (Screening), weeks 1-12, 16 and 26 week from enrollment
Title
Generalized Anxiety Disorder 7-item (GAD-7)
Description
Change in anxiety symptoms. 7 items are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.
Time Frame
Baseline (Screening), weeks 1-12 and 16 and 26 week from enrollment
Secondary Outcome Measure Information:
Title
Panic Disorder Severity Scale Self-report
Description
Change in panic symptoms. Items are summed into a total score. Total scores range between 0 and 28, with higher scores representing more severe self-reported symptoms of panic.
Time Frame
Baseline (Screening), week 8, 16 and 26 week from enrollment
Title
Social Interaction Anxiety Scale (6 items)
Description
Change in social anxiety symptoms. Items from the two measures are summed into a total score. Total scores range between 0 and 24, with higher scores representing more severe self-reported symptoms of social phobia
Time Frame
Baseline (Screening), week 8, 16 and 26 week from enrollment
Title
Social Phobia Scale-Short form (6 items)
Description
Change in social anxiety symptoms. Items from the two measures are summed into a total score. Total scores range between 0 and 24, with higher scores representing more severe self-reported symptoms of social phobia
Time Frame
Baseline (Screening), week 8, 16 and 26 week from enrollment
Title
Quality of Life (EQ-ED-5L)
Description
Change in quality of life. Items are summed into six sub-total scores. The first five sub-total scores respectively assess various domains of quality of life (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
Each of the five sub-total scores range between 1 and 5, with higher scores representing greater self-reported severity and impairment in these various domains. The last sub-total score provides an overall index of health and can range between 0 and 100, with higher scores representing better self-reported health.
Time Frame
Baseline (Screening), week 8, 16 and 26 week from enrollment
Title
Mental Health Service Use, Medication, and Employment
Description
This measure is 19 items and measures direct and indirect cost of mental health symptoms. Frequency of visits to health specialists (e.g., family doctor, walk-in clinic, psychiatrist, psychologist, social worker, nurse/community nurse/psychiatric nurse) or use of health services (e.g. psychiatric day-patient/part-time treatment, alcohol or drug treatment program, self-help group, ambulance/paramedics, crisis service, hospital admission) in the previous 3 months for mental health reasons are collected. Medication use/changes in previous 3 months for mental health concerns. Questions about occupation, hours in contract, and time off work in previous 3 months for mental health concerns.
Time Frame
Baseline (Screening) and Week 26 week from enrollment
Title
Treatment Satisfaction
Description
Measure includes 19 questions assessing satisfaction with various aspects of Internet-CBT and also negative effects of treatment
Time Frame
Week 8, 16 and 26 week from enrollment
Title
Insomnia Severity Index (ISI)
Description
Measure includes 7 questions rated on a 0-4 point scale with higher scores indicative of higher levels of insomnia.
Time Frame
Baseline
Title
Sheehan Disability Scale (SDS)
Description
Higher total scores indicate a greater degree of impairment. Total scores range from 0 to 30. Scores in each of 3 specific life domains range from 0 to 10.
Time Frame
Baseline (Screening), week 8, 16 and 26 week from enrollment
Title
Life Events Checklist for DSM-5 (LEC-5)
Description
Life Events Checklist for DSM-5 (LEC-5). A checklist of common traumatic events used to establish the nature of the traumatic events a respondent has experienced. This questionnaire is not intended to be scored but is used for descriptive purposes.
Time Frame
Baseline (Screening)
Title
PTSD Checklist for DSM-5 (PCL-5)
Description
Higher total scores indicate greater severity of posttraumatic stress. Scores range from 0 to 80.
Time Frame
Baseline (Screening), week 8, 16 and 26 week from enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
Endorse symptoms of anxiety or depression
Resident of Saskatchewan
Access to a computer and the Internet
Exclusion Criteria:
Have a severe psychiatric illness (e.g. psychosis)
Assessed as being at high risk of suicide
Report severe problems with alcohol or drugs
Report severe cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather 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
Learn more about this trial
Optimizing Duration of Therapist-guided Internet-delivered Cognitive Behaviour Therapy
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