- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03957330
Therapeutic Moderators of Therapist-assisted Internet-delivered Cognitive Behavior Therapy
Therapeutics Moderators of Therapist-assisted Internet-delivered Cognitive Behavior Therapy for Depression and Anxiety
Depression and anxiety are common and prevalent conditions that often go untreated. In an attempt to increase timely and accessible psychological treatment, Internet-delivered cognitive behavioural therapy (ICBT) has emerged. ICBT involves delivering therapeutic content via structured online lessons. This is often combined with therapist guidance, such as once per week contact via secure messaging or phone calls over several months. Over the past several years, the investigators have been studying the efficacy of ICBT for symptoms of depression and anxiety and found ~70% of patient's fully complete treatment and demonstrate large improvement in symptoms. Although outcomes of ICBT are very impressive, there is some room for improvement in terms of completion rates and outcomes.
In this three-factorial randomized controlled trial, the investigators aim to contribute to the literature by examining whether the efficacy of ICBT in routine practice is moderated by amount of contact (once versus twice a week), inclusion of homework reflection questionnaire (yes vs no) and location of therapist (specialized unit vs community mental health clinic). Follow-up measures will be carried out at 3, 6 and 12 months after randomization. Primary outcomes are reduced anxiety and depression. Secondary outcomes include psychological distress, panic, social anxiety, trauma, health anxiety, quality of life, disability, intervention usage (e.g., completion rates, log-ins, emails sent), satisfaction, therapeutic alliance, and costs (e.g., health care utilization).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4S 0A2
- Online Therapy Unit, University of Regina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Community Mental Health Clinic
In this arm, clients will be assigned to therapists working in a community mental health clinic in Saskatchewan where the focus of the setting is primarily on face-to-face treatment and ICBT makes up a small component of the workload in the clinic.
|
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.
|
Experimental: Once a week therapist contact
In once a week treatment, therapists will email their clients once a week on a pre-determined day.
|
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.
|
Experimental: Reflection Questionnaire
In the reflection questionnaire, patients will be asked to complete the following questions five times during the treatment period (beginning lesson 2-5 and then at the point they complete post-questionnaires):
|
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.
|
Experimental: Specialized Internet Therapy Clinic
In this arm, clients will be assigned to therapists working in a specialized internet therapy clinic where the therapists only deliver ICBT.
|
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.
|
Experimental: Twice a week therapist contact
In twice a week treatment, therapists will email their clients twice a week on pre-determined days.
|
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.
|
Experimental: No Reflection Questionnaire
In this arm, no reflection questions will be asked of clients receiving ICBT.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire 9-item (PHQ-9)
Time Frame: Baseline, weeks 2, 4, 5, 7, 8 and 3-, 6-, and 12-month follow-up
|
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.
|
Baseline, weeks 2, 4, 5, 7, 8 and 3-, 6-, and 12-month follow-up
|
Generalized Anxiety Disorder 7-item (GAD-7)
Time Frame: Baseline, weeks 2, 4, 5, 7, 8, and 3-, 6-, and 12-month follow-up
|
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.
|
Baseline, weeks 2, 4, 5, 7, 8, and 3-, 6-, and 12-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Panic Disorder Severity Scale Self-report
Time Frame: Time Frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
|
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, week 8, and 3-, 6-, and 12-month follow-up
|
Social Interaction Anxiety Scale (6 items) and Social Phobia Scale-Short form (6 items)
Time Frame: Time Frame: Baseline, Week 8, 3-, 6-, and 12-month follow-up
|
Change in social anxiety symptoms.
Items from the two measures are summed into a total score.
Total scores range between 0 and 48, with higher scores representing more severe self-reported symptoms of social anxiety
|
Time Frame: Baseline, Week 8, 3-, 6-, and 12-month follow-up
|
PTSD Check List 5
Time Frame: Baseline, week 8 and 3-, 6-, and 12-month follow-up
|
Change in post-traumatic symptoms.
The measure consists of 20 questions rated 0 to 4; higher scores indicate more trauma symptoms The first section assesses for exposure to a traumatic event using a checklist question.
If the client endorses exposure to a traumatic event, they are provided the second section, which assesses severity of trauma symptoms.
Items are summed into a total score, which can range between 0 and 80. Higher scores represent more severe self-reported symptoms of trauma.
|
Baseline, week 8 and 3-, 6-, and 12-month follow-up
|
Short Health Anxiety Inventory-14
Time Frame: Baseline, week 8 and 3-, 6-, and 12-month follow-up
|
Change in health anxiety.
14 items with higher scores indicating higher levels of self-reported health anxiety.
|
Baseline, week 8 and 3-, 6-, and 12-month follow-up
|
Kessler Psychological Distress
Time Frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
|
Change in psychological distress.
Measured by 10-item scale rated 0 to 4; total score is created by summing items; higher scores signify greater psychological distress
|
Baseline, week 8, and 3-, 6-, and 12-month follow-up
|
Quality of life questionnaire (EQ-ED-5L)
Time Frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
|
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. |
Baseline, week 8, and 3-, 6-, and 12-month follow-up
|
Sheehan Disability Scale 3-item
Time Frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
|
Change in disability.
Measure consists of 3 items rated 0 to 10 and summed to create total score, with higher scores indicating greater disability
|
Baseline, week 8, and 3-, 6-, and 12-month follow-up
|
Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada
Time Frame: Baseline and 3-, 6-, and 12-month follow-up
|
Change in treatment costs.
A series of yes and no, rating, and frequency questions that are designed to ascertain the volume of medical consumption and productivity losses associated with mental health problems.
Questions are independently analyzed and, therefore, the TIP-C does not include a total score.
|
Baseline and 3-, 6-, and 12-month follow-up
|
Treatment Credibility Questionnaire
Time Frame: Baseline, week 8, and 3-month follow-up
|
Change in treatment credibility.
4 items are summed into a total score.
Higher scores representing greater perceptions of ICBT credibility.
|
Baseline, week 8, and 3-month follow-up
|
Working Alliance Inventory Short-Form
Time Frame: Baseline, week 8, and 3-, 6-, and 12-month follow-up
|
Measures therapeutic alliance.
Scores are summed into three sub-total scores, which respectively assess various domains of the therapeutic relationship (i.e., goal, task, and bond).
Sub-total scores each range between 5 and 20, with higher scores representing better therapeutic relationship in each of the three domains assessed.
|
Baseline, week 8, and 3-, 6-, and 12-month follow-up
|
Treatment Engagement
Time Frame: Week 8
|
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
|
Week 8
|
Treatment Satisfaction and Negative Effects Questionnaires
Time Frame: Week 8
|
Measure includes 19 questions assessing satisfaction with various aspects of Internet-CBT and also negative effects of treatment
|
Week 8
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-038
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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