- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04228575
Optimizing Duration of Therapist-guided Internet-delivered Cognitive Behaviour Therapy
Optimizing Duration of Therapist-guided Internet-delivered Cognitive Behaviour Therapy for Anxiety and Depression
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Extended Contact
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.
|
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: 8 Week ICBT no Booster
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.
|
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: Extended Contact with Booster
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. |
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: 8 week ICBT with Booster
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.
|
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 (Screening), weeks 1-12, 16 and 26 week from enrollment
|
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 (Screening), weeks 1-12, 16 and 26 week from enrollment
|
Generalized Anxiety Disorder 7-item (GAD-7)
Time Frame: Baseline (Screening), weeks 1-12 and 16 and 26 week from enrollment
|
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 (Screening), weeks 1-12 and 16 and 26 week from enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Panic Disorder Severity Scale Self-report
Time Frame: Baseline (Screening), week 8, 16 and 26 week from enrollment
|
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.
|
Baseline (Screening), week 8, 16 and 26 week from enrollment
|
Social Interaction Anxiety Scale (6 items)
Time Frame: Baseline (Screening), week 8, 16 and 26 week from enrollment
|
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
|
Baseline (Screening), week 8, 16 and 26 week from enrollment
|
Social Phobia Scale-Short form (6 items)
Time Frame: Baseline (Screening), week 8, 16 and 26 week from enrollment
|
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
|
Baseline (Screening), week 8, 16 and 26 week from enrollment
|
Quality of Life (EQ-ED-5L)
Time Frame: Baseline (Screening), week 8, 16 and 26 week from enrollment
|
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 (Screening), week 8, 16 and 26 week from enrollment
|
Mental Health Service Use, Medication, and Employment
Time Frame: Baseline (Screening) and Week 26 week from enrollment
|
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.
|
Baseline (Screening) and Week 26 week from enrollment
|
Treatment Satisfaction
Time Frame: Week 8, 16 and 26 week from enrollment
|
Measure includes 19 questions assessing satisfaction with various aspects of Internet-CBT and also negative effects of treatment
|
Week 8, 16 and 26 week from enrollment
|
Insomnia Severity Index (ISI)
Time Frame: Baseline
|
Measure includes 7 questions rated on a 0-4 point scale with higher scores indicative of higher levels of insomnia.
|
Baseline
|
Sheehan Disability Scale (SDS)
Time Frame: Baseline (Screening), week 8, 16 and 26 week from enrollment
|
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.
|
Baseline (Screening), week 8, 16 and 26 week from enrollment
|
Life Events Checklist for DSM-5 (LEC-5)
Time Frame: Baseline (Screening)
|
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.
|
Baseline (Screening)
|
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Baseline (Screening), week 8, 16 and 26 week from enrollment
|
Higher total scores indicate greater severity of posttraumatic stress.
Scores range from 0 to 80.
|
Baseline (Screening), week 8, 16 and 26 week from enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
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
- 2019-197
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
-
Lawson Health Research InstituteTerminated
Clinical Trials on Internet-delivered cognitive behaviour therapy
-
University of ReginaSaskatchewan Centre for Patient-Oriented ResearchCompletedDepression | Insomnia | AnxietyCanada
-
Karolinska InstitutetVastra Gotaland Region; Region Skane; Region StockholmRecruitingBody Dysmorphic DisordersSweden
-
University of ReginaSaskatchewan Centre for Patient-Oriented ResearchCompletedDepression | AnxietyCanada
-
University of ReginaCanadian Institutes of Health Research (CIHR)CompletedDepression | AnxietyCanada
-
Linkoeping UniversityKarolinska Institutet; Uppsala University; Umeå University; Stockholm UniversityUnknownBrain Plasticity and Cellular Aging After Internet-delivered CBT for Social Anxiety Disorder (UMEII)Anxiety Disorders | Social Anxiety DisorderSweden
-
Karolinska InstitutetRecruitingDepression | Anxiety Disorders | Insomnia | Psychiatric DisorderSweden
-
Karolinska InstitutetRegion StockholmRecruitingGeneralized Anxiety DisorderSweden
-
Uppsala University HospitalUppsala University; Karolinska UniversityCompleted
-
Uppsala University HospitalKarolinska Institutet; Uppsala UniversityCompleted
-
Karolinska InstitutetCompletedIrritable Bowel Syndrome | Functional Gastrointestinal DisordersSweden