AnxietyNCT03304392
Therapist-guided Internet-delivered Cognitive Behavioural Therapy
A study testing Personalized ICBT and Standard ICBT in people with Anxiety and Depression, run by University of Regina at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Personalized ICBT and Standard ICBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- 1 siteCanada
- Study dates
- 11 Oct 2017to 15 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Online Therapy Unit, University of Regina
Regina, Saskatchewan, S4S 0A2
About this study
Official title: 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.
- Conditions
- Anxiety, Depression
- Being tested
- Personalized ICBT, Standard ICBT
- Keywords
- anxiety, depression, internet-delivered cognitive behaviour therapy, randomized controlled trial, patient-centered, knowledge implementation, mental health system, therapist-assistance
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized ICBTBehavioural
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.
Standard ICBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized ICBT | Experimental | 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. Receives: Behavioral: Personalized ICBT |
| Standard ICBT | Active comparator | 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. Receives: Behavioral: Standard ICBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression
Measured by Patient Health Questionnaire - 9 Item (PHQ-9)
Measured: baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up
Change in anxiety
Measured by Generalize Anxiety Disorder - 7 Item (GAD7)
Measured: baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up
Secondary outcomes (12)
Change in psychological distress
Measured by Kessler 10-Item Scale
Measured: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Change in disability
Measure by Sheehan Disability Scale-3 Item
Measured: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Change in panic symptoms
Measured by Panic Disorder Severity Scale-Self Report
Measured: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Change in social anxiety symptoms
Measured by Social Interaction Anxiety Scale
Measured: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Change in social phobia symptoms
Measured by Social Phobia Scale-Short form
Measured: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Change in post-traumatic symptoms
Measured by PTSD Checklist 5
Measured: 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
Measured by EQ-5D-5L
Measured: baseline, 8 weeks, 3 months, 6 months, and 1 year follow up
Change in treatment costs
Measured by Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada
Measured: Part 1 and 2: baseline, 3 months, 6 months, and 1 year follow up; Part 3: baseline and 1 year follow up
Therapeutic alliance
Measured by Working Alliance Inventory-Short Form
Measured: 8 weeks
Treatment credibility
Measured by Credibility Questionnaire
Measured: baseline and 8 weeks
Treatment satisfaction
Measured by Internet-CBT Treatment Satisfaction Measure
Measured: 8 weeks
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start11 Oct 2017
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Heather D Hadjistavropoulos, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304392
- Sponsor's protocol ID
- 375860
- Status last verified
- Nov 2019
- First submitted
- 29 Sep 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Mental Health Care by Improving the Delivery of Therapist-guided, Internet-delivered Cognitive Behavioural Therapy in Clinical Practice
- ClinicalTrials.gov ID
- NCT03304392
- Acronym / sponsor ID
- 375860
- Conditions
- Anxiety, Depression
- Keywords
- anxiety, depression, internet-delivered cognitive behaviour therapy, randomized controlled trial, patient-centered, knowledge implementation, mental health system, therapist-assistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 9 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized ICBT | Experimental | Behavioral: Personalized ICBTAn 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. |
| Standard ICBT | Active comparator | Behavioral: Standard ICBTAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized ICBTAn 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. | Behavioural | Personalized ICBT |
| Standard ICBTAn 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. | Behavioural | Standard ICBT |
Primary outcome
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)
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)
12 secondary outcomes
Change in psychological distress
Time frame: 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
Change in panic symptoms
Time frame: 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
Change in social phobia symptoms
Time frame: 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
Change in quality of life symptoms
Time frame: 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
Therapeutic alliance
Time frame: 8 weeks
Treatment credibility
Time frame: baseline and 8 weeks
Treatment satisfaction
Time frame: 8 weeks
Engagement
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather D Hadjistavropoulos, PhD principal investigator
University of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized ICBT and Standard ICBT in people with Anxiety and Depression, run by University of Regina at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression (time frame: baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.