AnxietyNCT05523492
Exploring Use of Internet-Delivered Cognitive Behaviour Therapy (ICBT) by Diverse Ethnocultural People of Saskatchewan
A study testing Internet-delivered Cognitive Behavioural Therapy in people with Anxiety and Depression, run by University of Regina at 1 site in Canada.
Trial summary
In an attempt to increase timely and accessible psychological treatment for depression and anxiety, Internet-delivered Cognitive Behaviour Therapy (ICBT) has emerged. In ICBT, patients review treatment materials online and complete relevant exercises to learn cognitive behavioural strategies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Internet-delivered Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jun 2022to 20 Feb 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Endorse symptoms of anxiety or depression
- Resident of Saskatchewan
- Access to a computer and the Internet
- Self-identifying as having a diverse ethnocultural background
Who cannot join
- Have a severe unmanaged psychiatric illness (e.g. psychosis)
- Assessed as being at high risk of suicide
- Report severe problems with alcohol or drugs
- Report severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pathways and Barriers to Access and Utilization of Internet-Delivered Cognitive Behaviour Therapy (ICBT) by Diverse Ethnocultural People of Saskatchewan
In an attempt to increase timely and accessible psychological treatment for depression and anxiety, Internet-delivered Cognitive Behaviour Therapy (ICBT) has emerged. In ICBT, patients review treatment materials online and complete relevant exercises to learn cognitive behavioural strategies. They also commonly access brief therapist support through weekly emails or phone calls.
Data analysis of ICBT offered via the Online Therapy Unit in Saskatchewan has found lower participation in ICBT among individuals from diverse (non-white/ Caucasian) ethnocultural backgrounds. Furthermore, feedback from participants has identified opportunities to improve ICBT by: 1) simplifying language to improve clarity; 2) adding audiovisual content to aid with learning ICBT strategies; and 3) adding in diverse examples/stories to show applicability of ICBT to individuals with diverse backgrounds. The purpose of this study is to evaluate an ICBT program that has been improved in this way, called the Culturally Enhanced Wellbeing Course. Specifically, the observational pilot study with 30 clients from diverse ethnocultural backgrounds aims to examine improvements in depression and anxiety from pre to post treatment as well as patient experiences with the Culturally Enhanced Wellbeing Course.
Read the detailed description
In the last 10 years, the Online Therapy Unit has successfully provided ICBT to more than 10000 people experiencing mental health problems and there has been a growing demand and utilization of ICBT in Saskatchewan. However, a recent analysis of service utilization trends over six years shows that there has been a consistently low (11%) participation from the people of diverse (non-white/ Caucasian) ethnocultural groups in the ICBT program, called the Wellbeing Course. Furthermore, the number of ICBT lessons completed by the participants of diverse ethnocultural backgrounds was significantly lower compared to white/Caucasian participants.
Review of feedback from participants from diverse ethnocultural backgrounds indicated a need to simplify the language of the course, and diversify the narratives in the stories which accompany the lessons to illustrate how the exercises can be used and how past participants have found the course. Participants also suggested the addition of audiovisual elements in conjunction with text throughout the lessons to improve understanding of materials.
In this study, we will aim to evaluate the Culturally Enhanced Wellbeing Course among 30 treatment-seeking adults in Saskatchewan from diverse cultural backgrounds.
The Culturally Enhanced Wellbeing Course will be evaluated through pre-post-treatment assessments using self-report questionnaires and individual semi-structured telephone interviews conducted toward the end of treatment.
- Conditions
- Anxiety, Depression
- Being tested
- Internet-delivered Cognitive Behavioural Therapy
- Keywords
- anxiety, depression, therapist-assistance, internet-delivered cognitive behaviour therapy, patient-centred therapy, knowledge implementation, mental health system
- 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.
Internet-delivered Cognitive Behavioural TherapyBehavioural
All clients will receive the Culturally Enhanced Wellbeing Course. The Course was originally developed at Macquarie University in Australia and was then culturally enhanced by the Online Therapy Unit in Saskatchewan Canada. The course is a trans-diagnostic Internet-delivered cognitive behaviour therapy intervention targeting symptoms of depression and anxiety. 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 order over 8 weeks. Therapists will spend ~15 mins. per week/per client offering support via emails and or phone calls.
| Study group | Role | What they receive |
|---|---|---|
| Culturally Enhanced Wellbeing Course | Experimental | For this study, the ICBT program, called the Wellbeing Course was culturally enhanced by simplifying language for individuals with limited command of English, acknowledging cultural differences and increase representation in imagery. Audiovisual components were included to provide a brief summary of each lesson. Furthermore, additional client stories were added to the intervention to diversify narratives and be more representative of the clients seeking this intervention. Receives: Behavioral: Internet-delivered Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire 9-item (PHQ-9)
Tracking the 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.
Measured: Baseline (Screening), weeks 1-8, and 20 week from enrollment
Generalized Anxiety Disorder 7-item (GAD-7)
Tracking the 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.
Measured: Baseline (Screening), weeks 1-8 and 20 week from enrollment
ICBT Experience Interview Guide
This measure includes 12 items to gain feedback on participant experience of Wellbeing Course.
Measured: Week 6
Mid-point Additional Resource Satisfaction Questionnaire
Gathering feedback on the Additional Resources up to this time point. This measure includes 3 questions, one in which is open-ended.
Measured: Week 4 from enrollment
Post-treatment Additional Resource Satisfaction Questionnaire
Gathering feedback on the Additional Resources up to this time point. This measure includes 3 questions, one in which is open-ended.
Measured: Week 8 from enrollment
Mid-point Patient Story Satisfaction Questionnaire
Gathering feedback on the patient stories up to this time point. This measure includes 4 questions to quantify quality of participant Stories.
Measured: Week 4 from enrollment
Post-treatment Patient Story Satisfaction Questionnaire
Gathering feedback on the patient stories up to this time point. This measure includes 4 questions to quantify quality of participant Stories.
Measured: Week 8 from enrollment
Secondary outcomes (2)
Adjustment Disorder New Model 8 (ADNM)
Measure includes 8 questions to determine severity of impact of a specific event. High scores indicate a greater degree of Adjustment Disorder
Measured: Baseline (Screening) week 8 and week 20 from enrollment
Treatment Satisfaction
Measure includes 17 questions assessing satisfaction with various aspects of ICBT and also negative effects of treatment. Items are not summed but are examined individually.
Measured: Week 8 from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start14 Jun 2022
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Responsible party
- Sponsor
- Investigators
- Heather Hadjistavropoulos, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523492
- Sponsor's protocol ID
- 2019-197b
- Status last verified
- May 2023
- First submitted
- 29 Aug 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sapkota RP, Valli E, Dear BF, Titov N, Hadjistavropoulos HD. Satisfaction, engagement, and outcomes in internet-delivered cognitive behaviour therapy adapted for people of diverse ethnocultural groups: an observational trial with benchmarking. Front Psychiatry. 2024 Mar 4;15:1270543. doi: 10.3389/fpsyt.2024.1270543. eCollection 2024.
PubMed 38501087
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathways and Barriers to Access and Utilization of Internet-Delivered Cognitive Behaviour Therapy (ICBT) by Diverse Ethnocultural People of Saskatchewan
- ClinicalTrials.gov ID
- NCT05523492
- Acronym / sponsor ID
- 2019-197b
- Conditions
- Anxiety, Depression
- Keywords
- anxiety, depression, therapist-assistance, internet-delivered cognitive behaviour therapy, patient-centred therapy, knowledge implementation, mental health system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 31 Aug 2022 (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.
In an attempt to increase timely and accessible psychological treatment for depression and anxiety, Internet-delivered Cognitive Behaviour Therapy (ICBT) has emerged. In ICBT, patients review treatment materials online and complete relevant exercises to learn cognitive behavioural strategies. They also commonly access brief therapist support through weekly emails or phone calls.
Data analysis of ICBT offered via the Online Therapy Unit in Saskatchewan has found lower participation in ICBT among individuals from diverse (non-white/ Caucasian) ethnocultural backgrounds. Furthermore, feedback from participants has identified opportunities to improve ICBT by: 1) simplifying language to improve clarity; 2) adding audiovisual content to aid with learning ICBT strategies; and 3) adding in diverse examples/stories to show applicability of ICBT to individuals with diverse backgrounds. The purpose of this study is to evaluate an ICBT program that has been improved in this way, called the Culturally Enhanced Wellbeing Course. Specifically, the observational pilot study with 30 clients from diverse ethnocultural backgrounds aims to examine improvements in depression and anxiety from pre to post treatment as well as patient experiences with the Culturally Enhanced Wellbeing Course.
Detailed description
In the last 10 years, the Online Therapy Unit has successfully provided ICBT to more than 10000 people experiencing mental health problems and there has been a growing demand and utilization of ICBT in Saskatchewan. However, a recent analysis of service utilization trends over six years shows that there has been a consistently low (11%) participation from the people of diverse (non-white/ Caucasian) ethnocultural groups in the ICBT program, called the Wellbeing Course. Furthermore, the number of ICBT lessons completed by the participants of diverse ethnocultural backgrounds was significantly lower compared to white/Caucasian participants.
Review of feedback from participants from diverse ethnocultural backgrounds indicated a need to simplify the language of the course, and diversify the narratives in the stories which accompany the lessons to illustrate how the exercises can be used and how past participants have found the course. Participants also suggested the addition of audiovisual elements in conjunction with text throughout the lessons to improve understanding of materials.
In this study, we will aim to evaluate the Culturally Enhanced Wellbeing Course among 30 treatment-seeking adults in Saskatchewan from diverse cultural backgrounds.
The Culturally Enhanced Wellbeing Course will be evaluated through pre-post-treatment assessments using self-report questionnaires and individual semi-structured telephone interviews conducted toward the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Culturally Enhanced Wellbeing Course | Experimental | Behavioral: Internet-delivered Cognitive Behavioural TherapyFor this study, the ICBT program, called the Wellbeing Course was culturally enhanced by simplifying language for individuals with limited command of English, acknowledging cultural differences and increase representation in imagery. Audiovisual components were included to provide a brief summary of each lesson. Furthermore, additional client stories were added to the intervention to diversify narratives and be more representative of the clients seeking this intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- Endorse symptoms of anxiety or depression
- Resident of Saskatchewan
- Access to a computer and the Internet
- Self-identifying as having a diverse ethnocultural background
Key exclusion criteria (4 listed)
- Have a severe unmanaged psychiatric illness (e.g. psychosis)
- Assessed as being at high risk of suicide
- Report severe problems with alcohol or drugs
- Report severe cognitive impairment
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 |
|---|---|---|
| Internet-delivered Cognitive Behavioural TherapyAll clients will receive the Culturally Enhanced Wellbeing Course. The Course was originally developed at Macquarie University in Australia and was then culturally enhanced by the Online Therapy Unit in Saskatchewan Canada. The course is a trans-diagnostic Internet-delivered cognitive behaviour therapy intervention targeting symptoms of depression and anxiety. 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 order over 8 weeks. Therapists will spend ~15 mins. per week/per client offering support via emails and or phone calls. | Behavioural | Culturally Enhanced Wellbeing Course |
Primary outcome
Patient Health Questionnaire 9-item (PHQ-9)
Time frame: Baseline (Screening), weeks 1-8, and 20 week from enrollment
Tracking the 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)
Time frame: Baseline (Screening), weeks 1-8 and 20 week from enrollment
Tracking the 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.
ICBT Experience Interview Guide
Time frame: Week 6
This measure includes 12 items to gain feedback on participant experience of Wellbeing Course.
Mid-point Additional Resource Satisfaction Questionnaire
Time frame: Week 4 from enrollment
Gathering feedback on the Additional Resources up to this time point. This measure includes 3 questions, one in which is open-ended.
Post-treatment Additional Resource Satisfaction Questionnaire
Time frame: Week 8 from enrollment
Gathering feedback on the Additional Resources up to this time point. This measure includes 3 questions, one in which is open-ended.
Mid-point Patient Story Satisfaction Questionnaire
Time frame: Week 4 from enrollment
Gathering feedback on the patient stories up to this time point. This measure includes 4 questions to quantify quality of participant Stories.
Post-treatment Patient Story Satisfaction Questionnaire
Time frame: Week 8 from enrollment
Gathering feedback on the patient stories up to this time point. This measure includes 4 questions to quantify quality of participant Stories.
2 secondary outcomes
Adjustment Disorder New Model 8 (ADNM)
Time frame: Baseline (Screening) week 8 and week 20 from enrollment
Treatment Satisfaction
Time frame: Week 8 from enrollment
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 10 May 2023.
- Derived from this study: PubMed 38501087Sapkota RP, Valli E, Dear BF, Titov N, Hadjistavropoulos HD. Satisfaction, engagement, and outcomes in internet-delivered cognitive behaviour therapy adapted for people of diverse ethnocultural groups: an observational trial with benchmarking. Front Psychiatry. 2024 Mar 4;15:1270543. doi: 10.3389/fpsyt.2024.1270543. eCollection 2024.
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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 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 Internet-delivered Cognitive Behavioural Therapy 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 4 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 10 May 2023. 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?
Patient Health Questionnaire 9-item (PHQ-9) (time frame: Baseline (Screening), weeks 1-8, and 20 week from enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05523492, which also lists 1 linked publication.
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 10 May 2023.