DepressionNCT06298279
Assessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel
A study testing Tunneled Delivery, Personalized Delivery and Standard Resources in people with Depression and Anxiety, run by University of Regina at 1 site in Canada.
Trial summary
This study is a randomized factorial trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet delivered cognitive behaviour therapy tailored for public safety personnel with tunneled of personalized course delivery and with or without the incorporation of social learning resources. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Stress Disorders, Post-Traumatic
- What is being tested?
- Tunneled Delivery, Personalized Delivery and Standard Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteCanada
- Study dates
- 12 Mar 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- At least 18 years of age
- Current or former public safety personnel (or public safety personnel trainee)
- Residing in Canada at time of enrollment
- Has regular access to the internet
- Confirms intent to participate in study
Who cannot join
- Not 18 years of age or older
- Not a current or former public safety personnel (or public safety personnel trainee)
- Not residing in Canada at time of enrollment
- Does not have regular access to the internet
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Department of Psychology, University of Regina
Regina, Saskatchewan, S4S 0A2
Heather D Hadjistavropoulos, PhD, 306-585-5133, heather.hadjistavropoulos@uregina.ca
Caeleigh A Landry, MSc, 306-337-2473, caeleigh.landry@uregina.ca
About this study
Official title: A Randomized Factorial Trial of Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel: Examining the Impact of Content Delivery Method
This study is a randomized factorial trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet delivered cognitive behaviour therapy tailored for public safety personnel with tunneled of personalized course delivery and with or without the incorporation of social learning resources.
Read the detailed description
Background---- Public Safety Personnel (PSP) are at an increased risk of developing mental disorders. PSP also face many barriers to accessing mental health services (e.g., stigma, location, time). The PSP Wellbeing Course is a transdiagnostic internet-delivered cognitive behaviour therapy (ICBT) course that has been specifically tailored to PSP. The effectiveness of the therapist-guided course and a self-guided course have both been supported. Consistent with the larger literature on self-guided ICBT, engagement with and outcomes of the self-guided PSP Wellbeing Course could be strengthened. Persuasive design describes using technology to influence human behaviour. The current study is designed to assess the impact of different timing options (i.e., tunneled vs. personalized) and increased social learning (i.e., standard versus enhanced social learning) on user experience, adherence, and outcomes in ICBT.
Methods--- Participants will be recruited via posts on the PSPNET social media platforms (i.e., Twitter and Facebook) and emails distributed by PSP organizations. Members of the PSPNET team will also reach out to contacts within PSP organizations to ask them to tell their colleagues about the proposed research. All interested participants will be directed to the study website (www.pspnet.ca) to complete an online screening questionnaire. As part of this questionnaire, they will be presented with a consent form explaining the screening. After consent is given, clients will be assessed for eligibility using an online screening questionnaire. The online screening questionnaire captures demographic information (e.g., sex, ethnicity, location), information about depression and other mental health issues, and background information (e.g., medical history, mental health history, symptoms).
After completing the questionnaires, participant responses will be reviewed by PSP staff for eligibility. Clients who are eligible will be randomized into one of four conditions. Participants who do not meet criteria, but are over the age of 18, will not be randomized and will instead be enrolled into the "treatment-as-usual" version of the course, which consists of a tunneled delivery and standard resources. Ineligible participants' data will not be included in analyses. Individuals under the age of 18 will not be eligible for any services.The two factors in the trial are:
Factor 1: Tunneled course delivery or personalized course delivery
Factor 2: Standard or enhanced social learning resources.
As this is a factorial trial with two factors, each client will be randomized to one of four conditions:
Condition 1: Tunneled Delivery and Standard Resources Condition 2: Tunneled Delivery and Enhanced Social Learning Resources Condition 3: Personalized Delivery and Standard Resources Condition 4: Personalized Delivery and Enhanced Social Learning Resources
Randomization will occur within 2 business-days of completion of the screening questionnaires.
All participants will receive the Self-Guided PSP Wellbeing Course, a transdiagnostic internet intervention. The program is an adaptation of a previous Australian course, the Wellbeing Course. The course involved 5 lessons that are typically completed over an 8 week period, though participants will have access to the course materials for up to 26 weeks. The content is focused on cognitive behavior therapy and 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). All participants are presented with worksheets at the end of each lesson that contain exercises that facilitate skill acquisition. Participants will be sent automatic emails reminding them to stay engaged with the lessons and to complete questionnaires. Participants will complete questionnaires at screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment).
- Conditions
- Depression, Anxiety, Stress Disorders, Post-Traumatic
- Being tested
- Tunneled Delivery, Personalized Delivery, Standard Resources, Enhanced Social Learning Resources, Transdiagnostic Self-Guided ICBT
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tunneled DeliveryBehavioural
Participants will be offered a pre-determined pathway to completing the 8-week course
Personalized DeliveryBehavioural
Participants will be able to complete course modules at their own pace and in the order that most interests them.
Standard ResourcesBehavioural
Participants will receive the resources as typically included in the Self-Guided PSP Wellbeing Course.
Enhanced Social Learning ResourcesBehavioural
Participants will receive additional intervention content.
Transdiagnostic Self-Guided ICBTBehavioural
An ICBT course that is completed without the guidance of a therapist.
| Study group | Role | What they receive |
|---|---|---|
| Tunneled Delivery/Standard Resources | Experimental | In this arm, participants will be guided through the Self-Guided PSP Wellbeing Course in a predetermined order and using predetermined timing. Future lessons will "unlock" as previous lessons are completed.
Participants receiving the standard resources will be presented with resources that are typically presented in PSPNET courses. This includes lesson slides case stories, do-it yourself guides, and frequently asked questions pages. Receives: Behavioral: Tunneled Delivery; Behavioral: Standard Resources; Behavioral: Transdiagnostic Self-Guided ICBT |
| Tunneled Delivery/Enhanced Social Learning Resources | Experimental | In this arm, participants will be guided through the Self-Guided PSP Wellbeing Course in a predetermined order and using predetermined timing. Future lessons will "unlock" as previous lessons are completed.
Participants receiving the enhanced social learning resources will receive the same resources offered in the standard conditions (i.e., lesson slides, case stories, do-it-yourself guides, and frequently asked questions pages) and will also receive additional resources. Additional resources will include homework records to accompany the case stories, de-identified quotations from previous clients for each lesson, and a motivational video encouraging them to engage with the course. Receives: Behavioral: Tunneled Delivery; Behavioral: Enhanced Social Learning Resources; Behavioral: Transdiagnostic Self-Guided ICBT |
| Personalized Delivery/Standard Resources | Experimental | In this arm, participants will be able to navigate through the course modules in whichever order and at whatever pace they like. Participants will not have to complete one lesson in order to gain access to the following lesson.
Participants receiving the standard resources will be presented with resources that are typically presented in the course. This includes lesson slides, case stories, do-it yourself guides, and frequently asked questions pages. Receives: Behavioral: Personalized Delivery; Behavioral: Standard Resources; Behavioral: Transdiagnostic Self-Guided ICBT |
| Personalized Delivery/Enhanced Social Learning Resources | Experimental | In this arm, participants will be able to navigate through the course modules in whichever order and at whatever pace they like. Participants will not have to complete one lesson in order to gain access to the following lesson.
Participants receiving the enhanced social learning resources will receive the same resources offered in the standard conditions (i.e., lesson slides, case stories, do-it-yourself guides, and frequently asked questions pages) and will also receive additional resources. Additional resources will include homework records to accompany the case stories, de-identified quotations from previous clients for each lesson, and a motivational video encouraging them to engage with the course. Receives: Behavioral: Personalized Delivery; Behavioral: Enhanced Social Learning Resources; Behavioral: Transdiagnostic Self-Guided ICBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder 7-item (GAD-7)
Change in total GAD-7 anxiety score which can range from 0 to 21. Higher scores indicate greater anxiety (worse outcome)
Measured: Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Patient Health Questionnaire-9 (PHQ-9)
Change in total PHQ-9 score which can range from 0 to 27. Higher scores indicate greater depression (worse outcome)
Measured: Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)
PTSD Checklist for the DSM-5 (PCL-5)
Change in total PCL-5 score which can range from 0 to 80. Higher scores indicate greater posttraumatic stress symptoms (worse outcome)
Measured: Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Engagement
Internal portal recordings of participant how many lessons participants accessed, how many additional resources were accessed, and the dates of access. Greater course access is indicative of greater engagement within the course.
Measured: From date of enrollment to 26 weeks (post-treatment)
Secondary outcomes (6)
Work and Social Adjustment Scale (WSAS)
Change in total WSAS score which can range from 0 to 40. Higher scores indicate greater levels of distress related to functional impairment (worse outcome)
Measured: Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Brief Resilience Scale (BRS)
Change in total BRS score which can range from 0 to 30. Higher scores indicate greater resilience (better outcome)
Measured: Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Healthcare Use Questionnaire
Bespoke questionnaire regarding access to healthcare resources
Measured: Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Case Story Questionnaire
Bespoke questionnaire inquiring about participants' experiences with the case stories. Participants receiving enhanced social learning resources will be asked additional questions about the enhanced social learning resources.
Measured: 8-weeks (post-treatment)
Treatment Satisfaction Questionnaire
Bespoke 7-item questionnaire assessing participants' treatment satisfaction.
Measured: 8-weeks (post-treatment)
Digital Behavior Change Interventions Engagement Scale (DCBI)
The DBCI is a questionnaire where participants are asked to rate their feelings of engagement with online interventions, which can range from 0-56. Higher scores are indicative of more positive feelings about engagement.
Measured: 8-weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start12 Mar 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Factorial
- Model description
- Factor 1: Tunneled or Personalized Course Delivery Factor 2: Standard or Enhanced Social Learning Resources Participants will be randomly assigned to one of four treatment conditions (tunneled delivery of ICBT with standard resources, tunneled delivery of ICBT with enhanced social learning resources, personalized delivery ICBT with standard resources, personalized delivery of ICBT with enhanced social learning resources)
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298279
- Sponsor's protocol ID
- 2023-436
- Status last verified
- Apr 2026
- First submitted
- 14 Feb 2024
- Last updated
- 14 Apr 2026
- 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Factorial Trial of Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel: Examining the Impact of Content Delivery Method
- ClinicalTrials.gov ID
- NCT06298279
- Acronym / sponsor ID
- 2023-436
- Conditions
- Depression, Anxiety, Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Government of Canada
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 7 Mar 2024 (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.
This study is a randomized factorial trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet delivered cognitive behaviour therapy tailored for public safety personnel with tunneled of personalized course delivery and with or without the incorporation of social learning resources.
Detailed description
Background---- Public Safety Personnel (PSP) are at an increased risk of developing mental disorders. PSP also face many barriers to accessing mental health services (e.g., stigma, location, time). The PSP Wellbeing Course is a transdiagnostic internet-delivered cognitive behaviour therapy (ICBT) course that has been specifically tailored to PSP. The effectiveness of the therapist-guided course and a self-guided course have both been supported. Consistent with the larger literature on self-guided ICBT, engagement with and outcomes of the self-guided PSP Wellbeing Course could be strengthened. Persuasive design describes using technology to influence human behaviour. The current study is designed to assess the impact of different timing options (i.e., tunneled vs. personalized) and increased social learning (i.e., standard versus enhanced social learning) on user experience, adherence, and outcomes in ICBT.
Methods--- Participants will be recruited via posts on the PSPNET social media platforms (i.e., Twitter and Facebook) and emails distributed by PSP organizations. Members of the PSPNET team will also reach out to contacts within PSP organizations to ask them to tell their colleagues about the proposed research. All interested participants will be directed to the study website (www.pspnet.ca) to complete an online screening questionnaire. As part of this questionnaire, they will be presented with a consent form explaining the screening. After consent is given, clients will be assessed for eligibility using an online screening questionnaire. The online screening questionnaire captures demographic information (e.g., sex, ethnicity, location), information about depression and other mental health issues, and background information (e.g., medical history, mental health history, symptoms).
After completing the questionnaires, participant responses will be reviewed by PSP staff for eligibility. Clients who are eligible will be randomized into one of four conditions. Participants who do not meet criteria, but are over the age of 18, will not be randomized and will instead be enrolled into the "treatment-as-usual" version of the course, which consists of a tunneled delivery and standard resources. Ineligible participants' data will not be included in analyses. Individuals under the age of 18 will not be eligible for any services.The two factors in the trial are:
Factor 1: Tunneled course delivery or personalized course delivery
Factor 2: Standard or enhanced social learning resources.
As this is a factorial trial with two factors, each client will be randomized to one of four conditions:
Condition 1: Tunneled Delivery and Standard Resources Condition 2: Tunneled Delivery and Enhanced Social Learning Resources Condition 3: Personalized Delivery and Standard Resources Condition 4: Personalized Delivery and Enhanced Social Learning Resources
Randomization will occur within 2 business-days of completion of the screening questionnaires.
All participants will receive the Self-Guided PSP Wellbeing Course, a transdiagnostic internet intervention. The program is an adaptation of a previous Australian course, the Wellbeing Course. The course involved 5 lessons that are typically completed over an 8 week period, though participants will have access to the course materials for up to 26 weeks. The content is focused on cognitive behavior therapy and 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). All participants are presented with worksheets at the end of each lesson that contain exercises that facilitate skill acquisition. Participants will be sent automatic emails reminding them to stay engaged with the lessons and to complete questionnaires. Participants will complete questionnaires at screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Factor 1: Tunneled or Personalized Course Delivery Factor 2: Standard or Enhanced Social Learning Resources Participants will be randomly assigned to one of four treatment conditions (tunneled delivery of ICBT with standard resources, tunneled delivery of ICBT with enhanced social learning resources, personalized delivery ICBT with standard resources, personalized delivery of ICBT with enhanced social learning resources)
| Arm | Type | Receives |
|---|---|---|
| Tunneled Delivery/Standard Resources | Experimental | Behavioral: Tunneled Delivery, Behavioral: Standard Resources, Behavioral: Transdiagnostic Self-Guided ICBTIn this arm, participants will be guided through the Self-Guided PSP Wellbeing Course in a predetermined order and using predetermined timing. Future lessons will "unlock" as previous lessons are completed. Participants receiving the standard resources will be presented with resources that are typically presented in PSPNET courses. This includes lesson slides case stories, do-it yourself guides, and frequently asked questions pages. |
| Tunneled Delivery/Enhanced Social Learning Resources | Experimental | Behavioral: Tunneled Delivery, Behavioral: Enhanced Social Learning Resources, Behavioral: Transdiagnostic Self-Guided ICBTIn this arm, participants will be guided through the Self-Guided PSP Wellbeing Course in a predetermined order and using predetermined timing. Future lessons will "unlock" as previous lessons are completed. Participants receiving the enhanced social learning resources will receive the same resources offered in the standard conditions (i.e., lesson slides, case stories, do-it-yourself guides, and frequently asked questions pages) and will also receive additional resources. Additional resources will include homework records to accompany the case stories, de-identified quotations from previous clients for each lesson, and a motivational video encouraging them to engage with the course. |
| Personalized Delivery/Standard Resources | Experimental | Behavioral: Personalized Delivery, Behavioral: Standard Resources, Behavioral: Transdiagnostic Self-Guided ICBTIn this arm, participants will be able to navigate through the course modules in whichever order and at whatever pace they like. Participants will not have to complete one lesson in order to gain access to the following lesson. Participants receiving the standard resources will be presented with resources that are typically presented in the course. This includes lesson slides, case stories, do-it yourself guides, and frequently asked questions pages. |
| Personalized Delivery/Enhanced Social Learning Resources | Experimental | Behavioral: Personalized Delivery, Behavioral: Enhanced Social Learning Resources, Behavioral: Transdiagnostic Self-Guided ICBTIn this arm, participants will be able to navigate through the course modules in whichever order and at whatever pace they like. Participants will not have to complete one lesson in order to gain access to the following lesson. Participants receiving the enhanced social learning resources will receive the same resources offered in the standard conditions (i.e., lesson slides, case stories, do-it-yourself guides, and frequently asked questions pages) and will also receive additional resources. Additional resources will include homework records to accompany the case stories, de-identified quotations from previous clients for each lesson, and a motivational video encouraging them to engage with the course. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- Current or former public safety personnel (or public safety personnel trainee)
- Residing in Canada at time of enrollment
- Has regular access to the internet
- Confirms intent to participate in study
Key exclusion criteria (4 listed)
- Not 18 years of age or older
- Not a current or former public safety personnel (or public safety personnel trainee)
- Not residing in Canada at time of enrollment
- Does not have regular access to the internet
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 |
|---|---|---|
| Tunneled DeliveryParticipants will be offered a pre-determined pathway to completing the 8-week course | Behavioural | Tunneled Delivery/Enhanced Social Learning Resources, Tunneled Delivery/Standard Resources |
| Personalized DeliveryParticipants will be able to complete course modules at their own pace and in the order that most interests them. | Behavioural | Personalized Delivery/Enhanced Social Learning Resources, Personalized Delivery/Standard Resources |
| Standard ResourcesParticipants will receive the resources as typically included in the Self-Guided PSP Wellbeing Course. | Behavioural | Personalized Delivery/Standard Resources, Tunneled Delivery/Standard Resources |
| Enhanced Social Learning ResourcesParticipants will receive additional intervention content. | Behavioural | Personalized Delivery/Enhanced Social Learning Resources, Tunneled Delivery/Enhanced Social Learning Resources |
| Transdiagnostic Self-Guided ICBTAn ICBT course that is completed without the guidance of a therapist. | Behavioural | Personalized Delivery/Enhanced Social Learning Resources, Personalized Delivery/Standard Resources, Tunneled Delivery/Enhanced Social Learning Resources, Tunneled Delivery/Standard Resources |
Primary outcome
Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Change in total GAD-7 anxiety score which can range from 0 to 21. Higher scores indicate greater anxiety (worse outcome)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Change in total PHQ-9 score which can range from 0 to 27. Higher scores indicate greater depression (worse outcome)
PTSD Checklist for the DSM-5 (PCL-5)
Time frame: Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Change in total PCL-5 score which can range from 0 to 80. Higher scores indicate greater posttraumatic stress symptoms (worse outcome)
Engagement
Time frame: From date of enrollment to 26 weeks (post-treatment)
Internal portal recordings of participant how many lessons participants accessed, how many additional resources were accessed, and the dates of access. Greater course access is indicative of greater engagement within the course.
6 secondary outcomes
Work and Social Adjustment Scale (WSAS)
Time frame: Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Brief Resilience Scale (BRS)
Time frame: Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Healthcare Use Questionnaire
Time frame: Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Case Story Questionnaire
Time frame: 8-weeks (post-treatment)
Treatment Satisfaction Questionnaire
Time frame: 8-weeks (post-treatment)
Digital Behavior Change Interventions Engagement Scale (DCBI)
Time frame: 8-weeks (post-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tunneled Delivery, Personalized Delivery and Standard Resources in people with Depression and Anxiety, 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: looking for participants now, as of the sponsor's last update on 14 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather D Hadjistavropoulos, PhD ((306)585-5133, heather.hadjistavropoulos@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder 7-item (GAD-7) (time frame: Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)). The study lists 4 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 14 Apr 2026.