AnxietyNCT05606601
An Online Intervention Addressing Mental Health and Substance Use in University Students
A study testing Minder in people with Anxiety and Depression, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to assess the effectiveness of mobile app containing a range of evidence based tools to improve the mental health and substance use outcomes of university students. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Alcohol Use
- What is being tested?
- Minder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,489 participants
- Where
- 1 siteCanada
- Study dates
- 28 Sep 2022to 21 Jul 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Must be currently enrolled at participating university
- Must be 17 years or older
- Must have access to and be able to use a smart phone with Wi-Fi and/or mobile data
- Must be English speaking
Who cannot join
- 1) Any participants that self-identify as currently having a suicidal plan at the time of study enrollment
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 2A1
About this study
Official title: An Integrated Online Intervention Addressing Mental Health and Substance Use in University Students: A Randomized Controlled Trial
The purpose of this study is to assess the effectiveness of mobile app containing a range of evidence based tools to improve the mental health and substance use outcomes of university students.
Read the detailed description
There is a need for scalable interventions to support the mental health and substance use challenges experienced by university students. One means of addressing this need is through the use of e-mental health tools that facilitate self-management and connect students to in-person supports as needed. This is a randomized controlled trial of a mobile app designed to help university students manage their mental health and substance use via a set of evidence-based tools that have been integrated into a single mobile app. The recruitment of approximately 1500 students will occur through social media, promotion by faculty members and administrators, and other in-person recruitment methods. Assessments will be conducted using self-report web surveys at baseline, 14 days (interim assessment) and 30 days (follow-up assessment). The goal of the trial is to assess the effectiveness of the app in improving a range of mental health and substance use outcomes of university students from baseline to follow-up.
- Conditions
- Anxiety, Depression, Alcohol Use, Substance Use
- Being tested
- Minder
- Keywords
- Student Mental Health, Anxiety, Depression, Alcohol Use, Substance Use, Cannabis Use, Opioid Use, Stimulant Use, Online Intervention, E-mental Health
- Medical subject headings
- Anxiety Disorders, Depression, Alcohol Drinking, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinderBehavioural
There are four main components of the Minder app: The Chatbot, Services, Community, and Peer Coaching components. The Services component asks participants to complete a series of questions on various mental health, substance use, and general life issues. It then recommends community and on-campus resources based on their current needs. The Community component of the app matches individuals with groups (e.g., student clubs) and events at the university or in the broader community that they may be interested in. The Chatbot component of the app contains pre-formatted conversational scripts that users engage with via a "chatbot" and videos designed to teach evidence-based skills (e.g., cognitive strategies to manage anxiety) that can be applied to everyday life. To support use of the app, all users in the intervention group will be offered access to trained peer coaches to help users navigate the different app components and provide non-clinical peer support.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participants randomized into the intervention arm will be given immediate access to a fully functional version of the Minder app that includes baseline, interim and follow-up surveys and access to all app components and e-coaching. Receives: Behavioral: Minder |
| Control arm | No intervention | Participants randomized into the control arm will be given access to a restricted version of the app that only includes access to a generic study introduction video and baseline and follow up survey assessments delivered via the app. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in General anxiety symptomology from Baseline to Follow-up at 30 days
Assessed by the General Anxiety Disorder 7-Item (GAD-7) scale. Changes in anxiety symptomology from baseline to follow-up at 30 days will be based on total scores on the GAD-7 in both the intervention and control groups. Total scores range from 0 to 21 with higher scores indicating a worse outcome (i.e, a greater frequency of anxiety symptoms).
Measured: The GAD-7 will be administered to both the intervention and control groups at baseline and 30 days.
Change in Depressive symptomology from Baseline to Follow-up at 30 days
Assessed by the Patient Health Questionnaire 9-item (PHQ-9) scale. Changes in depressive symptomology from baseline to follow-up at 30 days will be based on total scores on the PHQ-9 in both the intervention and control groups. Total scores range from 0 to 29 with higher scores indicating a worse outcome (i.e., a greater frequency of depression symptoms).
Measured: The PHQ-9 will be administered to both the intervention and control group at baseline and 30 days.
Change in Alcohol consumption risk from Baseline to Follow-up at 30 days
Assessed by the alcohol consumption questions of the Alcohol Use Disorders Identification Test, Adapted for Use in the United States (USAUDIT-C). Changes in alcohol consumption risk from baseline to follow-up at 30 days will be based on total scores on the USAUDIT-C in both the intervention and control groups. Total scores range from 0 to 18 with higher scores indicating a worse outcome (i.e., a higher level of risky drinking).
Measured: The USAUDIT-C will be administered to the intervention and control groups at baseline and 30 days.
Secondary outcomes (10)
Frequency of cannabis consumption
Changes in frequency of cannabis consumption from baseline to follow-up at 30 days will be based on self-reported frequency of cannabis consumption in both the intervention and control groups.
Measured: Frequency of cannabis consumption will be assessed in the intervention and control groups at baseline and at 30 days.
Frequency of binge drinking
Changes in frequency of binge drinking from baseline to follow-up at 30 days will be based on responses to item 3 of the USAUDIT-C in both the intervention and control groups.
Measured: Frequency of binge drinking will be assessed in the intervention and control groups at baseline and at 30 days.
Frequency of alcohol use
Changes in frequency of alcohol use from baseline to follow-up at 30 days will be based on responses to items 1 and 2 of the USAUDIT-C in both the intervention and control groups.
Measured: Frequency of alcohol use will be assessed in the intervention and control groups at baseline and at 30 days.
Frequency of opioid use
Changes in frequency of opioid use from baseline to follow-up at 30 days will be based on self-reported frequency of both medical and non-medical opioid use in both the intervention and control groups.
Measured: Frequency of opioid use will be assessed in the intervention and control groups at baseline and at 30 days.
Frequency of non-medical stimulant use
Changes in frequency of non-medical stimulant use from baseline to follow-up at 30 days will be based on self-reported frequency of non-medical stimulant use in both the intervention and control groups.
Measured: Frequency of non-medical stimulant use will be assessed in the intervention and control groups at baseline and at 30 days.
Self-efficacy related to the management of substance use.
Changes in substance use self-efficacy from baseline to follow-up at 30 days will be based on self-reported measures in both the intervention and control groups. This is based on answers to the following 4 self-report survey questions assess different aspects of self-efficacy related to the management of substance use. Each question is scored separately using a response ranging from 1 (Not all confident) to 5 (Totally confident) with higher scores indicating a better outcome (i.e., greater self-efficacy).
- How confident are you that you could effectively manage any substance use problems you experience (e.g., cannabis, alcohol or other drugs)?
- How confident are you that you could manage your substance use without reaching out to the health system or other support services?
- How confident are you that you would know how to access substance use services if you felt you needed them?
- How likely are you to reach out to substance use services if you felt you needed them?
Measured: Substance use self-efficacy will be assessed in the intervention and control groups at baseline and at 30 days.
Readiness to change
Changes in level of readiness to change from baseline to follow-up at 30 days for the use of individual substances (alcohol, cannabis, opioids, and stimulants) will be based on responses to self-reported readiness to change ladder assessments in both the intervention and control groups. The self-reported readiness to change ladder assessments are single item self-report survey questions for each substance that ask participants to rate their readiness to change using a single Likert-type response scale that ranges from 0 (No thought of changing) to 10 (Taking action to change) with higher scores indicating a better outcome (i.e., higher readiness to change).
Measured: Readiness to change will be assessed in the intervention and control groups at baseline and at 30 days.
Mental Well-being
Changes in mental well-being from baseline to follow-up at 30 days will be based on total scores from the Short Warwick-Edinburgh Mental Wellbeing Scale in both the intervention and control groups. Total scores range from 7 to 35 with higher scores indicating better outcome (i.e., higher positive mental wellbeing).
Measured: The Short Warwick-Edinburgh Mental Wellbeing Scale will be administered in the intervention and control groups at baseline and at 30 days.
Self-efficacy related to the management of mental health.
Changes in mental health self-efficacy from baseline to 30-day follow-up are based on 5 self-reported survey questions in the intervention and control groups. Each question is scored separately using a Likert-type response ranging from 1 (Not at all confident/likely) to 5 (Totally confident/likely) with higher scores indicating a better outcome (i.e., greater self-efficacy).
- How confident are you that you could effectively manage any mental health problems you experience (e.g., stress, anxiety or depression)?
- How confident are you that you could manage your mental health without reaching out to the health system or other support services?
- How confident are you that you would know how to access mental health services if you felt you needed them?
- How likely are you to reach out to mental health services if you felt you needed them?
- How confident are you that you can manage your mental health problems without using alcohol or other drugs as a coping strategy?
Measured: Mental health self-efficacy will be assessed in the intervention and control groups at baseline and at 30 days.
Self-reported use of mental health services and supports
Changes in the use of mental health services and supports from baseline to 30-day follow-up will be based on responses to 2 self-reported survey questions in both the intervention and control groups. Change will be assessed by comparing responses to each question (yes or no) at baseline to 30-day follow-up. The questions ask if they have been diagnosed or treated by a professional for a list of conditions and whether they have used any mental health treatments (medication, psychotherapy, mindfulness, and online tools) in the past 30 days and currently. Two additional self-reported survey questions on accessing types of support services and having joined any university clubs or participated in any club-related events are only asked at 30-day follow-up.
Measured: Use of mental health services and supports will be assessed in the intervention and control groups at baseline and at 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start28 Sep 2022
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,489 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Vigo, University of British Columbia
- Investigators
- Daniel V Vigo, MD, Lic. Psych, DrPH, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606601
- Sponsor's protocol ID
- H21-03248
- Status last verified
- Sep 2023
- First submitted
- 2 Sep 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Y Wang A, Vereschagin M, G Richardson C, J Munthali R, Xie H, L Hudec K, Mori T, Munro L, V Vigo D. Examining the effects of engagement with an app-based mental health intervention: a secondary analysis of a randomized control trial with treatment non-compliance. Int J Ment Health Syst. 2025 Oct 9;19(1):30. doi: 10.1186/s13033-025-00688-4.
PubMed 41068963Vereschagin M, Wang AY, Richardson CG, Xie H, Munthali RJ, Hudec KL, Leung C, Wojcik KD, Munro L, Halli P, Kessler RC, Vigo DV. Effectiveness of the Minder Mobile Mental Health and Substance Use Intervention for University Students: Randomized Controlled Trial. J Med Internet Res. 2024 Mar 27;26:e54287. doi: 10.2196/54287.
PubMed 38536225Wang AY, Vereschagin M, Richardson CG, Xie H, Hudec KL, Munthali RJ, Munro L, Leung C, Kessler RC, Vigo DV. Evaluating the Effectiveness of a Codeveloped e-Mental Health Intervention for University Students: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Aug 30;12:e49364. doi: 10.2196/49364.
PubMed 37647105
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Online Intervention Addressing Mental Health and Substance Use in University Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05606601
- Acronym / sponsor ID
- H21-03248
- Conditions
- Anxiety, Depression, Alcohol Use, Substance Use
- Keywords
- Student Mental Health, Anxiety, Depression, Alcohol Use, Substance Use, Cannabis Use, Opioid Use, Stimulant Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,489 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 4 Nov 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.
The purpose of this study is to assess the effectiveness of mobile app containing a range of evidence based tools to improve the mental health and substance use outcomes of university students.
Detailed description
There is a need for scalable interventions to support the mental health and substance use challenges experienced by university students. One means of addressing this need is through the use of e-mental health tools that facilitate self-management and connect students to in-person supports as needed. This is a randomized controlled trial of a mobile app designed to help university students manage their mental health and substance use via a set of evidence-based tools that have been integrated into a single mobile app. The recruitment of approximately 1500 students will occur through social media, promotion by faculty members and administrators, and other in-person recruitment methods. Assessments will be conducted using self-report web surveys at baseline, 14 days (interim assessment) and 30 days (follow-up assessment). The goal of the trial is to assess the effectiveness of the app in improving a range of mental health and substance use outcomes of university students from baseline to follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: MinderParticipants randomized into the intervention arm will be given immediate access to a fully functional version of the Minder app that includes baseline, interim and follow-up surveys and access to all app components and e-coaching. |
| Control arm | No intervention | –Participants randomized into the control arm will be given access to a restricted version of the app that only includes access to a generic study introduction video and baseline and follow up survey assessments delivered via the app. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Must be currently enrolled at participating university
- Must be 17 years or older
- Must have access to and be able to use a smart phone with Wi-Fi and/or mobile data
- Must be English speaking
Key exclusion criteria (1 listed)
- 1) Any participants that self-identify as currently having a suicidal plan at the time of study enrollment
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 |
|---|---|---|
| MinderThere are four main components of the Minder app: The Chatbot, Services, Community, and Peer Coaching components. The Services component asks participants to complete a series of questions on various mental health, substance use, and general life issues. It then recommends community and on-campus resources based on their current needs. The Community component of the app matches individuals with groups (e.g., student clubs) and events at the university or in the broader community that they may be interested in. The Chatbot component of the app contains pre-formatted conversational scripts that users engage with via a "chatbot" and videos designed to teach evidence-based skills (e.g., cognitive strategies to manage anxiety) that can be applied to everyday life. To support use of the app, all users in the intervention group will be offered access to trained peer coaches to help users navigate the different app components and provide non-clinical peer support. | Behavioural | Intervention arm |
Primary outcome
Change in General anxiety symptomology from Baseline to Follow-up at 30 days
Time frame: The GAD-7 will be administered to both the intervention and control groups at baseline and 30 days.
Assessed by the General Anxiety Disorder 7-Item (GAD-7) scale. Changes in anxiety symptomology from baseline to follow-up at 30 days will be based on total scores on the GAD-7 in both the intervention and control groups. Total scores range from 0 to 21 with higher scores indicating a worse outcome (i.e, a greater frequency of anxiety symptoms).
Change in Depressive symptomology from Baseline to Follow-up at 30 days
Time frame: The PHQ-9 will be administered to both the intervention and control group at baseline and 30 days.
Assessed by the Patient Health Questionnaire 9-item (PHQ-9) scale. Changes in depressive symptomology from baseline to follow-up at 30 days will be based on total scores on the PHQ-9 in both the intervention and control groups. Total scores range from 0 to 29 with higher scores indicating a worse outcome (i.e., a greater frequency of depression symptoms).
Change in Alcohol consumption risk from Baseline to Follow-up at 30 days
Time frame: The USAUDIT-C will be administered to the intervention and control groups at baseline and 30 days.
Assessed by the alcohol consumption questions of the Alcohol Use Disorders Identification Test, Adapted for Use in the United States (USAUDIT-C). Changes in alcohol consumption risk from baseline to follow-up at 30 days will be based on total scores on the USAUDIT-C in both the intervention and control groups. Total scores range from 0 to 18 with higher scores indicating a worse outcome (i.e., a higher level of risky drinking).
10 secondary outcomes
Frequency of cannabis consumption
Time frame: Frequency of cannabis consumption will be assessed in the intervention and control groups at baseline and at 30 days.
Frequency of binge drinking
Time frame: Frequency of binge drinking will be assessed in the intervention and control groups at baseline and at 30 days.
Frequency of alcohol use
Time frame: Frequency of alcohol use will be assessed in the intervention and control groups at baseline and at 30 days.
Frequency of opioid use
Time frame: Frequency of opioid use will be assessed in the intervention and control groups at baseline and at 30 days.
Frequency of non-medical stimulant use
Time frame: Frequency of non-medical stimulant use will be assessed in the intervention and control groups at baseline and at 30 days.
Self-efficacy related to the management of substance use.
Time frame: Substance use self-efficacy will be assessed in the intervention and control groups at baseline and at 30 days.
Readiness to change
Time frame: Readiness to change will be assessed in the intervention and control groups at baseline and at 30 days.
Mental Well-being
Time frame: The Short Warwick-Edinburgh Mental Wellbeing Scale will be administered in the intervention and control groups at baseline and at 30 days.
Self-efficacy related to the management of mental health.
Time frame: Mental health self-efficacy will be assessed in the intervention and control groups at baseline and at 30 days.
Self-reported use of mental health services and supports
Time frame: Use of mental health services and supports will be assessed in the intervention and control groups at baseline and at 30 days.
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 18 Sep 2023.
- Derived from this study: PubMed 41068963Y Wang A, Vereschagin M, G Richardson C, J Munthali R, Xie H, L Hudec K, Mori T, Munro L, V Vigo D. Examining the effects of engagement with an app-based mental health intervention: a secondary analysis of a randomized control trial with treatment non-compliance. Int J Ment Health Syst. 2025 Oct 9;19(1):30. doi: 10.1186/s13033-025-00688-4.
- Derived from this study: PubMed 38536225Vereschagin M, Wang AY, Richardson CG, Xie H, Munthali RJ, Hudec KL, Leung C, Wojcik KD, Munro L, Halli P, Kessler RC, Vigo DV. Effectiveness of the Minder Mobile Mental Health and Substance Use Intervention for University Students: Randomized Controlled Trial. J Med Internet Res. 2024 Mar 27;26:e54287. doi: 10.2196/54287.
- Derived from this study: PubMed 37647105Wang AY, Vereschagin M, Richardson CG, Xie H, Hudec KL, Munthali RJ, Munro L, Leung C, Kessler RC, Vigo DV. Evaluating the Effectiveness of a Codeveloped e-Mental Health Intervention for University Students: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Aug 30;12:e49364. doi: 10.2196/49364.
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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.
Daniel V Vigo, MD, Lic. Psych, DrPH principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minder in people with Anxiety and Depression, run by University of British Columbia 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 4 inclusion and 1 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 18 Sep 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?
Change in General anxiety symptomology from Baseline to Follow-up at 30 days (time frame: The GAD-7 will be administered to both the intervention and control groups at baseline and 30 days.). The study lists 3 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 NCT05606601, which also lists 3 linked publications.
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 18 Sep 2023.