- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05606601
An Online Intervention Addressing Mental Health and Substance Use in University Students
An Integrated Online Intervention Addressing Mental Health and Substance Use in University Students: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6T 2A1
- University of British Columbia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
1) Any participants that self-identify as currently having a suicidal plan at the time of study enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intervention arm
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.
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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.
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No Intervention: Control arm
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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).
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The GAD-7 will be administered to both the intervention and control groups at baseline and 30 days.
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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.
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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).
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The PHQ-9 will be administered to both the intervention and control group at baseline and 30 days.
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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.
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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).
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The USAUDIT-C will be administered to the intervention and control groups at baseline and 30 days.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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Frequency of cannabis consumption will be assessed in the intervention and control groups at baseline and at 30 days.
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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.
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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.
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Frequency of binge drinking will be assessed in the intervention and control groups at baseline and at 30 days.
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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.
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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.
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Frequency of alcohol use will be assessed in the intervention and control groups at baseline and at 30 days.
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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.
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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.
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Frequency of opioid use will be assessed in the intervention and control groups at baseline and at 30 days.
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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.
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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.
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Frequency of non-medical stimulant use will be assessed in the intervention and control groups at baseline and at 30 days.
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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.
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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).
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Substance use self-efficacy will be assessed in the intervention and control groups at baseline and at 30 days.
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Readiness to change
Time Frame: Readiness to change will be assessed in the intervention and control groups at baseline and at 30 days.
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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).
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Readiness to change will be assessed in the intervention and control groups at baseline and at 30 days.
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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.
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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).
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The Short Warwick-Edinburgh Mental Wellbeing Scale will be administered in the intervention and control groups at baseline and at 30 days.
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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.
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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).
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Mental health self-efficacy will be assessed in the intervention and control groups at baseline and at 30 days.
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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.
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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.
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Use of mental health services and supports will be assessed in the intervention and control groups at baseline and at 30 days.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel V Vigo, MD, Lic. Psych, DrPH, University of British Columbia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H21-03248
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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