Clinical trial NCT05606601: An Online Intervention Addressing Mental Health and Substance Use in University Students
Official title: An Integrated Online Intervention Addressing Mental Health and Substance Use in University Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Alcohol Use
Substance Use
Keywords: Student Mental Health
Anxiety
Depression
Alcohol Use
Substance Use
Cannabis Use
Opioid Use
Stimulant Use
Online Intervention
E-mental Health
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 1489
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Must be currently enrolled at participating university
2. Must be 17 years or older
3. Must have access to and be able to use a smart phone with Wi-Fi and/or mobile data
4. Must be English speaking

Exclusion Criteria:

1) Any participants that self-identify as currently having a suicidal plan at the time of study enrollment

Primary outcomes:
measure: Change in General anxiety symptomology from Baseline to Follow-up at 30 days
timeFrame: The GAD-7 will be administered to both the intervention and control groups at baseline and 30 days.
measure: Change in Depressive symptomology from Baseline to Follow-up at 30 days
timeFrame: The PHQ-9 will be administered to both the intervention and control group at baseline and 30 days.
measure: Change in Alcohol consumption risk from Baseline to Follow-up at 30 days
timeFrame: The USAUDIT-C will be administered to the intervention and control groups at baseline and 30 days.
Secondary outcomes:
measure: Frequency of cannabis consumption
timeFrame: Frequency of cannabis consumption will be assessed in the intervention and control groups at baseline and at 30 days.
measure: Frequency of binge drinking
timeFrame: Frequency of binge drinking will be assessed in the intervention and control groups at baseline and at 30 days.
measure: Frequency of alcohol use
timeFrame: Frequency of alcohol use will be assessed in the intervention and control groups at baseline and at 30 days.
measure: Frequency of opioid use
timeFrame: Frequency of opioid use will be assessed in the intervention and control groups at baseline and at 30 days.
measure: Frequency of non-medical stimulant use
timeFrame: Frequency of non-medical stimulant use will be assessed in the intervention and control groups at baseline and at 30 days.
measure: Self-efficacy related to the management of substance use.
timeFrame: Substance use self-efficacy will be assessed in the intervention and control groups at baseline and at 30 days.
measure: Readiness to change
timeFrame: Readiness to change will be assessed in the intervention and control groups at baseline and at 30 days.
measure: Mental Well-being
timeFrame: The Short Warwick-Edinburgh Mental Wellbeing Scale will be administered in the intervention and control groups at baseline and at 30 days.
measure: Self-efficacy related to the management of mental health.
timeFrame: Mental health self-efficacy will be assessed in the intervention and control groups at baseline and at 30 days.
measure: Self-reported use of mental health services and supports
timeFrame: Use of mental health services and supports will be assessed in the intervention and control groups at baseline and at 30 days.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Daniel V Vigo, MD, Lic. Psych, DrPH
role: PRINCIPAL_INVESTIGATOR
References: