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Clinical Trials/NCT05606601
NCT05606601
Completed
Not Applicable

An Integrated Online Intervention Addressing Mental Health and Substance Use in University Students: A Randomized Controlled Trial

University of British Columbia1 site in 1 country1,489 target enrollmentSeptember 28, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
University of British Columbia
Enrollment
1489
Locations
1
Primary Endpoint
Change in Depressive symptomology from Baseline to Follow-up at 30 days
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 28, 2022
End Date
July 21, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel Vigo

Assistant Professor

University of British Columbia

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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 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 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).

Secondary Outcomes

  • Frequency of binge drinking(Frequency of binge drinking will be assessed in the intervention and control groups at baseline and at 30 days.)
  • Frequency of alcohol use(Frequency of alcohol use will be assessed in the intervention and control groups at baseline and at 30 days.)
  • Frequency of cannabis consumption(Frequency of cannabis consumption will be assessed in the intervention and control groups at baseline and at 30 days.)
  • Readiness to change(Readiness to change will be assessed in the intervention and control groups at baseline and at 30 days.)
  • Self-efficacy related to the management of substance use.(Substance use self-efficacy will be assessed in the intervention and control groups at baseline and at 30 days.)
  • Self-efficacy related to the management of mental health.(Mental health self-efficacy will be assessed in the intervention and control groups at baseline and at 30 days.)
  • Frequency of non-medical stimulant use(Frequency of non-medical stimulant use will be assessed in the intervention and control groups at baseline and at 30 days.)
  • Frequency of opioid use(Frequency of opioid use will be assessed in the intervention and control groups at baseline and at 30 days.)
  • Mental Well-being(The Short Warwick-Edinburgh Mental Wellbeing Scale will be administered in the intervention and control groups at baseline and at 30 days.)
  • Self-reported use of mental health services and supports(Use of mental health services and supports will be assessed in the intervention and control groups at baseline and at 30 days.)

Study Sites (1)

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