Depression Clinical Trial
Official title:
An Integrated Online Intervention Addressing Mental Health and Substance Use in University Students: A Randomized Controlled Trial
Verified date | September 2023 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1489 |
Est. completion date | July 21, 2023 |
Est. primary completion date | July 21, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 17 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | The GAD-7 will be administered to both the intervention and control groups at baseline and 30 days. | |
Primary | 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). | The PHQ-9 will be administered to both the intervention and control group at baseline and 30 days. | |
Primary | 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). | The USAUDIT-C will be administered to the intervention and control groups at baseline and 30 days. | |
Secondary | 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. | Frequency of cannabis consumption will be assessed in the intervention and control groups at baseline and at 30 days. | |
Secondary | 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. | Frequency of binge drinking will be assessed in the intervention and control groups at baseline and at 30 days. | |
Secondary | 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. | Frequency of alcohol use will be assessed in the intervention and control groups at baseline and at 30 days. | |
Secondary | 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. | Frequency of opioid use will be assessed in the intervention and control groups at baseline and at 30 days. | |
Secondary | 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. | Frequency of non-medical stimulant use will be assessed in the intervention and control groups at baseline and at 30 days. | |
Secondary | 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? |
Substance use self-efficacy will be assessed in the intervention and control groups at baseline and at 30 days. | |
Secondary | 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). | Readiness to change will be assessed in the intervention and control groups at baseline and at 30 days. | |
Secondary | 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). | The Short Warwick-Edinburgh Mental Wellbeing Scale will be administered in the intervention and control groups at baseline and at 30 days. | |
Secondary | 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? |
Mental health self-efficacy will be assessed in the intervention and control groups at baseline and at 30 days. | |
Secondary | 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. | 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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