Evaluate the Usefulness of Mental Health e-Learning

July 29, 2025 updated by: McMaster University

Randomized Trial to Evaluate the Usefulness of Mental Health e-Learning

In this proposal, the investigators plan to study the impact of In this proposal, we plan to study the impact of e-learning on mental health literacy and stigma related to anxiety and depression. Participants will be randomized to one of four groups - Depression e-Learning A, Depression e-Learning B, Anxiety e-Learning A, and Anxiety e-Learning B. All participants will be given access to all e-learning at the conclusion of the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S4L8
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Live in Canada
  • 45 years of age and over
  • Good command of the English language
  • Access to email and high speed internet
  • Comfortable using email and internet

Exclusion Criteria:

  • Lives outside of Canada
  • Not 45 years of age or over
  • Does not speak English,
  • Does not have access to email or high speed internet
  • Is not comfortable using email of internet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Depression e-Learning A
Other: Depression e-Learning A

Participants in Depression e-Learning A will be provided e-learning about depression, consisting of following components:

  1. One multimedia e-learning lesson on depression;
  2. A series of 4 'micro-learning' emails (2 emails/week) with small segments of content to reinforce the material from the lesson.

1. One multimedia e-learning lesson on depression; 2. A series of 4 'micro-learning' emails (2 emails/week) with small segments of content to reinforce the material from the lesson.
Experimental: Anxiety e-Learning A
Other: Anxiety e-Learning A

Participants in Anxiety e-Learning A will be provided e-learning about anxiety, consisting of following components:

  1. One multimedia e-learning lesson on anxiety;
  2. A series of 4 'micro-learning' emails (2 emails/week) with small segments of content to reinforce the material from the lesson.
Experimental: Depression e-Learning B
Other: Depression e-Learning B

Participants in Depression e-Learning B will be provided e-learning about depression, consisting of following components:

  1. One multimedia e-learning lesson on depression;
  2. A series of 4 'micro-learning' emails (2 emails/week) with small segments of content to reinforce the material from the lesson.

1. One multimedia e-learning lesson on depression; 2. A series of 4 'micro-learning' emails (2 emails/week) with small segments of content to reinforce the material from the lesson.
Experimental: Anxiety e-Learning B
Other: Anxiety e-Learning B

Participants in Anxiety e-Learning B will be provided e-learning about anxiety, consisting of following components:

  1. One multimedia e-learning lesson on anxiety;
  2. A series of 4 'micro-learning' emails (2 emails/week) with small segments of content to reinforce the material from the lesson.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the Depression Literacy Questionnaire
Time Frame: 0, 2, 4 weeks
The Depression Literacy Questionnaire assesses mental health literacy specific to depression. The questionnaire consists of 22 items which are true or false. Respondents can answer each item with one of three options - true, false, or I don't know. Each correct response receives one point. Higher scores indicate higher depression literacy.
0, 2, 4 weeks
Change from baseline in the Anxiety Literacy Questionnaire
Time Frame: 0, 2, 4 weeks
The Anxiety Literacy Questionnaire assesses mental health literacy specific to anxiety. The questionnaire consists of 22 items which are true or false. Respondents can answer each item with one of three options - true, false, or I don't know. Each correct response receives one point. Higher scores indicate higher depression literacy.
0, 2, 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the Depression Stigma Scale
Time Frame: 0, 2, 4 weeks
The Depression Stigma Scale is a 9-item assessment designed to measure stigma associated with depression with two subscales: personal and perceived. The Personal Stigma Subscale measures stigma in the respondents' own attitudes towards depression by asking them to indicate how strongly they personally agree with nine statements about depression. The Perceived Stigma Subscale measures the respondent's perception about the attitudes of others towards depression by asking them to indicate what they think most other people believe about the same nine statements. Responses to each item are measured on a five-point scale (ranging from zero 'strongly disagree' to four 'strongly agree'). Higher scores indicate higher levels of depression stigma.
0, 2, 4 weeks
Change from baseline in the Generalized Anxiety Stigma Scale
Time Frame: 0, 2, 4 weeks
The Generalised Anxiety Stigma Scale is analogous, but designed to measure stigma associated with anxiety disorders. It has two subscales: personal and perceived. The Personal Stigma Subscale measures stigma in the respondents' own attitudes towards anxiety disorders by asking them to indicate how strongly they personally agree with 10 statements about anxiety disorders. The Perceived Stigma Subscale measures the respondent's perception about the attitudes of others towards anxiety disorders by asking them to indicate what they think most other people believe about the same 10 statements. Responses to each item are measured on a five-point scale (ranging from zero 'strongly disagree' to four 'strongly agree'). Higher scores indicate higher levels of anxiety stigma.
0, 2, 4 weeks
Participant satisfaction
Time Frame: 2 weeks
A custom satisfaction questionnaire data adapted from the Information Assessment Method For All (IAM4all) will be collected and saved to assess satisfaction with the intervention.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Levinson_AFP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings