Depression, AnxietyNCT04122482
An Online Course for Improving Knowledge and Access to Mental Health Accommodations in Canadian Enterprises
A study testing Psychoeducation Course in people with Depression, Anxiety, run by University of Regina at 1 site in Canada.
Trial summary
Available research on mental health accommodations within the workplace suggests that employees with mental health concerns require accommodations (e.g., flexible scheduling, quiet spaces), but only a fraction of employees will receive the accommodations they have requested. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Psychoeducation Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteCanada
- Study dates
- 6 Sep 2019to 13 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are 18 years of age or older;
- are a resident of Canada;
- are experiencing at least clinically significant symptoms of anxiety and/or depression (i.e., symptoms are severe enough to impact work performance);
- I.e., a GAD-7 score of 10 or greater, or SIAS score of 7 or greater, SPS-6 score of 2 or greater, PHQ-0 score of 10 or greater, be absent from work a minimum of .3 days in the last 28 days, have a presenteeism score of 40 or greater.
- have not been hospitalized within the last year for mental health and/or suicide risk concerns;
- have access to a secure computer and the Internet, and is comfortable using technology.
Who cannot join
- are younger than 18 years of age;
- are not a resident of Canada;
- are experiencing minimal or no symptoms of anxiety and/or depression;
- have been hospitalized within the last year for mental health and/or suicide risk concerns;
- have unmanaged problems with alcohol, drugs, psychosis, or mania;
- do not have access to a secure computer and the Internet or is not comfortable using technology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of an Online Psychoeducation Course for Improving Knowledge and Access to Mental Health Accommodations in Canadian Enterprises
Available research on mental health accommodations within the workplace suggests that employees with mental health concerns require accommodations (e.g., flexible scheduling, quiet spaces), but only a fraction of employees will receive the accommodations they have requested. Reported barriers to receiving mental health accommodations include concerns regarding stigma, lack of knowledge about appropriate accommodations, financial constraints of the employer, and size of the organization. While there is growing research on workplace accommodations, there is a paucity of research available on interventions aimed at improving accommodation usage, particularly within SMEs. To address this gap, the intent of the proposed study is to develop and implement an online psychoeducation course to increase employees' accommodation knowledge and usage within Canadian enterprises. Once the course is developed, reviewed, and implemented, an additional aim of the proposed study will be to test the efficacy of the course using a two-arm, randomized controlled trial comparing the intervention to a wait-list control group. A total of 86 participants experiencing workplace impairments due to a depressive and/or anxiety disorder will be randomly assigned to a psychoeducation group or wait-list control group. A 2x3 repeated measures (i.e., pre-course, at four weeks and eight weeks) mixed model ANOVA will be used to analyze the effects of the intervention on accommodation requests, knowledge of accommodations, absenteeism/presenteeism rates, employee self-efficacy, and psychological symptoms. The results of the study may be used to develop future offerings of the course and improve mental health accommodations practices within Canadian enterprises.
Read the detailed description
In this study, the first phase of the study will be to develop the online psychoeducation course. Once the course is developed it will be reviewed by experts in the field of accommodations (e.g., Human Resource professionals, lawyers) and their suggestions will be reviewed and possibly implemented before the course is delivered to employees. Experts providing feedback will be asked to review and complete a consent form prior to reviewing one or more lessons. After reviewing a lesson, they will be provided with an opportunity to give lesson feedback through the completion of a short questionnaire. Total participation time is expected to be 1 hour. Experts will be eligible for the study if they meet the following criteria: (1) are 18 years of age or older; (2) have knowledge or experience with workplace accommodations; and (3) are Canadian residents. Experts will be excluded if he/she: (1) is not 18 years of age or older); (2) Do not have knowledge or experience with workplace accommodations; (3) are not a resident of Canada
The course will be comprised of the following lessons:
Lesson 1: Anxiety and depression in the workplace. This lesson will include information on how to identify symptoms of depression and anxiety in the workplace. To accomplish this the DSM-5 criteria for depression and anxiety will be provided along with practical work examples (e.g., difficulty with concentration in meetings). Participants will also be presented with examples of the functional limitations that are commonly associated with depression and anxiety symptoms (e.g., missing important deadlines due to procrastination behaviours). Information on the prevalence of depression and anxiety in Canada/World will also be provided to counteract any stigmatic attitudes or beliefs.
Lesson 2: Accommodations for mental health concerns. Within this lesson, participants will be presented with the Canadian legislation on reasonable workplace accommodations. This information will include a discussion on undue hardship and how this may impact the receipt and types of accommodations available within Canadian enterprises. Participants will also be provided with common examples of accommodations frequently identified within the research literature (e.g., flexible work schedules, quiet spaces). In addition, the benefits of receiving accommodations for mental health concerns (e.g., improved productivity, reduced symptomology) will be discussed. The lesson will conclude with the potential barriers (e.g., stigma, organizational barriers) and facilitators (e.g., supportive work environments) to requesting and receiving accommodations. Strategies to overcome potential barriers will also be addressed.
Lesson 3: Requesting an accommodation and disclosure. This lesson will focus on strategies for requesting an accommodation within a Canadian enterprise. This will include information on when, how, to whom, and what should be disclosed when requesting an accommodation. Employees will also be provided with information on the pros and cons of making an accommodation request. In addition, they will be provided with information on what to disclose when making the request (i.e., full disclosure ["I have depression] or selective disclosure ["I have an illness]), the pros and cons of disclosure, and information on the tasks for preparing to disclose. It will also be emphasized within the lesson that full disclosure may not be required to receive an acceptable accommodation.
Lesson 4: Future management. The psychoeducational course will conclude with a lesson on strategies for managing depression and anxiety symptoms within Canadian enterprises with or without an accommodation. This will include information on managing symptoms within the work environment such as, managing expectations, tackling avoidance strategies, progressive muscle relaxation, and fostering workplace relationships/supports.
The second aim of the proposed study will be to test the efficacy of the course using a two arm, randomized controlled trial. The sample size of 43 participants per arm is based on a power analysis for an ANOVA: repeated measures, between factors, with a medium effect size (f = 0.25), an alpha of 0.05, correlation among repeated measure of 0.5, and power of 0.80.
All interested participants will be directed to the study website (www.onlinetherapyuser.ca), where they will be presented with a consent form explaining the screening protocol (i.e., online screening consent). After consent is given, participants will be assessed for program eligibility using an Internet-delivered screening questionnaire. The online screening questionnaire captures demographic information (e.g., sex, ethnicity, location), contact details (e.g., telephone number, email address), eligibility information (e.g., medical history, mental health history, symptom measurements), and information on workplace functioning (e.g., self-reported absenteeism, presenteeism, disclosure questions, self-efficacy, self-stigma, workers' relation scale, workplace inclusion). This data will be made available to participants in an online survey created and hosted by REDcap (Research Electronic Data Capture) software.
Once participants have been assessed for program eligibility using the online screening tool, they will asked to schedule a telephone interview. During the telephone interview, the primary investigator will ask a series of follow-up questions (i.e., Telephone Interview Guide) to the online screening questionnaire to ensure program eligibility as per exclusion criteria. Participants who meet any of the exclusion criteria during the online screening phase will be provided with an explanation for their ineligibility and encouraged to contact the researcher via email if they have any questions or concerns.
Participants who are appropriate for the study will be assigned to their randomized group (i.e., Psycho-education course or wait-list control group). At this point, participants assigned to the psycho-education group will be provided user-names and temporary password words by phone to access the course. Participants assigned to the wait-list group will be provided with their user name and password 8 weeks following the telephone screening date. Before beginning the course, all participants will be presented with a course consent form that will explain the nature of the intervention.
The lessons will take approximately 30 to 45 minutes for participants to review. Once participants have completed a lesson, they will be granted access to the next lesson the following day, which will allow them to complete multiple lessons within any given week. To minimize time pressures, participants will be instructed that follow-up measures (i.e., same measures included in the screening questionnaire minus the AUDIT/DUDIT and clinical history) will be available four weeks and eight weeks after they have been provided access to the course. Should negative effects be observed (e.g. self-reported symptoms increase, absenteeism/presenteeism numbers significantly rise) at any point, participants will be reminded of the resources (e.g., family doctor, mental health websites, mental health agencies) available to them. These resources will be documented and posted on the website for easy reference.
The use of a wait-list control group will provide a comparison group to determine the effects of the psychoeducation course. It will also circumvent any ethical concerns with failing to provide a potentially helpful intervention. Participants assigned to the wait-list group will be assigned a start date eight weeks after the pre-screen interview and sent an automatic reminder email a few days prior to their start date. The wait-list group will also be sent a link through email to complete measures (i.e., PHQ-9, Accommodation/Disclosure questions, WHO HPQ) four-weeks after the telephone screen for comparison purposes and to maintain engagement in the study. No further contact will be provided during the eight-week wait-list period. Following completion of the wait-list period, the participants will be provided their user name and password so they may access the psycho-education course and measures will be requested again at 4-weeks and 8-weeks post course access.
- Conditions
- Depression, Anxiety
- Being tested
- Psychoeducation Course
- Keywords
- Mental health accommodation, Canadian buisness, Psychoeducation, ICBT
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation CourseBehavioural
Also called Wait-list Control
The investigators are assessing the efficacy of the accommodations course. Specifically, the investigators will evaluate the impact on requesting and receiving accommodations for anxiety and/or depression, employee knowledge of accommodations, and employee self-stigmatizing attitudes. The investigators will also assess if the course helps improve comfort level of disclosing a mental health diagnosis and rates of disclosure in the workplace.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | In this arm, participants will be given access to the course material shortly after eligibility criteria is confirmed. They will be asked to complete post-measures questionnaires at 4 weeks and 8 weeks following completion of the course material. Receives: Behavioral: Psychoeducation Course |
| Wait-list Control | Experimental | In this arm, participants will be given access to the course material 8 weeks following confirmation of their eligibility. During, the 8-week waiting period they will be asked to complete questionnaires at 4 weeks and 8 weeks. At 8 weeks they will be given access to the course material and will be asked to complete the same questionnaires 4- and 8-weeks following completion of the course material. Receives: Behavioral: Psychoeducation Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing change of requesting and/or receiving accommodations between course start date and 8 weeks post course completion.
We will be assessing the impact of the psychoeducation course on requesting and/or receiving workplace accommodations for anxiety and/or depression symptoms. This will be assessed using a questionnaire, which will include questions such as "Have you ever requested from your current company any change or accommodation in your job or workplace to better meet your mental health needs?" This questionnaire includes dichotomous questions (yes/no) and there is one scale that asks how comfortable participants are requesting an accommodation (min: 1; max: 10). A higher value represents more comfort requesting an accommodation.
Measured: 8 weeks
Efficacy of online psychoeducation course on self-stigmatizing attitudes as measured by Self-stigma of Mental Illness Scale - Short Form (SSMIS-SF)
We will be assessing the impact of the psychoeducation course on employees' self-stigmatizing attitudes. The investigators will be assessing 4 sub-scales (Aware, Agree, Apply, and Hurts Self). Each sub-scale has the following minimum and maximum values Min: 5 Max: 45 Higher values represent more self-stigmatizing attitudes.
Measured: 8 weeks
Assessing change in employee knowledge of accommodations between course start date and 8 weeks post course completion
We will be assessing employees' knowledge of accommodations before and after receiving the course material. This will be assessed using a questionnaire that includes likert scales and open-ended questions such as "On a scale from 1 to 10, where 1 is "no knowledge" and 10 is "very knowledgeable how much do you know about workplace accommodations for mental health conditions?" and "Please list the accommodations you are comfortable requesting?"
Measured: 8 weeks
Impact of receiving accommodations on absenteeism and presenteeism rates as measured by the World Health and Work Performance Questionnaire (WHO-HPQ).
Change in absenteeism and presenteeism rates in terms of the total number of missed work days or lower productivity days during the previous 28 days.
Measured: 8 weeks
Impact of receiving accommodations on employee self-efficacy as measured by New General Self-Efficacy Scale (NGSE).
Change in employees' self-efficacy scores during the previous 4 weeks. The total score is calculated by total score for each participant and taking the average rating of the items selected.
Minimum score: 1 Maxium score: 5 Lower values represent lower self-efficacy
Measured: 8 weeks
Impact of receiving accommodations on employee symptom severity as measured bygeneral anxiety measures (GAD-7)
Change in employees' self-reported symptom severity during the previous 4 weeks.
GAD-7- Min score = 0; Max score = 21 - Higher scores represents more severe symptoms
Measured: 8 weeks
Impact of receiving accommodations on employee symptom severity as measured by social interaction anxiety measures (SIAS-6).
Change in employees' self-reported symptom severity during the previous 4 weeks.
SIAS-6: Min score = 0; Max score = 24 - Higher scores represents more severe symptoms
Measured: 8 weeks
Impact of receiving accommodations on employee symptom severity as measured by social phobia anxiety measures (SPS-6).
Change in employees' self-reported symptom severity during the previous 4 weeks.
SPS-6: Min score = 0; Max score = 24 - Higher scores represents more severe symptoms
Measured: 8 weeks
Impact of receiving accommodations on employee symptom severity as measured by depression measures (PHQ-9)
Change in employees' self-reported symptom severity during the previous 4 weeks.
PHQ-9 - Min score = 0; Max score = 27 - Higher scores represents more severe symptoms
Measured: 8 weeks
Assessing change in employee relationships within the workplace as measured by the Workplace Relationships Scale (WRS).
Change in employees' workplace relationships during the previous 4 weeks.
WRS scores will range from:
Min: 9 Max: 63 Higher scores represents more interpersonal conflict at work.
Measured: 8 weeks
Identification of workplace accommodations received for anxiety and/or depression symptoms.
Participants will be asked to list any workplace accommodations they have received for the anxiety and/or depression symptoms in the past 4 weeks. This is an open-ended question and does not have a scale.
Measured: 8 weeks
Impact of supervisor's leadership and organizational inclusion on receiving an accommodation and disclosing in the workplace.
Supervisors Leader and Organizational Inclusion scales will be used to measure the impact of both on receiving an accommodation or disclosing in the workplace.
Supervisor Leadership - Min score = 7; Max score = 35 - Higher scores represents more supportive leadership style Organization Inclusion: Min score = 1; Max score = 34 - Higher scores represents a more inclusive and support organization.
Measured: 8 weeks
Secondary outcomes (4)
Impact of psychoeducation course on comfort level of disclosing a mental health condition in the workplace
Participants will be asked about their comfort level disclosing a mental health condition in the workplace in the previous 4 weeks. We will be using a likert scale where 1 equals Very Uncomfortable and 4 equal Very Comfortable. A higher value indicates more comfort disclosing.
Measured: 8 weeks
Impact of psychoeducation course on rates of disclosure in the workplace
Participants will be asked if they have disclosed and to whom they disclosed to in the workplace in the previous 4 weeks. Participants will be provided with a list of people (e.g., family, friends, co-workers) and will be asked to click all that apply. No scales will be used.
Measured: 8 weeks
Identification of the barriers and facilitators to requesting/receiving workplace accommodations for anxiety and/or depression symptoms
Participants will be asked to identify the barriers and facilitators for receiving workplace accommodations in the previous 4 weeks. This is an open-ended questions with no scales.
Measured: 8 weeks
Feedback on the course structure and content
Participants will provide feedback on the course structure and content so revisions can be made to future versions of the course.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start6 Sep 2019
- Primary completion21 Nov 2020
- Study completion13 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Factorial Assignment Factor 1: Receive course material immediately Factor 2: Receive course material in 8 weeks Each client will be randomized to one of two conditions: Condition 1: They receive access to the course material immediately. Condition 2: They receive access to the course material after 8 weeks.
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Hadjistavropoulos, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122482
- Sponsor's protocol ID
- 2019-126
- Status last verified
- Oct 2021
- First submitted
- 23 Sep 2019
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of an Online Psychoeducation Course for Improving Knowledge and Access to Mental Health Accommodations in Canadian Enterprises
- ClinicalTrials.gov ID
- NCT04122482
- Acronym / sponsor ID
- 2019-126
- Conditions
- Depression, Anxiety
- Keywords
- Mental health accommodation, Canadian buisness, Psychoeducation, ICBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 21 Nov 2020 (actual)
- Study completion
- 13 Mar 2021 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Available research on mental health accommodations within the workplace suggests that employees with mental health concerns require accommodations (e.g., flexible scheduling, quiet spaces), but only a fraction of employees will receive the accommodations they have requested. Reported barriers to receiving mental health accommodations include concerns regarding stigma, lack of knowledge about appropriate accommodations, financial constraints of the employer, and size of the organization. While there is growing research on workplace accommodations, there is a paucity of research available on interventions aimed at improving accommodation usage, particularly within SMEs. To address this gap, the intent of the proposed study is to develop and implement an online psychoeducation course to increase employees' accommodation knowledge and usage within Canadian enterprises. Once the course is developed, reviewed, and implemented, an additional aim of the proposed study will be to test the efficacy of the course using a two-arm, randomized controlled trial comparing the intervention to a wait-list control group. A total of 86 participants experiencing workplace impairments due to a depressive and/or anxiety disorder will be randomly assigned to a psychoeducation group or wait-list control group. A 2x3 repeated measures (i.e., pre-course, at four weeks and eight weeks) mixed model ANOVA will be used to analyze the effects of the intervention on accommodation requests, knowledge of accommodations, absenteeism/presenteeism rates, employee self-efficacy, and psychological symptoms. The results of the study may be used to develop future offerings of the course and improve mental health accommodations practices within Canadian enterprises.
Detailed description
In this study, the first phase of the study will be to develop the online psychoeducation course. Once the course is developed it will be reviewed by experts in the field of accommodations (e.g., Human Resource professionals, lawyers) and their suggestions will be reviewed and possibly implemented before the course is delivered to employees. Experts providing feedback will be asked to review and complete a consent form prior to reviewing one or more lessons. After reviewing a lesson, they will be provided with an opportunity to give lesson feedback through the completion of a short questionnaire. Total participation time is expected to be 1 hour. Experts will be eligible for the study if they meet the following criteria: (1) are 18 years of age or older; (2) have knowledge or experience with workplace accommodations; and (3) are Canadian residents. Experts will be excluded if he/she: (1) is not 18 years of age or older); (2) Do not have knowledge or experience with workplace accommodations; (3) are not a resident of Canada
The course will be comprised of the following lessons:
Lesson 1: Anxiety and depression in the workplace. This lesson will include information on how to identify symptoms of depression and anxiety in the workplace. To accomplish this the DSM-5 criteria for depression and anxiety will be provided along with practical work examples (e.g., difficulty with concentration in meetings). Participants will also be presented with examples of the functional limitations that are commonly associated with depression and anxiety symptoms (e.g., missing important deadlines due to procrastination behaviours). Information on the prevalence of depression and anxiety in Canada/World will also be provided to counteract any stigmatic attitudes or beliefs.
Lesson 2: Accommodations for mental health concerns. Within this lesson, participants will be presented with the Canadian legislation on reasonable workplace accommodations. This information will include a discussion on undue hardship and how this may impact the receipt and types of accommodations available within Canadian enterprises. Participants will also be provided with common examples of accommodations frequently identified within the research literature (e.g., flexible work schedules, quiet spaces). In addition, the benefits of receiving accommodations for mental health concerns (e.g., improved productivity, reduced symptomology) will be discussed. The lesson will conclude with the potential barriers (e.g., stigma, organizational barriers) and facilitators (e.g., supportive work environments) to requesting and receiving accommodations. Strategies to overcome potential barriers will also be addressed.
Lesson 3: Requesting an accommodation and disclosure. This lesson will focus on strategies for requesting an accommodation within a Canadian enterprise. This will include information on when, how, to whom, and what should be disclosed when requesting an accommodation. Employees will also be provided with information on the pros and cons of making an accommodation request. In addition, they will be provided with information on what to disclose when making the request (i.e., full disclosure ["I have depression] or selective disclosure ["I have an illness]), the pros and cons of disclosure, and information on the tasks for preparing to disclose. It will also be emphasized within the lesson that full disclosure may not be required to receive an acceptable accommodation.
Lesson 4: Future management. The psychoeducational course will conclude with a lesson on strategies for managing depression and anxiety symptoms within Canadian enterprises with or without an accommodation. This will include information on managing symptoms within the work environment such as, managing expectations, tackling avoidance strategies, progressive muscle relaxation, and fostering workplace relationships/supports.
The second aim of the proposed study will be to test the efficacy of the course using a two arm, randomized controlled trial. The sample size of 43 participants per arm is based on a power analysis for an ANOVA: repeated measures, between factors, with a medium effect size (f = 0.25), an alpha of 0.05, correlation among repeated measure of 0.5, and power of 0.80.
All interested participants will be directed to the study website (www.onlinetherapyuser.ca), where they will be presented with a consent form explaining the screening protocol (i.e., online screening consent). After consent is given, participants will be assessed for program eligibility using an Internet-delivered screening questionnaire. The online screening questionnaire captures demographic information (e.g., sex, ethnicity, location), contact details (e.g., telephone number, email address), eligibility information (e.g., medical history, mental health history, symptom measurements), and information on workplace functioning (e.g., self-reported absenteeism, presenteeism, disclosure questions, self-efficacy, self-stigma, workers' relation scale, workplace inclusion). This data will be made available to participants in an online survey created and hosted by REDcap (Research Electronic Data Capture) software.
Once participants have been assessed for program eligibility using the online screening tool, they will asked to schedule a telephone interview. During the telephone interview, the primary investigator will ask a series of follow-up questions (i.e., Telephone Interview Guide) to the online screening questionnaire to ensure program eligibility as per exclusion criteria. Participants who meet any of the exclusion criteria during the online screening phase will be provided with an explanation for their ineligibility and encouraged to contact the researcher via email if they have any questions or concerns.
Participants who are appropriate for the study will be assigned to their randomized group (i.e., Psycho-education course or wait-list control group). At this point, participants assigned to the psycho-education group will be provided user-names and temporary password words by phone to access the course. Participants assigned to the wait-list group will be provided with their user name and password 8 weeks following the telephone screening date. Before beginning the course, all participants will be presented with a course consent form that will explain the nature of the intervention.
The lessons will take approximately 30 to 45 minutes for participants to review. Once participants have completed a lesson, they will be granted access to the next lesson the following day, which will allow them to complete multiple lessons within any given week. To minimize time pressures, participants will be instructed that follow-up measures (i.e., same measures included in the screening questionnaire minus the AUDIT/DUDIT and clinical history) will be available four weeks and eight weeks after they have been provided access to the course. Should negative effects be observed (e.g. self-reported symptoms increase, absenteeism/presenteeism numbers significantly rise) at any point, participants will be reminded of the resources (e.g., family doctor, mental health websites, mental health agencies) available to them. These resources will be documented and posted on the website for easy reference.
The use of a wait-list control group will provide a comparison group to determine the effects of the psychoeducation course. It will also circumvent any ethical concerns with failing to provide a potentially helpful intervention. Participants assigned to the wait-list group will be assigned a start date eight weeks after the pre-screen interview and sent an automatic reminder email a few days prior to their start date. The wait-list group will also be sent a link through email to complete measures (i.e., PHQ-9, Accommodation/Disclosure questions, WHO HPQ) four-weeks after the telephone screen for comparison purposes and to maintain engagement in the study. No further contact will be provided during the eight-week wait-list period. Following completion of the wait-list period, the participants will be provided their user name and password so they may access the psycho-education course and measures will be requested again at 4-weeks and 8-weeks post course access.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Factorial Assignment Factor 1: Receive course material immediately Factor 2: Receive course material in 8 weeks Each client will be randomized to one of two conditions: Condition 1: They receive access to the course material immediately. Condition 2: They receive access to the course material after 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Psychoeducation CourseIn this arm, participants will be given access to the course material shortly after eligibility criteria is confirmed. They will be asked to complete post-measures questionnaires at 4 weeks and 8 weeks following completion of the course material. |
| Wait-list Control | Experimental | Behavioral: Psychoeducation CourseIn this arm, participants will be given access to the course material 8 weeks following confirmation of their eligibility. During, the 8-week waiting period they will be asked to complete questionnaires at 4 weeks and 8 weeks. At 8 weeks they will be given access to the course material and will be asked to complete the same questionnaires 4- and 8-weeks following completion of the course material. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- are 18 years of age or older;
- are a resident of Canada;
- are experiencing at least clinically significant symptoms of anxiety and/or depression (i.e., symptoms are severe enough to impact work performance);
- have not been hospitalized within the last year for mental health and/or suicide risk concerns;
- have access to a secure computer and the Internet, and is comfortable using technology.
Key exclusion criteria (6 listed)
- are younger than 18 years of age;
- are not a resident of Canada;
- are experiencing minimal or no symptoms of anxiety and/or depression;
- have been hospitalized within the last year for mental health and/or suicide risk concerns;
- have unmanaged problems with alcohol, drugs, psychosis, or mania;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducation CourseAlso: Wait-list ControlThe investigators are assessing the efficacy of the accommodations course. Specifically, the investigators will evaluate the impact on requesting and receiving accommodations for anxiety and/or depression, employee knowledge of accommodations, and employee self-stigmatizing attitudes. The investigators will also assess if the course helps improve comfort level of disclosing a mental health diagnosis and rates of disclosure in the workplace. | Behavioural | Intervention Group, Wait-list Control |
Primary outcome
Assessing change of requesting and/or receiving accommodations between course start date and 8 weeks post course completion.
Time frame: 8 weeks
We will be assessing the impact of the psychoeducation course on requesting and/or receiving workplace accommodations for anxiety and/or depression symptoms. This will be assessed using a questionnaire, which will include questions such as "Have you ever requested from your current company any change or accommodation in your job or workplace to better meet your mental health needs?" This questionnaire includes dichotomous questions (yes/no) and there is one scale that asks how comfortable participants are requesting an accommodation (min: 1; max: 10). A higher value represents more comfort requesting an accommodation.
Efficacy of online psychoeducation course on self-stigmatizing attitudes as measured by Self-stigma of Mental Illness Scale - Short Form (SSMIS-SF)
Time frame: 8 weeks
We will be assessing the impact of the psychoeducation course on employees' self-stigmatizing attitudes. The investigators will be assessing 4 sub-scales (Aware, Agree, Apply, and Hurts Self). Each sub-scale has the following minimum and maximum values Min: 5 Max: 45 Higher values represent more self-stigmatizing attitudes.
Assessing change in employee knowledge of accommodations between course start date and 8 weeks post course completion
Time frame: 8 weeks
We will be assessing employees' knowledge of accommodations before and after receiving the course material. This will be assessed using a questionnaire that includes likert scales and open-ended questions such as "On a scale from 1 to 10, where 1 is "no knowledge" and 10 is "very knowledgeable how much do you know about workplace accommodations for mental health conditions?" and "Please list the accommodations you are comfortable requesting?"
Impact of receiving accommodations on absenteeism and presenteeism rates as measured by the World Health and Work Performance Questionnaire (WHO-HPQ).
Time frame: 8 weeks
Change in absenteeism and presenteeism rates in terms of the total number of missed work days or lower productivity days during the previous 28 days.
Impact of receiving accommodations on employee self-efficacy as measured by New General Self-Efficacy Scale (NGSE).
Time frame: 8 weeks
Change in employees' self-efficacy scores during the previous 4 weeks. The total score is calculated by total score for each participant and taking the average rating of the items selected. Minimum score: 1 Maxium score: 5 Lower values represent lower self-efficacy
Impact of receiving accommodations on employee symptom severity as measured bygeneral anxiety measures (GAD-7)
Time frame: 8 weeks
Change in employees' self-reported symptom severity during the previous 4 weeks. GAD-7- Min score = 0; Max score = 21 - Higher scores represents more severe symptoms
Impact of receiving accommodations on employee symptom severity as measured by social interaction anxiety measures (SIAS-6).
Time frame: 8 weeks
Change in employees' self-reported symptom severity during the previous 4 weeks. SIAS-6: Min score = 0; Max score = 24 - Higher scores represents more severe symptoms
Impact of receiving accommodations on employee symptom severity as measured by social phobia anxiety measures (SPS-6).
Time frame: 8 weeks
Change in employees' self-reported symptom severity during the previous 4 weeks. SPS-6: Min score = 0; Max score = 24 - Higher scores represents more severe symptoms
Impact of receiving accommodations on employee symptom severity as measured by depression measures (PHQ-9)
Time frame: 8 weeks
Change in employees' self-reported symptom severity during the previous 4 weeks. PHQ-9 - Min score = 0; Max score = 27 - Higher scores represents more severe symptoms
Assessing change in employee relationships within the workplace as measured by the Workplace Relationships Scale (WRS).
Time frame: 8 weeks
Change in employees' workplace relationships during the previous 4 weeks. WRS scores will range from: Min: 9 Max: 63 Higher scores represents more interpersonal conflict at work.
Identification of workplace accommodations received for anxiety and/or depression symptoms.
Time frame: 8 weeks
Participants will be asked to list any workplace accommodations they have received for the anxiety and/or depression symptoms in the past 4 weeks. This is an open-ended question and does not have a scale.
Impact of supervisor's leadership and organizational inclusion on receiving an accommodation and disclosing in the workplace.
Time frame: 8 weeks
Supervisors Leader and Organizational Inclusion scales will be used to measure the impact of both on receiving an accommodation or disclosing in the workplace. Supervisor Leadership - Min score = 7; Max score = 35 - Higher scores represents more supportive leadership style Organization Inclusion: Min score = 1; Max score = 34 - Higher scores represents a more inclusive and support organization.
4 secondary outcomes
Impact of psychoeducation course on comfort level of disclosing a mental health condition in the workplace
Time frame: 8 weeks
Impact of psychoeducation course on rates of disclosure in the workplace
Time frame: 8 weeks
Identification of the barriers and facilitators to requesting/receiving workplace accommodations for anxiety and/or depression symptoms
Time frame: 8 weeks
Feedback on the course structure and content
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Hadjistavropoulos, PhD principal investigator
University of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation Course in people with Depression, Anxiety, run by University of Regina at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing change of requesting and/or receiving accommodations between course start date and 8 weeks post course completion. (time frame: 8 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.