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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05284123
Other study ID # 42483
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 12, 2021
Est. completion date May 31, 2024

Study information

Verified date June 2024
Source University of Waterloo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Untreated mental health problems can cause lasting harm to self-esteem, relationships, academics, productivity, and health. It is thus highly worrisome that only 18-36% of university students with significant mental health problems seek help. Many university campuses have responded to this mental health crisis by trying to increase students' mental health literacy (MHL), defined as "knowledge and beliefs about mental disorders which aid their recognition, management, or prevention''. Increasing MHL appears to increase knowledge about mental health services, but it does not increase actual treatment-seeking desire or action. One problem with this approach is that it falsely assumes that students struggling with their mental health will want to pursue services once they have learned more about mental disorders and the associated treatments available. However, most people with mental disorders do not initially recognize that they have a disorder and may dismiss information about mental disorders and mental health treatment as irrelevant. Feelings of shame are elevated in individuals with psychological disorders, and these feelings act as one of the strongest barriers to mental health treatment-seeking.Given the low rate of treatment-seeking on university campuses, research is needed to explore how best to facilitate mental health treatment seeking among distressed students, including those who may not self-identity as having a mental health problem. Research has yet to examine the potential role of self-compassion in relation to treatment-seeking behaviours. Self-compassion (SC) is conceptualized as responding to personal distress with gentleness and kindness in order to alleviate it, and it is negatively associated with shame. However, research has not yet explored whether the perceived benefits of SC in mitigating shame can affect mental health treatment-seeking outcomes. We propose that cultivating SC amongst psychologically distressed students will subsequently decrease shame, and thus, indirectly elevate willingness to seek mental health treatment. Thus, this study will examine the effects of a one-session SC workshop/intervention compared to a one-session MHL intervention on shame and mental health treatment-seeking. Participants will be distressed students recruited from the University of Waterloo, and will be randomly assigned to the SC intervention, MHL intervention, or control intervention.


Description:

The study will consist of four online surveys. During the first survey (Part 1; baseline), participants will answer a set of questionnaires. During the second survey (Part 2; 1-4 days after Part 1), participants will first answer a set of questionnaires. Then, they will be randomized to a self-compassion intervention, a mental health literacy intervention, or a control intervention. Then, participants will answer more questionnaires immediately after completing the intervention. During the third survey (Part 3; 14-17 days after Part 2) and fourth survey (Part 4; 3 months-3 months+7 days after Part 2), participants will answer a set of questionnaires.


Recruitment information / eligibility

Status Completed
Enrollment 265
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Undergraduate student at University of Waterloo with a SONA account - Scored 8+ on Kessler Psychological Distress Scale (K6; screener scale) Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Self-compassion workshop
The self-compassion workshop instructs participants to reflect on a source of shame, connect with their suffering related to it, and then direct feelings of support and understanding towards their suffering via a few brief writing tasks. This workshop also provides participants with basic information about mental health resources.
Mental health literacy workshop
The mental health literacy workshop provides participants with information about the symptoms and treatment of common mental disorders, and asks participants to reflect on what they learned through a couple brief writing tasks. This workshop also provides participants with basic information about mental health resources.
Control workshop
The control workshop provides participants with basic information about mental health resources.

Locations

Country Name City State
Canada University of Waterloo Waterloo Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary State Shame and Guilt Scale (shame subscale) Self-report questionnaire with 5 questions on a 5-point Likert scale (scored 1-5). Total scores range from 5-25, with higher decrease in score indicative of less momentary shame. Change from pre-intervention to immediately post-intervention
Primary Experience of Shame Scale Self-report questionnaire with 25 questions on a 4-point Likert scale (scored 1-4). Total scores range from 25-100, with higher decrease in score indicative of less shame. Change from baseline to 2 weeks and 3 months post-intervention
Primary Treatment-seeking intention questions (researcher-generated) 4 self-report questions to assess changes in intentions of seeking mental health treatment or resources. Change from baseline to immediately, 2 weeks, and 3 months post-intervention
Primary Treatment-seeking behaviours questions (researcher-generated) 5 self-report questions to assess changes in mental health treatment-seeking behaviours. Change from baseline to immediately, 2 weeks, and 3 months post-intervention
Primary Distress Disclosure Index Self-report questionnaire with 12 questions on a 5-point Likert scale (scored 1-5). Total scores range from 12-60, with higher increase in score indicative of greater distress disclosure. Change from baseline to immediately, 2 weeks, and 3 months post-intervention
Secondary Compassionate Engagement and Action Scale (adapted self-compassion subscale) Self-report questionnaire with 13 questions on a 10-point Likert scale (scored 1-10). Three questions are reverse-scored and not included in scoring. Total scores range from 10-100, with higher score indicative of greater momentary emotional engagement during intervention. Immediately post-intervention
Secondary Kessler Psychological Distress Scale (K6) Self-report questionnaire with 6 questions on a 5-point Likert scale (scored 0-4). Total scores range from 0-24, with higher decrease in score indicative of less psychological distress. Change from baseline to 2 weeks and 3 months post-intervention
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