Psychological DistressNCT05284123
The Impact of a Self-Compassion Intervention on Shame and Mental Health Treatment-Seeking
A study testing Self-compassion workshop and Mental health literacy workshop in people with Psychological Distress, run by University of Waterloo at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psychological Distress
- What is being tested?
- Self-compassion workshop and Mental health literacy workshop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteCanada
- Study dates
- 12 Nov 2021to 31 May 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergraduate student at University of Waterloo with a SONA account
- Scored 8+ on Kessler Psychological Distress Scale (K6; screener scale)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of a Brief Self-Compassion Intervention on Shame and Mental Health Treatment-Seeking Among Distressed University Students
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.
Read the detailed 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.
- Conditions
- Psychological Distress
- Being tested
- Self-compassion workshop, Mental health literacy workshop, Control workshop
- Keywords
- Self-compassion, Mental health literacy, University students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-compassion workshopOther
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 workshopOther
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 workshopOther
The control workshop provides participants with basic information about mental health resources.
| Study group | Role | What they receive |
|---|---|---|
| Self-compassion intervention | Experimental | Brief (20-minute) workshop with a self-compassion writing exercise and information about mental health resources available to students. Receives: Other: Self-compassion workshop |
| Mental health literacy intervention | Experimental | Brief (20-minute) workshop with information and a written reflection about common mental disorders, and information about mental health resources available to students. Receives: Other: Mental health literacy workshop |
| Control | Active comparator | Brief (7-minute) workshop with information about mental health resources available to students. Receives: Other: Control workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from pre-intervention to immediately post-intervention
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.
Measured: Change from baseline to 2 weeks and 3 months post-intervention
Treatment-seeking intention questions (researcher-generated)
4 self-report questions to assess changes in intentions of seeking mental health treatment or resources.
Measured: Change from baseline to immediately, 2 weeks, and 3 months post-intervention
Treatment-seeking behaviours questions (researcher-generated)
5 self-report questions to assess changes in mental health treatment-seeking behaviours.
Measured: Change from baseline to immediately, 2 weeks, and 3 months post-intervention
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.
Measured: Change from baseline to immediately, 2 weeks, and 3 months post-intervention
Secondary outcomes (2)
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.
Measured: Immediately post-intervention
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.
Measured: Change from baseline to 2 weeks and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start12 Nov 2021
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1/3 of the study participants (anticipated n=100) will be randomly assigned to the self-compassion intervention group, 1/3 of the participants (anticipated n=100) will be placed into the mental health literacy intervention group, and 1/3 of the study participants (anticipcated n=100) will be placed into the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Kelly, University of Waterloo
- Investigators
- Allison Kelly, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284123
- Sponsor's protocol ID
- 42483
- Status last verified
- Jun 2024
- First submitted
- 8 Mar 2022
- Last updated
- 4 Jun 2024
- 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Brief Self-Compassion Intervention on Shame and Mental Health Treatment-Seeking Among Distressed University Students
- ClinicalTrials.gov ID
- NCT05284123
- Acronym / sponsor ID
- 42483
- Conditions
- Psychological Distress
- Keywords
- Self-compassion, Mental health literacy, University students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 17 Mar 2022 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 1/3 of the study participants (anticipated n=100) will be randomly assigned to the self-compassion intervention group, 1/3 of the participants (anticipated n=100) will be placed into the mental health literacy intervention group, and 1/3 of the study participants (anticipcated n=100) will be placed into the control group.
| Arm | Type | Receives |
|---|---|---|
| Self-compassion intervention | Experimental | Other: Self-compassion workshopBrief (20-minute) workshop with a self-compassion writing exercise and information about mental health resources available to students. |
| Mental health literacy intervention | Experimental | Other: Mental health literacy workshopBrief (20-minute) workshop with information and a written reflection about common mental disorders, and information about mental health resources available to students. |
| Control | Active comparator | Other: Control workshopBrief (7-minute) workshop with information about mental health resources available to students. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Undergraduate student at University of Waterloo with a SONA account
- Scored 8+ on Kessler Psychological Distress Scale (K6; screener scale)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Self-compassion workshopThe 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. | Other | Self-compassion intervention |
| Mental health literacy workshopThe 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. | Other | Mental health literacy intervention |
| Control workshopThe control workshop provides participants with basic information about mental health resources. | Other | Control |
Primary outcome
State Shame and Guilt Scale (shame subscale)
Time frame: Change from pre-intervention to immediately post-intervention
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.
Experience of Shame Scale
Time frame: Change from baseline to 2 weeks and 3 months post-intervention
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.
Treatment-seeking intention questions (researcher-generated)
Time frame: Change from baseline to immediately, 2 weeks, and 3 months post-intervention
4 self-report questions to assess changes in intentions of seeking mental health treatment or resources.
Treatment-seeking behaviours questions (researcher-generated)
Time frame: Change from baseline to immediately, 2 weeks, and 3 months post-intervention
5 self-report questions to assess changes in mental health treatment-seeking behaviours.
Distress Disclosure Index
Time frame: Change from baseline to immediately, 2 weeks, and 3 months post-intervention
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.
2 secondary outcomes
Compassionate Engagement and Action Scale (adapted self-compassion subscale)
Time frame: Immediately post-intervention
Kessler Psychological Distress Scale (K6)
Time frame: Change from baseline to 2 weeks and 3 months post-intervention
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 4 Jun 2024.
- 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.
Allison Kelly, PhD principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-compassion workshop and Mental health literacy workshop in people with Psychological Distress, run by University of Waterloo 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 2 inclusion and 1 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 4 Jun 2024. 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?
State Shame and Guilt Scale (shame subscale) (time frame: Change from pre-intervention to immediately post-intervention). The study lists 5 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 4 Jun 2024.