NCT05284123

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

2.6 years

First QC Date

March 8, 2022

Last Update Submit

June 3, 2024

Conditions

Keywords

Self-compassionMental health literacyUniversity students

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Compassionate Engagement and Action Scale (adapted self-compassion subscale)

    Immediately post-intervention

  • Kessler Psychological Distress Scale (K6)

    Change from baseline to 2 weeks and 3 months post-intervention

Study Arms (3)

Self-compassion intervention

EXPERIMENTAL

Brief (20-minute) workshop with a self-compassion writing exercise and information about mental health resources available to students.

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.

Other: Mental health literacy workshop

Control

ACTIVE COMPARATOR

Brief (7-minute) workshop with information about mental health resources available to students.

Other: Control workshop

Interventions

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.

Self-compassion intervention

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.

Mental health literacy intervention

The control workshop provides participants with basic information about mental health resources.

Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Undergraduate student at University of Waterloo with a SONA account
  • Scored 8+ on Kessler Psychological Distress Scale (K6; screener scale)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L3G1, Canada

Location

Study Officials

  • Allison Kelly, PhD

    University of Waterloo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant will not know prior to their study participation that there are three different study conditions, and they will not find out which condition they were randomized to until the end of their study participation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 17, 2022

Study Start

November 12, 2021

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

June 4, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations