Status:

COMPLETED

Understanding and Intervening With State Shame and Self-criticism

Lead Sponsor:

University of Waterloo

Conditions:

Self-Criticism

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The goal of this clinical trial is to compare the momentary effects of a one-session intervention (compassion-based, logic-based, or placebo control) on individuals with high or low trait self-critici...

Detailed Description

This clinical trial consists of a two-part online study. Part 1 of this study collects baseline measures and screen out ineligible participants. Part 2 of this study will compare the momentary effects...

Eligibility Criteria

Inclusion

  • Inclusion Criteria for SONA participants:
  • Participants will be UWaterloo undergraduate students with a SONA account.
  • Participants must be able to listen to audio clips (either via device speakers or with headphones) during their study participation.
  • Inclusion Criteria for Prolific participants:
  • Participants will be adults (i.e., 18-64 years of age) with a Prolific account.
  • Participants must be able to listen to audio clips (either via device speakers or with headphones) during their study participation.
  • Prolific participants must also be first language English speakers.
  • Exclusion Criteria:
  • All exclusions will only be made prior to randomization of experimental conditions in Part 2 to abide by Consort guidelines for randomized controlled trials.
  • Any duplicate survey completions from the same participant for the same study survey, as indicated by their embedded ID code in their Qualtrics data, will be excluded from analysis. For Part 1, the most complete survey completion for each participant will be retained. For Part 2, the most complete survey completion for each participant will also be retained unless the participant has begun the shame induction exercise. If a participant in Part 2 has begun the shame induction and then completes another submission, they will be excluded.
  • Participants who do not complete Part 1 measures required for primary hypotheses will also be excluded from analyses (specifically, participants who do not complete the measures of trait self-criticism and trait self-compassion).
  • Participants who complete Part 1 but are not randomized to a condition in Part 2, will be excluded from analyses related to Part 2 variables. We will run ANOVAs and/or non-parametric Kruskal Wallis tests with continuous baseline data as the DVs to test if there are any significant differences between participants who do Part 2 and those who do not. We will also run Fisher-Freeman-Halton exact tests on categorical baseline data to test if there are any significant differences between participants who do Part 2 and those who do not.
  • Participants who respond to several scales within the same survey with overly consistent responses (i.e., appear to click the same response for every scale item, even though some are reverse scored, assessed via testing of scale variances) may be excluded from analyses involving that survey. Their data from other surveys will still be retained for other analyses.
  • Participants who complete a survey in an unreasonably short or long amount of time compared to the average participant may be excluded from analyses involving that survey. Their data from other surveys will still be retained for other analyses.
  • Participants who fail half or more of the attention checks in Part 1, and the first attention check prior to randomization in Part 2 will be excluded from the data.
  • Participants who were ineligible or withdrew consent will also be excluded from the data.
  • Prolific participants who could not complete the Captcha Verification question or fail one or both of the two bot check questions will also be excluded from the analyses.
  • We will inspect the distribution of scores on trait self-criticism and consider excluding extreme outliers with very low or very high scores.

Exclusion

    Key Trial Info

    Start Date :

    October 17 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 31 2023

    Estimated Enrollment :

    348 Patients enrolled

    Trial Details

    Trial ID

    NCT06200675

    Start Date

    October 17 2023

    End Date

    December 31 2023

    Last Update

    May 8 2024

    Active Locations (1)

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    University of Waterloo

    Waterloo, Ontario, Canada, N2L3G1