Clinical trial NCT06200675: Understanding and Intervening With State Shame and Self-criticism
Official title: How Best to Understand and Intervene With State Shame and Self-criticism: A Randomised Clinical Trial Comparing Two Theoretical Perspectives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-Criticism
Keywords: Self-compassion
Compassion
Online single-session intervention
Lead sponsor: University of Waterloo
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1/3 of the study participants (anticipated n=116) will be randomly assigned to the self-compassion intervention group, 1/3 of the participants (anticipated n=116) will be placed into the logic-based intervention group, and 1/3 of the study participants (anticipated n=116) will be placed into the control group.
Primary purpose: TREATMENT

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-criticism. The main questions it aims to answer are:

After a momentary shame induction, will a compassion-based intervention and a logic-based intervention both be more beneficial than a placebo control condition in terms of therapeutic outcomes?

Will the compassion-based intervention most effectively increase soothing affect, state self-compassion, and state self-reassurance?

Will the effects of these two interventions (1) differ as a function of the individual's trait self-criticism, and (2) will this be due to differing indirect effects of the intervention on safe/soothed feelings based on trait self-criticism?

Participants will first complete a set of baseline measures. Two to seven days later, they will be randomly assigned to one of three study conditions (i.e., compassion-based, logic-based, placebo control) after a brief shame induction. Participants will be asked to complete a set of questionnaires both before and after the shame induction as well as post-intervention.

This research will help us understand how best to intervene with the shame and self-criticism.

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 of a brief (10-15 minute) one-session online intervention (compassion-based, logic-based, or placebo control) after a shame induction. Participants assigned to the compassion-based intervention will be asked to engage in a self-compassion exercise, where they will be asked to write about and experience their feelings while connecting to their compassionate self. Participants assigned to the logic-based intervention will be asked to engage in a logic-based exercise that was adapted from a thought record often completed during CBT treatment. Participants assigned to the placebo control condition will be asked to listen to a portion of an audio recording of "The Hobbit." All conditions will involve audio recordings, and all participants will be asked to re-read what they wrote about their shame, engage in a writing task, and then re-read what they wrote during the intervention writing task.

Eligibility criteria: 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.

1. 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.
2. 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).
3. 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.
4. 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.
5. 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.
6. 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.
7. Participants who were ineligible or withdrew consent will also be excluded from the data.
8. 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.
9. We will inspect the distribution of scores on trait self-criticism and consider excluding extreme outliers with very low or very high scores.

Primary outcomes:
measure: State Shame and Guilt Scale (shame subscale)
timeFrame: Immediately pre-shame induction, immediately after the shame induction, immediately after the intervention
measure: Momentary self-criticism
timeFrame: Immediately pre-shame induction, immediately after the shame induction, immediately after the intervention
measure: Self-Assessment Manikin (Arousal and Pleasure subscales only)
timeFrame: Immediately pre-shame induction, immediately after the shame induction, immediately after the intervention
Secondary outcomes:
measure: Soothing affect
timeFrame: Immediately after the intervention
measure: State self-compassion assessed via Compassionate Engagement and Action Scale (adapted self-compassion subscale)
timeFrame: Immediately after the intervention
measure: State self-compassion assessed via State Self-Compassion Scale (adapted)
timeFrame: Immediately after the intervention
measure: Self-reported reassurance (researcher-generated)
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo
state: Ontario
Study officials:
affiliation: Associate Professor
name: Allison C. Kelly, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenberger, D., & Padesky, C. A. (1995). Mind over mood: A cognitive therapy treatment manual for clients. Guilford Press.
citation: Tolkien, J. R. R. (2009). The Hobbit (E-book ed.). HarperCollins.