Understanding and Intervening With State Shame and Self-criticism (NCT06200675) | Clinical Trial Compass
CompletedNot Applicable
Understanding and Intervening With State Shame and Self-criticism
Canada348 participantsStarted 2023-10-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
State Shame and Guilt Scale (shame subscale)
Timeframe: Immediately pre-shame induction, immediately after the shame induction, immediately after the intervention
2
Momentary self-criticism
Timeframe: Immediately pre-shame induction, immediately after the shame induction, immediately after the intervention
3
Self-Assessment Manikin (Arousal and Pleasure subscales only)
Timeframe: Immediately pre-shame induction, immediately after the shame induction, immediately after the intervention
. 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.