Understanding and Intervening With State Shame and Self-criticism

NCT06200675 | Completed

• 1 other identifier: 45443
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

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.

Conditions

Self-Criticism

Keywords

Self-compassion; Compassion; Online single-session intervention

Outcome Measures

Primary Outcomes (3)

• State Shame and Guilt Scale (shame subscale)

  Self-report questionnaire with 5 items on a 5-point Likert scale (scored 1-5). Mean scores range from 1-5, with higher scores indicating greater momentary feelings of shame.

  Immediately pre-shame induction, immediately after the shame induction, immediately after the intervention

• Momentary self-criticism

  Self-report questionnaire with 5 items on a 5-point Likert scale (scored 1-5). Mean scores range from 1-5, with higher scores indicating greater momentary self-criticism.

  Immediately pre-shame induction, immediately after the shame induction, immediately after the intervention

• Self-Assessment Manikin (Arousal and Pleasure subscales only)

  Self-report measure with 1 item assessing arousal and 1 item assessing pleasure, on a pictorial 9-point Likert scale (scores ranging from 1-9). Items are scored individually, and higher scores indicate greater degrees of arousal or pleasure.

  Immediately pre-shame induction, immediately after the shame induction, immediately after the intervention

Secondary Outcomes (4)

• Soothing affect

  Immediately after the intervention

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

  Immediately after the intervention

• State self-compassion assessed via State Self-Compassion Scale (adapted)

  Immediately after the intervention

• Self-reported reassurance (researcher-generated)

  Immediately after the intervention

Study Arms (3)

Compassion-based intervention

EXPERIMENTAL

Participants assigned to this intervention will be asked to engage in one brief (10-15 minute) online compassion-focused exercise, where they will be asked to connect to their inner compassionate self. They will be asked to stay connected to that feeling while rereading what they wrote about their feelings of shame and imagining it was someone else who wrote it. Participants will then be asked to write a compassionate response to themselves. Participants will then be asked to reread this response while remaining connected to their compassionate self.

Other: Compassion-based intervention

Logic-based intervention

EXPERIMENTAL

Participants assigned to this intervention will be asked to engage in one brief (10-15 minute) online logic-based exercise that was adapted from a thought record (Greenberger \& Padesky, 1995), which is often completed during cognitive behavioural therapy (CBT) treatment. Participants will be asked to reread what they wrote about their feelings of shame and chose a thought central to their shame to use for this exercise. Participants will be asked to generate evidence for and against their chosen thought, and then generate a more balanced thought. After the exercise, participants will be asked to reread their newly generated more balanced thought.

Other: Logic-based intervention

Placebo control condition

ACTIVE COMPARATOR

Participants assigned to this condition will be asked to listen to a portion of an audio recording of "The Hobbit" (Tolkien, 2009) and then re-read what they wrote about their feelings of shame. They will then be asked to write a reflection about the thoughts and feelings arising from doing so. They will then be asked to re-read what they wrote in this reflection.

Other: Placebo control condition

Interventions

Compassion-based intervention OTHER

Participants assigned to this intervention will be asked to engage in one brief compassion-focused exercise, where they will be asked to be asked to connect to their inner compassionate self. They will be asked to stay connected to that feeling while rereading what they wrote about their feelings of shame and imagining it was someone else who wrote it. Participants will then be asked to write a compassionate response to themselves. Participants will then be asked to reread this response while remaining connected to their compassionate self.

Compassion-based intervention

Logic-based intervention OTHER

Participants assigned to this intervention will be asked to engage in one brief (10-15 minute) online logic-based exercise that was adapted from a CBT thought record. Participants will be asked to reread what they wrote about their feelings of shame and chose a thought central to their shame to use for this exercise. Participants will be asked to generate evidence for and against their chosen thought, and then generate a more balanced thought. After the exercise, participants will be asked to reread their newly generated more balanced thought.

Logic-based intervention

Placebo control condition OTHER

Participants assigned to this intervention will be asked to listen to an audio recording of "The Hobbit" and then re-read what they wrote about their feelings of shame. They will then be asked to write a reflection about the thoughts and feelings arising from doing so. They will then be asked to re-read what they wrote in this reflection.

Placebo control condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Waterloo: lead

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L3G1, Canada

Location

Related Publications (2)

• Greenberger, D., & Padesky, C. A. (1995). Mind over mood: A cognitive therapy treatment manual for clients. Guilford Press.

  BACKGROUND

• Tolkien, J. R. R. (2009). The Hobbit (E-book ed.). HarperCollins.

  BACKGROUND

Study Officials

• Allison C. Kelly, PhD

  Associate Professor

  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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 11, 2024
• Study Start: October 17, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)