Understanding and Intervening With State Shame and Self-criticism

NCT ID: NCT06200675

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 348 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2023-12-31

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.

Conditions

Self-Criticism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Compassion-based intervention

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.

Group Type: EXPERIMENTAL

Compassion-based intervention

Intervention Type: 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.

Logic-based intervention

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.

Group Type: EXPERIMENTAL

Logic-based intervention

Intervention Type: 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.

Placebo control condition

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.

Group Type: ACTIVE_COMPARATOR

Placebo control condition

Intervention Type: 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.

Interventions

Compassion-based intervention

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.

Intervention Type: OTHER

Logic-based intervention

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.

Intervention Type: OTHER

Placebo control condition

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Allison Kelly

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison C. Kelly, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

University of Waterloo

Waterloo, Ontario, Canada

Countries

Canada

References

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Other Identifiers

45443

Identifier Type: -

Identifier Source: org_study_id