Self-CriticismNCT06200675
Understanding and Intervening With State Shame and Self-criticism
A study testing Compassion-based intervention and Logic-based intervention in people with Self-Criticism, run by University of Waterloo at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self-Criticism
- What is being tested?
- Compassion-based intervention and Logic-based intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 1 siteCanada
- Study dates
- 17 Oct 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Best to Understand and Intervene With State Shame and Self-criticism: A Randomised Clinical Trial Comparing Two Theoretical Perspectives
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?
Read more
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.
Read the 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
- Being tested
- Compassion-based intervention, Logic-based intervention, Placebo control condition
- Keywords
- Self-compassion, Compassion, Online single-session intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion-based interventionOther
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 interventionOther
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 conditionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Placebo control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Immediately pre-shame induction, immediately after the shame induction, immediately after the intervention
Secondary outcomes (4)
Soothing affect
This adapted measure consists of the Serenity Subscale of the PANAS-X, the Safe/Warmth Positive Affect Subscale of the Types of Positive Affect Scale, and researcher-generated items). Self-report questionnaire consists of 13 items on a 5-point Likert scale (scored 1-5). Mean scores range from 1-5, with higher scores indicating higher degrees of soothing affect.
Measured: Immediately after the intervention
State self-compassion assessed via Compassionate Engagement and Action Scale (adapted self-compassion subscale)
Self-report measure consisting of 13 items on a 10-point Likert scale (scored 1-10), with higher scores indicating greater state self-compassion.
Measured: Immediately after the intervention
State self-compassion assessed via State Self-Compassion Scale (adapted)
Self-report measure consisting of 6 items rated on a 5-point Likert scale (scored from 1-5). Mean scores range from 1-5, with higher scores indicating greater state self-compassion.
Measured: Immediately after the intervention
Self-reported reassurance (researcher-generated)
Self-report measure consisting of 4 items assessed on a 5-point Likert scale (scored 1-5). Mean scores range from 1-5, with higher scores indicating greater self-reassurance.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start17 Oct 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Self-CriticismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Kelly, University of Waterloo
- Investigators
- Allison C. Kelly, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200675
- Sponsor's protocol ID
- 45443
- Status last verified
- May 2024
- First submitted
- 19 Dec 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greenberger, D., & Padesky, C. A. (1995). Mind over mood: A cognitive therapy treatment manual for clients. Guilford Press.
Tolkien, J. R. R. (2009). The Hobbit (E-book ed.). HarperCollins.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Best to Understand and Intervene With State Shame and Self-criticism: A Randomised Clinical Trial Comparing Two Theoretical Perspectives
- ClinicalTrials.gov ID
- NCT06200675
- Acronym / sponsor ID
- 45443
- Conditions
- Self-Criticism
- Keywords
- Self-compassion, Compassion, Online single-session intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Compassion-based intervention | Experimental | Other: Compassion-based interventionParticipants 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. |
| Logic-based intervention | Experimental | Other: Logic-based interventionParticipants 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. |
| Placebo control condition | Active comparator | Other: Placebo control conditionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compassion-based interventionParticipants 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. | Other | Compassion-based intervention |
| Logic-based interventionParticipants 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. | Other | Logic-based intervention |
| Placebo control conditionParticipants 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. | Other | Placebo control condition |
Primary outcome
State Shame and Guilt Scale (shame subscale)
Time frame: Immediately pre-shame induction, immediately after the shame induction, immediately after the intervention
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.
Momentary self-criticism
Time frame: Immediately pre-shame induction, immediately after the shame induction, immediately after the intervention
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.
Self-Assessment Manikin (Arousal and Pleasure subscales only)
Time frame: Immediately pre-shame induction, immediately after the shame induction, immediately after the intervention
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.
4 secondary outcomes
Soothing affect
Time frame: Immediately after the intervention
State self-compassion assessed via Compassionate Engagement and Action Scale (adapted self-compassion subscale)
Time frame: Immediately after the intervention
State self-compassion assessed via State Self-Compassion Scale (adapted)
Time frame: Immediately after the intervention
Self-reported reassurance (researcher-generated)
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- BackgroundGreenberger, D., & Padesky, C. A. (1995). Mind over mood: A cognitive therapy treatment manual for clients. Guilford Press.
- BackgroundTolkien, J. R. R. (2009). The Hobbit (E-book ed.). HarperCollins.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison C. Kelly, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion-based intervention and Logic-based intervention in people with Self-Criticism, run by University of Waterloo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Shame and Guilt Scale (shame subscale) (time frame: Immediately pre-shame induction, immediately after the shame induction, immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06200675, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.