ShameNCT04600557
A Compassion-based Intervention for Internal and External Shame
A study testing Receiving compassionate responses from confederates and Receiving no response from confederates in people with Shame and Compassion, run by University of Texas at Austin at 1 site in United States.
Trial summary
This is a four-arm randomized pilot study aimed at reducing internal and/or external shame using self-compassion and/or compassion from others. The study is designed to test the theory that trait shame is comprised of both internal and external shame and to test compassion for others as an intervention for external… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shame, Compassion
- What is being tested?
- Receiving compassionate responses from confederates and Receiving no response from confederates
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 439 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2019to 18 Nov 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated levels of internal and external shame
- Can recall two shameful experiences
Who cannot join
- Active suicidal ideation as measured by endorsement of 2 (I would like to kill myself) or 3 (I would kill myself if I had the chance) on BDI-II item 9
- Endorses intent to harm or kill others
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin
Austin, Texas, 78705
About this study
This is a four-arm randomized pilot study aimed at reducing internal and/or external shame using self-compassion and/or compassion from others. The study is designed to test the theory that trait shame is comprised of both internal and external shame and to test compassion for others as an intervention for external shame.
Read the detailed description
Shame is a common, painful emotion involving negative evaluations of the self. It has been theorized that trait shame involves both internal shame (i.e., evaluating oneself negatively) and external shame (i.e., perceiving that others evaluate the self negatively). Shame is experienced across a variety of psychiatric illnesses, yet it has been highly understudied.
Self-compassion has been used as an intervention for reducing shame in a variety of research studies, often in the context of a specific psychiatric disorder. However, self-compassion interventions, which aim to change the way one thinks and feels about oneself, may specifically target internal shame but not external shame. It is proposed that receiving compassion from others is an analogous and plausible intervention for external shame. In order to test the theory that trait shame is comprised of both internal and external shame and to test compassion for others as an intervention for external shame, a four-arm randomized pilot study aimed at reducing internal and/or external shame using self-compassion and/or compassion from others is proposed here.
Participants (N=180) scoring high on both internal and external shame on self-report measures will be assessed at baseline using both questionnaires and a shame-memory recall. Participants will be randomized to one of four conditions: a) describing a shameful experience using a self-compassionate prompt and receiving no verbal responses from confederates (self-compassion only), b) describing a shameful experience using a neutral prompt and receiving compassionate responses from confederates (compassion from others only), c) both describing a shameful experience using a self-compassionate prompt and receiving compassionate responses from confederates (self-compassion plus compassion from others), or d) describing a shameful experience using a neutral prompt and receiving no verbal responses from confederates (sharing-only control). Participants will complete questionnaires and shame-memory recalls again immediately following the sharing intervention and at a one-week post-intervention follow-up.
The two primary outcome measures will be state internal shame, as measured by the Internalized Shame Sclae, and state external shame, as measured by the Other As a Shamer scale. Both the Internalized Shame Scale and Other As a Shamer scale will be administered at baseline (immediately pre-treatment), immediately post-treatment, and a one-week post-intervention follow-up. Secondary outcome measures will include the Positive and Negative Affect Scale, and a real-time assessment of state shame.
It is expected that (a) participants assigned to describe a shameful experience using self-compassionate instructions will display larger reductions in internal shame relative to those assigned to describe a shameful experience using neutral instructions; (b) participants who receive compassionate responses from others after sharing a shameful experience will display larger reductions in external shame relative to those assigned to a listening-only control; and (c) participants assigned to describe a shameful experience using self-compassionate instructions combined with receiving compassionate responses from others will display larger reductions in both internal and external shame relative to participants who receive either component alone.
- Conditions
- Shame, Compassion
- Being tested
- Describing a shameful experience using a self-compassionate prompt, Receiving compassionate responses from confederates, Describing a shameful experience using a neutral prompt, Receiving no response from confederates
- Keywords
- compassion, self-compassion, shame
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Describing a shameful experience using a self-compassionate promptBehavioural
Also called Self-compassionate prompt
Participants will be instructed to describe a shameful experience to two confederates using a self-compassionate prompt
Receiving compassionate responses from confederatesBehavioural
Also called Compassionate confederates
Following the participant's description of a shameful experience, two confederates will respond with compassionate responses
Describing a shameful experience using a neutral promptBehavioural
Also called Neutral prompt
Participants will be instructed to describe a shameful experience to two confederates using a neutral (i.e., not self-compassionate) prompt
Receiving no response from confederatesBehavioural
Also called Neutral confederates
Following the participant's description of a shameful experience, two confederates will not be allowed to provide any verbal response
| Study group | Role | What they receive |
|---|---|---|
| Self-compassion only | Experimental | Describing a shameful experience using a self-compassionate prompt and receiving no verbal responses from confederates Receives: Behavioral: Describing a shameful experience using a self-compassionate prompt; Behavioral: Receiving no response from confederates |
| Compassion from others only | Experimental | Describing a shameful experience using a neutral prompt and receiving compassionate responses from confederates Receives: Behavioral: Receiving compassionate responses from confederates; Behavioral: Describing a shameful experience using a neutral prompt |
| Self-compassion plus compassion from others | Experimental | Both describing a shameful experience using a self-compassionate prompt and receiving compassionate responses from confederates Receives: Behavioral: Describing a shameful experience using a self-compassionate prompt; Behavioral: Receiving compassionate responses from confederates |
| Sharing-only control | Active comparator | Describing a shameful experience using a neutral prompt and receiving no verbal responses from confederates Receives: Behavioral: Describing a shameful experience using a neutral prompt; Behavioral: Receiving no response from confederates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal shame
Measured by scores on Internalized Shame Scale (range: 0-120, higher indicates more shame)
Measured: One-week post-intervention
Internal shame
Measured by scores on Internalized Shame Scale (range: 0-120, higher indicates more shame)
Measured: 5 minutes post-intervention
External shame
Measured by scores on Other As Shamer Scale (range: 0-72, higher indicates more shame)
Measured: One-week post-intervention
External shame
Measured by scores on Other As Shamer Scale (range: 0-72, higher indicates more shame)
Measured: 5 minutes post-intervention
Secondary outcomes (12)
Shame activation
Real-time assessment of shame activation during shame memory recall tasks (range: 0-100)
Measured: 5 minutes post-intervention
Shame activation
Real-time assessment of shame activation during shame memory recall tasks (range: 0-100)
Measured: one-week follow-up
State shame
Micro-assessment of state shame using Positive and Negative Affect Scale (range: 1-5, higher indicates more shame)
Measured: 5 minutes post-intervention
State shame
Micro-assessment of state shame using Positive and Negative Affect Scale (range: 1-5, higher indicates more shame)
Measured: one-week follow-up
Electrodermal response to shame
Measured in microsiemens (μS) by Empatica E4 during shame memory recall tasks
Measured: 5 minutes post-intervention
Electrodermal response to shame
Measured in microsiemens (μS) by Empatica E4 during shame memory recall tasks
Measured: one-week follow-up
Blood volume pulse in reaction to shame
Changes in blood volume measured by Empatica E4 during shame memory recall tasks
Measured: 5 minutes post-intervention
Blood volume pulse in reaction to shame
Changes in blood volume measured by Empatica E4 during shame memory recall tasks
Measured: one-week follow-up
Motion in reaction to shame
Measured by 3-axis accelerometer sensor in the range [-2g, 2g] using Empatica E4 during shame memory recall tasks
Measured: 5 minutes post-intervention
Motion in reaction to shame
Measured by 3-axis accelerometer sensor in the range [-2g, 2g] using Empatica E4 during shame memory recall tasks
Measured: one-week follow-up
Skin temperature reaction to shame
Temperature measured in degrees Celcius by Empatica E4 during shame memory recall tasks
Measured: 5 minutes post-intervention
Skin temperature reaction to shame
Temperature measured in degrees Celcius by Empatica E4 during shame memory recall tasks
Measured: one-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start12 Feb 2019
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for ShameStudies 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
- Participants are randomly assigned to one of four conditions throughout the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Telch, University of Texas at Austin
- Investigators
- Michael J Telch, PhD, Principal investigator, Professor of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600557
- Sponsor's protocol ID
- 2018-07-0058
- Status last verified
- Nov 2021
- First submitted
- 10 Oct 2020
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cook, D. R. Measuring shame: the internalized shame scale. Alcoholism Treatment Quarterly, 1987; 4, 197- 215.
del Rosario, P.M., & White, R.M. The Internalized Shame Scale: Temporal stability, internal consistency, and principal components analysis. Personality and Individual Differences. 2006; 41, 95-103.
Goss, K., Gilbert, P., & Allen, S. An exploration of shame measures-I: The Other As Shamer scale. Person. Individ. Diff.,1994; 17(5), 713-717.
Andrews B, Qian M, Valentine JD. Predicting depressive symptoms with a new measure of shame: The Experience of Shame Scale. Br J Clin Psychol. 2002 Mar;41(Pt 1):29-42. doi: 10.1348/014466502163778.
PubMed 11931676Neff, K.D. The development and validation of a scale to measure self-compassion. Self and Identity. 2003; 2, 223-250.
Rybak, C.J. & Brown, B. Assessment of internalized shame: Validity and reliability of the Internalized Shame Scale. Alcoholism Treatment Quarterly. 1996; 14:1.
American Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing. 2013.
Au TM, Sauer-Zavala S, King MW, Petrocchi N, Barlow DH, Litz BT. Compassion-Based Therapy for Trauma-Related Shame and Posttraumatic Stress: Initial Evaluation Using a Multiple Baseline Design. Behav Ther. 2017 Mar;48(2):207-221. doi: 10.1016/j.beth.2016.11.012. Epub 2016 Nov 29.
PubMed 28270331Gilbert P. The evolution of social attractiveness and its role in shame, humiliation, guilt and therapy. Br J Med Psychol. 1997 Jun;70(2):113-47. doi: 10.1111/j.2044-8341.1997.tb01893.x.
PubMed 9210990Gilbert, P. What Is shame? Some core issues and controversies. In Shame: Interpersonal behavior, psychopathology, and culture. 1998.
Gilbert, P., & Procter, S. Compassionate mind training for people with high shame and self-criticism: Overview and pilot study of a group therapy approach. In Clinical Psychology and Psychotherapy. 2006; 13(6): 353-379. https://doi.org/10.1002/cpp.507
Johnson, E. A., & O'Brien, K. A. Self-Compassion Soothes the Savage EGO-Threat System: Effects on Negative Affect, Shame, Rumination, and Depressive Symptoms. Journal of Social and Clinical Psychology. 2013; 32(9), 939-963. https://doi.org/10.1521/jscp.2013.32.9.939
Judge, L., Cleghorn, A., McEwan, K., & Gilbert, P. An exploration of group-based compassion focused therapy for a heterogeneous range of clients presenting to a community mental health team. International Journal of Cognitive Therapy. 2012. https://doi.org/10.1521/ijct.2012.5.4.420
Kim S, Thibodeau R, Jorgensen RS. Shame, guilt, and depressive symptoms: a meta-analytic review. Psychol Bull. 2011 Jan;137(1):68-96. doi: 10.1037/a0021466.
PubMed 21219057Lewis, M. Shame: The exposed self. New York: Free Press. 1992.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Compassion-based Intervention for Internal and External Shame
- ClinicalTrials.gov ID
- NCT04600557
- Acronym / sponsor ID
- 2018-07-0058
- Conditions
- Shame, Compassion
- Keywords
- compassion, self-compassion, shame
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 23 Oct 2020 (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.
This is a four-arm randomized pilot study aimed at reducing internal and/or external shame using self-compassion and/or compassion from others. The study is designed to test the theory that trait shame is comprised of both internal and external shame and to test compassion for others as an intervention for external shame.
Detailed description
Shame is a common, painful emotion involving negative evaluations of the self. It has been theorized that trait shame involves both internal shame (i.e., evaluating oneself negatively) and external shame (i.e., perceiving that others evaluate the self negatively). Shame is experienced across a variety of psychiatric illnesses, yet it has been highly understudied.
Self-compassion has been used as an intervention for reducing shame in a variety of research studies, often in the context of a specific psychiatric disorder. However, self-compassion interventions, which aim to change the way one thinks and feels about oneself, may specifically target internal shame but not external shame. It is proposed that receiving compassion from others is an analogous and plausible intervention for external shame. In order to test the theory that trait shame is comprised of both internal and external shame and to test compassion for others as an intervention for external shame, a four-arm randomized pilot study aimed at reducing internal and/or external shame using self-compassion and/or compassion from others is proposed here.
Participants (N=180) scoring high on both internal and external shame on self-report measures will be assessed at baseline using both questionnaires and a shame-memory recall. Participants will be randomized to one of four conditions: a) describing a shameful experience using a self-compassionate prompt and receiving no verbal responses from confederates (self-compassion only), b) describing a shameful experience using a neutral prompt and receiving compassionate responses from confederates (compassion from others only), c) both describing a shameful experience using a self-compassionate prompt and receiving compassionate responses from confederates (self-compassion plus compassion from others), or d) describing a shameful experience using a neutral prompt and receiving no verbal responses from confederates (sharing-only control). Participants will complete questionnaires and shame-memory recalls again immediately following the sharing intervention and at a one-week post-intervention follow-up.
The two primary outcome measures will be state internal shame, as measured by the Internalized Shame Sclae, and state external shame, as measured by the Other As a Shamer scale. Both the Internalized Shame Scale and Other As a Shamer scale will be administered at baseline (immediately pre-treatment), immediately post-treatment, and a one-week post-intervention follow-up. Secondary outcome measures will include the Positive and Negative Affect Scale, and a real-time assessment of state shame.
It is expected that (a) participants assigned to describe a shameful experience using self-compassionate instructions will display larger reductions in internal shame relative to those assigned to describe a shameful experience using neutral instructions; (b) participants who receive compassionate responses from others after sharing a shameful experience will display larger reductions in external shame relative to those assigned to a listening-only control; and (c) participants assigned to describe a shameful experience using self-compassionate instructions combined with receiving compassionate responses from others will display larger reductions in both internal and external shame relative to participants who receive either component alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants are randomly assigned to one of four conditions throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Self-compassion only | Experimental | Behavioral: Describing a shameful experience using a self-compassionate prompt, Behavioral: Receiving no response from confederatesDescribing a shameful experience using a self-compassionate prompt and receiving no verbal responses from confederates |
| Compassion from others only | Experimental | Behavioral: Receiving compassionate responses from confederates, Behavioral: Describing a shameful experience using a neutral promptDescribing a shameful experience using a neutral prompt and receiving compassionate responses from confederates |
| Self-compassion plus compassion from others | Experimental | Behavioral: Describing a shameful experience using a self-compassionate prompt, Behavioral: Receiving compassionate responses from confederatesBoth describing a shameful experience using a self-compassionate prompt and receiving compassionate responses from confederates |
| Sharing-only control | Active comparator | Behavioral: Describing a shameful experience using a neutral prompt, Behavioral: Receiving no response from confederatesDescribing a shameful experience using a neutral prompt and receiving no verbal responses from confederates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elevated levels of internal and external shame
- Can recall two shameful experiences
Key exclusion criteria (2 listed)
- Active suicidal ideation as measured by endorsement of 2 (I would like to kill myself) or 3 (I would kill myself if I had the chance) on BDI-II item 9
- Endorses intent to harm or kill others
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 |
|---|---|---|
| Describing a shameful experience using a self-compassionate promptAlso: Self-compassionate promptParticipants will be instructed to describe a shameful experience to two confederates using a self-compassionate prompt | Behavioural | Self-compassion only, Self-compassion plus compassion from others |
| Receiving compassionate responses from confederatesAlso: Compassionate confederatesFollowing the participant's description of a shameful experience, two confederates will respond with compassionate responses | Behavioural | Compassion from others only, Self-compassion plus compassion from others |
| Describing a shameful experience using a neutral promptAlso: Neutral promptParticipants will be instructed to describe a shameful experience to two confederates using a neutral (i.e., not self-compassionate) prompt | Behavioural | Compassion from others only, Sharing-only control |
| Receiving no response from confederatesAlso: Neutral confederatesFollowing the participant's description of a shameful experience, two confederates will not be allowed to provide any verbal response | Behavioural | Self-compassion only, Sharing-only control |
Primary outcome
Internal shame
Time frame: One-week post-intervention
Measured by scores on Internalized Shame Scale (range: 0-120, higher indicates more shame)
Internal shame
Time frame: 5 minutes post-intervention
Measured by scores on Internalized Shame Scale (range: 0-120, higher indicates more shame)
External shame
Time frame: One-week post-intervention
Measured by scores on Other As Shamer Scale (range: 0-72, higher indicates more shame)
External shame
Time frame: 5 minutes post-intervention
Measured by scores on Other As Shamer Scale (range: 0-72, higher indicates more shame)
12 secondary outcomes
Shame activation
Time frame: 5 minutes post-intervention
Shame activation
Time frame: one-week follow-up
State shame
Time frame: 5 minutes post-intervention
State shame
Time frame: one-week follow-up
Electrodermal response to shame
Time frame: 5 minutes post-intervention
Electrodermal response to shame
Time frame: one-week follow-up
Blood volume pulse in reaction to shame
Time frame: 5 minutes post-intervention
Blood volume pulse in reaction to shame
Time frame: one-week follow-up
Motion in reaction to shame
Time frame: 5 minutes post-intervention
Motion in reaction to shame
Time frame: one-week follow-up
Skin temperature reaction to shame
Time frame: 5 minutes post-intervention
Skin temperature reaction to shame
Time frame: one-week follow-up
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 1 Dec 2021.
- BackgroundCook, D. R. Measuring shame: the internalized shame scale. Alcoholism Treatment Quarterly, 1987; 4, 197- 215.
- Backgrounddel Rosario, P.M., & White, R.M. The Internalized Shame Scale: Temporal stability, internal consistency, and principal components analysis. Personality and Individual Differences. 2006; 41, 95-103.
- BackgroundGoss, K., Gilbert, P., & Allen, S. An exploration of shame measures-I: The Other As Shamer scale. Person. Individ. Diff.,1994; 17(5), 713-717.
- Background: PubMed 11931676Andrews B, Qian M, Valentine JD. Predicting depressive symptoms with a new measure of shame: The Experience of Shame Scale. Br J Clin Psychol. 2002 Mar;41(Pt 1):29-42. doi: 10.1348/014466502163778.
- BackgroundNeff, K.D. The development and validation of a scale to measure self-compassion. Self and Identity. 2003; 2, 223-250.
- BackgroundRybak, C.J. & Brown, B. Assessment of internalized shame: Validity and reliability of the Internalized Shame Scale. Alcoholism Treatment Quarterly. 1996; 14:1.
- BackgroundAmerican Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing. 2013.
- Background: PubMed 28270331Au TM, Sauer-Zavala S, King MW, Petrocchi N, Barlow DH, Litz BT. Compassion-Based Therapy for Trauma-Related Shame and Posttraumatic Stress: Initial Evaluation Using a Multiple Baseline Design. Behav Ther. 2017 Mar;48(2):207-221. doi: 10.1016/j.beth.2016.11.012. Epub 2016 Nov 29.
- Background: PubMed 9210990Gilbert P. The evolution of social attractiveness and its role in shame, humiliation, guilt and therapy. Br J Med Psychol. 1997 Jun;70(2):113-47. doi: 10.1111/j.2044-8341.1997.tb01893.x.
- BackgroundGilbert, P. What Is shame? Some core issues and controversies. In Shame: Interpersonal behavior, psychopathology, and culture. 1998.
- BackgroundGilbert, P., & Procter, S. Compassionate mind training for people with high shame and self-criticism: Overview and pilot study of a group therapy approach. In Clinical Psychology and Psychotherapy. 2006; 13(6): 353-379. https://doi.org/10.1002/cpp.507
- BackgroundJohnson, E. A., & O'Brien, K. A. Self-Compassion Soothes the Savage EGO-Threat System: Effects on Negative Affect, Shame, Rumination, and Depressive Symptoms. Journal of Social and Clinical Psychology. 2013; 32(9), 939-963. https://doi.org/10.1521/jscp.2013.32.9.939
- Individual participant dataSharing planned: No
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Shame
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.
Michael J Telch, PhD principal investigator
Professor of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receiving compassionate responses from confederates and Receiving no response from confederates in people with Shame and Compassion, run by University of Texas at Austin at 1 site in United States.
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 2 inclusion and 2 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 1 Dec 2021. 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 United States. 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?
Internal shame (time frame: One-week post-intervention). The study lists 4 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 NCT04600557, which also lists 18 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 1 Dec 2021.