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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04600557
Other study ID # 2018-07-0058
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 12, 2019
Est. completion date November 18, 2021

Study information

Verified date November 2021
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 shame.


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.


Recruitment information / eligibility

Status Completed
Enrollment 439
Est. completion date November 18, 2021
Est. primary completion date November 18, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Elevated levels of internal and external shame - Can recall two shameful experiences Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Describing a shameful experience using a self-compassionate prompt
Participants will be instructed to describe a shameful experience to two confederates using a self-compassionate prompt
Receiving compassionate responses from confederates
Following the participant's description of a shameful experience, two confederates will respond with compassionate responses
Describing a shameful experience using a 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 confederates
Following the participant's description of a shameful experience, two confederates will not be allowed to provide any verbal response

Locations

Country Name City State
United States The University of Texas at Austin Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

References & Publications (18)

American Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing. 2013.

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. — View Citation

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. — View Citation

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.

Gilbert P. The evolution of social attractiveness and its role in shame, humiliation, guilt and therapy. Br J Med Psychol. 1997 Jun;70 ( Pt 2):113-47. Review. — View Citation

Gilbert, 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

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.

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. — View Citation

Lewis, M. Shame: The exposed self. New York: Free Press. 1992.

Lewis, M. The role of the self in shame. Social Research, 70, 1181-1204. 2003.

Luoma JB, Kohlenberg BS, Hayes SC, Fletcher L. Slow and steady wins the race: a randomized clinical trial of acceptance and commitment therapy targeting shame in substance use disorders. J Consult Clin Psychol. 2012 Feb;80(1):43-53. doi: 10.1037/a0026070. Epub 2011 Oct 31. — View Citation

Neff, 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.

Skinta, M. D., Lezama, M., Wells, G., & Dilley, J. W. Acceptance and Compassion-Based Group Therapy to Reduce HIV Stigma. Cognitive and Behavioral Practice. 2015. https://doi.org/10.1016/j.cbpra.2014.05.006

* Note: There are 18 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Internal shame Measured by scores on Internalized Shame Scale (range: 0-120, higher indicates more shame) One-week post-intervention
Primary Internal shame Measured by scores on Internalized Shame Scale (range: 0-120, higher indicates more shame) 5 minutes post-intervention
Primary External shame Measured by scores on Other As Shamer Scale (range: 0-72, higher indicates more shame) One-week post-intervention
Primary External shame Measured by scores on Other As Shamer Scale (range: 0-72, higher indicates more shame) 5 minutes post-intervention
Secondary Shame activation Real-time assessment of shame activation during shame memory recall tasks (range: 0-100) 5 minutes post-intervention
Secondary Shame activation Real-time assessment of shame activation during shame memory recall tasks (range: 0-100) one-week follow-up
Secondary State shame Micro-assessment of state shame using Positive and Negative Affect Scale (range: 1-5, higher indicates more shame) 5 minutes post-intervention
Secondary State shame Micro-assessment of state shame using Positive and Negative Affect Scale (range: 1-5, higher indicates more shame) one-week follow-up
Secondary Electrodermal response to shame Measured in microsiemens (µS) by Empatica E4 during shame memory recall tasks 5 minutes post-intervention
Secondary Electrodermal response to shame Measured in microsiemens (µS) by Empatica E4 during shame memory recall tasks one-week follow-up
Secondary Blood volume pulse in reaction to shame Changes in blood volume measured by Empatica E4 during shame memory recall tasks 5 minutes post-intervention
Secondary Blood volume pulse in reaction to shame Changes in blood volume measured by Empatica E4 during shame memory recall tasks one-week follow-up
Secondary Motion in reaction to shame Measured by 3-axis accelerometer sensor in the range [-2g, 2g] using Empatica E4 during shame memory recall tasks 5 minutes post-intervention
Secondary Motion in reaction to shame Measured by 3-axis accelerometer sensor in the range [-2g, 2g] using Empatica E4 during shame memory recall tasks one-week follow-up
Secondary Skin temperature reaction to shame Temperature measured in degrees Celcius by Empatica E4 during shame memory recall tasks 5 minutes post-intervention
Secondary Skin temperature reaction to shame Temperature measured in degrees Celcius by Empatica E4 during shame memory recall tasks one-week follow-up
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