Compassion Clinical Trial
Official title:
A Compassion-based Intervention for Internal and External Shame
Verified date | November 2021 |
Source | University of Texas at Austin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas at Austin | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas at Austin |
United States,
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 all — Click here to view all references
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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