NCT04600557

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
439

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2021

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

2.8 years

First QC Date

October 10, 2020

Last Update Submit

November 30, 2021

Conditions

ShameCompassion

Keywords

compassionself-compassionshame

Outcome Measures

Primary Outcomes (4)

  • Internal shame

    Measured by scores on Internalized Shame Scale (range: 0-120, higher indicates more shame)

    One-week post-intervention

  • Internal shame

    Measured by scores on Internalized Shame Scale (range: 0-120, higher indicates more shame)

    5 minutes post-intervention

  • External shame

    Measured by scores on Other As Shamer Scale (range: 0-72, higher indicates more shame)

    One-week post-intervention

  • External shame

    Measured by scores on Other As Shamer Scale (range: 0-72, higher indicates more shame)

    5 minutes post-intervention

Secondary Outcomes (12)

  • Shame activation

    5 minutes post-intervention

  • Shame activation

    one-week follow-up

  • State shame

    5 minutes post-intervention

  • State shame

    one-week follow-up

  • Electrodermal response to shame

    5 minutes post-intervention

  • +7 more secondary outcomes

Study Arms (4)

Self-compassion only

EXPERIMENTAL

Describing a shameful experience using a self-compassionate prompt and receiving no verbal responses from confederates

Behavioral: Describing a shameful experience using a self-compassionate promptBehavioral: Receiving no response from confederates

Compassion from others only

EXPERIMENTAL

Describing a shameful experience using a neutral prompt and receiving compassionate responses from confederates

Behavioral: Receiving compassionate responses from confederatesBehavioral: 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

Behavioral: Describing a shameful experience using a self-compassionate promptBehavioral: 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

Behavioral: Describing a shameful experience using a neutral promptBehavioral: Receiving no response from confederates

Interventions

Describing a shameful experience using a self-compassionate promptBEHAVIORAL

Participants will be instructed to describe a shameful experience to two confederates using a self-compassionate prompt

Also known as: Self-compassionate prompt
Self-compassion onlySelf-compassion plus compassion from others
Receiving compassionate responses from confederatesBEHAVIORAL

Following the participant's description of a shameful experience, two confederates will respond with compassionate responses

Also known as: Compassionate confederates
Compassion from others onlySelf-compassion plus compassion from others
Describing a shameful experience using a neutral promptBEHAVIORAL

Participants will be instructed to describe a shameful experience to two confederates using a neutral (i.e., not self-compassionate) prompt

Also known as: Neutral prompt
Compassion from others onlySharing-only control
Receiving no response from confederatesBEHAVIORAL

Following the participant's description of a shameful experience, two confederates will not be allowed to provide any verbal response

Also known as: Neutral confederates
Self-compassion onlySharing-only control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elevated levels of internal and external shame
  • Can recall two shameful experiences

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78705, United States

Location

Related Publications (18)

  • Cook, D. R. Measuring shame: the internalized shame scale. Alcoholism Treatment Quarterly, 1987; 4, 197- 215.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 11931676BACKGROUND

  • Neff, K.D. The development and validation of a scale to measure self-compassion. Self and Identity. 2003; 2, 223-250.

    BACKGROUND

  • Rybak, C.J. & Brown, B. Assessment of internalized shame: Validity and reliability of the Internalized Shame Scale. Alcoholism Treatment Quarterly. 1996; 14:1.

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 28270331BACKGROUND

  • Gilbert 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.

    PMID: 9210990BACKGROUND

  • Gilbert, P. What Is shame? Some core issues and controversies. In Shame: Interpersonal behavior, psychopathology, and culture. 1998.

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 21219057BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 22040285BACKGROUND

  • 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

    BACKGROUND

Study Officials

  • Michael J Telch, PhD

    Professor of Psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are not told which arm they are assigned to
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to one of four conditions throughout the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

October 10, 2020

First Posted

October 23, 2020

Study Start

February 12, 2019

Primary Completion

November 18, 2021

Study Completion

November 18, 2021

Last Updated

December 1, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)