Clinical trial NCT04600557: A Compassion-based Intervention for Internal and External Shame
Official title: A Compassion-based Intervention for Internal and External Shame
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shame
Compassion
Keywords: compassion
self-compassion
shame
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of four conditions throughout the study.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Internal shame
timeFrame: One-week post-intervention
measure: Internal shame
timeFrame: 5 minutes post-intervention
measure: External shame
timeFrame: One-week post-intervention
measure: External shame
timeFrame: 5 minutes post-intervention
Secondary outcomes:
measure: Shame activation
timeFrame: 5 minutes post-intervention
measure: Shame activation
timeFrame: one-week follow-up
measure: State shame
timeFrame: 5 minutes post-intervention
measure: State shame
timeFrame: one-week follow-up
measure: Electrodermal response to shame
timeFrame: 5 minutes post-intervention
measure: Electrodermal response to shame
timeFrame: one-week follow-up
measure: Blood volume pulse in reaction to shame
timeFrame: 5 minutes post-intervention
measure: Blood volume pulse in reaction to shame
timeFrame: one-week follow-up
measure: Motion in reaction to shame
timeFrame: 5 minutes post-intervention
measure: Motion in reaction to shame
timeFrame: one-week follow-up
measure: Skin temperature reaction to shame
timeFrame: 5 minutes post-intervention
measure: Skin temperature reaction to shame
timeFrame: one-week follow-up
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: Professor of Psychology
name: Michael J Telch, PhD
role: PRINCIPAL_INVESTIGATOR
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