A Compassion-based Intervention for Internal and External Shame

Study Overview
=================
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.

Official Title
-----------------
A Compassion-based Intervention for Internal and External Shame

Conditions
-----------------
Shame, Compassion

Intervention / Treatment
-----------------
* Behavioral: Describing a shameful experience using a self-compassionate prompt
* Behavioral: Receiving compassionate responses from confederates
* Behavioral: Describing a shameful experience using a neutral prompt
* Behavioral: Receiving no response from confederates


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to one of four conditions throughout the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-compassion only<br>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 prompt<br>* Participants will be instructed to describe a shameful experience to two confederates using a self-compassionate prompt<br>* Other names: Self-compassionate prompt;Behavioral: Receiving no response from confederates<br>* Following the participant's description of a shameful experience, two confederates will not be allowed to provide any verbal response<br>* Other names: Neutral confederates;|
| Experimental: Compassion from others only<br>Describing a shameful experience using a neutral prompt and receiving compassionate responses from confederates | Behavioral: Receiving compassionate responses from confederates<br>* Following the participant's description of a shameful experience, two confederates will respond with compassionate responses<br>* Other names: Compassionate confederates;Behavioral: Describing a shameful experience using a neutral prompt<br>* Participants will be instructed to describe a shameful experience to two confederates using a neutral (i.e., not self-compassionate) prompt<br>* Other names: Neutral prompt;|
| Experimental: Self-compassion plus compassion from others<br>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 prompt<br>* Participants will be instructed to describe a shameful experience to two confederates using a self-compassionate prompt<br>* Other names: Self-compassionate prompt;Behavioral: Receiving compassionate responses from confederates<br>* Following the participant's description of a shameful experience, two confederates will respond with compassionate responses<br>* Other names: Compassionate confederates;|
| Active Comparator: Sharing-only control<br>Describing a shameful experience using a neutral prompt and receiving no verbal responses from confederates | Behavioral: Describing a shameful experience using a neutral prompt<br>* Participants will be instructed to describe a shameful experience to two confederates using a neutral (i.e., not self-compassionate) prompt<br>* Other names: Neutral prompt;Behavioral: Receiving no response from confederates<br>* Following the participant's description of a shameful experience, two confederates will not be allowed to provide any verbal response<br>* Other names: Neutral confederates;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shame activation | Real-time assessment of shame activation during shame memory recall tasks (range: 0-100) | 5 minutes post-intervention | 
| Shame activation | Real-time assessment of shame activation during shame memory recall tasks (range: 0-100) | one-week follow-up | 
| State shame | Micro-assessment of state shame using Positive and Negative Affect Scale (range: 1-5, higher indicates more shame) | 5 minutes post-intervention | 
| State shame | Micro-assessment of state shame using Positive and Negative Affect Scale (range: 1-5, higher indicates more shame) | one-week follow-up | 
| Electrodermal response to shame | Measured in microsiemens (μS) by Empatica E4 during shame memory recall tasks | 5 minutes post-intervention | 
| Electrodermal response to shame | Measured in microsiemens (μS) by Empatica E4 during shame memory recall tasks | one-week follow-up | 
| Blood volume pulse in reaction to shame | Changes in blood volume measured by Empatica E4 during shame memory recall tasks | 5 minutes post-intervention | 
| Blood volume pulse in reaction to shame | Changes in blood volume measured by Empatica E4 during shame memory recall tasks | 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 | 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 | one-week follow-up | 
| Skin temperature reaction to shame | Temperature measured in degrees Celcius by Empatica E4 during shame memory recall tasks | 5 minutes post-intervention | 
| Skin temperature reaction to shame | Temperature measured in degrees Celcius by Empatica E4 during shame memory recall tasks | one-week follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
compassion, self-compassion, shame