Psychobiological Processes in Social Evaluation

August 27, 2024 updated by: Dr. Eva Pila, Western University, Canada

Psychobiological Processes in Social Evaluation: Pilot Testing a Self-Compassion Intervention for Weight Stigma

Higher-weight individuals face pervasive weight-related stigma and discrimination in their daily lives. There is conceptual and empirical evidence to suggest that weight stigma contributes to worse physical and psychological health outcomes, mediated by the deleterious psychobiological responses to psychosocial stress. Activating self-soothing emotional states (such as self-compassion) may protect against this psychobiological cascade, conferring resilience to negative social evaluation (such as weight stigma). This proof-of-concept study aims to establish the feasibility of an experimental protocol testing whether an acute self-compassion intervention can attenuate the psychobiological stress response to induced weight-based social-evaluative threat. Participants will be randomized into either self-compassion intervention or rest control groups. A standard body composition assessment will be used to induce weight stigma among young women who self-identify as "higher-weight." Stress-sensitive biomarkers (i.e., salivary cortisol and heart-rate variability) along with psychological indices of self-conscious emotions will be used to quantify the psychobiological stress response. This novel pilot study will contribute to efforts to understand the psychobiological processes by which self-compassion facilitates adaptive responding to acute stress, and will help inform future tests of interventions focused on mitigating the harmful health effects of social stigma.

Study Overview

Detailed Description

This is a randomized proof-of-concept experiment with two conditions: self-compassion intervention and no-intervention (i.e., quiet rest) control.

The primary objective of this pilot study is to examine the feasibility and establish parameter estimates for a laboratory protocol to quantify the psychobiological responses to a lab-based weight stigma induction. Feasibility will include process assessments (i.e., examine acceptability of both the self-compassion intervention and weight stigma induction to participants, establish feasibility of recruitment goals and examine participant demand), resource assessment (i.e., test the practicality of the proposed experimental protocol), management assessment (i.e., test research group's ability to implement experimental protocol including self-compassion intervention, weight-based social-evaluative induction and biological biomarker collection), and scientific assessment (i.e., establish parameter estimates for psychological and biological responses to self-compassion intervention and social-evaluative threat induction). Due to the unpredictable nature of the COVID context for biological sample collection, no a prior criteria for feasibility are established.

The secondary objective is to perform limited-efficacy testing of the self-compassion intervention in reducing the psychobiological stress response relative to control condition. Efficacy will be assessed by comparing pre/post manipulation biological (i.e., cortisol, heart rate variability) and psychological (i.e., state shame, guilt, distress, internalized weight bias) indices between conditions (i.e., self-compassion intervention, rest control).

N=60 young adult cis-gender women who perceive themselves to be "heavier-weight" will be recruited to participate. After a brief telephone pre-screening interview to determine eligibility, participants will book two lab visits to complete a baseline assessment and experimental manipulation.

The first in-lab session will comprise of the informed consent process and computerized surveys to collect demographic and psychological baseline measures. This session will also serve as acclimatization to the lab environment, to minimize anticipatory anxiety and/or novel environment effects that may confound psychobiological stress measures during the experimental manipulation. After providing written informed consent, participants will complete a computerized survey consisting of demographic and baseline psychological measures.

All experimental sessions will take place between 1 pm and 5 pm to control for diurnal variation in cortisol and will be conducted in a light- and temperature-controlled laboratory. Participants will fill out a computerized survey to assess baseline psychological indices, and will provide a 5-minute baseline heart-rate variability measurement and saliva sample (#1).

Participants will be randomized into one of two experimental conditions: acute self-compassion intervention or rest control. Over the next 30 minutes, participants who were randomized into the self-compassion condition will be guided through a multi-modal behavioural self-compassion intervention. Participants in the no-intervention (resting) control group will be asked to sit quietly for 30 minutes. Immediately after the self-compassion induction (or control), participants will complete a measure of state self-compassion as a manipulation check and will repeat state psychological measures taken at baseline.

An anthropometric assessment including a standard three-site (triceps, iliac crest, thigh) skinfold body composition assessment, height and weight measurements will be performed by two thin researchers to induce weight stigma. Participants will undergo the assessment while wearing a physically revealing outfit (i.e., sports bra and spandex shorts) which they will be asked to change into at the beginning of the weight-stigma induction. This paradigm has been shown to successfully induce social evaluative threat in young women, eliciting cortisol and body shame responses.

Immediately after the weight stigma induction, participants will be asked to complete a brief survey assessing psychological outcome measures and to provide a saliva sample (#2). Then, participants will be asked to wait quietly for a 35-minute minute recovery phase, during which saliva samples will again be collected at 10 (#3), 20 (#4) and 35-minutes (#5) post-stressor.

After the recovery session is over, participants will be asked to respond to open-ended funnel debriefing questions to assess the believability of the cover story and the success of deception. Participants will also be asked questions related to the acceptability of the experimental protocol and social-evaluative induction. Finally, participants will be fully debriefed.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • London, Ontario, Canada, N6A 3K7
        • Western University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 34 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Can read and communicate in English to provide informed consent
  • Cis-gender woman (self-reports their gender as woman and assigned sex at birth as female)
  • Age 18-34 inclusive
  • Self-identify as "heavy weight"
  • Currently taking oral contraceptives

Exclusion Criteria:

  • Current smoking; current other nicotine/tobacco use; or current recreational drug use
  • Current and active use of any oral prescription medication to treat a chronic health condition - excepting contraceptives
  • Chronic health conditions as diagnosed by a licensed medical professional such as psychiatric (including substance use disorder, eating disorder), endocrine, cardiovascular, respiratory, autoimmune or other chronic conditions - excepting obesity, which will still be included due to inconsistent findings regarding whether obesity impacts neuroendocrine stress responses.
  • Fever or acute illness/infection on day of experiment
  • Pregnant or currently breastfeeding
  • Prior experience with self-compassion training or compassion interventions, or prior experience with formal mindfulness or meditation training.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Compassion Intervention
Participants will be guided through an acute, 30-minute self-compassion intervention consisting of psychoeducation, guided loving-kindness meditation, compassionate imagery and a compassionate writing activity.
Participants will be guided through a 30-minute behavioural self-compassion intervention that seeks to mitigate their psychobiological responses to the subsequent weight stigma induction. The intervention is intended to induce a flexible self-compassionate mindset that will facilitate more adaptive psychological responding to stress and activate affiliative/self-soothing physiological systems that can dampen psychobiological stress reactivity. This acute self-compassion intervention will employ a multimodal, experiential approach that is regularly utilized in self-compassion training, drawing from approaches developed in Compassion-Focused Therapy and Mindful Self-Compassion.
No Intervention: Resting Control Intervention
Participants will be asked to sit quietly and independently for 30 minutes. They can read neutral magazines provided or their own reading/writing material, but will be asked not to use outside electronic devices or communicate with anyone external.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve for cortisol reactivity
Time Frame: Saliva samples will be collected at baseline, post-stigma induction (0 minutes), and at 10 (i.e. ~25 minutes post stressor onset, expected peak), 20 and 35 minutes post-induction
Salivary cortisol will be used to quantify hypothalamic pituitary adrenal axis reactivity. Salivary cortisol concentration will be determined using a commercial high sensitivity EIA kit (Salimetrics; Carlsbad, CA). All assessments will be used to calculate area under the curve with respect to ground, and area under the curve with respect to increase.
Saliva samples will be collected at baseline, post-stigma induction (0 minutes), and at 10 (i.e. ~25 minutes post stressor onset, expected peak), 20 and 35 minutes post-induction
Change in State Distress from baseline to post-stigma induction
Time Frame: Self-reported distress will measured at 3 points: baseline (~10 minutes after start of session), post self-compassion intervention or control (45 minutes after start) and post stigma induction (60 minutes after start).
State distress will be measured using a modified version of widely-used single-item Subjective Units of Distress scale (SUDS; Wolpe, 1990) requiring participants to indicate their current distress level on a visual analog scale (VAS) of 1-100 (where 1 is low distress and 100 is high distress).
Self-reported distress will measured at 3 points: baseline (~10 minutes after start of session), post self-compassion intervention or control (45 minutes after start) and post stigma induction (60 minutes after start).
Change in State Self-Conscious Body Emotions from baseline to post-stigma induction
Time Frame: Self-report body emotions will measured at 3 points: baseline (~10 minutes after start of session), post self-compassion intervention or control (45 minutes after start) and post stigma induction (60 minutes after start).
Purpose-built 4-item measure to assess the degree to which a participant feels self-conscious emotions about their body right now (i.e., body shame, body guilt, body embarrassment, body envy). Participants answer on a 5-point scale from 1 (very slightly or not at all) to 5 (extremely), where higher scores indicate greater levels of self-conscious body emotions.
Self-report body emotions will measured at 3 points: baseline (~10 minutes after start of session), post self-compassion intervention or control (45 minutes after start) and post stigma induction (60 minutes after start).
Change in State Shame and Guilt from baseline to post-stigma induction
Time Frame: Self-report shame and guilt will measured at 3 points: baseline (~10 minutes after start of session), post self-compassion intervention or control (45 minutes after start) and post stigma induction (60 minutes after start)
State Shame and Guilt Scale will quantify state shame and guilt. Participants indicate how each prompt describes how they are feeling right now on a 5-point scale: 1 = I do not feel this way at all; 3 = I feel this way somewhat; 5 = I feel this way very strongly. Higher scores indicate higher levels of state shame and guilt.
Self-report shame and guilt will measured at 3 points: baseline (~10 minutes after start of session), post self-compassion intervention or control (45 minutes after start) and post stigma induction (60 minutes after start)
Change in State Weight Bias Internalization from baseline to post-stigma induction
Time Frame: Self-report weight bias internalization measured at 3 points: baseline (~10 minutes after session start), post self-compassion intervention or control (45 minutes after start) and post induction (60 minutes after start).
Modified Weight Bias Internalization Scale will be modified to capture state-level weight bias internalization. Participants respond to each prompt on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree), where higher scores indicate greater internalized weight bias.
Self-report weight bias internalization measured at 3 points: baseline (~10 minutes after session start), post self-compassion intervention or control (45 minutes after start) and post induction (60 minutes after start).
Root mean square of successive differences in Heart Rate Variability (HRV)
Time Frame: 4 phases: baseline measurement (minutes 5-10), intervention (minutes 15-45), weight-stigma induction (minutes 45-60), recovery (minutes 60-95).]
Data from all phases will be used to calculate root mean square of successive differences (RMSSD) will be used to quantify vagally-mediated HRV (i.e., parasympathetic cardiac activity).
4 phases: baseline measurement (minutes 5-10), intervention (minutes 15-45), weight-stigma induction (minutes 45-60), recovery (minutes 60-95).]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

August 20, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-0000-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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