Psychobiological Processes in Social Evaluation: Pilot Testing a Self-Compassion Intervention for Weight Stigma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Area under the curve for cortisol reactivity
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participants will not be aware that they are randomized into one of two intervention conditions.
Eligibility Criteria
- Ages
- 18 Years to 34 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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.
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).
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.
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.
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.
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Eva Pila
Principal Investigator
Western University, Canada