Psychobiological Processes in Social Evaluation

NCT05107609 | Completed

• 1 other identifier: 2021-0000-E
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Stigma, Social; Weight, Body; Compassion; Stress Reaction

Outcome Measures

Primary Outcomes (6)

• Area under the curve for cortisol reactivity

  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

  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

  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

  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

  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)

  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).]

Study Arms (2)

Self-Compassion Intervention

EXPERIMENTAL

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.

Behavioral: Acute Self-Compassion Intervention

Resting Control Intervention

NO 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.

Interventions

Acute Self-Compassion Intervention BEHAVIORAL

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.

Self-Compassion Intervention

Eligibility Criteria

• Age: 18 Years - 34 Years
• Gender Eligibility Details: Participants must identify as cis-gender women (i.e., self-report their gender identity as woman and self-report their assigned sex at birth as female)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Western University

London, Ontario, N6A 3K7, Canada

Location

Related Publications (9)

• Bargh, J. A., & Chartrand, T. L. (2000). The mind in the middle: A practical guide to priming and automaticity research. In H. T. Reis & C. M. Judd (Eds.), Handbook of research methods in social and personality psychology (pp. 253-285). Cambridge University Press.

  BACKGROUND

• Cloudt MC, Lamarche L, Gammage KL. The impact of the amount of social evaluation on psychobiological responses to a body image threat. Body Image. 2014 Sep;11(4):350-6. doi: 10.1016/j.bodyim.2014.06.003. Epub 2014 Jun 28.

  PMID: 24981013 BACKGROUND

• Jackson AS, Pollock ML, Ward A. Generalized equations for predicting body density of women. Med Sci Sports Exerc. 1980;12(3):175-81.

  PMID: 7402053 BACKGROUND

• Lamarche, L., Gammage, K., Klentrou, P., Kerr, G., & Faulkner, G. (2014). Examining psychobiological responses to an anticipatory body image threat in women. Journal of Applied Biobehavioral Research, 19. doi: 10.1111/jabr.12022.

  BACKGROUND

• Lamarche, L., Gammage, K. L., Kerr, G., Faulkner, G., & Klentrou, P. (2016). Psychological and cortisol responses to and recovery from exposure to a body image threat. SAGE Open. https://doi.org/10.1177/2158244016642378

  BACKGROUND

• Marschall, D. E., Sanftner, J. L., & Tangney, J. P. (1994). The State Shame and Guilt Scale (SSGS). Fairfax, VA: George Mason University.

  BACKGROUND

• Pearl RL, Puhl RM. Measuring internalized weight attitudes across body weight categories: validation of the modified weight bias internalization scale. Body Image. 2014 Jan;11(1):89-92. doi: 10.1016/j.bodyim.2013.09.005. Epub 2013 Oct 4.

  PMID: 24100004 BACKGROUND

• Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.

  PMID: 29034226 BACKGROUND

• Wolpe, J., 1990. The Practice of Behavior Therapy, Rev. ed. Pergamon Press, New York.

  BACKGROUND

MeSH Terms

Conditions

Social Stigma; Body Weight; Fractures, Stress

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be aware that they are randomized into one of two intervention conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: November 4, 2021
• Study Start: November 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)