Clinical trial NCT05684614: Interoception and Emotion Regulation
Official title: Interoception and Emotion Regulation in Healthy Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mood Change
Emotion Regulation
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample in this study will represent a population of neurotypical individuals.

Brief summary: The goal of this observational study is to examine the role of interoception in emotion regulation of negative mood in healthy individuals.

Participants will fulfill several questionnaires and perform the Heartbeat Counting Task. Then, they will receive a negative mood induction procedure, after which they will be instructed to perform a spontaneous emotion regulation task. The mood will be assessed before and after the induction, as well as after the emotion regulation task. It is expected that greater interoceptive abilities will show a greater reduction of negative mood after the emotion regulation task than individuals with lower interoceptive abilities.

Detailed description: This study aims to examine the role of interoceptive abilities in the use of emotion regulation strategies and the success of emotion regulation in regulating the negative mood in healthy individuals. First, it is expected that better interoceptive functioning (namely, higher interoceptive accuracy and interoceptive sensibility) will facilitate the use of adaptive emotion regulation strategies (vs. maladaptive emotion regulation strategies) to regulate the negative mood. In addition, it is expected that individuals with greater interoceptive abilities will show greater efficacy in the emotion regulation process (i.e., greater reduction of negative mood after the emotion regulation task) than individuals with lower interoceptive abilities. However, it is hypothesized that interoceptive abilities will not be related to the induced negative affect.

The whole study is conducted in one single 1-hour session. First, participants will be screened to check eligibility inclusion/exclusion criteria. Second, eligible participants will complete baseline measures, namely, trait emotion regulation abilities and interoceptive abilities. Third, participants will complete a mood rating scale, after which they will be applied a negative mood induction procedure (MIP) that has previously been shown to effectively induce sadness. During this MIP, the heart rate variability will be recorded. Next, participants will complete the mood rating scale again. Later, they will perform a spontaneous emotion regulation task. In this task, participants will have 2 min to do, say, and/or think about whatever they need to feel better. Afterwards, participants will again rate their mood and complete the final measures regarding state emotion regulation. Finally, participants will receive a positive MIP (while recording their heart rate variability) and be debriefed. The study will be conducted following the principles stated in the Declaration of Helsinki.

Eligibility criteria: Inclusion Criteria:

* Aged above 18
* Absent symptoms of depression as described by scores ≤ 8 in the depression dimension of the Hospital Anxiety and Depression Scale (HADS) (Terol-Cantero et al., 2015; Zigmond \& Snaith, 1983)
* Not having cognitive, psychiatric, or neurological impairments (self-reported by participants)

Exclusion Criteria:

* History of/current substance abuse
* A medical condition that prevents participation in this study
* History of traumatic event exposure as self-reported.

Primary outcomes:
measure: Change in Mood before the negative induction, after the negative induction, and after the emotion regulation task
timeFrame: The whole study is conducted in a single experimental session: immediately before the negative mood induction procedure, immediately after the negative mood induction procedure, immediately after the emotion regulation task
Secondary outcomes:
measure: State difficulties in emotion regulation after the emotion regulation task
timeFrame: The whole study is conducted in a single experimental session: Immediately after the emotion regulation task
Other outcomes:
measure: Interoceptive accuracy before the negative mood induction procedure
timeFrame: The whole study is conducted in a single experimental session: Immediately before the negative mood induction procedure
measure: Interoceptive sensibility before the negative mood induction procedure
timeFrame: The whole study is conducted in a single experimental session: Immediately before the negative mood induction procedure
measure: Trait difficulties in emotion regulation
timeFrame: The whole study is conducted in a single experimental session: Immediately before the negative mood induction procedure
Locations:
city: Carcaixent
country: Spain
facility: Neurorrehabilitation Service of Hospital VIthas Aguas Vivas
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Neurorrehabiltiation Service of Hospital Vithas Virgen del Consuelo
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Faculty of Psychology and Speech Therapy, University of Valencia
state: Comunidad Valenciana
Study officials:
affiliation: Univeristy of Valencia
name: Rosa M Baños, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Katz BA, Lustig N, Assis Y, Yovel I. Measuring regulation in the here and now: The development and validation of the State Emotion Regulation Inventory (SERI). Psychol Assess. 2017 Oct;29(10):1235-1248. doi: 10.1037/pas0000420. Epub 2016 Dec 12.
citation: Pollatos O, Herbert BM, Mai S, Kammer T. Changes in interoceptive processes following brain stimulation. Philos Trans R Soc Lond B Biol Sci. 2016 Nov 19;371(1708):20160016. doi: 10.1098/rstb.2016.0016. Epub 2016 Oct 10.
citation: Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.
citation: Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment, 26(1), 41-54.
citation: Hervás, G., & Jódar, R. (2008). The Spanish version of the difficulties in emotion regulation scale. Clínica y Salud, 19(2), 139-156.
citation: Terol-Cantero, M. C., Cabrera-Perona, V., & Martín-Aragón, M. (2015). Hospital Anxiety and Depression Scale (HADS) review in Spanish samples. Anales de Psicología, 31(2), 494-503. https://doi.org/10.6018/analesps.31.2.172701
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.