Interoception and Emotion Regulation

Emotion Regulation Clinical Trial

— INTEROEMOTION3  

Official title:

Interoception and Emotion Regulation in Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05684614
• Other study ID #: 1533450
• Secondary ID: FPU18/01690
• Status: Completed
• Start date: September 6, 2022
• Est. completion date: March 13, 2023

Study information

• Verified date: December 2023
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: March 13, 2023
• Est. primary completion date: March 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emotion Regulation
• Mood Change

Intervention

Other:
• Negative mood induction procedure
The negative mood induction procedure (MIP) used in this study has previously been shown to effectively induce sadness. This MIP takes place in a virtual environment of an urban park and includes the following methods to induce negative mood: 1) Velten's tasks, consisting of interactive phrase formulations with negative thoughts and beliefs about the self (e.g., "I don't have any future"); 2) visualizing International Affective Pictures; and 3) recalling a negative autobiographical memory related to a significant loss (e.g., a person, a pet).
• Spontaneous emotion regulation task
Participants are instructed to use whatever strategy they want by doing, saying, and/or thinking whatever they want to feel better for 2 min
• Positive mood induction procedure
The positive mood induction procedure (MIP) used in this study has previously been shown to effectively induce sadness. This MIP takes place in a virtual environment of an urban park and includes the following methods to induce positive mood: 1) Velten's tasks, consisting of interactive phrase formulations with positive thoughts and beliefs (e.g., "Life is wonderful"); 2) visualizing International Affective Pictures; and 3) recalling a positive autobiographical memory

Locations

Country	Name	City	State
Spain	Neurorrehabilitation Service of Hospital VIthas Aguas Vivas	Carcaixent	Comunidad Valenciana
Spain	Faculty of Psychology and Speech Therapy, University of Valencia	Valencia	Comunidad Valenciana
Spain	Neurorrehabiltiation Service of Hospital Vithas Virgen del Consuelo	Valencia	Comunidad Valenciana

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (13)

Baños, R. M., Liaño, V., Botella, C., Alcañiz, M., Guerrero, B., & Rey, B. (2006). Changing Induced Moods Via Virtual Reality. In W. Ijsselsteijn, Y. de Kort, C. Midden, B. Eggen, & E. van den Hoven (Eds.), Persuasive technology. Lecture notes in computer science (pp. 7-15). Springer-Verlag. https://doi.org/10.1007/11755494_3

Eich, E., & Metcalfe, J. (1989). Mood dependent memory for internal versus external events. Journal of Experimental Psychology: Learning, Memory, and Cognition, 15(3), 443-455. https://doi.org/10.1037/0278-7393.15.3.443

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.

Hervás, G., & Jódar, R. (2008). The Spanish version of the difficulties in emotion regulation scale. Clínica y Salud, 19(2), 139-156.

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. — View Citation

Lang, P. J., Bradley, M. M., & Cuthbert, B. N. (1999). International affective picture system (IAPS). Instruction manual and affective ratings. The Center for Research in Psychophysiology, University of Florida

Lavender JM, Tull MT, DiLillo D, Messman-Moore T, Gratz KL. Development and Validation of a State-Based Measure of Emotion Dysregulation. Assessment. 2017 Mar;24(2):197-209. doi: 10.1177/1073191115601218. Epub 2016 Jul 27. — View 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. — View 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. — View Citation

Sanz, J. (2001). An instrument to evaluate the efficacy of mood induction procedures: The Scale for Mood Assessment. Análisis y Modificación de Conducta, 27(111), 71-110.

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

Velten E Jr. A laboratory task for induction of mood states. Behav Res Ther. 1968 Nov;6(4):473-82. doi: 10.1016/0005-7967(68)90028-4. No abstract available. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Interoceptive accuracy before the negative mood induction procedure	Heartbeat Counting Task. Scores range from 0 to 1, with higher scores indicating higher interoceptive accuracy.	The whole study is conducted in a single experimental session: Immediately before the negative mood induction procedure
Other	Interoceptive sensibility before the negative mood induction procedure	Multidimensional Assessment of Interoceptive Awareness-2. It assesses the following eight dimensions: Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Body Listening, and Trusting. Scores on these dimensions range from 0 to 5, where higher scores indicates higher levels of the corresponding dimension.	The whole study is conducted in a single experimental session: Immediately before the negative mood induction procedure
Other	Trait difficulties in emotion regulation	Difficulties in Emotion Regulation Scale. It assesses five dimensions, namely: Lack of Emotional Awareness, Nonacceptance of Emotional Responses, Lack of Emotional Clarity, Difficulties Engaging in Goal-Directed Behavior, and Lack of Emotional Control. Scores range from 1 to 5, with higher scores indicating higher difficulties in the corresponding dimension of ER.	The whole study is conducted in a single experimental session: Immediately before the negative mood induction procedure
Primary	Change in Mood before the negative induction, after the negative induction, and after the emotion regulation task	Sadness and joy dimensions of the Scale for Mood Assessment, with scores ranging from 0 to 10, where higher scores indicate higher levels of joy and sadness, respectively.	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	State difficulties in emotion regulation after the emotion regulation task	State Difficulties in Emotion Regulation Scale. It includes for dimensions, namely: Non acceptance, Modulate, Awareness, and Clarity, whose scores range from 1 to 5, where higher scores indicate higher difficulties in the corresponding dimension.	The whole study is conducted in a single experimental session: Immediately after the emotion regulation task