NCT05684614

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2023

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

December 6, 2022

Last Update Submit

December 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • State difficulties in emotion regulation after the emotion regulation task

    The whole study is conducted in a single experimental session: Immediately after the emotion regulation task

Other Outcomes (3)

  • Interoceptive accuracy before the negative mood induction procedure

    The whole study is conducted in a single experimental session: Immediately before the negative mood induction procedure

  • Interoceptive sensibility before the negative mood induction procedure

    The whole study is conducted in a single experimental session: Immediately before the negative mood induction procedure

  • Trait difficulties in emotion regulation

    The whole study is conducted in a single experimental session: Immediately before the negative mood induction procedure

Study Arms (1)

Healthy individuals

Adult individuals recruited from the community through announcements at the university and social media

Other: Negative mood induction procedureOther: Spontaneous emotion regulation taskOther: Positive mood induction procedure

Interventions

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).

Healthy individuals

Participants are instructed to use whatever strategy they want by doing, saying, and/or thinking whatever they want to feel better for 2 min

Healthy individuals

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

Healthy individuals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The sample in this study will represent a population of neurotypical individuals.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Neurorrehabilitation Service of Hospital VIthas Aguas Vivas

Carcaixent, Valencia, 46740, Spain

Location

Neurorrehabiltiation Service of Hospital Vithas Virgen del Consuelo

Valencia, Valencia, +34963177800, Spain

Location

Faculty of Psychology and Speech Therapy, University of Valencia

Valencia, Valencia, 46010, Spain

Location

Related 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

    BACKGROUND
  • 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.

    PMID: 5714990BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26297011BACKGROUND
  • 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.

    PMID: 27936820BACKGROUND
  • 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.

    PMID: 28080973BACKGROUND
  • 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.

    PMID: 30513087BACKGROUND
  • 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.

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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 6880820BACKGROUND

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Rosa M Baños, PhD

    Univeristy of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

December 6, 2022

First Posted

January 13, 2023

Study Start

September 6, 2022

Primary Completion

March 13, 2023

Study Completion

March 13, 2023

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations