- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05684614
Interoception and Emotion Regulation (INTEROEMOTION3)
Interoception and Emotion Regulation in Healthy Individuals
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Comunidad Valenciana
-
Carcaixent, Comunidad Valenciana, Spain, 46740
- Neurorrehabilitation Service of Hospital VIthas Aguas Vivas
-
Valencia, Comunidad Valenciana, Spain, +34963177800
- Neurorrehabiltiation Service of Hospital Vithas Virgen del Consuelo
-
Valencia, Comunidad Valenciana, Spain, 46010
- Faculty of Psychology and Speech Therapy, University of Valencia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy individuals
Adult individuals recruited from the community through announcements at the university and social media
|
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).
Participants are instructed to use whatever strategy they want by doing, saying, and/or thinking whatever they want to feel better for 2 min
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mood before the negative induction, after the negative induction, and after the emotion regulation task
Time Frame: 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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State difficulties in emotion regulation after the emotion regulation task
Time Frame: The whole study is conducted in a single experimental session: Immediately 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interoceptive accuracy before the negative mood induction procedure
Time Frame: The whole study is conducted in a single experimental session: Immediately 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
|
|
Interoceptive sensibility before the negative mood induction procedure
Time Frame: The whole study is conducted in a single experimental session: Immediately 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
|
|
Trait difficulties in emotion regulation
Time Frame: The whole study is conducted in a single experimental session: Immediately before the negative mood induction procedure
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rosa M Baños, PhD, Univeristy of Valencia
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- Hervás, G., & Jódar, R. (2008). The Spanish version of the difficulties in emotion regulation scale. Clínica y Salud, 19(2), 139-156.
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1533450
- FPU18/01690 (Other Grant/Funding Number: Ministerio de Ciencia e Innovación)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Emotion Regulation
-
VU University of AmsterdamUtrecht UniversityRecruiting
-
Douglas Mental Health University InstituteMcGill University; MedTeq; Natural Sciences and Engineering Research Council,... and other collaboratorsRecruiting
-
Miami UniversityUniversity of California, RiversideWithdrawn
-
University Grenoble AlpsActive, not recruiting
-
University of CyprusUniversity of Crete; VU University of Amsterdam; Eotvos Lorand UniversityRecruiting
-
Miami UniversityUniversity of California, RiversideEnrolling by invitation
-
Babes-Bolyai UniversityThe Executive Agency for Higher Education, Research, Development and Innovation...CompletedEmotion RegulationRomania
-
Virginia Commonwealth UniversityMind and Life Institute, Hadley, MassachusettsCompletedEmotion RegulationUnited States
-
University of California, Los AngelesEunice Kennedy Shriver National Institute of Child Health and Human Development...Recruiting
-
University of MiamiThe Children's Trust, Miami FLRecruiting
Clinical Trials on Negative mood induction procedure
-
Boston University Charles River CampusCompleted
-
University of Alabama at BirminghamTerminated
-
Ohio State UniversityCompletedAnxiety | Depressive Symptoms | Negative ThinkingUnited States
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedEndothelial Dysfunction | EmotionsUnited States
-
University of ValenciaCompletedLow Back Pain | Chronic Low-back PainSpain
-
Inonu UniversityCompletedSmartphone AddictionsTurkey (Türkiye)
-
University of Wisconsin, MadisonNational Institute on Aging (NIA); University of California, Irvine; University...Completed
-
Arizona State UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Georgia State UniversityRecruitingAlcohol Drinking | Sexual Behavior | Emotions | Sexual AggressionUnited States