Interoception and Emotion Regulation (INTEROEMOTION3)

December 4, 2023 updated by: Rosa M. Baños Rivera, University of Valencia

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

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

Observational

Enrollment (Actual)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rosa M Baños, PhD, Univeristy of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2022

Primary Completion (Actual)

March 13, 2023

Study Completion (Actual)

March 13, 2023

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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