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Completed

NCT Number: NCT05684614

Interoception and Emotion Regulation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Neurorrehabilitation Service of Hospital VIthas Aguas Vivas, Carcaixent, Valencia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Negative mood induction procedure

Other

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

Other

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

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Interoception and Emotion Regulation in Healthy Individuals

Acronym: INTEROEMOTION3

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2023
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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