INTEROEMOTION3: Interoception and Emotion Regulation

Sponsor
University of Valencia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05684614
Collaborator
(none)
100
3
6.8
33.3
4.9

Study Details

Study Description

Brief Summary

The goal of this observational study is to examine the role of interoception in emotion regulation of negative mood in individuals with acquired brain injury and 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.

Researchers will compare these relationships with those occurring in healthy individuals to see if the role of interception in regulating emotions changes after brain damage.

Condition or Disease Intervention/Treatment Phase
  • Other: Negative mood induction procedure
  • Other: Spontaneous emotion regulation task
  • Other: Positive mood induction procedure

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 individuals with acquired brain injury and 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. Furthermore, the relationships between these processes are not expected to be different between people with and without acquired brain injury.

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Interoception and Emotion Regulation in Individuals With Acquired Brain Injury and Healthy Individuals
Actual Study Start Date :
Sep 6, 2022
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Individuals with acquired brain injury

Adult individuals with stroke or traumatic brain injury who are undergoing a long-term interdisciplinary neurological rehabilitation program.

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).

Other: 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

Other: 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

Healthy individuals

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

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).

Other: 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

Other: 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

Outcome Measures

Primary Outcome Measures

  1. Change in Mood before the negative induction, after the negative induction, and after the emotion regulation task [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 Outcome Measures

  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]

    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.

  2. Emotion regulation strategies used after the emotion regulation task [The whole study is conducted in a single experimental session: Immediately after the emotion regulation task]

    State Emotion Regulation Inventory. It assesses the use of four different strategies, namely, Distraction, Reappraisal, Brooding, and Acceptance. Scores on these dimensions range from 1 to 7, where higher scores indicate higher use of the corresponding strategy.

  3. Heart rate variability during the negative and the positve mood induction procedures [The whole study is conducted in a single experimental session: During the negative and the positive mood induction procedures]

    Time domain measures will be considered such as the standard deviation of normal-to-normal intervals (SDNN) or the square of the root of the mean of the sum of square differences between adjacent NN intervals (RMSSD)

Other Outcome Measures

  1. 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]

    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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria for the clinical group:
  • Having a diagnosis of a stroke or traumatic brain injury (TBI) as evidenced by neuroimaging (i.e., computed tomography scan or magnetic resonance imaging).

  • 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)

  • Moderate to good cognitive and language functioning to ensure an adequate following of instructions of the study procedures successfully.

Exclusion Criteria for the clinical group:
  • History of psychiatric disorders, substance abuse, or neurological disorders other than stroke or traumatic brain injury

  • A medical condition that prevents participation in this study

  • History of traumatic event exposure as self-reported.

Inclusion Criteria for the control group:
  • 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 for the control group:
  • History of/current substance abuse

  • A medical condition that prevents participation in this study

  • History of traumatic event exposure as self-reported.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Neurorrehabilitation Service of Hospital VIthas Aguas Vivas Carcaixent Comunidad Valenciana Spain 46740
2 Neurorrehabiltiation Service of Hospital Vithas Virgen del Consuelo Valencia Comunidad Valenciana Spain +34963177800
3 Faculty of Psychology and Speech Therapy, University of Valencia Valencia Comunidad Valenciana Spain 46010

Sponsors and Collaborators

  • University of Valencia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rosa M. Baños Rivera, Full Professor, University of Valencia
ClinicalTrials.gov Identifier:
NCT05684614
Other Study ID Numbers:
  • 1533450
  • FPU18/01690
First Posted:
Jan 13, 2023
Last Update Posted:
Jan 13, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2023