Mood ChangeINTEROEMOTION3NCT05684614
Interoception and Emotion Regulation
An observational study of Mood Change and Emotion Regulation, run by University of Valencia at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mood Change, Emotion Regulation
- What is being tested?
- Negative mood induction procedure, Spontaneous emotion regulation task and Positive mood induction procedure
- How many people
- 117 participants
- Where
- 3 sitesSpain
- Study dates
- 6 Sep 2022to 13 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The sample in this study will represent a population of neurotypical individuals.
Who may be able to join
- 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)
Who cannot join
- History of/current substance abuse
- A medical condition that prevents participation in this study
- History of traumatic event exposure as self-reported.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Neurorrehabilitation Service of Hospital VIthas Aguas Vivas
Carcaixent, Valencia, 46740
Neurorrehabiltiation Service of Hospital Vithas Virgen del Consuelo
Valencia, Valencia, +34963177800
Faculty of Psychology and Speech Therapy, University of Valencia
Valencia, Valencia, 46010
About this study
Official title: 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.
Read the 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.
- Conditions
- Mood Change, Emotion Regulation
- Being tested
- Negative mood induction procedure, Spontaneous emotion regulation task, Positive mood induction procedure
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative mood induction procedureOther
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 taskOther
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 procedureOther
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Adult individuals recruited from the community through announcements at the university and social media Receives: Other: Negative mood induction procedure; Other: Spontaneous emotion regulation task; Other: Positive mood induction procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: The whole study is conducted in a single experimental session: Immediately after the emotion regulation task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start6 Sep 2022
- Primary completion13 Mar 2023
- Study completion13 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Mood ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa M. Baños Rivera, University of Valencia
- Investigators
- Rosa M Baños, PhD, Principal investigator, Univeristy of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684614
- Sponsor's protocol ID
- 1533450
- Other IDs
- FPU18/01690
- Acronym
- INTEROEMOTION3
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2022
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 5714990Lang, 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.
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.
PubMed 26297011Katz 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.
PubMed 27936820Pollatos 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.
PubMed 28080973Mehling 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.
PubMed 30513087Gratz, 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.
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
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.
PubMed 6880820
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interoception and Emotion Regulation in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05684614
- Acronym / sponsor ID
- INTEROEMOTION3 / 1533450
- Conditions
- Mood Change, Emotion Regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | Other: Negative mood induction procedure, Other: Spontaneous emotion regulation task, Other: Positive mood induction procedureAdult individuals recruited from the community through announcements at the university and social media |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sample in this study will represent a population of neurotypical individuals.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- History of/current substance abuse
- A medical condition that prevents participation in this study
- History of traumatic event exposure as self-reported.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative mood induction procedureThe 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 | Healthy individuals |
| Spontaneous emotion regulation taskParticipants are instructed to use whatever strategy they want by doing, saying, and/or thinking whatever they want to feel better for 2 min | Other | Healthy individuals |
| Positive mood induction procedureThe 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 | Other | Healthy individuals |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- BackgroundBaños, 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: PubMed 5714990Velten 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.
- BackgroundLang, 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
- BackgroundEich, 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
- BackgroundSanz, 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: PubMed 26297011Lavender 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.
- Background: PubMed 27936820Katz 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.
- Background: PubMed 28080973Pollatos 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.
- Background: PubMed 30513087Mehling 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.
- BackgroundGratz, 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.
- BackgroundHervás, G., & Jódar, R. (2008). The Spanish version of the difficulties in emotion regulation scale. Clínica y Salud, 19(2), 139-156.
- BackgroundTerol-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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa M Baños, PhD principal investigator
Univeristy of Valencia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Change and Emotion Regulation, run by University of Valencia at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05684614, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.