Stress, PhysiologicalITP-RSANCT04786496
Wise Interventions and Responses to Stress
A study testing ITP+SA Wise intervention and ITP Wise intervention in people with Stress, Physiological and Stress, Psychological, run by University of Deusto at 1 site in Spain.
Trial summary
This study compares the effects of two wise interventions (implicit theory of personality intervention and implicit theory of personality intervention plus self-affirmation) with a control condition in the stress responses of young adults. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Physiological, Stress, Psychological, Social Stress
- What is being tested?
- ITP+SA Wise intervention and ITP Wise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2019to 21 Feb 2020
- Phase
- Interventional
- 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 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent by the participants.
- To be fluent in Spanish.
Who cannot join
- Having cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Wise Interventions in Psychophysiological Responses to Stress
This study compares the effects of two wise interventions (implicit theory of personality intervention and implicit theory of personality intervention plus self-affirmation) with a control condition in the stress responses of young adults. Responses include respiratory sinus arrhythmia, heart rate, skin conductance level, cortisol levels, and mood.
Read the detailed description
Whereas several studies indicate that implicit theory of personality interventions (ITP) are promising in the prevention of depressive symptoms, evidence about the effects of the ITP intervention on stress pathways is scarce. The current study aims to elucidate the effects of ITP on psychophysiological responses to social stress in young adults during their transition to university. Based on preliminary findings that ITP was more effective among younger adolescents in reducing depressive symptoms and that a combination of ITP with self-affirmation (SA) was more effective in the prevention of other risky behaviors, the current study proposes that the addition of a SA component could increase the effectiveness of the ITP intervention when responding to stress. Thus, this study compares the effects of the ITP alone and in combination with a SA component in psychophysiological responses to a standardized social stressor (the Trier Social Stress Test, TSST). Both interventions (i.e., ITP+SA and ITP) are compared with a control condition (CC) in indicators of the autonomic nervous system (heart rate -HR-, respiratory sinus arrhythmia -RSA-, skin conductance level -SCL-), the hypothalamic-pituitary-adrenal axis (cortisol level), and subjective mood. The investigators expect that participants in both ITP interventions, and in ITP+SA intervention in particular, will display better stress responses during the stressful tasks compared with participants in the CC (i.e., lower HR and SCL increase, lower RSA suppression, and lower cortisol and negative mood increase). The investigators also expect that participants would display better recovery after the stressful tasks (i.e., higher HR and SCL decrease, and higher RSA increase).
Finally, this research will examine whether depressive symptoms moderate the effects of the intervention on stress responses. Previous research has shown that depression has been associated with dysregulated stress responses both at the autonomic nervous system and hypothalamic-pituitary-adrenal axis. Moreover, some studies have found that interventions are more effective among participants at risk to reduce both depression and stress. Therefore, the ITP intervention, alone and in combination with SA, could be more beneficial among those participants with higher levels of depressive symptoms.
- Being tested
- ITP+SA Wise intervention, ITP Wise intervention, Control condition
- Keywords
- Trier Social Stress Test, Social Stress, Stress reactivity, Heart Rate, Respiratory Sinus Arrhythmia, Skin Conductance Level, Cortisol, Mood, Young Adults
- Medical subject headings
- Stress, Psychological, Depression, Arrhythmia, Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITP+SA Wise interventionBehavioural
Intervention designed to promote well-being and resilience in late adolescents and young adults. It includes two components: a self-affirmation (SA) activity and an ITP intervention. The SA component includes a list of values so that they could choose the three most important for them. Next, they are asked to write why those selected values are the most important to them. The ITP component resembled the intervention developed by David S. Yeager and colleagues and it was adapted to first year university students. It consisted of three parts. First, participants are asked to read scientific studies that provide evidence that behaviors are controlled pathways in the brain that have the potential to be changed under the right circumstances. Second, participants read several testimonials purportedly written by second year university students to bring credibility to the ITP. Finally, participants are asked to write their own version of such a narrative (self-persuasive writing exercise).
ITP Wise interventionBehavioural
Intervention designed to promote well-being and resilience in late adolescents and young adults based on four general types of change strategies: (1) scientific knowledge, (2) generation of new meanings, (3) commitment through action, and (4) active reflection. It includes the ITP component described above for the ITP+SA Wise intervention.
Control conditionBehavioural
The control intervention was designed to have a similar structure than the experimental interventions, including also reading and writing tasks, but that they were not in any way related to the contents of the experimental interventions. In particular, participants were asked to read an article about the fire that took place in the Notre Dame cathedral in Paris that had been recently published in a newspaper. Starting from the accident of the Notre Dame cathedral, the article focuses on reflecting on the problem of heritage conservation and analyzing the situation of other important cathedrals. After reading the article, the participants were asked to write a few lines evaluating in their opinion the importance of the conservation of historical buildings such as those mentioned and how much of the public economic budget should be used for heritage conservation.
| Study group | Role | What they receive |
|---|---|---|
| ITP+SA Wise intervention (Incremental Theory of Personality Intervention with Self-affirmations) | Experimental | Wise intervention (based on ITP and SA) consisting on several tasks to be completed individually. 30 minutes Receives: Behavioral: ITP+SA Wise intervention |
| ITP Wise intervention (Incremental Theory of Personality Intervention) | Experimental | Wise intervention (based on ITP) consisting on several tasks to be completed individually. 30 minutes Receives: Behavioral: ITP Wise intervention |
| Control Intervention | Other | Educational intervention (about heritage conservation) consisting on several tasks to be completed individually. 30 minutes Receives: Behavioral: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline levels of cortisol in saliva at recovery (immediately after the procedure -Trier Social Stress Task-).
Participants provided saliva samples to be assayed for neuroendocrine levels to measure cortisol. They were directed to transfer saliva from their mouths to a tube. The sample tubes were carefully labelled and stored in a freezer at -25 ºC until they were sent to the Medikosta Laboratory.
Measured: Baseline and immediately after the math phase of the Trier Social Stress Task.
Change from baseline levels of heart-rate (HR) at the time of the procedure (i.e., during the Trier Social Stress Task) and recovery (i.e., immediately after the Trier Social Stress Task).
Electrocardiogram (ECG) to measure heart-rate (HR) was recorded using the BioPac M150 system at a sampling rate of 1000 Hz and AcqKnowledge® 4.0 software.
Measured: Baseline, during the procedure, and immediately after the procedure (i.e., the Trier Social Stress Task).
Change from baseline levels of heart-rate variability (HRV) at the time of the procedure (i.e., during the Trier Social Stress Task) and recovery (i.e., immediately after the Trier Social Stress Task).
Electrocardiogram (ECG) to measure heart-rate variability (HRV) was recorded using the BioPac M150 system at a sampling rate of 1000 Hz and AcqKnowledge® 4.0 software.
Measured: Baseline, during the procedure, and immediately after the procedure (i.e., the Trier Social Stress Task).
Change from baseline levels of skin conductance level (SCL) at the time of the procedure (i.e., during the Trier Social Stress Task) and recovery (i.e., immediately after the Trier Social Stress Task).
Electrodermal Activity to measure skin conductance level (SCL) was recorded using the BioPac M150 system at a sampling rate of 1000 Hz and AcqKnowledge® 4.0 software.
Measured: Baseline, during the procedure, and immediately after the procedure (i.e., the Trier Social Stress Task).
Change from baseline scores of the subscale for Negative Mood of the Scale for Mood Assessment (Sanz, 2001) at recovery (immediately after the procedure -Trier Social Stress Task-).
Self reported transitory negative moods measured by 12 items (assessing depression, anxiety, and hostility) scored on an 11-point scale from 0 (nothing) to 10 (a lot), yielding a total between 0 and 120 (with higher scores meaning higher negative moods).
Measured: Baseline and immediately after the math phase of the Trier Social Stress Task.
Change from baseline scores of the subscale for Positive Mood of the Scale for Mood Assessment (Sanz, 2001) at recovery (immediately after the procedure -Trier Social Stress Task-).
Self reported transitory positive mood measured by 4 items (assessing elation) scored on an 11-point scale from 0 (nothing) to 10 (a lot), yielding a total between 0 and 40 (with higher scores meaning higher positive mood).
Measured: Baseline and immediately after the math phase of the Trier Social Stress Task.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Sep 2019
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PhysiologicalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized (balanced for sex and levels of depression and social anxiety) to one of three groups (i.e., ITP+SA, ITP, and CC) in parallel for the duration of the study. Given the relevance of depression and social anxiety during stress tasks such as the TSST, these measures were used to balance participants within intervention and control groups. Specifically, a cluster analysis using mean scores on depression and social anxiety was conducted, resulting in a four-cluster solution according to the participants' level of depression and social anxiety. One-third of the males of each cluster and one-third of the females of each cluster were randomly assigned to each of the experimental conditions (i.e., ITP+SA, ITP, and CC). This allowed the three conditions to be balanced in gender and social anxiety and depression scores
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Deusto
- Sponsor type
- University, hospital or other
- Collaborators
- Basque Country Government, Spanish Government
- Responsible party
- Principal investigator, Esther Calvete, University of Deusto
- Investigators
- Esther Calvete, PhD, Principal investigator, University of Deusto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786496
- Sponsor's protocol ID
- ITP
- Acronym
- ITP-RSA
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data will be available at OSF when the results of the study are published.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Wise Interventions in Psychophysiological Responses to Stress
- ClinicalTrials.gov ID
- NCT04786496
- Acronym / sponsor ID
- ITP-RSA / ITP
- Keywords
- Trier Social Stress Test, Social Stress, Stress reactivity, Heart Rate, Respiratory Sinus Arrhythmia, Skin Conductance Level, Cortisol, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of DeustoUniversity, hospital or other
- Collaborators
- Basque Country Government, Spanish Government
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 8 Mar 2021 (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.
This study compares the effects of two wise interventions (implicit theory of personality intervention and implicit theory of personality intervention plus self-affirmation) with a control condition in the stress responses of young adults. Responses include respiratory sinus arrhythmia, heart rate, skin conductance level, cortisol levels, and mood.
Detailed description
Whereas several studies indicate that implicit theory of personality interventions (ITP) are promising in the prevention of depressive symptoms, evidence about the effects of the ITP intervention on stress pathways is scarce. The current study aims to elucidate the effects of ITP on psychophysiological responses to social stress in young adults during their transition to university. Based on preliminary findings that ITP was more effective among younger adolescents in reducing depressive symptoms and that a combination of ITP with self-affirmation (SA) was more effective in the prevention of other risky behaviors, the current study proposes that the addition of a SA component could increase the effectiveness of the ITP intervention when responding to stress. Thus, this study compares the effects of the ITP alone and in combination with a SA component in psychophysiological responses to a standardized social stressor (the Trier Social Stress Test, TSST). Both interventions (i.e., ITP+SA and ITP) are compared with a control condition (CC) in indicators of the autonomic nervous system (heart rate -HR-, respiratory sinus arrhythmia -RSA-, skin conductance level -SCL-), the hypothalamic-pituitary-adrenal axis (cortisol level), and subjective mood. The investigators expect that participants in both ITP interventions, and in ITP+SA intervention in particular, will display better stress responses during the stressful tasks compared with participants in the CC (i.e., lower HR and SCL increase, lower RSA suppression, and lower cortisol and negative mood increase). The investigators also expect that participants would display better recovery after the stressful tasks (i.e., higher HR and SCL decrease, and higher RSA increase).
Finally, this research will examine whether depressive symptoms moderate the effects of the intervention on stress responses. Previous research has shown that depression has been associated with dysregulated stress responses both at the autonomic nervous system and hypothalamic-pituitary-adrenal axis. Moreover, some studies have found that interventions are more effective among participants at risk to reduce both depression and stress. Therefore, the ITP intervention, alone and in combination with SA, could be more beneficial among those participants with higher levels of depressive symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants were randomized (balanced for sex and levels of depression and social anxiety) to one of three groups (i.e., ITP+SA, ITP, and CC) in parallel for the duration of the study. Given the relevance of depression and social anxiety during stress tasks such as the TSST, these measures were used to balance participants within intervention and control groups. Specifically, a cluster analysis using mean scores on depression and social anxiety was conducted, resulting in a four-cluster solution according to the participants' level of depression and social anxiety. One-third of the males of each cluster and one-third of the females of each cluster were randomly assigned to each of the experimental conditions (i.e., ITP+SA, ITP, and CC). This allowed the three conditions to be balanced in gender and social anxiety and depression scores
| Arm | Type | Receives |
|---|---|---|
| ITP+SA Wise intervention (Incremental Theory of Personality Intervention with Self-affirmations) | Experimental | Behavioral: ITP+SA Wise interventionWise intervention (based on ITP and SA) consisting on several tasks to be completed individually. 30 minutes |
| ITP Wise intervention (Incremental Theory of Personality Intervention) | Experimental | Behavioral: ITP Wise interventionWise intervention (based on ITP) consisting on several tasks to be completed individually. 30 minutes |
| Control Intervention | Other | Behavioral: Control conditionEducational intervention (about heritage conservation) consisting on several tasks to be completed individually. 30 minutes |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Informed consent by the participants.
- To be fluent in Spanish.
Key exclusion criteria (1 listed)
- Having cardiovascular disease.
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 |
|---|---|---|
| ITP+SA Wise interventionIntervention designed to promote well-being and resilience in late adolescents and young adults. It includes two components: a self-affirmation (SA) activity and an ITP intervention. The SA component includes a list of values so that they could choose the three most important for them. Next, they are asked to write why those selected values are the most important to them. The ITP component resembled the intervention developed by David S. Yeager and colleagues and it was adapted to first year university students. It consisted of three parts. First, participants are asked to read scientific studies that provide evidence that behaviors are controlled pathways in the brain that have the potential to be changed under the right circumstances. Second, participants read several testimonials purportedly written by second year university students to bring credibility to the ITP. Finally, participants are asked to write their own version of such a narrative (self-persuasive writing exercise). | Behavioural | ITP+SA Wise intervention (Incremental Theory of Personality Intervention with Self-affirmations) |
| ITP Wise interventionIntervention designed to promote well-being and resilience in late adolescents and young adults based on four general types of change strategies: (1) scientific knowledge, (2) generation of new meanings, (3) commitment through action, and (4) active reflection. It includes the ITP component described above for the ITP+SA Wise intervention. | Behavioural | ITP Wise intervention (Incremental Theory of Personality Intervention) |
| Control conditionThe control intervention was designed to have a similar structure than the experimental interventions, including also reading and writing tasks, but that they were not in any way related to the contents of the experimental interventions. In particular, participants were asked to read an article about the fire that took place in the Notre Dame cathedral in Paris that had been recently published in a newspaper. Starting from the accident of the Notre Dame cathedral, the article focuses on reflecting on the problem of heritage conservation and analyzing the situation of other important cathedrals. After reading the article, the participants were asked to write a few lines evaluating in their opinion the importance of the conservation of historical buildings such as those mentioned and how much of the public economic budget should be used for heritage conservation. | Behavioural | Control Intervention |
Primary outcome
Change from baseline levels of cortisol in saliva at recovery (immediately after the procedure -Trier Social Stress Task-).
Time frame: Baseline and immediately after the math phase of the Trier Social Stress Task.
Participants provided saliva samples to be assayed for neuroendocrine levels to measure cortisol. They were directed to transfer saliva from their mouths to a tube. The sample tubes were carefully labelled and stored in a freezer at -25 ºC until they were sent to the Medikosta Laboratory.
Change from baseline levels of heart-rate (HR) at the time of the procedure (i.e., during the Trier Social Stress Task) and recovery (i.e., immediately after the Trier Social Stress Task).
Time frame: Baseline, during the procedure, and immediately after the procedure (i.e., the Trier Social Stress Task).
Electrocardiogram (ECG) to measure heart-rate (HR) was recorded using the BioPac M150 system at a sampling rate of 1000 Hz and AcqKnowledge® 4.0 software.
Change from baseline levels of heart-rate variability (HRV) at the time of the procedure (i.e., during the Trier Social Stress Task) and recovery (i.e., immediately after the Trier Social Stress Task).
Time frame: Baseline, during the procedure, and immediately after the procedure (i.e., the Trier Social Stress Task).
Electrocardiogram (ECG) to measure heart-rate variability (HRV) was recorded using the BioPac M150 system at a sampling rate of 1000 Hz and AcqKnowledge® 4.0 software.
Change from baseline levels of skin conductance level (SCL) at the time of the procedure (i.e., during the Trier Social Stress Task) and recovery (i.e., immediately after the Trier Social Stress Task).
Time frame: Baseline, during the procedure, and immediately after the procedure (i.e., the Trier Social Stress Task).
Electrodermal Activity to measure skin conductance level (SCL) was recorded using the BioPac M150 system at a sampling rate of 1000 Hz and AcqKnowledge® 4.0 software.
Change from baseline scores of the subscale for Negative Mood of the Scale for Mood Assessment (Sanz, 2001) at recovery (immediately after the procedure -Trier Social Stress Task-).
Time frame: Baseline and immediately after the math phase of the Trier Social Stress Task.
Self reported transitory negative moods measured by 12 items (assessing depression, anxiety, and hostility) scored on an 11-point scale from 0 (nothing) to 10 (a lot), yielding a total between 0 and 120 (with higher scores meaning higher negative moods).
Change from baseline scores of the subscale for Positive Mood of the Scale for Mood Assessment (Sanz, 2001) at recovery (immediately after the procedure -Trier Social Stress Task-).
Time frame: Baseline and immediately after the math phase of the Trier Social Stress Task.
Self reported transitory positive mood measured by 4 items (assessing elation) scored on an 11-point scale from 0 (nothing) to 10 (a lot), yielding a total between 0 and 40 (with higher scores meaning higher positive mood).
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 8 Mar 2021.
- Individual participant dataSharing planned: Yes. Raw data will be available at OSF when the results of the study are published.
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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.
Esther Calvete, PhD principal investigator
University of Deusto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ITP+SA Wise intervention and ITP Wise intervention in people with Stress, Physiological and Stress, Psychological, run by University of Deusto at 1 site 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 2 inclusion and 1 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 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 from baseline levels of cortisol in saliva at recovery (immediately after the procedure -Trier Social Stress Task-). (time frame: Baseline and immediately after the math phase of the Trier Social Stress Task.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2021; AzTrials last refreshed its copy on 29 Oct 2026.