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Completed

NCT Number: NCT04786496

Wise Interventions and 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.

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Key information

Conditions

Stress, Physiological Arrhythmia, Sinus Arrhythmias, Cardiac Behavior Behavioral Symptoms Cardiovascular Diseases Depression Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Social Stress Stress, Psychological

Age range

18 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Deusto

Bilbao, Vizcaya, 48003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Informed consent by the participants.
  • To be fluent in Spanish.

Exclusion criteria

  • Having cardiovascular disease.

Treatment and study plan

ITP+SA Wise intervention

Behavioral

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 intervention

Behavioral

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 condition

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

Sponsors and collaborators

Lead sponsor

University of Deusto

Other

Collaborators

  • Basque Country Government
  • Spanish Government

Registry information

Official study title

Effects of Wise Interventions in Psychophysiological Responses to Stress

Acronym: ITP-RSA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2021
Registry last updated
Mar 8, 2021

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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