Wise Interventions and Responses to Stress

NCT ID: NCT04786496

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-02-21

Brief 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. 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.

Conditions

Stress, Physiological; Stress, Psychological; Social Stress; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

ITP+SA Wise intervention (Incremental Theory of Personality Intervention with Self-affirmations)

Wise intervention (based on ITP and SA) consisting on several tasks to be completed individually. 30 minutes

Group Type: EXPERIMENTAL

ITP+SA Wise intervention

Intervention Type: 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 (Incremental Theory of Personality Intervention)

Wise intervention (based on ITP) consisting on several tasks to be completed individually. 30 minutes

Group Type: EXPERIMENTAL

ITP Wise intervention

Intervention Type: 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 Intervention

Educational intervention (about heritage conservation) consisting on several tasks to be completed individually. 30 minutes

Group Type: OTHER

Control condition

Intervention Type: 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.

Interventions

ITP+SA Wise intervention

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).

Intervention Type: BEHAVIORAL

ITP Wise intervention

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.

Intervention Type: BEHAVIORAL

Control condition

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Having cardiovascular disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Basque Country Government

UNKNOWN

Sponsor Role: collaborator

Spanish Government

UNKNOWN

Sponsor Role: collaborator

University of Deusto

OTHER

Sponsor Role: lead

Responsible Party

Esther Calvete

Principal Investigator, Deusto Stress Research Team, University of Deusto

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esther Calvete, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Deusto

Locations

University of Deusto

Bilbao, Vizcaya, Spain

Countries

Spain

Other Identifiers

ITP

Identifier Type: -

Identifier Source: org_study_id