Clinical trial NCT04786496: Wise Interventions and Responses to Stress
Official title: Effects of Wise Interventions in Psychophysiological Responses to Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Physiological
Stress, Psychological
Social Stress
Depression
Keywords: Trier Social Stress Test
Social Stress
Stress reactivity
Heart Rate
Respiratory Sinus Arrhythmia
Skin Conductance Level
Cortisol
Mood
Young Adults
Lead sponsor: University of Deusto
Sponsor class: OTHER
Collaborators: name: Basque Country Government
name: Spanish Government
First posted: 2021-03-08
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion criteria:

* Having cardiovascular disease.

Primary outcomes:
measure: Change from baseline levels of cortisol in saliva at recovery (immediately after the procedure -Trier Social Stress Task-).
timeFrame: Baseline and immediately after the math phase of the Trier Social Stress Task.
measure: 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).
timeFrame: Baseline, during the procedure, and immediately after the procedure (i.e., the Trier Social Stress Task).
measure: 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).
timeFrame: Baseline, during the procedure, and immediately after the procedure (i.e., the Trier Social Stress Task).
measure: 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).
timeFrame: Baseline, during the procedure, and immediately after the procedure (i.e., the Trier Social Stress Task).
measure: 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-).
timeFrame: Baseline and immediately after the math phase of the Trier Social Stress Task.
measure: 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-).
timeFrame: Baseline and immediately after the math phase of the Trier Social Stress Task.
Secondary outcomes:
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: University of Deusto
state: Vizcaya
Study officials:
affiliation: University of Deusto
name: Esther Calvete, PhD
role: PRINCIPAL_INVESTIGATOR
References: