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Clinical Trials/NCT05839015
NCT05839015
Not Yet Recruiting
N/A

Efficacy of an Smartphone App Intervention Based on Self-Compassion for Mental Health Among University Students During and After Covid-19: a Randomized Clinical Trial

Federal University of Health Science of Porto Alegre0 sites150 target enrollmentMarch 20, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mental Health Issue
Sponsor
Federal University of Health Science of Porto Alegre
Enrollment
150
Primary Endpoint
Change in Anxiety
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Since the beginning of Covid-19, there has been an increase in the incidence of mental disorders and psychopathological symptoms, such as depression, anxiety and stress, among university students. Even with the end of social distancing, many students still have losses in emotional well-being, so psychotherapeutic interventions are important for the recovery and promotion of the mental health of this public. Interventions based on self-compassion have been associated with improving the mental health of different audiences, either by reducing psychopathological symptoms (such as anxiety) or improving positive constructs associated with mental health, such as hope and optimism. One way to administer interventions based on self-compassion is through mHealth technologies, which have been consolidating since the pandemic. Some studies sought to assess the benefits of self-compassion-based interventions administered in the mHealth format among university students suggest that they have acceptability and are effective regarding indicators of emotional well-being. However, in Brazil, there is still no digital intervention for the cultivation of self-compassion among university students, which could help to mitigate the deleterious effects of the pandemic on mental health. Considering this gap, an intervention based on self-compassion administered via a smartphone app called "Eu + Compassivo" was developed. The present study seeks to evaluate its efficacy in mental health indicators, both psychopathological symptoms and Positive Psychology constructs.

Registry
clinicaltrials.gov
Start Date
March 20, 2024
End Date
December 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Health Science of Porto Alegre
Responsible Party
Principal Investigator
Principal Investigator

Bruno Luis Schaab

Principal Investigator

Federal University of Health Science of Porto Alegre

Eligibility Criteria

Inclusion Criteria

  • Must be enrolled in a course that originally works in the face-to-face format
  • Having basic knowledge of the use of smartphones
  • Owning a smartphone with internet access and the Android or IOS system
  • At least mild depressive, anxiety or stress symptoms
  • Exclusion Criteria
  • Diagnosed with any serious and persistent mental disorder

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Anxiety

Time Frame: T1 (pre), T2 (6-week)

Depression, Anxiety and Stress Scale (DASS-21) - The measure has 21 items arranged in 3 dimensions (depression, anxiety and stress) through a Likert scale ranging from "did not apply to me at all" (0) to "applied to me very much, or most of the time" (3). The sum of the items provides a score between 0 and 21 regarding anxiety. The higher the score, the greater the anxiety.

Change in Stress

Time Frame: T1 (pre), T2 (6-week)

Depression, Anxiety and Stress Scale (DASS-21) - The measure has 21 items arranged in 3 dimensions (depression, anxiety and stress) through a Likert scale ranging from "did not apply to me at all" (0) to "applied to me very much, or most of the time" (3). The sum of the items provides a score between 0 and 21 regarding stress. The higher the score, the greater the stress.

Change in Depression

Time Frame: T1 (pre) to T2 (6-week)

Depression, Anxiety and Stress Scale (DASS-21) - The measure has 21 items arranged in 3 dimensions (depression, anxiety and stress) through a Likert scale ranging from "did not apply to me at all" (0) to "applied to me very much, or most of the time" (3). The sum of the items provides a score between 0 and 21 regarding depression. The higher the score, the greater the depression.

Change in Self-Compassion

Time Frame: T1 (pre), T2 (6-week)

Self-Compassion Scale - The measure has 26 items scored on a Likert scale, ranging from "almost never" (1) to "almost always" (5). The higher the score, the greater the sel-compassion.

Change in Compassion

Time Frame: T1 (pre), T2 (6-week)

Santa Clara Brief Compassion Scale - The measure has 5 items arranged on a Likert scale, ranging from "not at all true for me" (1) to "very true for me" (7). The higher the score, the greater the compassion.

Change in Emotional Well-Being

Time Frame: T1 (pre), T2 (6-week)

Well-being Index (WHO-5) - It is a generic measure that assesses emotional well-being. It has 5 items, ranging from "at no time" (0) to "all the time" (5) on a Likert scale, providing a score that varies between 0 and 25. The higher the score, the greater the emotional well-being.

Secondary Outcomes

  • Change in Optimism(T1 (pre), T2 (6-week))
  • Change in Life Satisfaction(T1 (pre), T2 (6-week))
  • Change in Hope(T1 (pre), T2 (6-week))
  • Change in Emotional Self-Regulation(T1 (pre), T2 (6-week))
  • Change in Positive Affect(T1 (pre), T2 (6-week))
  • Change in Negative Affect(T1 (pre), T2 (6-week))

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