Clinical trial NCT05839015: Efficacy of an Smartphone App Intervention Based on Self-compassion for Mental Health Among University Students
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health Issue
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2023-05-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change in Depression
timeFrame: T1 (pre) to T2 (6-week)
measure: Change in Anxiety
timeFrame: T1 (pre), T2 (6-week)
measure: Change in Stress
timeFrame: T1 (pre), T2 (6-week)
measure: Change in Self-Compassion
timeFrame: T1 (pre), T2 (6-week)
measure: Change in Compassion
timeFrame: T1 (pre), T2 (6-week)
measure: Change in Emotional Well-Being
timeFrame: T1 (pre), T2 (6-week)
Secondary outcomes:
measure: Change in Hope
timeFrame: T1 (pre), T2 (6-week)
measure: Change in Emotional Self-Regulation
timeFrame: T1 (pre), T2 (6-week)
measure: Change in Positive Affect
timeFrame: T1 (pre), T2 (6-week)
measure: Change in Negative Affect
timeFrame: T1 (pre), T2 (6-week)
measure: Change in Optimism
timeFrame: T1 (pre), T2 (6-week)
measure: Change in Life Satisfaction
timeFrame: T1 (pre), T2 (6-week)
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Health Sciences of Porto Alegre
name: Caroline Tozzi Reppold, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Health Sciences of Porto Alegre
name: Prisla Ücker Calvetti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Health Sciences of Porto Alegre
name: Sílvio César Cazella, PhD
role: PRINCIPAL_INVESTIGATOR
References: