Efficacy of an Smartphone App Intervention Based on Self-compassion for Mental Health Among University Students

NCT05839015 | Not Yet Recruiting

• 1 other identifier: bruno.schaabUFCSPA
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mental Health Issue

Outcome Measures

Primary Outcomes (6)

• Change in Depression

  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.

  T1 (pre) to T2 (6-week)

• Change in Anxiety

  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.

  T1 (pre), T2 (6-week)

• Change in Stress

  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.

  T1 (pre), T2 (6-week)

• Change in Self-Compassion

  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.

  T1 (pre), T2 (6-week)

• Change in Compassion

  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.

  T1 (pre), T2 (6-week)

• Change in Emotional Well-Being

  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.

  T1 (pre), T2 (6-week)

Secondary Outcomes (6)

• 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)

• Change in Optimism

  T1 (pre), T2 (6-week)

Study Arms (2)

Intervention

EXPERIMENTAL

This is group wil use "Eu + Compassivo" app.

Behavioral: mHealth Intervention Based on Self-Compassion

Control

NO INTERVENTION

This group will be made up of a waiting list.

Interventions

mHealth Intervention Based on Self-Compassion BEHAVIORAL

Self-compassion techniques aim at developing compassionate skills for emotion regulation, such as self-kindness, recognition of common humanity, and mindfulness.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosed with any serious and persistent mental disorder

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Officials

• Caroline Tozzi Reppold, PhD

  Federal University of Health Sciences of Porto Alegre

  PRINCIPAL INVESTIGATOR

• Prisla Ücker Calvetti, PhD

  Federal University of Health Sciences of Porto Alegre

  PRINCIPAL INVESTIGATOR

• Sílvio César Cazella, PhD

  Federal University of Health Sciences of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Luis Schaab, MSc.

CONTACT

+55 51 99947-4493; bruno.schaab@ufcspa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: May 3, 2023
• Study Start: March 20, 2024
• Primary Completion: July 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share