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

March 18, 2024 updated by: Bruno Luis Schaab, Federal University of Health Science of Porto Alegre

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
This is group wil use "Eu + Compassivo" app.
Behavioral: mHealth Intervention Based on Self-Compassion
Self-compassion techniques aim at developing compassionate skills for emotion regulation, such as self-kindness, recognition of common humanity, and mindfulness.
No Intervention: Control
This group will be made up of a waiting list.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
T1 (pre) to T2 (6-week)
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.
T1 (pre), T2 (6-week)
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.
T1 (pre), T2 (6-week)
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.
T1 (pre), T2 (6-week)
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.
T1 (pre), T2 (6-week)
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.
T1 (pre), T2 (6-week)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Hope
Time Frame: T1 (pre), T2 (6-week)
Adult Dispositional Hope Scale - The instrument has 21 items arranged in a two-dimensional structure (self-centered hope and altruistic hope), scored on a two-column 6-point Likert scale, which express, respectively, the ideas of desire and expectation in relation to the content of each item ( 0 = do not want; 5 = want very much; 0 = do not believe; 5 = believe very much). The higher the score, the greater the hope.
T1 (pre), T2 (6-week)
Change in Emotional Self-Regulation
Time Frame: T1 (pre), T2 (6-week)
Emotional Dysregulation Scale - The measure has 15 items arranged on a 4-point Likert scale, ranging from "none of the times/not at all" (0) to "always" (5). The higher the score, the greater the emotional dysregulation.
T1 (pre), T2 (6-week)
Change in Positive Affect
Time Frame: T1 (pre), T2 (6-week)
The Positive and Negative Affect Schedule (PANAS) - The measure has 20 items arranged on a Likert scale, 10 of which are negative affects and 10 are positive affects, ranging from "very slightly or not at all" (1) to "extremely" (5). The sum of the scores of each item provides a score that varies between 10 and 50 for positive affect. The higher the score, the greater the positive affect.
T1 (pre), T2 (6-week)
Change in Negative Affect
Time Frame: T1 (pre), T2 (6-week)
The Positive and Negative Affect Schedule (PANAS) - The instrument has 20 items arranged on a Likert scale, 10 of which are negative affects and 10 are positive affects, ranging from "very slightly or not at all" (1) to "extremely" (5). The sum of the scores of each item provides a score that varies between 10 and 50 for negative affect. The higher the score, the greater the negative affect.
T1 (pre), T2 (6-week)
Change in Optimism
Time Frame: T1 (pre), T2 (6-week)
Revised Life Orientation Test - The measure has 10 items arranged on a Likert scale ranging from "strongly disagree" (1) to "strongly agree" (5). The higher the score, the greater the optimism.
T1 (pre), T2 (6-week)
Change in Life Satisfaction
Time Frame: T1 (pre), T2 (6-week)
Satisfaction With Life Scale (SWLS) - The measure has 5 items arranged on a Likert scale ranging from "strongly disagree" (1) to "strongly agree" (7). The sum of the scores for each item provides a score between 5 and 35. The higher the score, the greater the life satisfaction.
T1 (pre), T2 (6-week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Health Science of Porto Alegre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • bruno.schaabUFCSPA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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