Mental Health IssueNCT05839015
Efficacy of an Smartphone App Intervention Based on Self-compassion for Mental Health Among University Students
A study testing mHealth Intervention Based on Self-Compassion in people with Mental Health Issue, run by Federal University of Health Science of Porto Alegre.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- mHealth Intervention Based on Self-Compassion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosed with any serious and persistent mental disorder
Trial locations and contacts
No sites are listed yet.
About this study
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
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
- Being tested
- mHealth Intervention Based on Self-Compassion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Intervention Based on Self-CompassionBehavioural
Self-compassion techniques aim at developing compassionate skills for emotion regulation, such as self-kindness, recognition of common humanity, and mindfulness.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This is group wil use "Eu + Compassivo" app. Receives: Behavioral: mHealth Intervention Based on Self-Compassion |
| Control | No intervention | This group will be made up of a waiting list. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T1 (pre), T2 (6-week)
Secondary outcomes (6)
Change in Hope
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.
Measured: T1 (pre), T2 (6-week)
Change in Emotional Self-Regulation
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.
Measured: T1 (pre), T2 (6-week)
Change in Positive Affect
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.
Measured: T1 (pre), T2 (6-week)
Change in Negative Affect
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.
Measured: T1 (pre), T2 (6-week)
Change in Optimism
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.
Measured: T1 (pre), T2 (6-week)
Change in Life Satisfaction
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.
Measured: T1 (pre), T2 (6-week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start20 Mar 2024 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Bruno Luis Schaab, Federal University of Health Science of Porto Alegre
- Investigators
- Caroline Tozzi Reppold, PhD, Principal investigator, Federal University of Health Sciences of Porto AlegrePrisla Ücker Calvetti, PhD, Principal investigator, Federal University of Health Sciences of Porto AlegreSílvio César Cazella, PhD, Principal investigator, Federal University of Health Sciences of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839015
- Sponsor's protocol ID
- bruno.schaabUFCSPA
- Status last verified
- Mar 2024
- First submitted
- 14 Oct 2022
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05839015
- Acronym / sponsor ID
- bruno.schaabUFCSPA
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: mHealth Intervention Based on Self-CompassionThis is group wil use "Eu + Compassivo" app. |
| Control | No intervention | –This group will be made up of a waiting list. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Diagnosed with any serious and persistent mental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth Intervention Based on Self-CompassionSelf-compassion techniques aim at developing compassionate skills for emotion regulation, such as self-kindness, recognition of common humanity, and mindfulness. | Behavioural | Intervention |
Primary outcome
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 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 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.
6 secondary outcomes
Change in Hope
Time frame: T1 (pre), T2 (6-week)
Change in Emotional Self-Regulation
Time frame: T1 (pre), T2 (6-week)
Change in Positive Affect
Time frame: T1 (pre), T2 (6-week)
Change in Negative Affect
Time frame: T1 (pre), T2 (6-week)
Change in Optimism
Time frame: T1 (pre), T2 (6-week)
Change in Life Satisfaction
Time frame: T1 (pre), T2 (6-week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Tozzi Reppold, PhD principal investigator
Federal University of Health Sciences of Porto Alegre
Prisla Ücker Calvetti, PhD principal investigator
Federal University of Health Sciences of Porto Alegre
Sílvio César Cazella, PhD principal investigator
Federal University of Health Sciences of Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Intervention Based on Self-Compassion in people with Mental Health Issue, run by Federal University of Health Science of Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Luis Schaab, MSc. (+55 51 99947-4493, bruno.schaab@ufcspa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression (time frame: T1 (pre) to T2 (6-week)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.