SIYA-PT: An Internet-based CBT Intervention to Enhance Low Self-esteem Among Portuguese Emerging Adults

November 6, 2026 updated by: Ivanilda B. Costa, Lusofona University

SIYA-PT: An Internet-based CBT Intervention to Enhance Low Self-esteem

This study investigates whether an eHealth cognitive-behavioural therapy (CBT) intervention for low self-esteem, SIYA-PT, is acceptable and feasible for an ethnically diverse population of emerging adults in Portugal.

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.

Detailed Description

Low self-esteem (LSE) is a negative cognitive representation of the self, based on personal experience, and it influences how information is processed.

LSE has been linked to worse psychological adjustment, and research has found that CBT-based interventions using Fennell's cognitive model of low self-esteem were able to improve participants' self-esteem.

SIYA-PT is a cultural adaptation of SIYA, a guided internet-based CBT intervention developed for Swedish adolescents, and it is based on Cognitive Model of Low Self-Esteem, Self-Determination Theory, and Self-Compassion Theory. SIYA-PT has 7 modules that will be presented to participants, one module per week.

The investigators aim to evaluate whether a culturally adapted iCBT intervention is accepted by Portuguese emerging adults - people aged 18 to 29 years old - and whether it is feasible in enhancing self-esteem and improving anxiety and depressive symptoms and quality of life.

This study is a pilot-randomised controlled trial. The study will have an intervention group (IG) that will receive the intervention (SIYA-PT) immediately after randomisation, and a waitlist control group (WCG) that will receive the intervention after follow-up, 3 months after IG finishes their intervention.

The investigators aim to recruit at least 58 participants with LSE, considering a 31% dropout.

The main outcomes of the study are self-esteem, quality of life and anxiety and depressive symptoms and the secondary outcomes are self-compassion and assertiveness.

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.
58

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.

Study Locations

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

18 years to 29 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Scores of ≤15 on the Rosenberg Self-esteem Scale and <120 on the Robson Self-concept Questionnaire indicating low self-esteem;
  • Scores of ≤ 50 on the WHOQOL-BREF indicating low quality of life
  • Age between 18 and 29 years old
  • Fluency in written and spoken Portuguese
  • Daily access to a device with an internet connection
  • Not receiving any psychological intervention
  • If on psychopharmacological treatment, must be in treatment for at least three months and the dosage must be stable for at least one month
  • Residence in Portugal

Exclusion Criteria:

  • Severe psychiatric disorders such as Depressive Disorder or Suicidal ideation, which will be self-reported on the Sociodemographic Questionnaire and assessed through a Structured Interview developed by the research team
  • Alcohol Use Disorder, which will be assessed using the Alcohol Use Disorder Identification Test
  • Personal relationship with PHD student (e.g., former patients or students, friends, family members)

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: Treatment
  • 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 Group (IG)

IG will have access to the intervention (SIYA-PT). The participants will have an individual login to use the platform, and have access to the modules and the measures that need to be filled out throughout the study.
Behavioral: SIYA-PT

SIYA-PT has seven modules:

Module 1 - Introduction Module 2 - Achievements and self-esteem Module 3 - Relationships and self-esteem Module 4 - Independence and self-esteem Module 5 - Dealing with adversities Module 6 - Self-acceptance Module 7 - Termination and continuation
Other: Waitlist Control Group (WCG)

WCG will not receive the intervention while IG goes through SIYA-PT. The participants will have an individual login to access the platform to answer the self-reported measures weekly to monitor their well-being. The participants will also have access to messaging to be able to contact the clinical psychologist on the platform if there is increase in their, e.g., anxiety and depressive symptoms. After the end of IG intervention and the follow-up , three months, WCG will receive the same SIYA-PT intervention.
Behavioral: SIYA-PT

SIYA-PT has seven modules:

Module 1 - Introduction Module 2 - Achievements and self-esteem Module 3 - Relationships and self-esteem Module 4 - Independence and self-esteem Module 5 - Dealing with adversities Module 6 - Self-acceptance Module 7 - Termination and continuation

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
The Rosenberg Self-esteem Scale (RSE)
Time Frame: Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up

A 10-item self-report measure to assess global self-esteem. The RSE (Rosenberg, 1965; Pechorro et al., 2011) uses a 4-point Likert scale to rate agreement with the statements, from 0 (Strongly disagree) to 3 (Strongly agree). Scores vary from 0 to 30, with higher scores indicating higher levels of global self-esteem.
Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up
Robson Self-Concept Questionnaire (RSCQ)
Time Frame: Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up

A 30-item self-report measure to assess global self-esteem. The RSCQ (Robson, 1989) uses a 7-point Likert scale to rate agreement with each statement, from 0 (Completely disagree) to 7 (Completely agree). Scores vary from 0 to 210, with higher scores indicating higher levels of global self-esteem.
Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up
Generalised Anxiety Disorder 7-item Scale (GAD-7)
Time Frame: Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up

A seven-item self-report measure to assess generalised anxiety disorder according to DSM-IV criteria. GAD-7 (Spitzer et al., 2006; Sousa et al., 2015) uses a 4-point Likert scale to rate how often one has experienced the described situation, from 0 (Never) to 3 (Almost every day). Scores vary from 0 to 21, with higher scores indicating higher levels of anxiety.
Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up
Patient Health Questionnaire 9-item (PHQ-9)
Time Frame: Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up

A nine-item self-report measure to assess depressive symptoms according to DSM-IV criteria. PHQ-9 (Kroenke et al., 2001; Lamela et al., 2020) uses a 4-point Likert scale to rate how often one has experienced the described situation, from 0 (Never) to 3 (Almost every day). Scores vary from 0 to 27, with higher scores indicating higher levels of depressive symptoms.
Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up
WHOQOL-BREF
Time Frame: Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up

A 26-item self-report measure with four domains (physical health, psychological health, social relationships and environment) to assess perceived quality of life. WHOQOL-BREF (The WHOQOL Group, 1998; Vaz Serra et al., 2006) uses a 5-point Likert scale, from 1 ("Very Poor", "Not at all" or "Very dissatisfied") to 5 ("Very good", "Completely", "Always" or "Very satisfied") to ask how one feels about their quality of life, health, or other areas of their life. Scores vary from 0 to 100, with higher scores indicating higher perceived quality of life.
Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up

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
Self-Compassion Scale (SCS)
Time Frame: Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up

A 26-item self-report measure with six subscales (Self-Kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification) that assesses how one typically responds in difficult times in terms of self-compassion. SCS (Neff, 2003; Castilho & Pinto-Gouveia, 2015) uses a 5-point Likert scale to rate how often one does each behaviour described in each item, from 1 (Almost never) to 5 (Almost always). Higher scores indicate higher levels of self-compassion.
Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up
The Rathus Assertiveness Schedule (RAS)
Time Frame: Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up

A 30-item self-report measure to assess assertive behaviour. RAS (Rathus, 1973; Detry & Castro, 1990) uses a 6-point Likert scale to rate how well each item describes the person, from 5 (Very much like me) to 0 (Very much unlike me). Scores vary from 0 to 30, with higher scores indicating higher assertiveness.
Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Alcohol Use Disorder Identification Test (AUDIT)
Time Frame: pre-intervention (baseline)

A 10-item self-report measure to screen for three areas (alcohol consumption, dependence symptoms and alcohol-related problems) of alcohol-use-related problems using a 5-point Likert scale. AUDIT (WHO, 1989) scores vary from 0 to 40, from 0 to 4, with higher scores indicating higher levels of alcohol-use-related problems.
pre-intervention (baseline)
Structure interview
Time Frame: pre-intervention (baseline)

An interview guide with 14 questions developed by the research team based on questions from Mini International Neuropsychiatric Interview (Sheehan et al., 1998)'s subscale for Suicide Ideation and DSM-5-TR criteria for Major Depressive Disorder with a dichotomous answer - No or Yes.
pre-intervention (baseline)

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.
Lusofona University

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.
Fundação para a Ciência e a Tecnologia
Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Universidade de Coimbra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
January 1, 2027

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.
November 30, 2027

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.
November 30, 2027

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).
November 3, 2026

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.
November 6, 2026

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.
November 13, 2026

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.
November 13, 2026

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.
November 6, 2026

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.
November 1, 2026

More Information

Terms related to this study

Keywords

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.
  • 2024.00914.BD
  • 2024.00914.BD (Other Grant/Funding Number: Fundação para a Ciência e a Tecnologia)
  • https://doi.org/10.54499/2024. (Other Identifier: Fundação para a Ciência e a Tecnologia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study participants have not given consent for their individual data to be shared with other researchers.

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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