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

6 de noviembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

58

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 29 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.

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

Otro: 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.

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The Rosenberg Self-esteem Scale (RSE)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Self-Compassion Scale (SCS)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Alcohol Use Disorder Identification Test (AUDIT)
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de enero de 2027

Finalización primaria (Estimado)

30 de noviembre de 2027

Finalización del estudio (Estimado)

30 de noviembre de 2027

Fechas de registro del estudio

Enviado por primera vez

3 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de noviembre de 2026

Publicado por primera vez (Actual)

13 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2024.00914.BD
  • 2024.00914.BD (Otro número de subvención/financiamiento: Fundação para a Ciência e a Tecnologia)
  • https://doi.org/10.54499/2024. (Otro identificador: Fundação para a Ciência e a Tecnologia)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .