- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07935863
SIYA-PT: An Internet-based CBT Intervention to Enhance Low Self-esteem Among Portuguese Emerging Adults
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
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
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ivanilda B. Costa, MSc
- Número de teléfono: +351920086596
- Correo electrónico: siya.pt.project@gmail.com
Ubicaciones de estudio
-
-
Lisbon District
-
Lisbon, Lisbon District, Portugal
- Ivanilda B. Costa
-
Contacto:
- Ivanilda B. Costa, MSc
- Número de teléfono: +351920086596
- Correo electrónico: siya.pt.project@gmail.com
-
Contacto:
- Patrícia M. Pascoal, PhD
- Correo electrónico: patricia.pascoal@ulusofona.pt
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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
Publicaciones y enlaces útiles
Publicaciones Generales
- Neff KD. Self-Compassion: Theory, Method, Research, and Intervention. Annu Rev Psychol. 2023 Jan 18;74:193-218. doi: 10.1146/annurev-psych-032420-031047. Epub 2022 Aug 12.
- Deci, E. L., & Ryan, R. M. (2000). The" what" and" why" of goal pursuits: Human needs and the self-determination of behavior. Psychological Inquiry, 11(4), 227-268. https://doi.org/10.1207/S15327965PLI1104_01
- Fennell, M. J. V. (1997). Low self-esteem: A cognitive perspective. Behavioural and Cognitive Psychotherapy, 25(1), 1-25. https://doi.org/10.1017/S1352465800015368
- Berg M, Lindegaard T, Flygare A, Sjobrink J, Hagvall L, Palmeback S, Klemetz H, Ludvigsson M, Andersson G. Internet-based CBT for adolescents with low self-esteem: a pilot randomized controlled trial. Cogn Behav Ther. 2022 Sep;51(5):388-407. doi: 10.1080/16506073.2022.2060856. Epub 2022 May 3.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
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)?
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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .