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

6. november 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

58

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 29 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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

Annen: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Rosenberg Self-esteem Scale (RSE)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Self-Compassion Scale (SCS)
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Alcohol Use Disorder Identification Test (AUDIT)
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

30. november 2027

Studiet fullført (Antatt)

30. november 2027

Datoer for studieregistrering

Først innsendt

3. november 2026

Først innsendt som oppfylte QC-kriteriene

6. november 2026

Først lagt ut (Faktiske)

13. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2024.00914.BD
  • 2024.00914.BD (Annet stipend/finansieringsnummer: Fundação para a Ciência e a Tecnologia)
  • https://doi.org/10.54499/2024. (Annen identifikator: Fundação para a Ciência e a Tecnologia)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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