- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ivanilda B. Costa, MSc
- Telefonnummer: +351920086596
- E-mail: siya.pt.project@gmail.com
Studiesteder
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Lisbon District
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Lisbon, Lisbon District, Portugal
- Ivanilda B. Costa
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Kontakt:
- Ivanilda B. Costa, MSc
- Telefonnummer: +351920086596
- E-mail: siya.pt.project@gmail.com
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Kontakt:
- Patrícia M. Pascoal, PhD
- E-mail: patricia.pascoal@ulusofona.pt
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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 |
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Andet: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The Rosenberg Self-esteem Scale (RSE)
Tidsramme: Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up
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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
|
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Robson Self-Concept Questionnaire (RSCQ)
Tidsramme: Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up
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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
|
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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
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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
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Patient Health Questionnaire 9-item (PHQ-9)
Tidsramme: Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up
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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
|
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WHOQOL-BREF
Tidsramme: Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-Compassion Scale (SCS)
Tidsramme: Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up
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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
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The Rathus Assertiveness Schedule (RAS)
Tidsramme: Pre-intervention (baseline), post-intervention (up to 8 weeks), and at the three-month follow-up
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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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Alcohol Use Disorder Identification Test (AUDIT)
Tidsramme: pre-intervention (baseline)
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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)
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Structure interview
Tidsramme: pre-intervention (baseline)
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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)
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2024.00914.BD
- 2024.00914.BD (Andet bevillings-/finansieringsnummer: Fundação para a Ciência e a Tecnologia)
- https://doi.org/10.54499/2024. (Anden identifikator: Fundação para a Ciência e a Tecnologia)
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
Study participants have not given consent for their individual data to be shared with other researchers.
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