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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04668287
Other study ID # WUTimisoara
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2020
Est. completion date December 18, 2020

Study information

Verified date February 2023
Source West University of Timisoara
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to measure the impact of an online intervention on students' self-esteem, using the model outlined by Melanie Fennell.


Description:

The purpose of this study is to test the level of students' self-esteem (explicit and implicit) before and after an online intervention. All selected participants will enjoy one of the online working groups led by a psychologist for five weeks. In these group sessions, students will be trained to identify how their low self-esteem was developed, what are those factors that maintain their low self-esteem and what can they do for improving their low self-esteem, using Fennell model.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date December 18, 2020
Est. primary completion date November 13, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Low Self-Esteem (Cut-off=35 at Rosenberg self-esteem scale) - Being first year student in West University of Timisoara Exclusion Criteria: - Severe clinical depression symptoms (Cut-off=15 at PHQ9) - Severe clinical anxiety symptoms (Cut-off=15 at GAD7)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Increasing self-esteem
During 5 weeks, participants will be part of one of the working groups in which they'll be taught by a counselor about how a low self-esteem develops and what have to be done for improving self-esteem, based on the Melanie Fennel' model.

Locations

Country Name City State
Romania West University of Timi?oara Timisoara

Sponsors (1)

Lead Sponsor Collaborator
West University of Timisoara

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Rosenberg's Self Esteem Scale Rosenberg's Self Esteem Scale is a self-esteem measure widely used in social-science research. It is a ten-item likert-type scale with items answered on a four-point scale-from strongly disagree to strongly agree. The scale measures global self-worth by measuring both positive and negative feelings about the self. The minimum score of Rosenberg's Self Esteem Scale is 10 and the highest one is 40. A higher score means a better outcome. Change from Pre- to Post-Intervention (5 weeks)
Secondary Name Letter Test Name Letter Test is used to measure implicit self-esteem by testing the tendency to evaluate alphabetical letters in one's name, especially initials, particularly favorably. Change from Pre- to Post-Intervention (5 weeks)
Secondary Academic Burnout Scale This scale is designed to measure the level of students' burnout. It contains 3 subscales: Exhaustion (minimum score: 5, maximum: 25), Cynicism (minimum score: 5, maximum: 25), Inefficacy (minimum score: 6, maximum: 30). A higher score means a worse outcome. Beside that, it can be scored Core Burnout, as sum between Exhaustion and Cynicism. Change from Pre- to Post-Intervention (5 weeks)
Secondary Generalised Anxiety Disorder Assessment (GAD7) Generalised Anxiety Disorder Assessment is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity. The minimum score of Generalised Anxiety Disorder Assessment is 0 and the highest one is 21. A higher score means a worse outcome (a higher level of anxiety). Change from Pre- to Post-Intervention (5 weeks)
Secondary Patient Health Questionnaire-9 (PHQ9) Patient Health Questionnaire-9 was designed to measure participant's severity of depression using DSM IV criteria. The minimum score of Patient Health Questionnaire-9 is 0 and the highest one is 27. A higher score means a worse outcome (more severe symptoms of depression). Change from Pre- to Post-Intervention (5 weeks)
Secondary Treatment Satisfaction Questionnaire Treatment Satisfaction Questionnaire is a scale designed to measure the level of students' satisfaction with intervention. The items refer to the content of the intervention, being open and close questions. Post-Intervention (5 weeks)
Secondary Therapeutic factors A 9 item questionnaire designed to measure the impact of some of the therapeutic factors as universality, altruism, instillation of hope, etc (Yalom, I. D., & Leszcz, M. (Collaborator). (2005). The theory and practice of group psychotherapy (5th ed.)). For each of the 9 factors, the minimum score is 1 and the maximum one is 5. A higher score means a better outcome (that factor is relevant for intervention). Post-Intervention (5 weeks)
Secondary System usability A 10 item questionnaire designed to measure participants' satisfaction with Zoom, the online platform used for weekly meetings. The minimum score of System Usability Scale is 10 and the highest one is 50. A higher score means a better outcome. Post-Intervention (5 weeks)
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