- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04668287
Improving Students' Self-esteem With an Online Intervention (SSEONI)
May 9, 2024 updated by: West University of Timisoara
Improving Students' Self-esteem With an Online Intervention Based on the Fennel Model: An Open-label, Uncontrolled Pilot Trial
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Timişoara, Romania, 320104
- West University of Timisoara
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Increasing Self-Esteem
All participants will be included in working groups.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Rosenberg's Self Esteem Scale
Time Frame: Change from Pre- to Post-Intervention (5 weeks)
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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.
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Change from Pre- to Post-Intervention (5 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Name Letter Test
Time Frame: Change from Pre- to Post-Intervention (5 weeks)
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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.
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Change from Pre- to Post-Intervention (5 weeks)
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Academic Burnout Scale
Time Frame: Change from Pre- to Post-Intervention (5 weeks)
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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.
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Change from Pre- to Post-Intervention (5 weeks)
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Generalised Anxiety Disorder Assessment (GAD7)
Time Frame: Change from Pre- to Post-Intervention (5 weeks)
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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).
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Change from Pre- to Post-Intervention (5 weeks)
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Patient Health Questionnaire-9 (PHQ9)
Time Frame: Change from Pre- to Post-Intervention (5 weeks)
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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).
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Change from Pre- to Post-Intervention (5 weeks)
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Treatment Satisfaction Questionnaire
Time Frame: Post-Intervention (5 weeks)
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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.
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Post-Intervention (5 weeks)
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Therapeutic factors
Time Frame: Post-Intervention (5 weeks)
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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).
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Post-Intervention (5 weeks)
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System usability
Time Frame: Post-Intervention (5 weeks)
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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.
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Post-Intervention (5 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 11, 2020
Primary Completion (Actual)
November 13, 2020
Study Completion (Actual)
December 18, 2020
Study Registration Dates
First Submitted
December 8, 2020
First Submitted That Met QC Criteria
December 14, 2020
First Posted (Actual)
December 16, 2020
Study Record Updates
Last Update Posted (Actual)
May 10, 2024
Last Update Submitted That Met QC Criteria
May 9, 2024
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- WUTimisoara
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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