Self EsteemSSEONINCT04668287
Improving Students' Self-esteem With an Online Intervention
A study testing Increasing self-esteem in people with Self Esteem, run by West University of Timisoara at 1 site in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Self Esteem
- What is being tested?
- Increasing self-esteem
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteRomania
- Study dates
- 11 Nov 2020to 18 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Low Self-Esteem (Cut-off=35 at Rosenberg self-esteem scale)
- Being first year student in West University of Timisoara
Who cannot join
- Severe clinical depression symptoms (Cut-off=15 at PHQ9)
- Severe clinical anxiety symptoms (Cut-off=15 at GAD7)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Self Esteem
- Being tested
- Increasing self-esteem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increasing self-esteemBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Increasing Self-Esteem | Other | All participants will be included in working groups. Receives: Behavioral: Increasing self-esteem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Pre- to Post-Intervention (5 weeks)
Secondary outcomes (7)
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.
Measured: Change from Pre- to Post-Intervention (5 weeks)
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.
Measured: Change from Pre- to Post-Intervention (5 weeks)
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).
Measured: Change from Pre- to Post-Intervention (5 weeks)
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).
Measured: Change from Pre- to Post-Intervention (5 weeks)
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.
Measured: Post-Intervention (5 weeks)
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).
Measured: Post-Intervention (5 weeks)
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.
Measured: Post-Intervention (5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start11 Nov 2020
- Primary completion13 Nov 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EsteemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-Label Pilot Study
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- West University of Timisoara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668287
- Sponsor's protocol ID
- WUTimisoara
- Acronym
- SSEONI
- Status last verified
- Feb 2023
- First submitted
- 8 Dec 2020
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Students' Self-esteem With an Online Intervention Based on the Fennel Model: An Open-label, Uncontrolled Pilot Trial
- ClinicalTrials.gov ID
- NCT04668287
- Acronym / sponsor ID
- SSEONI / WUTimisoara
- Conditions
- Self Esteem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- West University of TimisoaraUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-Label Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Increasing Self-Esteem | Other | Behavioral: Increasing self-esteemAll participants will be included in working groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Low Self-Esteem (Cut-off=35 at Rosenberg self-esteem scale)
- Being first year student in West University of Timisoara
Key exclusion criteria (2 listed)
- Severe clinical depression symptoms (Cut-off=15 at PHQ9)
- Severe clinical anxiety symptoms (Cut-off=15 at GAD7)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increasing self-esteemDuring 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. | Behavioural | Increasing Self-Esteem |
Primary outcome
Changes in Rosenberg's Self Esteem Scale
Time frame: Change from Pre- to Post-Intervention (5 weeks)
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.
7 secondary outcomes
Name Letter Test
Time frame: Change from Pre- to Post-Intervention (5 weeks)
Academic Burnout Scale
Time frame: Change from Pre- to Post-Intervention (5 weeks)
Generalised Anxiety Disorder Assessment (GAD7)
Time frame: Change from Pre- to Post-Intervention (5 weeks)
Patient Health Questionnaire-9 (PHQ9)
Time frame: Change from Pre- to Post-Intervention (5 weeks)
Treatment Satisfaction Questionnaire
Time frame: Post-Intervention (5 weeks)
Therapeutic factors
Time frame: Post-Intervention (5 weeks)
System usability
Time frame: Post-Intervention (5 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increasing self-esteem in people with Self Esteem, run by West University of Timisoara at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Rosenberg's Self Esteem Scale (time frame: Change from Pre- to Post-Intervention (5 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.