NCT04668287

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
Last Updated

May 10, 2024

Status Verified

February 1, 2023

Enrollment Period

2 days

First QC Date

December 8, 2020

Last Update Submit

May 9, 2024

Conditions

Self Esteem

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Name Letter Test

    Change from Pre- to Post-Intervention (5 weeks)

  • Academic Burnout Scale

    Change from Pre- to Post-Intervention (5 weeks)

  • Generalised Anxiety Disorder Assessment (GAD7)

    Change from Pre- to Post-Intervention (5 weeks)

  • Patient Health Questionnaire-9 (PHQ9)

    Change from Pre- to Post-Intervention (5 weeks)

  • Treatment Satisfaction Questionnaire

    Post-Intervention (5 weeks)

  • +2 more secondary outcomes

Study Arms (1)

Increasing Self-Esteem

OTHER

All participants will be included in working groups.

Behavioral: Increasing self-esteem

Interventions

Increasing self-esteemBEHAVIORAL

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.

Increasing Self-Esteem

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low Self-Esteem (Cut-off=35 at Rosenberg self-esteem scale)
  • Being first year student in West University of Timisoara

You may not qualify if:

  • Severe clinical depression symptoms (Cut-off=15 at PHQ9)
  • Severe clinical anxiety symptoms (Cut-off=15 at GAD7)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West University of Timișoara

Timișoara, 320104, Romania

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Open-Label Pilot Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 16, 2020

Study Start

November 11, 2020

Primary Completion

November 13, 2020

Study Completion

December 18, 2020

Last Updated

May 10, 2024

Record last verified: 2023-02

Locations

RO(1)