Selected Aspects of Mental Health of Athletes | NCT04259541

Studies
Selected Aspects of Mental Health of Athletes

NCT04259541

Sponsor

University of Primorska

Status

Completed

Last Update Posted

Oct 6, 2021Actual

Enrollment

360Actual

Phase

Not provided

Conditions

Mental Health Disorder

Interventions

Psychodiagnostic

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2, 2020Actual

Primary Completion Date

Nov 5, 2020Actual

Completion Date

Jan 1, 2021Actual

First Submitted Date

Feb 5, 2020

First Submission Date that Met QC Criteria

Feb 5, 2020

First Posted Date

Feb 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2021

Last Update Posted Date

Oct 6, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Masa Cernelic Bizjak, Principal investigator, University of PrimorskaPrincipal Investigator

Lead Sponsor

University of PrimorskaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will assess the prevalence of mental health problems among different athletes. The study is based on the application of the battery of psychodiagnostic questionnaires, which were chosen aiming at investigating the prevalence of different symptoms related to problems in mental health or disorders.

This descriptive cross-sectional study will undertake sample with athletes categorized by the quality of their achievement.

Detailed Description

In the field of sports, there is a lot of knowledge about sports injuries, nutrition and regeneration. Much less is known about mental health among athletes. The investigators often think that the incidence of mental problems is low among top athletes. As the main cause of this misconception, the authors attribute the idealization of sports and athletes. Both the professional and the lay public are often of the opinion that only mentally strong individuals can be successful, which of course means that there is no place in the highest level for individuals with mental problems and disorders.

The clinical study will be performed with 400-500 athletes of both genders aged 18 to 40, from Slovenia. The investigators will invite all athletes who have been categorized in the current year and classified into the membership category, i.e. national, international, world or Olympic class (there were 500 at the last categorization) and they compete in various sports disciplines. The study will be designed as a cross-sectional study. For the purpose of the research, the investigators will use a battery of psychodiagnostic questionnaires consisting of five parts: demographics and sport characteristic, depression symptomatic, anxiety symptomatic, eating problems, alcohol use and abuse and resilience characteristics of individual athlete.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

360Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Psychodiagnostic	Diagnostic Test	Intensity and frequency of specific symptoms, signs of problems in mental health

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intensity and frequency of specific symptoms	Intensity and frequency of specific symptoms could be the signs of problems in mental health	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Depressive symptomatology	The degree of depressive symptomatology (physical, affective, cognitive and behavioral symptoms) will be measured with The Depression Scale Center	Baseline
Pathological eating patterns

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Included in competitive play
Is a professional athlete or participates in organized professional sports activities

Exclusion Criteria:

Present injuries
Recreational athletes
Any other significant diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Atletes at a competitive level, coming from different sports.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Primorska, Faculty of health care		Izola			Slovenia

IPD Sharing Statement Module

Plan to Share IPD

Description

Group participant data will be available to other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001523	Mental Disorders

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

The degree of pathological eating patterns will be measured with Eating Attitude Test Questionnaire (EAT-26; Garner and Garfinkel, 1979) as high levels of preoccupation with diet, weight, and other pathological eating patterns.