AFFIRMATICS: Epidemiology of Assertiveness and Emotion Management Disorders in People With Tourette's Syndrome

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06136572

Collaborator

(none)

350

Enrollment

Location

Arm

Anticipated Duration (Months)

29.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to evaluate the proportion of assertiveness difficulties in Tourette syndrome. Participants will complete several e-questionnaires (on assertiveness, Tourette severity, quality of life, self-esteem and comorbidities like depression, anxiety...).

Condition or Disease	Intervention/Treatment	Phase
Tourette Syndrome	Diagnostic Test: Rathus Assertiveness scale	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Epidemiology of Assertiveness and Emotion Management Disorders in People With Tourette's Syndrome

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rathus Assertiveness scale All participants	Diagnostic Test: Rathus Assertiveness scale Questionnaire completion

Arm

Intervention/Treatment

Experimental: Rathus Assertiveness scale

All participants

Diagnostic Test: Rathus Assertiveness scale

Questionnaire completion

Outcome Measures

Primary Outcome Measures

Rathus assertiveness questionnaire [5 minutes at inclusion]
The Rathus assertiveness questionnaire includes 30 items, each scores from -3 to +30. A total score inferior or equal to -9 reveals assertiveness difficulties.

Secondary Outcome Measures

MOVES [less than 5 minutes at inclusion]
The MOVES is a self-questionnaire including 20 items which measures the severity of the Tourette syndrome. Several scores are defined : motor tics, vocal tics, obsession, compulsion and other phenomena. The higher the score, the greater the severity.
HADS [3 minutes at inclusion]
The HADS is a self-questionnaire to assess depression (7 items) and anxiety (7 items).
ASRS-5 [2 minutes at inclusion]
The Adult AD-HD Self-Report Scale (ASRS-5) is a scale to assess the presence of Attention-Deficit / Hyperactivity Disorder. We used the first 6 items of the questionnaire for the screening of ADHD. The total score ranges from 0 to 24 and a cut off of 13 shows good screening performance.
Rosenberg Self-Esteem Scale [2-3 minutes at inclusion]
The Rosenberg Self-Esteem Scale is a self-questionnaire on self-esteem. It includes 10 items. The lower the score, the lower the self-esteem.
DERS [5 minutes at inclusion]
The Difficulties in Emotion Regulation Scale (DERS) is a self-questionnaire including 36 items. Lower scores indicate the presence of difficulties in emotion regulation.
GTS-QoL [5 minutes at inclusion]
The GTS-QoL is a specific Gilles de la Tourette Syndrome Quality of Life Scale. It consists of 27 items giving 6 dimensions: "Psychological", "Physical and activities of daily life", "Obsessive-compulsive", "Cognitive", "Social" and "Echo-coprophenomena", scored out of 100. The scores the highest represent a poorer quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Tourette syndrome
Participants aged 18 years or over

Exclusion Criteria:

Participants under legal protection
Inability to complete questionnaires alone

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Clermont-Ferrand	Clermont-Ferrand		France

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator: Isabelle JALENQUES, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT06136572

Other Study ID Numbers:

RNI 2023 JALENQUES

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tourette Syndrome

Syndrome

Study Results

No Results Posted as of Nov 18, 2023