Cognitive and Behavioral Therapy of Anxiety in Williams Syndrome

NCT03827525 | Unknown

• 1 other identifier: RECHMPL18_0375
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with Williams-Beuren syndrome are eight times more likely to suffer from anxiety compared to the general population. Few therapeutic solutions are proposed to these patients. The objective of this research is to validate a cognitive and behavioral therapy anxiety protocol for patients with this syndrome.

Conditions

Williams Syndrome; Anxiety

Keywords

Williams Syndrome; Anxiety; Cognitive and Behavioral Therapy; Intellectual Disability

Outcome Measures

Primary Outcomes (1)

• Likert anxiety Scale

  Repeated evaluation of his anxiety by the patient with the Likert scale. Each day, the patient quantifies his anxiety with the scale with a score from 0 to 9.

  From day 0 to month 5.

Secondary Outcomes (4)

• Hamilton Anxiety Scale

  This score will be obtained at the pre therapy visit (day 0), at the visit of the end of the therapy (month 5), and at the visit of the end of the research (month 8)

• Inhibition score

  This score will be obtained at the pre therapy visit (day 0), at the visit of the end of the therapy (month 5), and at the visit of the end of the research (month 8)

• salivary cortisol

  This sample will be obtained at the pretherapy visit (day 0), and at the visit of the end of the research (month 8).

• WHOQOL-BREF score

  This score will be obtained at the pre therapy visit (day 0), at the visit of the end of the therapy (month 5), and at the visit of the end of the research (month 8).

Study Arms (1)

Cognitive and Behavioral Therapy

There is no group, the study will be based on single case method. The sudy concerns 5 patients with a Williams Syndrome

Behavioral: Cognitive and Behavioral Therapy

Interventions

Cognitive and Behavioral Therapy BEHAVIORAL

9 sessions of Cognitive and Behavioral Therapy will be realised with the patient by a clinical psychologist. They will last between 1h and 1h30.

Cognitive and Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

5 adults with a Williams Syndrome

You may qualify if:

• Diagnosis of Williams Syndrome
• Complaint about anxiety
• years old and more
• Score of 7 or more at the CELF-4 (it is a scale assessing the language)
• informed consent signed

You may not qualify if:

• Scoring less than 7 at the CELF-4
• Hearing impairment
• Visual impairment

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Fondation Jérôme Lejeune: collaborator
• association autour des Williams: collaborator
• réseau de santé Maladies Rares: collaborator

Study Sites (1)

Arnaud de villeneuve Hospital

Montpellier, Hérault, 34295, France

RECRUITING

Related Publications (4)

• Vereenooghe L, Langdon PE. Psychological therapies for people with intellectual disabilities: a systematic review and meta-analysis. Res Dev Disabil. 2013 Nov;34(11):4085-102. doi: 10.1016/j.ridd.2013.08.030. Epub 2013 Sep 18.

  PMID: 24051363 BACKGROUND

• Royston R, Howlin P, Waite J, Oliver C. Anxiety Disorders in Williams Syndrome Contrasted with Intellectual Disability and the General Population: A Systematic Review and Meta-Analysis. J Autism Dev Disord. 2017 Dec;47(12):3765-3777. doi: 10.1007/s10803-016-2909-z.

  PMID: 27696186 BACKGROUND

• Unwin G, Tsimopoulou I, Kroese BS, Azmi S. Effectiveness of cognitive behavioural therapy (CBT) programmes for anxiety or depression in adults with intellectual disabilities: A review of the literature. Res Dev Disabil. 2016 Apr-May;51-52:60-75. doi: 10.1016/j.ridd.2015.12.010. Epub 2016 Jan 22.

  PMID: 26803286 BACKGROUND

• Lehman N, Trouillet R, Genevieve D. Evaluation of the Effectiveness of Therapy for Anxiety in Williams Beuren Syndrome Using a Smartphone App: Protocol for a Single-Case Experiment. JMIR Res Protoc. 2023 Apr 3;12:e44393. doi: 10.2196/44393.

  PMID: 37010888 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Salivary sample will be obtained to evaluate salivary cortisol. Then the sample will be destroyed.

MeSH Terms

Conditions

Williams Syndrome; Anxiety Disorders; Intellectual Disability

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Aortic Stenosis, Supravalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Chromosome Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Natacha LEHMAN

  Department of Medical Genetics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David GENEVIEVE, MH PD

CONTACT

04 67 33 61 04; d-genevieve@chu-montpellier.fr

Natacha LEHMAN, master 2

CONTACT

0467335972; n-lehman@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 1, 2019
• Study Start: August 29, 2019
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: October 18, 2019

Record last verified: 2019-01

Locations

FR (1)