Cognitive and Behavioral Therapy of Anxiety in Williams Syndrome

Anxiety Clinical Trial

— WILL-COPE  

Official title:

Cognitive and Behavioral Therapy of Anxiety in Williams Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03827525
• Other study ID #: RECHMPL18_0375
• Status: Recruiting
• Start date: August 29, 2019
• Est. completion date: April 29, 2021

Study information

• Verified date: January 2019
• Source: University Hospital, Montpellier
• Contact: David GENEVIEVE, MH PD
• Phone: 04 67 33 61 04
• Email: d-genevieve[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Most studies agree that anxiety disorders are more frequent in people with intellectual disabilities that in the general population. Williams syndrome (WS) is a rare disease, associated with an anxiety rate 8 times higher than in the general population. The therapeutic solutions proposed in this population remain limited, in particular concerning approaches without the use of medication. The objective of the study is to evaluate the effectiveness of a program of Cognitive and Behavioral Therapies (CBT) in Williams Syndrome (WS). For this, an ABA-type protocol will be used. It consists of evaluating the effectiveness of an interventional program longitudinally, using a single case type study. Adults patients with WS and suffering from anxiety will be recruited. They will be enrolled in a program consisting in nine sessions of a psychotherapy program targeting anxiety. There will be a pretherapy visit (day 0), nine sessions of psychotherapy (month 0 to month 5) and a visit 3 month after the end of the therapy (at month 8) : the visit of the end of the research (V10). The expected results will be to validate a psychotherapeutic program for patients with WS suffering of anxiety. This program might be extended to other patients with intellectual disability.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: April 29, 2021
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Williams Syndrome

• Complaint about anxiety

• 18 years old and more

• Score of 7 or more at the CELF-4 (it is a scale assessing the language)

• informed consent signed

Exclusion Criteria:

• Scoring less than 7 at the CELF-4

• Hearing impairment

• Visual impairment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Syndrome
• Williams Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Arnaud de villeneuve Hospital	Montpellier	Hérault

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Montpellier	association autour des Williams, Fondation Jérôme Lejeune, réseau de santé Maladies Rares

Country where clinical trial is conducted

France, 

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hamilton Anxiety Scale	Hamilton anxiety scale will be realised with the patient by a clinical psychologist. It is an evaluation of the anxiety based on 14 questions and observations of the patient. The questions are rated according to the severity of the symptoms: anxious mood, depressed mood, somatic symptoms...Symptoms are evaluated using 5 degrees of severity, from absence of severity to disabling intensity. The overall score ranges from 0 to 60.	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)
Secondary	Inhibition score	the inhibition will be assessed with the Go/no Go test which last 3 minutes.	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)
Secondary	salivary cortisol	The sample will be realised by a nurse. The level of cortisol is related to the level of stress.	This sample will be obtained at the pretherapy visit (day 0), and at the visit of the end of the research (month 8).
Secondary	WHOQOL-BREF score	this scale evaluates the quality of life with 26 questions. For each question, the quality of life is evaluated from very low to very high (5 levels). It will be completed by the person of trust.	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).