Clinical trial NCT03827525: Cognitive and Behavioral Therapy of Anxiety in Williams Syndrome
Official title: Cognitive and Behavioral Therapy of Anxiety in Williams Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Williams Syndrome
Anxiety
Keywords: Williams Syndrome
Anxiety
Cognitive and Behavioral Therapy
Intellectual Disability
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Fondation Jérôme Lejeune
name: association autour des Williams
name: réseau de santé Maladies Rares
First posted: 2019-02-01
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 5 adults with a Williams Syndrome

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Likert anxiety Scale
timeFrame: From day 0 to month 5.
Secondary outcomes:
measure: Hamilton Anxiety Scale
timeFrame: 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)
measure: Inhibition score
timeFrame: 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)
measure: salivary cortisol
timeFrame: This sample will be obtained at the pretherapy visit (day 0), and at the visit of the end of the research (month 8).
measure: WHOQOL-BREF score
timeFrame: 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).
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Arnaud de villeneuve Hospital
state: Hérault
Study officials:
affiliation: Department of Medical Genetics
name: Natacha LEHMAN
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.