Cognitive and Behavioral Therapy of Anxiety in Williams Syndrome

Brief Title

Cognitive and Behavioral Therapy of Anxiety in Williams Syndrome

Official Title

Cognitive and Behavioral Therapy of Anxiety in 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.
    


Study Type

Observational


Primary Outcome

Likert anxiety Scale

Secondary Outcome

 Hamilton Anxiety Scale

Condition

Williams Syndrome

Intervention

Cognitive and Behavioral Therapy

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

5

Start Date

August 29, 2019

Completion Date

April 29, 2021

Primary Completion Date

April 29, 2021

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Natacha LEHMAN, 04 67 33 61 04, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03827525

Organization ID

RECHMPL18_0375


Responsible Party

Sponsor

Study Sponsor

University Hospital, Montpellier

Collaborators

 Fondation Jérôme Lejeune

Study Sponsor

Natacha LEHMAN, Principal Investigator, Department of Medical Genetics


Verification Date

January 2019