Cognitive and Behavioral Therapy of Anxiety in Williams Syndrome (WILL-COPE)

October 17, 2019 updated by: University Hospital, Montpellier
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

5 adults with a Williams Syndrome

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Likert anxiety Scale
Time Frame: From day 0 to month 5.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Anxiety Scale
Time Frame: 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)
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)
Inhibition score
Time Frame: 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)
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)
salivary cortisol
Time Frame: This sample will be obtained at the pretherapy visit (day 0), and at the visit of the end of the research (month 8).
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).
WHOQOL-BREF score
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Fondation Jérôme Lejeune
association autour des Williams
réseau de santé Maladies Rares

Investigators

  • Principal Investigator: Natacha LEHMAN, Department of Medical Genetics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2019

Primary Completion (Anticipated)

April 29, 2021

Study Completion (Anticipated)

April 29, 2021

Study Registration Dates

First Submitted

January 29, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 18, 2019

Last Update Submitted That Met QC Criteria

October 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL18_0375

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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