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Cognitive and Behavioral Therapy of Anxiety in Williams Syndrome

Cognitive and Behavioral Therapy of Anxiety in Williams Syndrome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03827525
Acronym
WILL-COPE
Enrollment
5
Registered
2019-02-01
Start date
2019-08-29
Completion date
2021-04-29
Last updated
2019-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Williams Syndrome

Keywords

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

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.

Interventions

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

Sponsors

Fondation Jérôme Lejeune
CollaboratorOTHER
association autour des Williams
CollaboratorUNKNOWN
réseau de santé Maladies Rares
CollaboratorUNKNOWN
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Likert anxiety ScaleFrom 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.

Secondary

MeasureTime frameDescription
Hamilton Anxiety ScaleThis 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.
Inhibition scoreThis 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.
salivary cortisolThis 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.
WHOQOL-BREF scoreThis 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.

Countries

France

Contacts

Primary ContactDavid GENEVIEVE, MH PD
d-genevieve@chu-montpellier.fr04 67 33 61 04
Backup ContactNatacha LEHMAN, master 2
n-lehman@chu-montpellier.fr0467335972

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026