Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 17, 2022
Open Peer Review Period: Nov 17, 2022 - Nov 24, 2022
Date Accepted: Feb 19, 2023
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
A single case experimental designed protocol to evaluate the effectiveness of anxiety therapy with a Smartphone application in Williams Beuren syndrome
ABSTRACT
Background:
Williams syndrome (WS-OMIM 194050, orphaned number: Orpha 904) is a rare condition mostly associated with intellectual disability. People with Williams syndrome are eight times more likely to have anxiety disorders than the general population. Therapeutic solutions to treat the anxiety remain limited, particularly concerning non-pharmacological therapy. However, cognitive behavioural therapy (CBT) has been found efficacious in managing anxiety disorders and can be used for people with intellectual disability.
Objective:
This paper describes a protocol for assessing the efficiency of a CBT program based on a digital support for people with Williams syndrome and anxiety based on a research methodology designed for rare diseases.
Methods:
Five individuals with Williams syndrome and anxiety will be recruited. They will undergo nine CBT sessions. Participants will perform daily self-assessments of anxiety by using a digital app, which will allow for ecological and repeated evaluation of the anxiety. This digital app will provide a support for each therapy session. Anxiety, and quality of life will be externally assessed before and after the program. Participants will be assessed at 3-month follow-up. This is a single-case intervention research design with multiple baselines implying repeated measures of judgement criteria. The present protocol ensures high internal validity and will help identify encouraging contributions for later clinical trials.
Results:
Participant recruitment and data collection began in September 2019 and it is projected that the study findings will be available for dissemination by spring 2023.
Conclusions:
This study will allow for assessing the efficiency of CBT program based on digital support to treat anxiety in people with Williams syndrome. Finally, the program could be used as an example of non-pharmacological therapy for rare diseases. Clinical Trial: ClinicalTrials.gov Protocol Identifier ID: NCT03827525
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.