Developing a Psychosexual Education App With Artificial Intelligence
ConditionSexual Dysfunction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorLondon Metropolitan University
About this trial
The goal of this clinical trial is to establish the effectiveness of a resource based educational psychosexual app for patients attending a waiting list for psychosexual therapy. The app will provide information on sexual dysfunction, kegel exercises, cognitive and mindfulness exercises, along with suitable resources providing information on sexual functioning for men and women. The app will integrate artificial intelligence to improve user experience and efficiency.
The current waiting lists for the National Health Service Psychosexual services are approximately 6 months. Based on this, a pre test post test study measuring participants' sexual functioning, well being, cognitive mindfulness and quality of life will be taken at points 0, 8 and 16 weeks.
Outcomes will assess whether the app was sufficient for these domains. This might further reduce the strain on the National Health Service's resources.
It is hypothesised that app use from weeks 0, 8, and 16 follow up will improve sexual functioning, well being, quality of life, and cognitive mindfulness.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Must be aged 18 years and above
Must have a laptop, computer, or mobile phone. The App can only be accessed on smartphones and laptops.
Must have been referred to the National Health Service with a psychosexual presentation
Must be currently awaiting psychosexual therapy
Disqualifiers
Aged below 18 years
Do not possess a mobile phone, computer or laptop
Are not part of a National Health Service referral system
Do not have a psychosexual presentation
Trial design
Design model
Single group
Treatments tested in this trial
Psychosexual education app with artificial intelligence
Other interventionDevelopment of the App will contain the following features: 1. A basic Mac for iphone Operating System development 2. General Data Protection Regulation compliance legal certification 3. Hosting and cloud services 4. Security Features: for encryption and secure authentication user sign in 5. Analytics Integration: for integrating app analytics tools 6. Push Notifications: incorporated into the app 7. Legal and Compliance additional General Data Protection Regulation certified 8. Custom Artificial Intelligence Models Interactive Learning Tools Artificial Intelligence will create interactive educational materials on sexual function and dysfunction 9. Artificial Intelligence cloud services 10. Natural Language Processing. Artificial Intelligence will process textual data from the feedback questions to identify emerging topics and concerns in sexual function and participants' experiences using the app.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Pre test post testOther 1 intervention
Trial outcomes
Primary outcomes
1
Female Sexual Function Index
This is a 19 item questionnaire on sexual function, including sexual desire, orgasm, lubrication, sexual satisfaction and pain. It has five response categories. Scores include severe 2-7.2, moderate 7.3-14.4, mild to moderate 14.5-21.6, mild 21.7- 28.1 cut-off value, and no female sexual dysfunction 28.2 -36.The lower the score, the higher the level of sexual dysfunction. Cronbach alpha is 0.820 and higher.
Time frame
0, 8 and 16 weeks2
The International Index of Erectile Function
This is a 16 item questionnaire on sexual function, including sexual attempts, completed attempts and satisfaction. It has varied response categories. There is a 6 response category for questions 1 to 9 based on sexual attempts. Questions 10 to 15 consist of five response categories, examining sexual satisfaction. Higher scores equate to higher levels of sexual functioning. Cronbach alpha is between 0.80 and 0.90.
Time frame
0, 8 and 16 weeks3
Premature Ejaculation Diagnostic Tool
This consists of 5 questions and 3 sections. The first section and question concern delayed ejaculation. For this question, there are five response categories. This is followed by section 2, which consists of two questions based on ejaculation quality and the levels of stimulation required. The third section consists of two questions which address levels of frustration based on a 5 response categories. The higher the score the higher the level of ejaculatory difficulties. The Cronbach alpha is 0.70.
Time frame
0, 8 and 16 weeksSecondary outcomes
1
Cognitive mindfulness
This is a 10 item questionnaire with 5 response categories 1 never or rarely true through 5 very often always true. Cronbach's alpha ranges between 0.69 and 0.76. Subscale scoring is divided into five areas: observing, describing, acting with awareness, non judging, and non reactivity. Higher scores indicate greater endorsement of mindfulness.
Time frame
0, 8 and 16 weeks2
Short Warwick Edinburgh Mental Wellbeing Scale
A 7 item questionnaire with 5 response categories looking at functioning and feeling aspects of wellbeing. The response categories include 1, none of the time, to 5, all of the time. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing. The Cronbach alpha is equal to or greater than 0.70.
Time frame
0, 8 and 16 weeks3
Adapted Quality of life questionnaire
This is a 9 item questionnaire with 5 response categories, including 1= strongly agree to 5= strongly disagree, that looks at general, social, and health related quality of life. The higher the score, the higher the quality of life. The Cronbach alpha ranges between 0.70 and 0.90.
Time frame
0, 8 and 16 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
London Metropolitan University
Lead sponsor
Homerton University Hospital NHS Foundation Trust
Collaborator
Barts & The London NHS Trust
Collaborator
Source ClinicalTrials.gov
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