An interventional study of Psychosexual education app with artificial intelligence in Sexual Dysfunction, sponsored by London Metropolitan University. Not yet recruiting. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by London Metropolitan University · Not applicable, Interventional, and Supportive care
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.
Sexual dysfunction is a group of disorders which affect male and female sexual functioning and negatively impact self-esteem, sexual self efficacy and well being. For women, sexual dysfunction may include sexual interest and arousal disorder, orgasmic disorder, Genito-pelvic pain penetration disorder and substance and medication induced sexual dysfunction. For men, sexual dysfunction may include erectile dysfunction, premature ejaculation or rapid ejaculation, delayed ejaculation, hypoactive sexual desire disorder and substance and medication induced sexual dysfunction.
As part of psychosexual counselling, varied integrative approaches are used quite often, including brief cognitive behavioural therapy, which extends over 6 to 8 sessions. Interventions might also include the use of mindful compassion for varying psychosexual presentations, which are practised in some National Health Services.
An additional adjunct intervention might include psychosexual education. Psychosexual education is diverse and provides information and resources on all aspects of sexual functioning, guidelines and motivational strategies for engaging in varied sexual activities, sexual intimacy and anatomy. Psychosexual education may provide information on sexual health knowledge. These can be delivered in various formats, such as educational programs, face to face education, and internet based and virtual interventions. Recent applications have centred on e learning, including computer based, online and offline presentations. Using an e learning delivery in healthcare services challenges the barriers of resources, time and space. Talking about sex might prove discomforting or embarrassing; for some, cultural, gender or religious factors might further compound open dialogue on sexual matters. Using an e learning approach might target a wider geographic demographic, making it easier for diverse people to access evidence based information whilst minimising discomfort or embarrassment.
One such e learning delivery system is smartphone applications. Most apps included Kegel exercises and working with thoughts and emotions.
Artificial Intelligence has recently been incorporated into apps to improve user experience and efficiency. Artificial intelligence can identify trends in sexual health, behaviour, and attitude. Artificial Intelligence can teach sexuality, sexual health, and behaviour with limited or no human interaction needed.
Limited evidence based psychosexual educational apps are incorporating artificial intelligence to support sexual functioning among men and women. More so among those on a waitlist for National Health Service psychosexual therapeutic support. Indeed, despite the diverse range of biopsychosocial approaches provided by the National Health Service to support sexual dysfunction, waiting lists can be up to 6 months. Therefore, a waiting period without support might further impact sexual function, sexual health, well being and quality of life.
This initial study will target patients on the National Health Service waiting list for psychosexual therapy. This will consist of a psychosexual education app integrating artificial intelligence. Pre test post test measurements will be taken at 0, 8, and 16 weeks, aligning with National Health Service waiting periods. Outcomes will assess well being, quality of life, cognitive mindfulness, sexual functioning, and whether the app was sufficient for participants difficulties. This might further reduce the strain on National Health Service 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.
385 studies on the registry are indexed under Sexual Dysfunction, Physiological; 72 are open to participants now.
This study's planned enrollment of 150 is above the median of 72 across 263 interventional studies indexed under Sexual Dysfunction, Physiological.
Browse Sexual Dysfunction, Physiological studies →London Metropolitan University is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Repeated measures within subject design
Other: Psychosexual education app with artificial intelligence
Development 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.
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
No study locations are listed for this record.
Plan to share: No — The National Health Service will anonymise data before analysis. This will need to be confirmed whether the data can be made available for analysis due to ethical considerations.
Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.
Of 100 non-industry interventional studies with no phase under Sexual Dysfunction, Physiological, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 3 months is below that.
Counting every sponsor, half of 112 studies reached it within 20 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Sexual Dysfunction, Physiological →
London Metropolitan University