Developing a Psychosexual Education App With Artificial Intelligence

NCT07152847 | Not Yet Recruiting DMC

• 1 other identifier: T2- SSSP-2025-16
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sexual Dysfunction

Keywords

Psychosexual app; Artificial intelligence; Cognitive mindfulness; Well being; Quality of life

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  0, 8 and 16 weeks

Secondary Outcomes (3)

• Cognitive mindfulness

  0, 8 and 16 weeks

• Short Warwick Edinburgh Mental Wellbeing Scale

  0, 8 and 16 weeks

• Adapted Quality of life questionnaire

  0, 8 and 16 weeks

Study Arms (1)

Pre test post test

OTHER

Repeated measures within subject design

Other: Psychosexual education app with artificial intelligence

Interventions

Psychosexual education app with artificial intelligence OTHER

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.

Pre test post test

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Self defined male or female based on the assessments used
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Must have been on a National Health Service psychosexual waiting list for less than one month
• Must be fluent in reading and writing English, as this is a clinical trial, the investigators wanted to ensure that participants fully understand what was expected.
• The Patient Health Questionnaire 2 screening for depression must have a score range between 0 to 2 negative
• The Generalised Anxiety Disorder questionnaire 2 screening for anxiety must have a score range between 0 to 2 negative

You may not qualify if:

• 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
• Are currently or starting psychosexual therapy
• Have difficulties understanding or speaking English
• The Patient Health Questionnaire 2 screening outcomes 3 and above
• The Generalised Anxiety Disorder questionnaire 2 screening outcomes 3 and above

Sponsors & Collaborators

• London Metropolitan University: lead
• Homerton University Hospital NHS Foundation Trust: collaborator
• Barts & The London NHS Trust: collaborator

Related Publications (9)

• Fischer OJ, Marguerie M, Brotto LA. Sexual Function, Quality of Life, and Experiences of Women with Ovarian Cancer: A Mixed-Methods Study. Sex Med. 2019 Dec;7(4):530-539. doi: 10.1016/j.esxm.2019.07.005. Epub 2019 Sep 7.

  PMID: 31501030 BACKGROUND

• Dubinskaya A, Heard JR, Choi E, Cohen T, Anger J, Eilber K, Scott V. Female sexual health digital resources: women and health care providers need more options. Sex Med Rev. 2023 Jun 27;11(3):174-178. doi: 10.1093/sxmrev/qead016.

  PMID: 37102305 BACKGROUND

• Faubion SS, Rullo JE. Sexual Dysfunction in Women: A Practical Approach. Am Fam Physician. 2015 Aug 15;92(4):281-8.

  PMID: 26280233 BACKGROUND

• Jurin T, Sostaric M, Jokic-Begic N, Lauri Korajlija A. mSexHealth: An Overview of Mobile Sexual Health Applications. J Sex Marital Ther. 2023;49(2):129-140. doi: 10.1080/0092623X.2022.2079576. Epub 2022 Jun 2.

  PMID: 35652779 BACKGROUND

• Karim H, Choobineh H, Kheradbin N, Ravandi MH, Naserpor A, Safdari R. Mobile health applications for improving the sexual health outcomes among adults with chronic diseases: A systematic review. Digit Health. 2020 Feb 20;6:2055207620906956. doi: 10.1177/2055207620906956. eCollection 2020 Jan-Dec.

  PMID: 32128234 BACKGROUND

• Lou IX, Chen J, Ali K, Chen Q. Relationship Between Hypertension, Antihypertensive Drugs and Sexual Dysfunction in Men and Women: A Literature Review. Vasc Health Risk Manag. 2023 Nov 3;19:691-705. doi: 10.2147/VHRM.S439334. eCollection 2023.

  PMID: 37941540 BACKGROUND

• Nicol A, Chung E. Male sexual dysfunction: Clinical diagnosis and management strategies for common sexual problems. Aust J Gen Pract. 2023 Jan-Feb;52(1-2):41-45. doi: 10.31128/AJGP-09-22-6559.

  PMID: 36796767 BACKGROUND

• Pettigrew JA, Novick AM. Hypoactive Sexual Desire Disorder in Women: Physiology, Assessment, Diagnosis, and Treatment. J Midwifery Womens Health. 2021 Nov;66(6):740-748. doi: 10.1111/jmwh.13283. Epub 2021 Sep 12.

  PMID: 34510696 BACKGROUND

• Vosoughi N, Maasoumi R, Haeri Mehrizi AA, Ghanbari Z. The Effect of Psychosexual Education on Promoting Sexual Function, Genital Self-Image, and Sexual Distress among Women with Rokitansky Syndrome: A Randomized Controlled Clinical Trial. J Pediatr Adolesc Gynecol. 2022 Feb;35(1):73-81. doi: 10.1016/j.jpag.2021.06.008. Epub 2021 Jul 13.

  PMID: 34271197 BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Artificial Intelligence

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Algorithms; Mathematical Concepts

Study Officials

• Samantha Banbury

  London Met Uni

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Banbury

CONTACT

07535448999; banburs1@staff.londonmet.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A pre test post test study will be used to ensure that all participants receive this intervention after providing consent. No control group will be used as the investigators determined that it would be unfair to exclude participants from accessing the app resources. Quality of life and well being will be prioritised, hence the decision to conduct a pre test post test study. Since this is quasi experimental, associations between the app intervention and variable outcomes will be made. Recruitment will be via the National Health Service, for which a separate ethics submission will be made. Recruitment will be based on psychosexual services at the National Health Service. The average waiting list for psychosexual National Health Service services is 6 months. This consideration was necessary when determining the design of this study. There must be no overlap between using the intervention and receiving psychosexual counselling, as this might skew outcomes.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 3, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share