Developing a Psychosexual Education App With Artificial Intelligence

Official title

Developing a Psychosexual Education App With Artificial Intelligence for National Health Service Patients on a Psychosexual Services Waiting List: A Pilot Pre Test Post Test Study

Overview

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.

Detailed description

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.

Interventions

• 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 Artifici

Primary outcome measures

• Female Sexual Function Index [Time frame: 0, 8 and 16 weeks]
• The International Index of Erectile Function [Time frame: 0, 8 and 16 weeks]
• Premature Ejaculation Diagnostic Tool [Time frame: 0, 8 and 16 weeks]

Secondary outcome measures (3)

• Cognitive mindfulness [Time frame: 0, 8 and 16 weeks]
• Short Warwick Edinburgh Mental Wellbeing Scale [Time frame: 0, 8 and 16 weeks]
• Adapted Quality of life questionnaire [Time frame: 0, 8 and 16 weeks]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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
• 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
• Faubion SS, Rullo JE. Sexual Dysfunction in Women: A Practical Approach. Am Fam Physician. 2015 Aug 15;92(4):281-8. PMID 26280233
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07152847 · T2- SSSP-2025-16

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗