Developing a Psychosexual Education App With Artificial Intelligence

NCT ID: NCT07152847

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-09-30

Study Completion Date

2027-03-31

Brief Summary

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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

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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.

Conditions

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Sexual Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pre test post test

Repeated measures within subject design

Group Type OTHER

Psychosexual education app with artificial intelligence

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Homerton University Hospital NHS Foundation Trust

OTHER

Sponsor Role collaborator

Barts & The London NHS Trust

OTHER

Sponsor Role collaborator

London Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Samantha Banbury

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samantha Banbury

Role: PRINCIPAL_INVESTIGATOR

London Met Uni

Central Contacts

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Samantha Banbury

Role: CONTACT

07535448999

References

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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.

Reference Type BACKGROUND
PMID: 31501030 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37102305 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 26280233 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35652779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32128234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37941540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36796767 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34510696 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34271197 (View on PubMed)

Other Identifiers

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T2- SSSP-2025-16

Identifier Type: -

Identifier Source: org_study_id

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