i-Minds: a digital intervention for young people exposed to online sexual abuse
| ISRCTN | ISRCTN43130832 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43130832 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 301517 |
| Protocol serial number | IRAS 301517, CPMS 51349 |
| Sponsor | Greater Manchester Mental Health NHS Foundation Trust |
| Funder | National Institute for Health Research |
- Submission date
- 21/03/2022
- Registration date
- 12/04/2022
- Last edited
- 25/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Online sexual abuse (OSA) of young people has increased, can have serious effects on their development and mental health, and has become an important priority for health and social care services. The National Institute for Health and Care Excellence (NICE) has recognised the identification of effective interventions for improving the wellbeing of young people who have experienced OSA and preventing further harm as a research priority. Young people can report OSA to government agencies and social media companies, but there are currently few tried and tested (evidence-based) or helpful treatments available. The NHS urgently needs an accessible intervention to support young people who have experienced OSA. Interventions aimed at improving mentalisation (the ability to understand one's own thoughts and feelings and those of others) is increasingly applied to treat young people with varied mental health difficulties. Young people who have experienced OSA are reluctant to seek in-person support and are generally comfortable receiving online support. A digital intervention aimed at improving mentalisation in OSA may reduce the risk for future harm and help young people become more resilient and able to manage distress that might result from OSA experiences.
Who can participate?
Young people aged 12-18 years who have experienced OSA that has led to distress who are receiving support from a service such as the NHS or Kooth for their mental health, though OSA does not necessarily have to be the primary focus of their support.
What does the study involve?
Participants use an app-based intervention over the period of 6 weeks. The intervention is largely based on mentalisation approaches which aim to boost the ability to understand the mental states of oneself and others. This approach has seen increasing application in the support of young people's mental health. The purpose of the i-Minds app is to help people better mentalise and therefore make them less vulnerable to the ongoing risk of online harm and further re-victimisation online. It is not intended to prevent or treat a medical condition.
What are the possible benefits and risks of participating?
The study hopes that the intervention may reduce distress by supporting young people to develop their mentalisation capacity and gain valuable psychoeducational insight into OSA and how best to avoid further re-victimisation in the future. Whilst all possible steps have been implemented to ensure the safety of young people taking part in the study, it is possible that when accessing the materials in the app, young people may become upset due to reliving memories of the OSA. Appropriate support will be provided throughout the study and there are a number of methods used in the app to help calm and soothe young people if they start to feel upset.
Where is the study run from?
University of Manchester (UK)
When is the study starting and how long is it expected to run for?
March 2018 to April 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Prof. Sandra Bucci
sandra.bucci@manchester.ac.uk
Contact information
Principal investigator
School of Psychological Sciences
University of Manchester
2nd Floor, Zochonis Building
Brunswick Street
Manchester
M13 9PL
United Kingdom
 ORCID ID |
0000-0002-6197-5333 |
|---|---|
| Phone | +44 (0)1613060422 |
| sandra.bucci@manchester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-center non-randomized mixed methods feasibility clinical trial and nested qualitative study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | i-Minds: a digital intervention to improve mental health and interpersonal resilience for young people who have experienced online sexual abuse - a non-randomised feasibility clinical trial and nested qualitative study |
| Study acronym | i-Minds |
| Study objectives | As this is a feasibility clinical trial, there are no a-priori hypotheses. Instead, the study aims to determine the feasibility, acceptability and usability of the digital intervention (an app) and how to best integrate the app into existing routine care pathways. |
| Ethics approval(s) |
Approved 15/12/2021, West of Scotland Research Ethics Committee 4 (Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 (0)141 314 0213; WestofScotland.ResearchEthicsCommittee4@ggc.scot.nhs.uk), ref: 21/WS/0160 |
| Health condition(s) or problem(s) studied | App-based support for young people who have experienced distress associated with online or technology-facilitated sexual abuse |
| Intervention | Non-randomised mixed methods feasibility clinical trial with all participants receiving the intervention (novel app-based intervention using a mentalisation-based approach to improve resilience and reduce risk of re-victimisation and further harm associated with online sexual abuse). The intervention window is 6 weeks. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Feasibility of delivering the app will be assessed via recruitment and retention data congruent with all relevant fields of the CONSORT statement for feasibility studies. Assessment will take place across the recruitment and data collection period (months 1-11 of trial). |
| Key secondary outcome measure(s) |
1. Exploration of whether the app brings about clinically meaningful change in outcomes, measured via a battery of questionnaires measuring mentalisation, problematic internet use, emotional distress, online abuse-related stress, emotion regulation, interpersonal sensitivity, views/attitudes towards close interpersonal relationships and resilience, app satisfaction. Assessment will take place at baseline (pre-app use) and post 6-week intervention window (post-treatment). |
| Completion date | 30/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 46 |
| Key inclusion criteria | 1. 12-18 years old 2. Have been exposed to online sexual abuse and report associated distress 3. Are receiving support from NHS CAMHS, SARC or e-therapy providers (Kooth) and will continue to be actively supported by the service over the duration of the trial 4. Willing to use an app designed to support YP-OSA 5. Proficient in speaking and writing in English 6. Have the capacity to consent 7. Consent to providing their username to the research team (Kooth participants only) |
| Key exclusion criteria | 1. Have insufficient verbal and written command of English 2. Have moderate learning difficulties (as assessed by their direct care team) 3. Are at risk of current or recent (past month) suicidality |
| Date of first enrolment | 01/05/2022 |
| Date of final enrolment | 31/03/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centres
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
Ashton-under-lyne
OL6 7SR
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
London
W2 6LG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Future requests to access data will be via the project’s CI (Prof. Sandra Bucci; sandra.bucci@manchester.ac.uk) and will be only approved on a case-by-case basis when sharing of data will not incur any risk of participant identification, and only when secondary users will be from a bona fide research organisation and have been granted suitable regulatory approval to further interrogate the data. The exact procedures for accessing the final datasets, as well as relevant meta-data and statistical code used in all quantitative analyses, will be approved by the PSC and made available to prospective future users upon request addressed to the CI and in keeping with our ethical approvals. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/03/2023 | 24/03/2023 | Yes | No |
| Basic results | 25/11/2024 | No | No | ||
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | 28/03/2024 | 02/04/2024 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 3 | 09/05/2022 | 07/03/2023 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN43130832_PROTOCOL_V3_09May22.pdf
- Protocol file
- ISRCTN43130832_BasicResults.pdf
- Basic results
Editorial Notes
25/11/2024: The following changes were made
1. Total final enrolment added.
2. The Intention to publish date was changed from 01/05/2024 to 01/05/2025.
3. Basic results added.
02/04/2024: Publication reference added.
24/03/2023: Publication reference added.
07/03/2023: Protocol uploaded (not peer reviewed).
06/05/2022: The trial website has been added.
04/04/2022: Trial's existence confirmed by the West of Scotland Research Ethics Committee 4.
