Engagement and acceptability of a digital programme for anxiety
| ISRCTN | ISRCTN52546704 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52546704 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 327897 |
| Protocol serial number | IRAS 327897 |
| Sponsor | ieso Digital Health |
| Funder | ieso Digital Health |
- Submission date
- 28/04/2023
- Registration date
- 20/09/2023
- Last edited
- 23/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study tests a 6-week digital programme, delivered via a smartphone app, designed to help people develop skills to cope with stress, worry, or anxiety. Mental health apps are being widely used, but evidence shows that many people do not find these very engaging. In this study, the researchers are testing their new programme to understand whether people find it useful for them and how it makes them feel. The programme also contains a digital guide that is powered by machine learning. In this study the researchers are also testing our machine-learning models to help make the conversations more engaging. The programme has been developed by a team of accredited clinicians. It is a smartphone app with a combination of therapist videos, educational content, and worksheets developed based on research and evidence, such as principles underlying cognitive behavioural therapy (CBT).
Who can participate?
Patients aged over 18 years primarily presenting with anxiety symptoms
What does the study involve?
Participants are either referred to ieso’s internet-enabled cognitive behavioural therapy (IECBT) service through an NHS trust, self-refer via ieso’s website or respond to an online advert for the study. Participants will be asked to download the app on their own smartphone in order to complete the activities in their own time. A clinician will assess eligibility, obtain informed consent, and monitor the participant’s progress throughout. If participants stay on schedule the programme will take 6 weeks, but if they fall behind it could take longer. They will have a maximum of 9 weeks to complete the programme.
Participants complete the digital programme using a smartphone at home on their own. At the start, middle and end of the programme they will be asked to complete some questionnaires about how they are feeling and their experience with the app. Participants will be invited to have a typed conversation with one of our study clinicians before and after completing the programme. The programme takes around 6 weeks to complete. Each week there are up to three sessions, which on average take 20 minutes, though some will be longer and some shorter than this. These sessions will have a typed, text-based conversation with the digital guide. Participants will be talking to the guide by typing into a chat window, like a WhatsApp conversation. Sometimes the guide will respond with text and other times they will respond with videos or activities to complete.
What are the possible benefits and risks of participating?
Whilst the researchers cannot guarantee any clinical benefits from taking part in this study, it is hoped that people find this programme beneficial. Taking part in this study will help the researchers to improve their digital programme in order to improve access to mental healthcare for as many people as possible.
It is not anticipated that taking part in this study will pose a significant risk. Participants will be using a smartphone app for up to 2 hours per week. Although unlikely, they may experience common side effects of using apps, like headaches, but the researchers don’t think there is anything different about their app compared to other ones.
It is important to understand that the app will ask questions about people’s thoughts and feelings, and they will be asked to complete questionnaires that ask about their anxiety and mood symptoms. This can be distressing for some people. Throughout the study they will be able to contact one of the research team via email if their anxiety or mood symptoms get worse. In addition, the research coordinators will check the anxiety and mood questionnaire scores weekly and will notify the participant’s allocated clinician if deemed necessary.
Where is the study run from?
ieso Digital Health (UK)
When is the study starting and how long is it expected to run for?
February 2023 to May 2024
Who is funding the study?
ieso Digital Health (UK)
Who is the main contact?
1. Dr Clare Palmer, c.palmer@iesohealth.com
2. Ms Emily Marshall, e.marshall@iesohealth.com
Contact information
Principal investigator
ieso Digital Health
The Jeffreys Building
Cowley Road
Cambridge
CB4 0DS
United Kingdom
| Phone | +44 (0)8000745560 |
|---|---|
| e.marshall@iesohealth.com |
Public
ieso Digital Health
The Jeffreys Building
Cowley Road
Cambridge
CB4 0DS
United Kingdom
| Phone | +44 (0)8000745560 |
|---|---|
| c.palmer@iesohealth.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre single intervention arm prospective observational study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Evaluating engagement and acceptability of ieso’s 6-week digital programme for adults experiencing symptoms of anxiety |
| Study acronym | Nil known |
| Study objectives | The primary objective is to evaluate the engagement and acceptability of ieso’s digital programme with clinical support for adults with anxiety symptoms. The aim is to understand: 1. How users engage with the programme 2. Whether participants use the programme as intended and complete all the modules along the schedule provided 3. Whether the programme meets their needs The secondary objectives are to determine the feasibility of this study protocol for future clinical trial design and generate preliminary safety data. The exploratory objectives are to generate preliminary effectiveness data for anxiety symptoms and understand the effect of the programme on additional outcomes, such as mood, work and social adjustment and psychological flexibility, in order to inform the design of future clinical trials. |
| Ethics approval(s) | Approved 14/07/2023, West of Scotland REC 4 (Research Ethics, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, UK; +44 (0)141 314 0213; WoSREC4@ggc.scot.nhs.uk), ref: 23/WS/0081 |
| Health condition(s) or problem(s) studied | Anxiety symptoms in adults |
| Intervention | The intervention consists of a 6-week digital programme that follows a pre-defined set of psychoeducational activities with a clinical oversight wrap-around model. These activities will be made available at specific time points throughout the 6-week programme to enable time between sessions for reflection and practice of activities. Each week, three new activities will be made available on a specific timed schedule throughout the week. Participants will be able to interact with all of the available content in their own time over the course of each week. Each week participants will be asked to complete the Generalised Anxiety Disorder Assessment (GAD-7) and Patient Health Questionnaire-9 (PHQ-9) within the device as part of the programme to measure changes in anxiety/mood. Participants will also complete a set of validated questionnaires to measure other behavioural outcomes (prior to the intervention, at the mid-point and after completing the intervention. For a sub-sample of participants, the researchers will collect additional data about the user experience, acceptability and safety of the digital programme in the form of semi-structured interviews. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | ieso’s digital programme |
| Primary outcome measure(s) |
Current primary outcome measures as of 26/04/2024: |
| Key secondary outcome measure(s) |
1. Recruitment rate across different recruitment methods and referral avenues |
| Completion date | 31/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Total final enrolment | 300 |
| Key inclusion criteria | Current inclusion criteria as of 26/04/2024: 1. Individuals must be over 18 years old at the time of recruitment 2. Anxiety must be the primary presenting issue that individuals are seeking help for (i.e. with a GAD-7 score >7), with symptoms of anxiety and worry typically associated with Generalised Anxiety Disorder (GAD) 3. If depressive symptoms are present at screening, these are not within the severe range (i.e., participants must have a PHQ-9 score <16) 4. Individuals must be able and willing to sign a consent form prior to the study 5. Individuals must be registered with a GP in the UK 6. Individuals must have access to a smartphone with an internet connection Previous inclusion criteria: 1. Individuals must be over 18 years old at the time of recruitment 2. Anxiety must be the primary presenting issue that individuals are seeking help for (i.e. with a GAD-7 score >7), with symptoms of anxiety and worry typically associated with Generalised Anxiety Disorder (GAD) 3. If depressive symptoms are present, these are not within the severe range (i.e., participants must have a PHQ-9 score <16) 4. Individuals must be able and willing to sign a consent form prior to the study 5. Individuals must be registered with a GP in the UK 6. Individuals must have access to a smartphone with an internet connection |
| Key exclusion criteria | 1. Individuals currently receiving psychological therapy 2. Individuals who are not suitable for CBT, this includes individuals with a comorbid diagnosis (a diagnosis of multiple disorders) of psychotic or personality disorder, autism spectrum condition or intellectual disability 3. Individuals who have a formal diagnosis of an untreated mental health condition including substance misuse (except for GAD, MDD or Mixed Anxiety and Depression) 4. Individuals who have Post Traumatic Stress Disorder (PTSD), Obsessive Compulsive Disorder (OCD) or Panic Disorder 5. Individuals who have had a change in psychiatric medication in the past 3 months 6. Individuals who display a significant risk of harm to self, to others or from others 7. Individuals who do not have access to an Internet-enabled device or an Internet connection 8. Individuals who have a low level of literacy in the English language. People who cannot write or read emails or texts will be excluded from this study because they will be unable to utilise the intervention 9. Individuals who have an impairment that will prevent them from using a phone app and/or who usually rely on accessibility features (note: this app has not yet gone through accessibility evaluation) 10. Individuals who become unsuitable for treatment within an NHS primary care mental health service. The normal NHS Talking Therapies for Anxiety and Depression (TTAD) exclusion criteria will be applied whereby people who become actively suicidal or present as a risk to or from others require a referral on to a more specialised, secondary care service. In addition, people who are experiencing symptoms of psychosis, hyper-mania, severe cognitive impairment, severe personality disorder or severe learning disability are also deemed as being unsuitable for a TTAD service. These people will be excluded from this study and referred on to more specialised services. 11. People who are already involved in or who have previously participated in our user research relating to this digital programme |
| Date of first enrolment | 09/10/2023 |
| Date of final enrolment | 02/02/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centre
St. Johns Innovation Park
Cowley Road
Cambridge
CB4 0DS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/05/2025 | 23/05/2025 | Yes | No | |
| Basic results | 23/05/2025 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN52546704 BasicResultsSummary_ISRCTN.pdf
- Basic results
Editorial Notes
23/05/2025: The following changes were made to the trial record:
1. The basic results have been uploaded as an additional file.
2. Publication reference added.
26/04/2024: The following changes were made to the study record:
1. The primary outcome measures, inclusion criteria were changed.
2. Total final enrolment added.
3. The recruitment start date was changed from 18/09/2023 to 09/10/2023.
4. The recruitment end date was changed from 11/12/2023 to 02/02/2024.
5. The overall study end date was changed from 11/03/2024 to 31/05/2024.
6. The intention to publish date was changed from 01/06/2024 to 07/06/2024.
01/08/2023: Study's existence confirmed by the West of Scotland REC 4.
