Active assistance for psychological therapy
National clinical guidelines recommend a treatment known as cognitive behavioural therapy (CBT) for people who have experienced psychosis. To help increase access to helpful strategies, we have developed a CBT-informed mobile phone app (Actissist) for people who have experienced a first episode of psychosis.
The app was tested in an initial pilot trial in 2015/16 and the results are available in the publications section below. We have now completed a definitive trial and will be publishing the results of this trial shortly.
Read the feedback from healthcare professionals on our testimonials page.
We have a number of published studies available for free online.
Actissist 2 Statistical Analysis Plan
This document details the presentation and analysis strategy for the primary papers reporting results from the Actissist 2.0 trial.
Actissist 2 Study Protocol
Our smartphone app (Actissist) empowers patients to make informed choice in real–time about their treatment and to act promptly under their own control – we believe we have the potential to transform community care for SMI patients.
Read the Actissist Study Protocol for more information.
Learning Points from a Multidisciplinary Collaboration
The involvement of multidisciplinary stakeholders in the design, development and delivery of Actissist has been fundamental to our development approach. Qualitative interviews, focus groups, an expert reference group and ongoing user feedback have generated different perspectives and ideas that would not have been generated by the research team alone. Along with some challenges, this collaborative working has also led to the development, inclusion and improvement of the app design and content.
Actissist proof-of-concept trial results
In our proof-of-concept trial, we found that Actissist appeared to be acceptable and safe to use, people enjoyed using the app, and it showed promise for treatment efficacy. Full results are available in Schizophrenia Bulletin.
World Psychiatry Letter
We recently published a letter in the journal World Psychiatry detailing the lessons learned from the Actissist proof-of-concept trial.
Developing a measure to assess therapeutic alliance
In the proof-of-concept study, we explored service user views about the concept of a therapeutic alliance with digital health apps and adapted a commonly used measure of face-to-face therapeutic alliance (the Agnew Relationship Measure) for use within mobile health interventions (mARM). The paper is free to access.
Actissist proof-of-concept study protocol
In 2015, we published a trial protocol for the proof-of-concept study. In the protocol we describe the app in more detail, the study design and the measures used. We will also be publishing the study protocol for the current trial in the near future. View the trial protocol for the proof-of-concept study.
In 2016, we published a review of the literature exploring how acceptable digital health interventions, like Actissist, are for people who experience psychosis or bipolar disorder. We found that once people received a digital health intervention, they enjoyed using it; however, we also found that prior to receiving an intervention, acceptability was lower. Full results are available in the Journal of Medical Internet Research.
Staff focus groups
We recently conducted focus groups with staff working in secondary care services to explore their views towards the use of digital health interventions in mental health care settings. We found that staff were cautiously optimistic about the potential role that digital tools could play in mental health services. See the results.
We also conducted staff focus groups as part of the Actissist proof-of-concept trial. Early Intervention staff were again optimistic about the potential for a CBT-informed app for individuals with early psychosis. Our findings are available here.
Qualitative interviews with service users
During the proof-of-concept study we interviewed participants who had experienced a first episode of psychosis. Participants were largely positive about the use of an app for psychosis because they had the potential to be progressive, modern and relevant. However, data security and privacy concerns were raised as barriers that could impact willingness and desire to use an app. The full results from these interviews can be found here.
Members of our research team also interviewed 18 participants experiencing severe mental health problems about their views towards the use of technology in secondary care services. Participants already used technology to self-manage their mental health and could see a variety of benefits of using technology in their day-to-day lives, but similar concerns regarding security and data access were raised, as well as the fear that technology may be used to replace face-to-face care. Our full results are available online
The digital revolution and its impact on mental healthcare
Members of our team published an article reviewing the current literature in the field of digital mental health. Based on the empirical evidence available, we discuss the barriers and facilitators to the delivery and implementation of digital tools in secondary care mental health services and the potential impact of digitally mediation on human communication and mental health.
The full paper can be read here.
In the news
- Professor Sandra Bucci has secured the second ever Schizophrenia International Research Society (SIRS) Research Harmonisation Group (RHG) award.
- Professor Sandra Bucci awarded NIHR Professorship.
- Phone app has promising signs for mental health patients
- Patients with early psychosis may benefit from app on how to cope with symptoms
- The Mental Elf website recently published a blog summarising our research exploring the views of mental health staff towards digital health interventions.
We are regularly updating the website with the milestones and achievements over this three year project. You can also see regular updates written by members of the research team on our project blog.
We are delighted to announce that we have secured the second ever Schizophrenia International Research Society (SIRS) Research harmonisation group (RHG) award.
Our award will focus on developing a comprehensive tool and procedure for reporting adverse events in studies using digital health platforms for people with psychosis/schizophrenia. In this work, we will draw on existing datasets, and members’ international expertise, to catalogue the full spectrum of adverse events occurring within ≥22 studies across ≥5 countries. This shared empirical data will provide the basis for a Delphi consensus process defining what constitutes an adverse event in a digital health context, and develop ideal reporting procedures.
April 2020 to July 2021
We worked remotely throughout the COVID-19 pandemic. We finalised all the follow up assessments for the trial and conducted qualitative exit interviews with both staff and service users remotely. We obtained some additional funding from the Medical Research Council to support the roll out of the app to both the PlayStore and Apple Store and are in the final phase of making the app available for both Android and iOS operating systems.
We have also submitted the app for ORCHA review and are awaiting the outcome. As the clinical aspects of the trial finished in September 2020, we are delighted that all the clinical research workers successfully moved onto other posts, including clinical psychology training and Assistant Psychologist posts. Since the clinical aspect of the trial has finished, our software engineers have been busy making updates to the app to ensure it works across all digital platforms.
Professor Bucci also successfully secured a prestigious National Institute for Health Research (NIHR) Research Professorship to take the app and other digital solutions forward. The focus of her Professorship is to co-produce a contextually responsive and predictive digital health system within re-designed digital care pathways. The system will improve the quality and efficiency of care in psychosis, and will be delivered by a digitally confident and capable workforce.
Since obtaining the NIHR Professorship, we have built our digital mental health team. In April 2021, we welcomed Anna Webster to the team, who will work as the Project Manager across a range of digital mental health studies. In May 2021, we also welcomed Dr Emily Eisner, an Early Career Researcher with significant expertise in the Digital Mental Health field. We are continuing to grow our team to ensure we deliver high-quality, evidence-based, digital mental health research.
January to March 2020
- In February we held our first expert reference group (ERG) of the year attended by a range of individuals with expertise in mental health, research and software engineering. This included individuals of lived experience of psychosis, mental healthcare staff, academics and software engineers. In the group, we showed the group the app, provided updates about the project and sought feedback on the framework we had developed for the analysis of qualitative interviews.Thanks to all those who gave their time to participate in the group.
- In February, Sandra also presented the rationale and development of the Actissist app and findings from the Actissist proof-of-concept study to psychiatrists working in Greater Manchester Mental Health Foundation Trust.
- In March, we moved to working from home in line with government and University guidelines for physical distancing. The team are still keeping in regular contact with each other through zoom coffee mornings. To maintain routine, we are still working 9-5 and conducting follow-up interviews with Actissist participants via remote methods and have developed standard operating procedures for working in these changing circumstances.
October to December 2019
- In October, Sandra delivered a presentation about the digital therapeutic alliance at the NRS Mental Health Network Annual Scientific Meeting in Glasgow.
- In November, Sandra travelled to Belgium to present at the Visionary Seminar on Personalised Health about her work in the field of digital mental health.
- We were delighted to reach our recruitment target at the end of November. In total we recruited 172 participants from Greater Manchester and Mental Health NHS Foundation Trust and Pennine Care NHS Foundation Trust. Many thanks to all the staff and service users who helped us to achieve this target.
July to September 2019
- In July, Sandra presented findings from the Actissist proof-of-concept study, associated qualitative studies and progress so far on the Actissist 2 project at the 9th World Congress of Behavioural and Cognitive Therapies in Berlin. Other projects in the same symposium included IMPACHS and EMPOWER.
- In August, Sandra travelled to Australia to present a keynote talk at a symposium on the digital therapeutic alliance hosted by the University of Melbourne School of Computing and Information Systems,
- Whilst in Australia, Sandra and Katherine also delivered talks at the Orygen Seminar series.
- August was a very busy month! Matt and Sandra also delivered a presentation outlining the collaborative and multidisciplinary nature of the development of Actissist at the MedInfo 17th World Congress in Lyon.
- Sandra was invited to write a blog describing the recent innovations in the field of digital mental health for IEPA Early Intervention in Mental Health. The blog can be found by clicking here.
- By the end of September, we had recruited 152 participants for the project.
April to June 2019
- In May, we were invited to attend a research event organised by Pennine Care NHS Foundation Trust at the University of Manchester aiming to disseminate research to clinicians in the trust. At the event, Natalie and Liz manned a research table where we had the app on tablet computers for attendees to engage with and information about referring to the project. Sandra also delivered a presentation about the use of digital health in early psychosis.
- Our new paper highlighting research findings from our previous work with clinicians was published in May in the journal Frontiers in Psychiatry. In this qualitative study, we found that clinicians could see a CBT-informed app for psychosis working in early intervention services as a way to improve access and empower service users.
- We also published a paper in the journal Psychology and Psychotherapy where we reviewed the field of digital health for secondary care mental health services, identifying barriers and facilitators and the impact of digitally mediated communication on human interaction.
- We had recruited 134 participants by the end of June.
January to March 2019
- In January, Sandra and Matt presented a talk at the Division of Psychology and Mental Health research seminar where they spoke about how they worked together to develop the Actissist smartphone app. It was interesting for us all to hear how the technology team and the clinical team collaborated and the challenges and benefits associated with the multidisciplinary approach to the development and design of the app.
- In February, we held an expert reference group where we discussed the progress of the trial so far and important elements of both the design of the app and the research project. The expert reference group gave valuable feedback about the new avatars on the app and the updated design features. We also asked the ERG for their input about the end of trial procedures, where they gave feedback on a debrief form for use when we leave participants and a future opportunities form.
- In March we conducted our first qualitative interview of the project. Once participants have finished using the app, we select some people to be interviewed about their views towards the app, how they used the app on a day-to-day basis and how they can see the app working in services in the future. We’re looking forward to speaking to more people about the app to help inform the design and implementation of Actissist in the future.
- Natalie attended a social media workshop at the University of Birmingham where she presented work from our previous qualitative studies about incorporating social media tools within digital health interventions.
- The Division of Psychology and Mental Health holds a social responsibility event called “What do Psychological Scientists do?” where local students from Greater Manchester Schools are invited to hear about the research being done in the department, the undergraduate Psychology programme and careers in psychological science. Natalie delivered a stand at the event about psychosis research where students were able to find out more information about psychosis and were shown the new technologies being used in the department to help people manage their mental health.
- By the end of March, we had recruited 111 participants to the project.
October to December 2018
- By the end of December 2018, we recruited 85 participants to the trial (exactly half way to our total recruitment target). This was a huge achievement – thanks to all the research staff, NHS staff, our expert reference and participants for helping us reach this point!
- Sandra presented Actissist at the IEPA 11 Conference as part of a digital health symposium. More details about the IEPA conferences can be found if you click on the following link: https://www.iepaconference.org/iepa11/
- In October, Sandra was invited to be a keynote speaker at the Global E-Mental Health conference in Australia: https://www.newcastle.edu.au/research-and-innovation/global-leadership/e-mental-health
- We published our qualitative work with service users exploring their views towards the role of digital technology in the management of psychosis in JMIR Mental Health.
July to September 2018
- We recruited a total of 57 participants by the end of September 2018.
- We held our quarterly Expert Reference Group where we asked for feedback on the next version of the Actissist app and future study materials.
- We released Actissist version 2 to new participants on the trial.
April to June 2018
- We held a public and patient involvement group with service users who had all experienced early psychosis to co-design two recovery videos that we could add to the recovery video section on the app based on feedback from the Actissist proof-of-concept study and completed filming in June.
- We recruited 33 participants to the project between April and June 2018.
- Actissist was presented at the annual Pint of Science event in Manchester.
- The findings from the proof-of-concept study were published in the journal Schizophrenia Bulletin.
January to March 2018
- We held our first expert reference group, where we presented the app for the first time to the group and sought feedback on specific features such as the topics the app covers and factsheet subjects and project design such as recruitment methods.
- Sandra Bucci (Principal Investigator) and Natalie Berry (Research Assistant) attended the European Society for Research on Internet Interventions (ESRII) 5th Scientific Meeting in Dublin to present the findings from the Actissist proof-of-concept study and qualitative interviews with service users exploring views towards digital health for psychosis.
- We have started to visit early intervention services and community mental health teams in two Greater Manchester NHS Trusts to show staff the Actissist app.
- We started recruiting participants to the trial.
- By the end of March, we recruited our first four participants.
October to December 2017
- We received NHS ethics approval.
- We set-up an Actissist Trial Steering Group Committee/Data and Ethics Committee, which will meet annually to review the progress of the trial.
- We also set-up a dedicated expert reference group, a group of individuals with lived experience, clinicians, academics and software engineers, to collaborate and co-design project and app features.
- Sandra Bucci (Principal Investigator), Gillian Haddock (Co-Investigator) and Natalie Berry (Research Assistant) travelled to Berlin for the International Society for Research on Internet Interventions (ISRII) 9th Scientific Meeting to present findings from several projects including the Actissist proof-of-concept study and qualitative work with mental health care staff exploring views towards digital health.
The Actissist app was developed and trialled over a 26-month period. We found that the Actissist app appeared to be safe and acceptable for people experiencing early psychosis.
We have now completed a large-scale definitive randomised controlled trial. Findings will be published shortly.
We will continually work to improve and develop the app, and the development will be informed by both service users and staff. We are trialling the app to see whether:
- people like using the app
- the app improves people’s mental health.
Find out more about our methods below.
Staff and service user design
We believe it’s important that service users and staff have an influence on the design of the app. To make sure that Actissist is tailored to service users’ wants, expectations and needs, the proof-of-concept study started out by collecting information from both early intervention service users and staff about what they think an app for early psychosis should look like. This was done through one-to-one interviews with service users and focus groups with staff. We also interviewed some participants after they had used the app in the pilot trial to ask them how they found the app and for suggestions for content and design features. These suggestions were incorporated into a new version of the Actissist app for use in the Actissist 2.0 trial. The findings of these interviews and focus groups will also be published in a scientific journal.
Expert reference group
Throughout the proof-of-concept study expert reference groups were held with service users and staff to help inform the development of the app. We also had an expert reference group for the Actissist 2.0 trial, who met several times a year to provide expert views about the app and the trial.
We fed the findings from our interviews and focus groups back to our technical team who worked hard to make sure that as many of the ideas raised during the interviews and focus groups were included into the design of the app. We now have a working version of the new Actissist app, which members of our research team have tested out for a week to make sure that it works the way we designed it to work. We have also beta tested the app. A beta test is the last testing phase, which allowed us to identify any ‘bugs’ or problems within the app. During beta testing, we gave the app to some NHS staff members to try it out for a week and then asked them for feedback so we could make further improvements. The app was then tested in a larger group of people from Greater Manchester Mental Health NHS Foundation Trust and Pennine Care NHS Foundation Trust.
Tested in clinical trials
We asked 170 service users experiencing early psychosis to help us test out whether Actissist works or not. A computer chose at random whether a participant uses Actissist or another app called ClinTouch. We couldn’t choose who used which app. ClinTouch helps people to keep track of their mental health by recording experiences and feelings as they are happening. The purpose of giving some people the ClinTouch app was that it gave us something to compare Actissist with. We invited 85 people to try out the Actissist app for 12 weeks and 85 participants to try out the ClinTouch app for 12 weeks. Participants had the choice of using either their own phone or a phone loaned to them by the research team. A member of the research team provided each participant with a training session on how to use the apps. Whichever app the person selected to use, they met with a researcher at the start and end of the study, and then12 weeks after the study had ended. During these meetings, people were asked to fill out some questionnaires about their day-to-day life, substance use, feelings and symptoms. The answers people gave helped the research team to monitor people’s progress, understand more about how people were feeling during the study and whether this had changed. These questionnaires didn’t identify anyone by name and were not seen by the participant’s healthcare team.
We have received positive feedback on Actissist from psychologists and other staff who have used the app.
See what health professionals have to say about the app.
Meet members of the research team behind the Actissist app and view their research profiles for more information.
Professor Sandra Bucci – Principal Investigator
Sandra Bucci (ClinPsyD) developed her research interest in serious mental illness while working at the University of Newcastle, Australia on a National Health and Medical Research Council funded trial. She went on to obtain a psychologist post in an early intervention service and completed her clinical psychology doctoral training in 2006, moving to the UK and taking up a clinical academic role at the University of Manchester and Complex Cases Team, Greater Manchester Mental Health NHS Foundation Trust (GMMH).
She is an NIHR Research Professor, Professor of Clinical Psychology at the University of Manchester, Honorary Consultant Clinical Psychologist at GMMH, co-Director of the Complex Trauma and Resilience Research Unit (GMMH), Director of Affigo CiC, and Editor of the British Psychological Society journal Psychology and Psychotherapy, Theory, Research and Practice. She leads a programme of research focused on developing digital solutions for people with severe mental health problems and is the Clinical Safety Officer of the Actissist app.
Professor John Ainsworth – Co-Investigator
John is a Professor of Health Informatics at the University of Manchester; he is also Director of the Centre for Health Informatics, the MRC Health eResearch Centre, part of the Farr Institute and Connected Health Cities. John works at the intersection of information technology and healthcare research focusing on applying information technology to improving health care. His research interests include harnessing computing technology to enable novel clinical research, using information technology to improve health services, applying emerging computing technologies to create novel interventions and development of software as a diagnostic and/or therapeutic medical device.
Professor Gillian Haddock – Co-Investigator
Gillian is Head of the Division of Psychology Mental Health at The University of Manchester. She is also the Manchester Director of the North West Mental Health Alliance, a joint initiative with the Universities of Liverpool and Lancaster to enhance mental health research and treatment in the North West of England. She holds honorary consultant clinical psychology appointments in NHS mental health trusts in the north west of England. Gillian has been awarded over £5 million pounds in external research funds with colleagues on trials evaluating psychological therapies for people with psychosis and has 20 years’ experience in conducting clinical trials within the NHS.
Professor Katherine Berry – Co-Investigator
Katherine is a Senior Lecturer and Clinical Psychologist who is based at The University of Manchester. Her main area of expertise is interpersonal relationships in people with a diagnosis of psychosis. After completing her PhD exploring the relevance of attachment theory in psychosis, she obtained a fellowship to develop and evaluate an intervention to improve staff-patient relationships in inpatient settings.
Professor Dawn Edge – Co-Investigator
Dawn is a Senior Lecturer at The University of Manchester and is the University’s academic lead for equality, diversity and inclusion. Her post involves teaching at both undergraduate and postgraduate levels within the Division of Psychology and Mental Health. Dawn is interested in the intersections between psycho-social determinants of health. Her research is primarily focused on improving outcomes and reducing inequalities experienced by marginalised and under-served populations.
Professor Richard Emsley – Co-Investigator
Richard is a Professor of Medical Statistics and Trials Methodology at the Institute of Psychiatry, Psychology and Neuroscience, King’s College London. Prior to this, he was Professor of Medical Statistics at The University of Manchester and Deputy Director of the Manchester Clinical Trials Unit. His research aims to answer four key questions: Are treatments effective? How do they work? What factors make them work more effectively? Which groups are they most effective for?
Professor Shôn Lewis – Co-Investigator
Shôn has been Professor of Adult Psychiatry at the University of Manchester since 1994. He has been Chair of the Royal College of Psychiatrists’ research committee and served on the Wellcome Trust and the MRC Neurosciences and Mental Health Boards. His research interests focus on risk factors and new interventions in schizophrenia and psychosis, including the use of new technologies. He receives research funding from MRC, NIHR and EU. He was elected in 2008 as a fellow of the Academy of Medical Sciences. He has also held an NIHR Senior Investigator award since 2008. He also works as an honorary consultant psychiatrist in Manchester Mental Health and Social Care Trust.
Mr Matthew Machin – Technical lead
Matt has over 20 years’ experience in software engineering as a developer, software development manager and technical programme manager. He currently leads a multi-disciplinary team of software engineers, UI designers, software test specialists and project managers based in the Health e-Research Centre. Matt’s primary area of interest is Connected Health including the development of smartphone apps and the use of wearable devices for people with long-term health conditions.