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ACTISSIST 2.0

Active assistance for psychological therapy

 

 

Project background

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 are developing 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 received funding to conduct a larger-scale randomised controlled trial over three years (until October 2020).

The aims of this project are to see whether:

  • people will use the app
  • people like using the app
  • the app improves people’s mental health.
Who is eligible to take part?
We are currently recruiting participants for the trial who are:

  • accessing services from an early intervention team or community mental health team;
  • accessing services from Greater Manchester Mental Health NHS Foundation Trust or Pennine Care NHS Foundation Trust;
  • experienced a first episode of psychosis within the past five years;
  • 16 years of age or over.
How can people take part?
We are accepting self-referrals or referrals through care teams. Anyone who is interested in participating can either speak to their care team about the project or contact the research team directly.
Who funds this research and who granted ethical approval?
This research is funded thanks to a grant from the Medical Research Council (MRC). The MRC and their advisors have reviewed and approved our plans. This research project has also received ethical approval from the West of Scotland NHS Research Ethics Committee (Ref. 17/WS/0221) with approval granted from the participating Trusts’ Research and Innovation departments.

Publications

We have a number of published studies available for free online.

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.
Systematic review
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

In the news

Our progress

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.

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.

 

 

Developing Actissist

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 started a large-scale, randomised controlled trial which will run until October 2020.

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 suggestions for content and design features. These suggestions have now been 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 have an expert reference group for the Actissist 2.0 trial, who meet several times a year to provide expert views about the app and the trial.
Software design
We have fed the findings from our interviews and focus groups back to our technical team who have worked hard to make sure that as many of the ideas raised during the interviews and focus groups have been 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 now finished beta testing 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 is now being tested in a larger group of people from Greater Manchester Mental Health NHS Foundation Trust and Pennine Care NHS Foundation Trust.
Trialling Actissist
We will ask 170 service users experiencing early psychosis to help us test out whether Actissist works or not. A computer will choose at random whether a participant uses Actissist or another app called ClinTouch. We cannot choose who uses 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 is that it will give us something to compare Actissist with. We are inviting 85 people to try out the Actissist app for 12 weeks and 85 participants to try out the ClinTouch app for 12 weeks. Participants will have the choice of using either their own phone or a phone loaned to them by the research team. A member of the research team will provide each participant with a training session on how to use the apps. Whichever app someone is selected to use, they will meet with a researcher at the start and end of the study, and then12 weeks after the study has ended. During these meetings, people will be asked to fill out some questionnaires about their day-to-day life, substance use, feelings and symptoms. The answers people give will help the research team to monitor people’s progress and understand more about how people have been feeling during the study and whether this has changed. These questionnaires will not identify anyone by name and will not be seen by the participant’s healthcare team.

Research team

Meet members of the research team behind the Actissist app and view their research profiles for more information.

Dr Sandra Bucci – Principal Investigator
Sandra BucciSandra 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. She moved to the UK as a Research Fellow in Clinical Psychology at Manchester. Sandra was appointed Senior Lecturer in 2014 and is the social responsibility lead for the Division of Psychology and Mental Health. Alongside her University role, Sandra is also an honorary consultant clinical psychologist with Greater Manchester Mental Health NHS Foundation Trust and is a director of Affigo, CIC, a not-for-profit social enterprise company.

View Sandra’s research profile

Professor John Ainsworth – Co-Investigator
John AinsworthJohn 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.

View John’s research profile

Professor Gillian Haddock – Co-Investigator
Gillian HaddockGillian 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.

View Gillian’s research profile

Dr Katherine Berry – Co-Investigator
Katherine BerryKatherine 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.

View Katherine’s research profile

Dr Dawn Edge – Co-Investigator
Dawn EdgeDawn 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.

View Dawn’s research profile

Professor Richard Emsley – Co-Investigator
Richard EmsleyRichard 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?

View Richard’s research profile

Professor Shôn Lewis – Co-Investigator
Shon LewisShôn 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.

View Shôn’s research profile

Mr Matthew Machin – Technical lead

Matt MachinMatt 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.

Dr Natalie Berry – Research Assistant
Natalie BerryNatalie joined The University of Manchester in 2014 as a PhD student investigating how technology can be used to deliver psychological interventions for people who experience severe mental health problems and was awarded her PhD in January 2018. Her research interests focus on exploring how people currently use technology to self-manage their mental health, the acceptability of digital health interventions for severe mental health problems, and the impact of technology use on symptoms. Natalie joined the Actissist 2.0 team in October 2017 as a research assistant.

View Natalie’s research profile

Dr Elizabeth Lewis – Research Assistant
Elizabeth LewisAfter completing an MSc in research methods for psychology, Elizabeth worked within adult social care coordinating care visits for older people. Following this, she worked on a wide range of research projects including:

  • the effectiveness of interventions within preschool speech and language therapy;
  • historical research considering Whittingham Asylum to inform future mental health interventions;
  • and the management of adult social care, which was the focus of her PhD.

Recently she has considered the effectiveness and implementation of digital interventions for bipolar and psychosis.

View Elizabeth’s research profile

Dr Alyson Williams – Project Officer
Alyson WilliamsAfter completing her PhD in Psychology (Sheffield, 2000), Alyson initially worked as a researcher on the standardization of a language development assessment tool for children at the University of Manchester before moving to the National Evaluation of Sure Start at Birkbeck, London to manage the field research team collecting data from families. Returning to Manchester in 2004, Alyson joined the project management team of the National Confidential Inquiry into Suicide and Homicide by People with Mental Illness, a UK-wide programme examining suicide and homicide by individuals in the recent care of secondary mental health services. Alyson joined the Actissist 2.0 team in November 2017 as Project Officer.

View Alyson’s research profile

Rose Dickin - Research Assistant

Hannah is an undergraduate Psychology student at the University of Manchester, who joined the Actissist 2.0 team in June 2019 as a summer intern. She is interested in how the future of mental health care, with innovations like e-health, can be made broadly accessible to reach people

Hannah Davies - Summer Intern

Hannah is an undergraduate Psychology student at the University of Manchester, who joined the Actissist 2.0 team in June 2019 as a summer intern. She is interested in how the future of mental health care, with innovations like e-health, can be made broadly accessible to reach people.

 

 

Contact us

Principal Investigator

Dr Sandra Bucci
Tel: +44 (0)161 306 0406
Email: sandra.bucci@manchester.ac.uk

Project Officer

Dr Alyson Williams
Tel: +44 (0)161 306 0428
Email: alyson.williams@manchester.ac.uk

 

Research Assistant

Dr Natalie Berry
Tel: +44 (0)161 306 2619
Email: natalie.berry@manchester.ac.uk

Research Assistant

Dr Elizabeth Lewis
Tel: +44 (0)161 306 2619
Email: elizabeth.lewis-2@manchester.ac.uk

 

 

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