Active Assistance for Psychological Therapy 2.0 (Actissist 2.0)

Plain English Summary

Background and study aims
Severe mental illness (SMI) such as schizophrenia affects 24 million people worldwide, with costs to society estimated at nearly £12bn in England. It typically starts in early adulthood and up to 80% relapse within 5 years, resulting in unscheduled acute care and adverse effects on psychosocial development. The main treatment for psychosis is medication and psychosocial interventions. Currently, the delivery of psychosocial interventions for psychosis by scheduled appointment can result in indicators of relapse either being missed or treated too late. There is a need for innovative, timely, efficient and cost-effective solutions to improve the speed and quality of recovery in psychosis, over and above conventional drug and psychosocial treatments. The NHS has a clear digital agenda for addressing mental health challenges, aiming to fully harness the information technology revolution, and self-management in long-term conditions is a cornerstone of NHS policy. Smartphones offer an unprecedented opportunity to drive improvements in treatment quality, efficiency, cost, access and facilitate self-management. A user-informed, personalised, smartphone app, Actissist, has been developed which delivers a theory-driven psychological intervention that is unconstrained by traditional service settings. Patients can complete the intervention swiftly in the course of daily life over 12-weeks and this technology is feasible, safe and acceptable. The aim of this study is to refine the software and assess its effectiveness in early psychosis.

Who can participate?
Adults (16 or older) with early psychosis (within 5 years of initial episode) who are in contact with Early Intervention Services or Secondary Care Services

What does the study involve?
Participants are randomly allocated to one of two groups: the treatment group or the control group. Eighty-five people in the treatment group are asked to use the Actissist app on top of their usual treatment, and 85 people are asked to use a symptom monitoring app (ClinTouch) plus their usual care. Before using the apps, participants are asked to complete some questionnaires about their feelings and experiences. Participants also receive a training session on how to use the app and receive weekly telephone calls from a researcher to see how people are getting on with using the app. Participants using the Actissist app also meet with the researcher to set a goal to work towards while using the app. After 12 weeks of using the apps, participants are invited to complete the same questionnaires they filled out at the start of the study and additional questions about how they felt about the app they received. Some participants are interviewed to find out what it was like being involved in the study at the end of the 12-week study period. People who do not wish to take part in the study, but who are interested in providing their views about apps for psychosis, are also interviewed. Mental health care staff are also invited to attend interviews to give their views about the implementation of apps for early psychosis in mental health services. Finally, surveys are given to participants, in addition to service users and staff who are not participants. These surveys can be completed online via a secure website or with paper-based questionnaires. Questions in the survey focus on participants’ technology ownership and their interest in using technology support options for early psychosis.

What are the possible benefits and risks of participating?
It is not known whether the Actissist app will result in improvements. For this reason, participant feedback, views, experiences and input are important to help towards the development of an app that could improve access and choice over treatment options for people with experience of psychosis. Some people also enjoy completing the tasks involved in taking part in research and being given the opportunity to speak with someone about their experiences. Some people may find it difficult to answer questions about their feelings. However, in an early study and in the development of the ClinTouch app, very few people have reported feeling distressed through completing the questions.

Where is the study run from?
The study is being run from the University of Manchester, who are working with various Early Intervention and Secondary Care Services based at trusts across the North West of England

When is the study starting and how long is it expected to run for?
March 2018 to June 2020.

Who is funding the study?
Medical Research Council (MRC) (UK)

Who is the main contact?
1. Dr Sandra Bucci (PI)
sandra.bucci@manchester.ac.uk
2. Dr Alyson Williams (Project Officer)
alyson.williams@manchester.ac.uk

Study website

Contact information

Dr Sandra Bucci
Scientific

Division of Psychology and Mental Health
School of Health Sciences
Zochonis Building
University of Manchester
Brunswick Street
Manchester
M13 9PL
United Kingdom

ORCID ID	0000-0002-6197-5333
Phone	+44 (0)161 306 0422
Email	sandra.bucci@manchester.ac.uk

Dr Alyson Williams
Public

Division of Psychology and Mental Health
School of Health Sciences
Zochonis Building
University of Manchester
Brunswick Street
Manchester
M13 9PL
United Kingdom

Phone	+44 (0)161 306 0428
Email	Alyson.williams@manchester.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

The University of Manchester
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

"ROR"	https://ror.org/027m9bs27

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

17/04/2025: Publication reference added.
08/10/2021: The following changes have been made:
1. Internal review.
2. The trial acronym has been added.
3. The intention to publish date has been changed from 30/03/2021 to 30/12/2021.
4. The total final enrolment number has been changed from 170 to 172.
29/12/2020: Publication reference added.
10/09/2020: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/09/2020 to 27/09/2020.
2. The intention to publish date was changed from 01/01/2021 to 30/03/2021.
3. Trial website added.
11/12/2019: The total final enrolment was added.
30/09/2019: The recruitment end date was changed from 30/09/2019 to 30/11/2019.
27/03/2019: The condition has been changed from "Specialty: Mental health, Primary sub-specialty: Psychosis; UKCRC code/ Disease: Mental Health/ Organic, including symptomatic, mental disorders" to "Psychosis" following a request from the NIHR.
30/05/2018: Internal review.
23/04/2018: The study hypothesis and primary outcome measure were updated.
20/03/2018: The secondary outcome measures, inclusion and exclusion criteria were updated.