Condition category
Injury, Occupational Diseases, Poisoning
Date applied
17/07/2020
Date assigned
11/11/2020
Last edited
11/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Acquired brain injury – injury caused to the brain by an event like an accident or infection – can have profound and life-changing consequences. Treatment typically focuses on rehabilitation – trying to recover as much function as possible in commonly-affected areas like mobility and thinking skills, and helping people compensate for long-term problems.
We have worked with patients to develop a new treatment that focuses on wellbeing by building opportunities for positive psychological experiences, positive health behaviours and social connectivity.

This project will test the feasibility of running a full-scale trial of our treatment and answer important questions about how best to run such a trial.

Who can participate?
Adults over 18 years, with acquired brain injury and psychological distress, living in the community.

What does the study involve?
Participants will be randomly assigned to either ‘treatment as usual’ or ‘group-based positive psychotherapy.’ The intervention consists of an eight-week group-based positive psychotherapy that has been developed by the researchers. The intervention will be delivered by clinical psychologists working in NHS brain injury services. Each session lasts 2.5 hours with activities to try at home between sessions. Several measures will be recorded at baseline, after the eight-week intervention and at 3 months follow-up.

What are the possible benefits and risks of participating?
The study will provide important information that is needed to establish if a full-scale study could take place. The intended benefits of this will be to increase wellbeing and decreasing psychological distress for people with an acquired brain injury, as well as giving a meaningful role to survivors of brain injuries.

A level of ‘psychological distress’ is an eligibility criteria for participation in the intervention, therefore some psychological distress may be experienced during the intervention, we have safety procedures in place to manage this. Acquired brain injuries can cause different types of cognitive problems, we have set out eligibility criteria relating to cognition so we can be reasonably sure the participants will be able to engage in the intervention. This also means we can avoid including participants that may be unable to engage in the intervention, which could potentially cause them psychological distress. Like in all studies, there is a risk of data breaches that could expose confidential information. We have managed this by not including personally identifiable participant information on our database, including data procedures for all staff to follow, and by setting a training standard for all staff involved in the study.

Public involvement
Our research is shaped by the feedback that we have received from brain-injury survivors. They have told us clearly what they want from healthcare providers. Our patients have been involved in developing the new treatment and planning this proposal. A key aspect of our treatment is the use of patient-mentors. Importantly, three service users are co-applicants on our application and all have experienced the intervention as participants and mentors. These individuals have individual skills that add considerable value to the intervention as well as the research team.

Where is the study run from?
Swansea University (UK)

When is the study starting and how long is it expected to run for?
October 2019 to October 2021

Who is funding the study?
Health and Care Research Wales (UK)

Who is the main contact?
Dr Andrew Kemp, a.h.kemp@swansea.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Kemp

ORCID ID

Contact details

707c Vivian Tower
Department of Psychology
Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom
+44 (0) 1792 604561
a.h.kemp@swansea.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 271251

Study information

Scientific title

Group-based positive psychotherapy for people living with Acquired Brain Injury: A feasibility study

Acronym

PP4ABI

Study hypothesis

The methodological approach will be feasible to determine the clinical and cost-effectiveness of a novel positive psychology intervention in a future trial for people living with ABI compared to a ‘treatment as usual’ control group (TAU)

Ethics approval

Approved 06/01/2020, Health Research Authority and Health Care Research Wales (Health Care Research Wales, Castle Bridge 4, 15-19 Cowbridge road East, Cardiff, CF11 9AB, UK; +44 (0)7973 687815; Wales.REC1@wales.nhs.uk), ref: 19/WA/0336

Study design

Feasibility multi-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Acquired brain injury

Intervention

Participants will be randomly assigned using an electronic database system, to either ‘treatment as usual’ or ‘group-based positive psychotherapy.’ The novel intervention consists of an eight week group-based positive psychotherapy that has been developed by the researchers. The intervention has been developed using the ‘GENIAL’ model of well-being. The intervention will be delivered by clinical psychologists working in NHS brain injury services. Each session last 2.5 hours with activities to try at home between sessions. Several measures will be recorded at baseline, after the eight week intervention and at 3 months follow-up.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The primary outcome regarding feasibility will be assessed against the ACCEPT criteria for the trial. This includes recruitment across sites, recruitment rate, intervention compliance clinicians, interventions compliance participants, randomisation process, data collection from participants, attrition rates and differences between groups in serious adverse events (SAEs) measured using case report forms and patient records.

Secondary outcome measures

1. Psychological distress measured using the DASS-21 at time 1 (before the intervention), 2 (after the intervention), and 3 (follow-up at 3 months)
2. Well-being measured using the PERMA profiler at time 1, 2 and 3
3. General health and well-being using heart rate variability at time 1, 2 and 3
4. General capability measured using the ICECAP-A at time 1, 2 and 3
5. General health state and quality of life using the EQ-5D-5L at time 1, 2 and 3
6. Health care costs using the client service receipt inventory (CSRI) at time 1 and 3
7. Participant experience of recruitment, eligibility, consent and their experience of several aspects of the intervention (session context, length, homework, their experience of using the materials) will be explored using qualitative methods and analysis. This only applies to the participants who attended the positive psychotherapy group at time 2

Overall trial start date

01/10/2019

Overall trial end date

01/10/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Confirmed diagnosis of ABI
2. Ability to actively engage in the intervention as determined by their neuropsychological assessment scores and their clinician
3. Living in the community
4. Psychological distress (evidenced by their scores on the Depression, Anxiety and Stress Scales)
5. Age 18 y or older
6. Living within the catchment area of one of the participating health boards
7. At least three-month post injury at the point of recruitment allowing time for spontaneous recovery and for the person to become aware of their difficulties and the implications of this on their lives

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Receptive or expressive language difficulties, or extremely low memory function that may preclude people from engaging meaningfully
2. Medical or psycho-social reasons (based on risk assessment by the referring clinician)
3. Potentially disruptive to other group members as determined by their clinician
4. Not able to provide informed consent

Recruitment start date

01/04/2021

Recruitment end date

01/05/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Morriston Hospital
Traumatic Brain Injury Service Morriston
Swansea
SA6 6NL
United Kingdom

Trial participating centre

Morriston Hospital
Brain Injury and Complex Neurological Service Old Creche Building Morriston
Swansea
SA6 6NL
United Kingdom

Trial participating centre

Rookwood Hospital
Cardiff Brain Injury Team 18-20 Fairwater Road Llandaff Cardiff
Cardiff
CF5 2YN
United Kingdom

Sponsor information

Organisation

Research & Development, Swansea Bay University Local Health Board

Sponsor details

Room 104
Floor 1
Institute of Life Science 2
Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom
+44 (0)1792 957585
Jemma.Hughes@wales.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health and Care Research Wales

Alternative name(s)

The Health and Care Research Wales, Ymchwil Iechyd a Gofal Cymru

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

We plan to publish our findings in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

01/07/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/11/2020: Uploaded protocol version 2.0, 16 April 2020 (not peer reviewed). 24/08/2020: Trial’s existence confirmed by HRA and Health and Care Research Wales (HCRW).