Behavioural activation in social isolation (BASIL+): Benefiting from activities while you socially isolate to help your mood and wellbeing
| ISRCTN | ISRCTN63034289 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63034289 |
| IRAS number | 293203 |
| Secondary identifying numbers | IRAS 293203, CPMS 47687 |
- Submission date
- 05/02/2021
- Registration date
- 05/02/2021
- Last edited
- 25/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Older adults (those aged 65 years and over) who have long term physical health conditions (such as asthma, diabetes, heart problems) are more likely to experience depression, which can lead to poorer quality of life. As a result of the Covid-19 pandemic, older adults and those with physical health conditions, including long-term health conditions, have been instructed by the UK government to follow social distancing/isolation guidelines (to include strict isolation for the most vulnerable in this group) to protect their own and other’s health. This isolation will lead to a disruption of daily routine, loss of social contact and loneliness; and this in turn may further increase the risk of depression and anxiety in this group. Furthermore, some element of social isolation may well persist through successive waves of the Covid-19 pandemic.
Behavioural Activation (BA) is a form of support which might be useful for people who become socially isolated. A core element of this psychological approach is to help people maintain or introduce activities which are important to them. Such activities may benefit physical and emotional wellbeing by helping people stay connected with the world and remain active.
We have already adapted BA (‘BA Support’) to support older adults with long term physical health conditions and depression to improve their physical and emotional wellbeing. This BA Support will now be used to support older adults with physical health conditions (including long-term health conditions) who are socially isolated and at risk of depression and loneliness. We have now tested this BA Support in a pilot study called Behavioural Activation in Social Isolation (BASIL-C19 - see ISRCTN94091479). We now need to test this BA Support in a much larger group of people to determine whether the BA Support can benefit older adults with physical health conditions to help prevent or reduce depression and loneliness during isolation. The results will be useful in mitigating the psychological impacts of Covid-19, and will be helpful beyond the pandemic in understanding how best to prevent or mitigate depression or loneliness in older people, and especially those who are socially isolated.
Who can participate?
People who are 65 years and over, have two or more long term physical health conditions or a health condition which may require self-isolation (or ‘shielding’) due to Covid-19, and who may be experiencing symptoms of low mood or depression.
What does the study involve?
People who are suitable and happy to take part in the study (participants) will be asked to complete a study questionnaire with a researcher over the telephone. They will then be randomly allocated (this is done by a computer, and is like flipping a coin) to either receive the BA Support (approximately 295 participants) or to continue with their usual care in addition to receiving information about sources of support for maintaining health and wellbeing (approximately 295 participants). No treatment will be withheld and all participants will continue to receive the care and support they might usually do whilst taking part in the study.
Participants who are allocated to the BA Support group will be offered up to eight BA Support sessions over up to a 12 week period. These sessions will involve working with a BASIL support worker who is trained in the BA Support. Participants will also be provided with a booklet which the BASIL support worker will help them to work through. The BASIL support worker will help people to plan changes that aim to support their physical and emotional wellbeing during isolation. The sessions will take place over the telephone (or video call, depending on resources and participant preference). The first session may last around one hour and further sessions will usually last for about 30 minutes. The BASIL support worker may also speak with other professionals involved in the participant’s healthcare.
All participants are asked to complete a study questionnaire over the telephone with a researcher or online after they have been in the study one month, three months and 12 months. Participants may also be asked if they would like to provide their feedback about taking part in the study and receiving the BA Support sessions. BASIL support workers and caregivers may also be invited to discuss their views and experiences of the study and the BA support.
What are the possible benefits and risks of participating?
It is not known whether taking part in this study will help participants since BA has not been used in this way before, but participants may receive additional support which is not usually available to them. Taking part could help improve future support offered to older adults who have health conditions and who may also experience low mood, loneliness and/or social isolation. There are no anticipated risks to people taking part in the study, but it will take up some of their time to complete the study questionnaires. Participants who receive the BA Support sessions will also spend some time working through the sessions and the associated activities.
Where is the study run from?
The BASIL+ study is being run from the University of York, in collaboration with Tees, Esk and Wear Valley NHS Foundation Trust. Participants will be recruited from across England.
When is the study starting and how long is it expected to run for?
October 2020 to February 2023
Who is funding the study?
The study is funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (PGfAR) (UK)
Who is the main contact?
Dr Liz Littlewood
liz.littlewood@york.ac.uk
Contact information
Public
Mental Health and Addictions Research Group
Department of Health Sciences
University of York
Faculty of Science
Heslington
York
YO10 5DD
United Kingdom
 ORCID ID |
0000-0002-4606-4590 |
|---|---|
| Phone | +44 (0)1904328182 |
| liz.littlewood@york.ac.uk |
Scientific
Mental Health and Addictions Research Group
Department of Health Sciences
University of York
Faculty of Science
Heslington
York
YO10 5DD
United Kingdom
| ORCID ID |
0000-0002-8236-6983 |
|---|---|
| Phone | +44 (0)1904321370 |
| simon.gilbody@york.ac.uk |
Scientific
Tees, Esk and Wear Valleys NHS Foundation Trust
Research and Development
Flatts Lane Centre
Flatts Lane
Normanby
Middlesbrough
TS6 0SZ
United Kingdom
| ORCID ID |
0000-0003-3898-3340 |
|---|---|
| Phone | +44 (0)1642 283501 |
| david.ekers@nhs.net |
Study information
| Study design | Multicentre two arm parallel group individually randomized controlled trial with embedded qualitative evaluation and economic evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Behavioural Activation in Social IsoLation (BASIL+): A pragmatic fully-powered randomised controlled trial of a behavioural activation intervention to mitigate depression and loneliness in older adults with long-term health conditions during isolation |
| Study acronym | BASIL+ |
| Study objectives | The overarching aim of the BASIL trials programme is to determine whether the impacts of social isolation can be mitigated by preventing or reducing depression and loneliness. In our pilot BASIL trial (BASIL-C19 - ISRCTN94091479) we have tested our ability to deliver the study and to capture our key primary and secondary outcomes. The next phase of the BASIL research programme is to undertake a definitive randomised controlled trial (BASIL+) to determine the clinical and cost-effectiveness of the BA intervention. |
| Ethics approval(s) | Approved 11/12/2020, Yorkshire and The Humber – Leeds West Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44(0)207 104 8018; leedswest.rec@hra.nhs.uk), ref: 20/YH/0347 |
| Health condition(s) or problem(s) studied | Depression and loneliness in older adults with physical health conditions |
| Intervention | Participants will be randomly allocated 1:1 to either the behavioural activation intervention group or the usual care with signposting information group. Active intervention: Behavioural Activation (BA) within a Collaborative Care framework. BA aims to help people maintain or introduce activities which are important to them; such activities may benefit their physical and emotional wellbeing by helping people to stay connected with the world and remain active. The practitioner (BASIL support worker) and participant work together to develop a collaborative treatment plan that seeks to reinstate or introduce behaviours that connect people to sources of positive reinforcement (valued activities). The BA intervention has been previously adapted for older adults with multiple long term conditions (as part of the existing NIHR MODS programme of research RP-PG-0217-20006 https://www.fundingawards.nihr.ac.uk/award/RP-PG-0217-20006) and has now been further adapted to consider social isolation in the BASIL pilot trial (ISRCTN94091479). Participants will be offered up to 8 BA sessions over up to a 12 week period, delivered by trained BASIL support workers and supported by a self-help booklet. Sessions will be delivered over the telephone (and/or via video call where feasible and acceptable). As part of the collaborative care framework, BASIL support workers will liaise with other professionals relevant to the participant's healthcare needs as appropriate (to include for example medication management). Control intervention: usual care as provided by current NHS and/or third sector providers, in addition to signposting to reputable sources of self-help and information on maintaining physical and mental wellbeing. The duration of treatment and follow-up for both groups is 12 months post-randomisation. |
| Intervention type | Behavioural |
| Primary outcome measure | Self-reported depression severity (as measured by the Patient Health Questionnaire-9) at 3 months post-randomisation. |
| Secondary outcome measures | Measured at baseline, 1, 3 and 12 months post-randomisation (unless otherwise stated): 1. Depression (PHQ9) at baseline, 1 and 12 months post-randomisation 2. Loneliness (De Jong Gierveld Scale - 11 items) 3. Anxiety (GAD-7) 4. Social Networks and Isolation (Lubben Social Network Scale – 6 items) 5. Health-Related Quality of Life (SF-12v2 and EQ5D-3L) 6. A brief bespoke questionnaire will be used to collect health service use data |
| Overall study start date | 01/10/2020 |
| Completion date | 31/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | 392 |
| Total final enrolment | 435 |
| Key inclusion criteria | 1. Older adults aged 65 years or over 2. Two or more long-term physical health conditions OR a health condition that may indicate they are within a ‘clinically extremely vulnerable’ group in relation to Covid-19 3. Depressive symptoms as indicated by a score of ≥5 on the Patient Health Questionnaire-9 (PHQ9) |
| Key exclusion criteria | 1. Have cognitive impairment 2. Have bipolar disorder/psychosis/psychotic symptoms 3. Have alcohol or drug dependence 4. Are in the palliative phase of illness 5. Have active suicidal ideation 6. Are currently receiving psychological therapy 7. Are unable to speak or understand English |
| Date of first enrolment | 08/02/2021 |
| Date of final enrolment | 28/02/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Flatts Lane Centre
Flatts Lane
Normanby
Middlesbrough
TS6 0SZ
United Kingdom
Heslington
York
YO10 5DD
United Kingdom
Jubilee Road
Gosforth
Newcastle upon Tyne
NE3 3XT
United Kingdom
London
SW10 0LR
United Kingdom
Trust Management
Lydeard House
Taunton
TA1 5DA
United Kingdom
Skimped Hill Lane
Bracknell
RG12 1BQ
United Kingdom
Willerby Hill
Beverley Road
Willerby
Hull
HU10 6ED
United Kingdom
Victoria Road
Saltaire
Shipley
BD18 3LD
United Kingdom
Limekiln Lane
Vauxhall
Liverpool
L5 8XR
United Kingdom
Mark Lane
Leeds
LS2 8JA
United Kingdom
Bowthorpe Road
Norwich
NR2 3TU
United Kingdom
Bridge Park Plaza
Bridge Park Road
Leicester
LE4 8PQ
United Kingdom
Cardiff
CF23 9PN
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Development
Flatts Lane Centre
Flatts Lane
Normanby
Middlesbrough
TS6 0SZ
England
United Kingdom
| Phone | +44(0)1642 283501 |
|---|---|
| TEWV.ResearchAndDevelopment@nhs.net | |
| Website | https://www.tewv.nhs.uk/ |
"ROR" |
https://ror.org/04s03zf45 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 24/03/2022 | 25/03/2022 | Yes | No | |
| Statistical Analysis Plan | version 1.1 | 26/09/2022 | 21/10/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/02/2024 | 05/02/2024 | Yes | No | |
| Other publications | Embedded cost utility analysis | 19/01/2025 | 25/04/2025 | Yes | No |
Additional files
Editorial Notes
25/04/2025: Publication reference added.
05/02/2024: Publication reference added.
27/02/2023: The following changes were made to the trial record:
1. The overall end date was changed from 28/02/2023 to 31/03/2023.
2. The total final enrolment was added.
21/10/2022: The following changes were made to the trial record:
1. The statistical analysis plan was uploaded as an additional file.
2. The quantitative data analysis section of the BASIL+ protocol has been updated to include two analyses (with the first of these reporting the primary outcome data in view of the prioritisation of research in response to the Covid-19 pandemic) and that this updated analysis plan was discussed with and agreed by the MODS/BASIL independent Joint Programme/Trial Steering and Data Monitoring & Ethics Committee on 15th June 2022; and the updated BASIL+ protocol was approved by NHS REC and HRA on 4th October 2022.
25/03/2022: Publication reference added.
24/01/2022: The following changes have been made:
1. The recruitment end date was changed from 31/01/2022 to 28/02/2022.
2. The target number of participants and the total target enrolment have been changed from 590 to 392.
3. The total final enrolment number which was previously listed as 392 has been removed.
06/01/2022: The total final enrolment number has been added.
30/11/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2021 to 31/01/2022.
2. The overall trial end date has been changed from 31/10/2022 to 28/02/2023 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 31/07/2023 to 30/11/2023.
4. The trial participating centres "Leicestershire Partnership NHS Trust" and "Llanedeyrn Health Centre" have been added.
05/02/2021: Trial’s existence confirmed by National Institute for Health Research (NIHR)
