Behavioural Activation for Social IsoLation (BASIL+) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial.
<h4>Introduction</h4>Depression is a leading mental health problem worldwide. People with long-term conditions are at increased risk of experiencing depression. The COVID-19 pandemic led to strict social restrictions being imposed across the UK population. Social isolation can have negat...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2022-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0263856 |
| _version_ | 1818273927653228544 |
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| author | Lauren Burke Elizabeth Littlewood Samantha Gascoyne Dean McMillan Carolyn A Chew-Graham Della Bailey Claire Sloan Caroline Fairhurst Kalpita Baird Catherine Hewitt Andrew Henry Eloise Ryde Leanne Shearsmith Peter Coventry Suzanne Crosland Elizabeth Newbronner Gemma Traviss-Turner Rebecca Woodhouse Andrew Clegg Tom Gentry Andrew Hill Karina Lovell Sarah Dexter Smith Judith Webster David Ekers Simon Gilbody |
| author_facet | Lauren Burke Elizabeth Littlewood Samantha Gascoyne Dean McMillan Carolyn A Chew-Graham Della Bailey Claire Sloan Caroline Fairhurst Kalpita Baird Catherine Hewitt Andrew Henry Eloise Ryde Leanne Shearsmith Peter Coventry Suzanne Crosland Elizabeth Newbronner Gemma Traviss-Turner Rebecca Woodhouse Andrew Clegg Tom Gentry Andrew Hill Karina Lovell Sarah Dexter Smith Judith Webster David Ekers Simon Gilbody |
| author_sort | Lauren Burke |
| collection | DOAJ |
| description | <h4>Introduction</h4>Depression is a leading mental health problem worldwide. People with long-term conditions are at increased risk of experiencing depression. The COVID-19 pandemic led to strict social restrictions being imposed across the UK population. Social isolation can have negative consequences on the physical and mental wellbeing of older adults. In the Behavioural Activation in Social IsoLation (BASIL+) trial we will test whether a brief psychological intervention (based on Behavioural Activation), delivered remotely, can mitigate depression and loneliness in older adults with long-term conditions during isolation.<h4>Methods</h4>We will conduct a two-arm, parallel-group, randomised controlled trial across several research sites, to evaluate the clinical and cost-effectiveness of the BASIL+ intervention. Participants will be recruited via participating general practices across England and Wales. Participants must be aged ≥65 with two or more long-term conditions, or a condition that may indicate they are within a 'clinically extremely vulnerable' group in relation to COVID-19, and have scored ≥5 on the Patient Health Questionnaire (PHQ9), to be eligible for inclusion. Randomisation will be 1:1, stratified by research site. Intervention participants will receive up to eight intervention sessions delivered remotely by trained BASIL+ Support Workers and supported by a self-help booklet. Control participants will receive usual care, with additional signposting to reputable sources of self-help and information, including advice on keeping mentally and physically well. A qualitative process evaluation will also be undertaken to explore the acceptability of the BASIL+ intervention, as well as barriers and enablers to integrating the intervention into participants' existing health and care support, and the impact of the intervention on participants' mood and general wellbeing in the context of the COVID-19 restrictions. Semi-structured interviews will be conducted with intervention participants, participant's caregivers/supportive others and BASIL+ Support Workers. Outcome data will be collected at one, three, and 12 months post-randomisation. Clinical and cost-effectiveness will be evaluated. The primary outcome is depressive symptoms at the three-month follow up, measured by the PHQ9. Secondary outcomes include loneliness, social isolation, anxiety, quality of life, and a bespoke health services use questionnaire.<h4>Discussion</h4>This study is the first large-scale trial evaluating a brief Behavioural Activation intervention in this population, and builds upon the results of a successful external pilot trial.<h4>Trial registration</h4>ClinicalTrials.Gov identifier ISRCTN63034289, registered on 5th February 2021. |
| first_indexed | 2024-12-12T22:05:44Z |
| format | Article |
| id | doaj.art-4c5391ea4019487cb645f4892c7fef25 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-12T22:05:44Z |
| publishDate | 2022-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-4c5391ea4019487cb645f4892c7fef252022-12-22T00:10:23ZengPublic Library of Science (PLoS)PLoS ONE1932-62032022-01-01173e026385610.1371/journal.pone.0263856Behavioural Activation for Social IsoLation (BASIL+) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial.Lauren BurkeElizabeth LittlewoodSamantha GascoyneDean McMillanCarolyn A Chew-GrahamDella BaileyClaire SloanCaroline FairhurstKalpita BairdCatherine HewittAndrew HenryEloise RydeLeanne ShearsmithPeter CoventrySuzanne CroslandElizabeth NewbronnerGemma Traviss-TurnerRebecca WoodhouseAndrew CleggTom GentryAndrew HillKarina LovellSarah Dexter SmithJudith WebsterDavid EkersSimon Gilbody<h4>Introduction</h4>Depression is a leading mental health problem worldwide. People with long-term conditions are at increased risk of experiencing depression. The COVID-19 pandemic led to strict social restrictions being imposed across the UK population. Social isolation can have negative consequences on the physical and mental wellbeing of older adults. In the Behavioural Activation in Social IsoLation (BASIL+) trial we will test whether a brief psychological intervention (based on Behavioural Activation), delivered remotely, can mitigate depression and loneliness in older adults with long-term conditions during isolation.<h4>Methods</h4>We will conduct a two-arm, parallel-group, randomised controlled trial across several research sites, to evaluate the clinical and cost-effectiveness of the BASIL+ intervention. Participants will be recruited via participating general practices across England and Wales. Participants must be aged ≥65 with two or more long-term conditions, or a condition that may indicate they are within a 'clinically extremely vulnerable' group in relation to COVID-19, and have scored ≥5 on the Patient Health Questionnaire (PHQ9), to be eligible for inclusion. Randomisation will be 1:1, stratified by research site. Intervention participants will receive up to eight intervention sessions delivered remotely by trained BASIL+ Support Workers and supported by a self-help booklet. Control participants will receive usual care, with additional signposting to reputable sources of self-help and information, including advice on keeping mentally and physically well. A qualitative process evaluation will also be undertaken to explore the acceptability of the BASIL+ intervention, as well as barriers and enablers to integrating the intervention into participants' existing health and care support, and the impact of the intervention on participants' mood and general wellbeing in the context of the COVID-19 restrictions. Semi-structured interviews will be conducted with intervention participants, participant's caregivers/supportive others and BASIL+ Support Workers. Outcome data will be collected at one, three, and 12 months post-randomisation. Clinical and cost-effectiveness will be evaluated. The primary outcome is depressive symptoms at the three-month follow up, measured by the PHQ9. Secondary outcomes include loneliness, social isolation, anxiety, quality of life, and a bespoke health services use questionnaire.<h4>Discussion</h4>This study is the first large-scale trial evaluating a brief Behavioural Activation intervention in this population, and builds upon the results of a successful external pilot trial.<h4>Trial registration</h4>ClinicalTrials.Gov identifier ISRCTN63034289, registered on 5th February 2021.https://doi.org/10.1371/journal.pone.0263856 |
| spellingShingle | Lauren Burke Elizabeth Littlewood Samantha Gascoyne Dean McMillan Carolyn A Chew-Graham Della Bailey Claire Sloan Caroline Fairhurst Kalpita Baird Catherine Hewitt Andrew Henry Eloise Ryde Leanne Shearsmith Peter Coventry Suzanne Crosland Elizabeth Newbronner Gemma Traviss-Turner Rebecca Woodhouse Andrew Clegg Tom Gentry Andrew Hill Karina Lovell Sarah Dexter Smith Judith Webster David Ekers Simon Gilbody Behavioural Activation for Social IsoLation (BASIL+) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial. PLoS ONE |
| title | Behavioural Activation for Social IsoLation (BASIL+) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial. |
| title_full | Behavioural Activation for Social IsoLation (BASIL+) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial. |
| title_fullStr | Behavioural Activation for Social IsoLation (BASIL+) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial. |
| title_full_unstemmed | Behavioural Activation for Social IsoLation (BASIL+) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial. |
| title_short | Behavioural Activation for Social IsoLation (BASIL+) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial. |
| title_sort | behavioural activation for social isolation basil trial behavioural activation to mitigate depression and loneliness among older people with long term conditions protocol for a fully powered pragmatic randomised controlled trial |
| url | https://doi.org/10.1371/journal.pone.0263856 |
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