Behavioural Activation in Social IsoLation (BASIL): Benefiting from activities to improve your mood while you are socially isolating

Not Applicable

Completed

• Conditions: Depression and loneliness in older adults with long-term physical health conditions; Mental and Behavioural Disorders

• Registration Number: ISRCTN94091479
• Lead Sponsor: Tees, Esk and Wear Valleys NHS Foundation Trust

Brief Summary

2021 Results article in https://doi.org/10.1371/journal.pmed.1003779 (added 13/10/2021) 2022 Preprint results in https://doi.org/10.1101/2022.06.20.22276641 Long-term results (added 24/06/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36223980/ Long term results (added 13/10/2022) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/36914198/ interview data from the embedded qualitative study describing acceptability (added 14/08/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-09
• Study Completion: 2021-12-31
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Older adults aged 65 years or over
2. Two or more long term physical health conditions

Exclusion Criteria

Older adults who:
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported depression severity (as measured by the Patient Health Questionnaire 9) at 1 month post-randomisation

Secondary Outcome Measures

Name	Time	Method
At 1, 3 and 12 months post-randomisation (unless otherwise stated):<br>1. Depression (PHQ9) at 3 and 12 months post-randomisation<br>2. Anxiety (GAD-7)<br>3. Loneliness (De Jong Gierveld Scale - 11 items) <br>4. Health Related Quality of Life (SF-12v2) <br>5. A brief bespoke questionnaire will be used to collect health service use data at all study time-points (baseline and 1, 3 and 12 months post-randomisation)<br>6. In addition, we will capture estimates of rates of recruitment; randomisation; retention, intervention delivery and engagement. These will be described using a standard CONSORT flow diagram, and these will provide estimates to enable the design of a fully powered BASIL trial