Flu and Mood in Older Adults

• Research type

  Research Study

• Full title

  Enhancing Influenza vaccination by optimising mood in older adults: a randomised controlled clinical trial

• IRAS ID

  258310

• Contact name

  Kavita Vedhara

• Contact email

  kavita.vedhara@nottingham.ac.uk

• Sponsor organisation

  University of Nottingham

• Clinicaltrials.gov Identifier

  NCT03956329

• Duration of Study in the UK

  0 years, 9 months, 29 days

• Research summary

  Research Summary
  Vaccine effectiveness has been shown to be sub-optimal in populations with compromised or deteriorating immune systems. The flu vaccine for instance has been shown to have an efficacy of approximately 40-60% for the general population, but only 17-53% in older adults. Previous work has suggested that psychological factors such as positive mood may influence the effectiveness of flu vaccines. This work suggests that improved positive mood on the day of vaccination may increase the number of flu antibodies, which predicts protection from flu. A feasibility study recently trialled a digital positive mood intervention designed to briefly improve mood at the time of vaccination, compared to a neutral intervention. This study demonstrated that the intervention was feasible in primary care, and significantly improved mood in the positive mood arm only. There was also a trend for higher post-vaccination levels of antibodies. The present study aims to trial an enhanced version of this positive mood intervention. Studies have shown that individualised interventions may be more effective than standardised interventions at a range of health related outcomes. Therefore the present study will compare the original positive mood intervention with an individualised version, and usual care in 650 older adults receiving the flu vaccine. We will examine participation, drop-out, and engagement rates; determine intervention effects on positive mood and immunity; and collect information on health service usage through medical records no later than 12 months post-vaccination. Participants will attend their local GP surgery on 2 occasions (for vaccination and 4 week follow up) and will have a blood sample taken on each visit to assess vaccine response. We will also conduct post-trial interviews with a sample of participants involved in the study. Together these data will inform the design of a future larger trial.

  Summary of Results
  The study was designed to explore the effects of two brief positive mood interventions (standardised and individualised) versus usual care on mood and immunological responses (antibody responses) at four weeks following seasonal influenza vaccination in older adults (>65 years).
  The primary aim was to determine whether a standardised and/or individualised intervention was capable of improving the positive mood of older adults immediately prior to influenza vaccination compared to usual vaccination care. Thus, mood was the primary outcome in this study and was the basis for power calculations.
  The secondary aim was to assess whether there were differences between the groups in terms of four week antibody response to vaccination. Whilst the trial was not powered to detect significant changes in this outcome, it was used to estimate the size of the effect on antibody response.

  Participants
  In total, 660 older adults (65-85 years old) from 13 clinical practices in the East Midlands were recruited to participate in the For-ME (Flu and Mood in Older Adults) study. Nurses, health care assistants, and other NHS staff helped run the study alongside a team of researchers at The University of Nottingham.

  Key Findings
  We collected information regarding positive mood before and after one of two brief mood-enhancing digital interventions or usual care, immediately prior to flu vaccination in adults aged 65 years and over. Blood tests also allowed us to see whether there were differences between groups in terms of how people in each study group responded to the flu vaccine, and therefore how likely they were to be protected from flu.

  Key findings included:
  Participant recruitment and retention were high, suggesting that the approach to recruitment and strategies used to minimise drop-out were acceptable to participants and were effective.

  Those who received either the standardised and individualised intervention had significantly higher levels of positive mood compared to those who received usual care, but there were no significant differences between the standardised and individualised groups.

  There were no significant differences between any of the groups in terms of response to the flu vaccine in terms of IgG antibody levels, despite the differences between groups in terms of mood.

  Arrangements for Publication and Dissemination The above findings are currently being prepared for submission for publication in peer-reviewed scientific journals (e.g., Brain, Behaviour, and Immunity), and will be presented at academic conferences (e.g. UKSBM). The findings will also be disseminated to both the participants and GP practices involved in the study.

• REC name

  East Midlands - Nottingham 1 Research Ethics Committee

• REC reference

  19/EM/0081

• Date of REC Opinion

  2 Apr 2019

• REC opinion

  Further Information Favourable Opinion