Flu and Mood in Older Adults
Condition: Vaccination; Infection
Study type: Interventional

Summary: 
      Randomised control trial comparing the effects of a standardised and individualised positive
      affect digital intervention versus usual care on mood and antibody responses to influenza
      vaccination in older adults.
    

Detailed description: 
      Infectious diseases are important causes of morbidity and mortality worldwide, and
      vaccinations are vital to reducing the risk of disease. Vaccine efficacy, however, is
      dependent on the immune system's ability to respond to vaccination antigens. Influenza
      vaccines play an important role in combating influenza. However, some populations, such as
      older adults, respond poorly to vaccination due to their compromised immune systems, with
      efficacy at 17-53% (compared to 70-90% in young adults).

      Behavioural and psychological influences have been shown to alter immune responses. An
      observational study looking into behavioural and psychological effects, which have been
      identified as immune modulators (stress, physical activity, nutrition, mood and sleep) found
      greater positive mood on the day of vaccination predicted significantly greater antibody
      responses to influenza vaccination. Following this, a feasibility study carried out on 110
      older adults demonstrated the ability to enhance positive mood prior to influenza vaccination
      using a brief digital intervention.

      The clinical trial will be the next phase of this research, where the cohort will consist of
      650 participants, aged over 65 years, who will receive the quadrivalent, cell-grown influenza
      vaccination, immediately after one of three conditions. These conditions include: the control
      arm of usual participant care for vaccination; participants watching a 15-minute digital
      intervention via a tablet that does not allow content selection; and a personalised digital
      intervention that allows for participant selection of content they would like to view for 15
      minutes. The purpose of these digital interventions is to enhance positive mood of patients
      prior to vaccination.

      The primary aim of this trial is to explore which of two brief interventions has the largest
      effect on positive mood, compared with usual care. The secondary aim is to measure vaccine
      specific antibody responses, with the hypothesis that individuals with enhanced positive mood
      will present larger vaccine specific antibody responses.

      This trial will also allow data collection on exploring recruitment, attrition, intervention
      engagement, and practicality of collecting clinical data available through electronic records
      and self-report measures to inform the design of a future definitive trial.
    

Intervention name(s): Standardised Digital Intervention; Individualised Digital Intervention
Intervention type(s): Other; Other
Intervention description(s): Video intervention designed to induce an increase in positive mood in older adults. Includes comedy clips, uplifting music and positive imagery. Intervention approximately 15-20 minutes in length. This includes 3 short comedy clips (fork handles sketch, the two Ronnie's; A room with a view - faulty towers; Tim Vine Live stand-up extract), uplifting music (Jailhouse Rock - Elvis Presley; Happy Together - The Turtles), jokes and positive imagery. The content of the intervention has been informed by patient and public involvement, focus groups with older adults, and pilot testing.; Similar to the standardised digital intervention, however, participants will be able to individualise the intervention by choosing video clips from a limited menu of choices. Intervention approximately 15-20 minutes in length. The 4 categories include stand-up comedy (Michael McIntyre, Tim Vine and Victoria Wood), sit-com (Fawlty Towers, Only Fools and Horses and Two Ronnies), music (Elvis Presley, Last Night at the Proms, Roy Orbison) and variety (Britain's Got Talent, Strictly Come Dancing, Terry Wogan). Participants are able to select 3 of the videos, which are roughly 5 minutes in length, to reach a total of 15-20 minutes of content.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Positive Affect; Influenza Vaccination; Positive Mood; Vaccination; Randomised Control Trial