Mood and Influenza Vaccine Response: A Feasibility Trial
Condition: Vaccination; Infection
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      This study is a 2-arm, parallel, randomised controlled feasibility trial of a brief video
      intervention designed to induce positive affect (mood) in older adults in primary care
      settings prior to the receipt of influenza vaccination. Participants will be randomised into
      two conditions: experimental and active control. In the experimental condition, participants
      will view the approximately 15 minute long intervention video immediately prior to
      vaccination. In the active control condition, participants will view a matched video that is
      designed to be mood neutral. Pre-and-post positive affect levels will be assessed by
      self-report questionnaires. Immune response to the intervention and vaccination responses
      will be assessed in saliva and serum samples respectively.

      The objectives of the study are to assess the impact of the intervention on mood, immune
      function, and antibody response to influenza vaccination in older adults. This feasibility
      trial will also allow data collection on exploring recruitment, attrition, intervention
      engagement, and practicality of collecting clinical data available through electronic records
      to inform the design of a future definitive trial.
    

Detailed description: 
      The Centers for Disease Control (CDC) describe vaccinations as among the 10 most significant
      health achievements ever documented; and for many conditions they have been an unmitigated
      success (e.g., smallpox). There are, however, several populations in whom vaccine
      effectiveness is far from optimal. These populations are typically contending with underlying
      immune impairment by virtue of their advancing age and/or the presence of co-existing
      diseases (e.g., cancer). As a consequence, vaccines are most likely to fail those whom they
      most seek to benefit: individuals at the greatest risk of ill health.

      This has prompted research into treatments that enhance immune function prior to vaccination,
      so called vaccine adjuvants. The aim of such treatments is to optimise the response the
      immune system makes to the vaccine antigens and, in so doing, increase the likelihood that
      the vaccine confers protection.

      One area in which there has been interest is in the potential for developing
      psycho-behavioural vaccine adjuvants. There is considerable evidence that psychological and
      behavioural factors can modulate immunity; with diet, physical activity, stress, affect,
      sleep and social support all associated with immune response.

      The investigators recently conducted a longitudinal observational cohort study of multiple
      psychological (positive affect, negative affect, stress) and behavioural (physical activity,
      sleep, diet) influences on short and long-term antibody responses to influenza vaccination in
      older adults. This identified positive affect as the most influential psycho-behavioural
      factor on influenza-specific antibody responses, independently predicting both short and
      long-term antibody responses in the weakest immunogenic strain above and beyond known
      demographic and clinical determinants. Intriguingly, the investigators also observed
      preliminary evidence that positive affect on the day of vaccination was more predictive of
      antibody responses following vaccination than mood measured over the longer period
      surrounding vaccination. As influenza-specific antibodies are a well-established correlate of
      protection from serologically and clinically diagnosed influenza incidence, these data
      suggest that increasing positive affect immediately prior to vaccination could be used as a
      non-pharmacological vaccine adjuvant.

      Through a series of systematic steps, including focus groups and interviews with older adults
      and health care professionals, the investigators have recently developed a brief, positive
      affect intervention - designed to improve short-term mood in older adults and be deliverable
      within primary care. It is hoped this could act as a psycho-behavioural adjuvant to enhance
      poor responses to influenza vaccination in older adults. Before performing a definitive trial
      of the intervention's effectiveness, a feasibility trial is needed for number of reasons:

        1. To assess whether our intervention can enhance positive affect (mood)

        2. To collect information regarding likely recruitment, effect sizes, and attrition rates
           for informing the necessary size of a larger definitive trial

        3. To examine the practicality and acceptability of delivering the intervention in routine
           primary care settings

        4. To explore the feasibility of obtaining outcome data on healthcare usage for a large
           scale trial (hospitalisation, GP visits for flu-like symptoms from medical records)

      In line with the above, the investigators will be conducting a 2-arm, parallel, randomised
      controlled feasibility trial of a brief video intervention designed to induce positive affect
      (mood) in older adults in primary care settings prior to the receipt of influenza
      vaccination. Participants will be randomised into two conditions: experimental and active
      control. In the experimental condition, participants will view the approximately 15 minute
      long intervention video immediately prior to vaccination. In the active control condition,
      participants will view a matched video that is designed to be mood neutral. Pre-and-post
      positive affect levels will be assessed by self-report questionnaires. Immune response to the
      intervention and vaccination responses will be assessed in saliva (pre/post intervention) and
      serum samples (pre/4 weeks post-vaccination/16weeks post-vaccination) respectively.
    

Intervention name(s): Positive Affect Intervention; Neutral Control Intervention; Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
Intervention type(s): Other; Other; Biological
Intervention description(s): See Previous Description; See Previous Description; Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Positive Affect; Positive Mood; Influenza Vaccination; Vaccination; Randomised Controlled Trial