Mood and Influenza Vaccine Response: A Feasibility Trial

NCT03144518 | Completed Results

• 1 other identifier: 17039
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaccination; Infection

Keywords

Positive Affect; Positive Mood; Influenza Vaccination; Vaccination; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Mood Outcome Scores [Multiple]

  Affective Slider (Betella \& Verschure, 2016), consists of two single item visual analogue scales. Scores for each are presented as a value from 0 to 100 with higher scores indicating greater pleasure (VAS-Valence) and arousal (VAS-Arousal). Positive and Negative Affect Schedule (Watson et al., 1988). Positive and negative affect subscales were created by summing the scores of positive and negative adjectives respectively. For each sub scale, minimum score = 10, maximum score = 50 with higher scores indicating greater positive and negative affect respectively. Pictorial scale of positive affect (unvalidated, internally developed). Participants completed a single-item photo-based measure of positive affect tailored for older adults. Participants were presented with six groups of images depicting varying degrees of positive affect, and indicate which best reflected how they felt at that moment. Minumum score 1, maximum score 6, higher scores indicate greater positive affect.

  Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline).

Secondary Outcomes (5)

• Recruitment

  Baseline

• Attrition

  4 weeks (post-vaccination), 16 Weeks (post-vaccination)

• Secretory IgA Response

  Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline).

• Vaccine Specific IgG Response

  4 weeks (post-vaccination), 16 Weeks (post-vaccination)

• Health Care Utilization

  Baseline to 6 months post-vaccination

Study Arms (2)

Experimental

EXPERIMENTAL

Participants in the experimental condition will view a video designed to induce positive affect. 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.

Other: Positive Affect Intervention; Biological: Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)

Active Control

ACTIVE COMPARATOR

Participants in the control condition will view a video of matched length to the experimental condition video, but not designed to induce mood change. This includes short documentary clips (a pride in pencils; model railways, lecture extract on hydration), neutral music and images.

Other: Neutral Control Intervention; Biological: Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)

Interventions

Positive Affect Intervention OTHER

See Previous Description

Experimental

Neutral Control Intervention OTHER

See Previous Description

Active Control

Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care) BIOLOGICAL

Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)

Active Control; Experimental

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Males and Females aged 65-85 years (inclusive)
• Received influenza vaccination for the 2016/17 season
• Eligible to receive 2017/18 influenza vaccination as part of usual care
• Ability to give informed consent

You may not qualify if:

• Males and Females aged less than 65 or over 85 years (exclusive)
• Did not receive influenza vaccination for the 2016/17 season
• Ineligible to receive 2017/18 influenza vaccination as part of usual care
• Unable to provide informed consent
• Deemed by health care provider to be:
• Too physically frail to participate
• Diagnosed with dementia or other cognitive condition which would make participation difficult
• Insufficient command of English language
• Influenza vaccination contraindicated
• Sufficiently impaired of hearing or vision that exposure to the intervention or control video content as intended would be compromised
• Those for whom the collection of blood samples is contraindicated.

Sponsors & Collaborators

• University of Nottingham: lead
• Northumbria University: collaborator

Study Sites (1)

University of Nottingham

Nottingham, United Kingdom

Location

Related Publications (11)

• Andre FE, Booy R, Bock HL, Clemens J, Datta SK, John TJ, Lee BW, Lolekha S, Peltola H, Ruff TA, Santosham M, Schmitt HJ. Vaccination greatly reduces disease, disability, death and inequity worldwide. Bull World Health Organ. 2008 Feb;86(2):140-6. doi: 10.2471/blt.07.040089.

  PMID: 18297169 BACKGROUND

• Jefferson T, Smith S, Demicheli V, Harnden A, Rivetti A, Di Pietrantonj C. Assessment of the efficacy and effectiveness of influenza vaccines in healthy children: systematic review. Lancet. 2005 Feb 26-Mar 4;365(9461):773-80. doi: 10.1016/S0140-6736(05)17984-7.

  PMID: 15733718 BACKGROUND

• Calder PC, Jackson AA. Undernutrition, infection and immune function. Nutr Res Rev. 2000 Jun;13(1):3-29. doi: 10.1079/095442200108728981.

  PMID: 19087431 BACKGROUND

• Simpson R, Spielmann G. Exercise and Immunosenescence. In: Bosch J, Phillips A, Lord J, eds. Immunosenescence. New York: : Springer Science 2013. 159-78.

  BACKGROUND

• Centers for Disease Control and Prevention (CDC). Ten great public health achievements--worldwide, 2001-2010. MMWR Morb Mortal Wkly Rep. 2011 Jun 24;60(24):814-8.

  PMID: 21697806 BACKGROUND

• Segerstrom SC, Miller GE. Psychological stress and the human immune system: a meta-analytic study of 30 years of inquiry. Psychol Bull. 2004 Jul;130(4):601-30. doi: 10.1037/0033-2909.130.4.601.

  PMID: 15250815 BACKGROUND

• Pressman SD, Cohen S. Does positive affect influence health? Psychol Bull. 2005 Nov;131(6):925-971. doi: 10.1037/0033-2909.131.6.925.

  PMID: 16351329 BACKGROUND

• Bryant PA, Trinder J, Curtis N. Sick and tired: Does sleep have a vital role in the immune system? Nat Rev Immunol. 2004 Jun;4(6):457-67. doi: 10.1038/nri1369. No abstract available.

  PMID: 15173834 BACKGROUND

• Uchino BN. Social support and health: a review of physiological processes potentially underlying links to disease outcomes. J Behav Med. 2006 Aug;29(4):377-87. doi: 10.1007/s10865-006-9056-5. Epub 2006 Jun 7.

  PMID: 16758315 BACKGROUND

• Coudeville L, Bailleux F, Riche B, Megas F, Andre P, Ecochard R. Relationship between haemagglutination-inhibiting antibody titres and clinical protection against influenza: development and application of a bayesian random-effects model. BMC Med Res Methodol. 2010 Mar 8;10:18. doi: 10.1186/1471-2288-10-18.

  PMID: 20210985 BACKGROUND

• Ayling K, Fairclough L, Buchanan H, Wetherell MA, Vedhara K. Mood and influenza vaccination in older adults: A randomized controlled trial. Health Psychol. 2019 Nov;38(11):984-996. doi: 10.1037/hea0000786. Epub 2019 Aug 5.

  PMID: 31380684 DERIVED

MeSH Terms

Conditions

Infections; Influenza, Human

Interventions

Parturition

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Limitations and Caveats

The study did not include a usual care comparator. Blinding potentially compromised by common reactions of participants to the positive mood intervention (e.g., laughter). Demand characteristics. Lack of ethnic diversity within sample

Results Point of Contact

• Title: Dr Kieran Ayling
• Organization: University of Nottingham

kieran.ayling@nottingham.ac.uk

+44 1158466908

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 8, 2017
• Study Start: September 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: May 31, 2018
• Last Updated: July 15, 2019
• Results First Posted: July 15, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)