Vaccination; InfectionNCT03144518
Mood and Influenza Vaccine Response: A Feasibility Trial
A study testing Positive Affect Intervention in people with Vaccination; Infection, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccination; Infection
- What is being tested?
- Positive Affect Intervention
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2017to 31 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Trial of a Brief Positive Affect Intervention to Improve the Effectiveness of Influenza Vaccine Response in Older Adults.
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.
Read the 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:
- To assess whether our intervention can enhance positive affect (mood)
- To collect information regarding likely recruitment, effect sizes, and attrition rates for informing the necessary size of a larger definitive trial
- To examine the practicality and acceptability of delivering the intervention in routine primary care settings
- 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.
- Conditions
- Vaccination; Infection
- Being tested
- Positive Affect Intervention, Neutral Control Intervention, Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
- Keywords
- Positive Affect, Positive Mood, Influenza Vaccination, Vaccination, Randomised Controlled Trial
- Medical subject headings
- Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Affect InterventionOther
See Previous Description
Neutral Control InterventionOther
See Previous Description
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Neutral Control Intervention; Biological: Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline).
Secondary outcomes (5)
Recruitment
Recruitment rates to inform a future definitive trial
Measured: Baseline
Attrition
Attrition - to inform a future definitive trial
Measured: 4 weeks (post-vaccination), 16 Weeks (post-vaccination)
Secretory IgA Response
Secretory IgA levels measured in saliva samples via ELISA. This is a non-specific measure of immunological response
Measured: Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline).
Vaccine Specific IgG Response
IgG levels against the 4 vaccine strains measured via ELISA.
Values represent equivalent ug/ml based on diluted sample absorbance value interpolation against a standard IgG curve, multiplied by the serum dilution score (i.e., 4000).
Measured: 4 weeks (post-vaccination), 16 Weeks (post-vaccination)
Health Care Utilization
Via medical records, we assessed health care usage potentially attributable to flu-like symptoms (e.g., GP visits, hospitalisation, antibiotic prescription) during the 6 months post-vaccination
Measured: Baseline to 6 months post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start1 Sep 2017
- Primary completion1 Nov 2017
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Vaccination; InfectionStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Northumbria University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144518
- Sponsor's protocol ID
- 17039
- Status last verified
- Apr 2019
- First submitted
- 28 Apr 2017
- Last updated
- 15 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18297169Jefferson 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.
PubMed 15733718Calder PC, Jackson AA. Undernutrition, infection and immune function. Nutr Res Rev. 2000 Jun;13(1):3-29. doi: 10.1079/095442200108728981.
PubMed 19087431Simpson R, Spielmann G. Exercise and Immunosenescence. In: Bosch J, Phillips A, Lord J, eds. Immunosenescence. New York: : Springer Science 2013. 159-78.
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.
PubMed 21697806Segerstrom 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.
PubMed 15250815Pressman SD, Cohen S. Does positive affect influence health? Psychol Bull. 2005 Nov;131(6):925-971. doi: 10.1037/0033-2909.131.6.925.
PubMed 16351329Bryant 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.
PubMed 15173834Uchino 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.
PubMed 16758315Coudeville 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.
PubMed 20210985Ayling 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.
PubMed 31380684
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial of a Brief Positive Affect Intervention to Improve the Effectiveness of Influenza Vaccine Response in Older Adults.
- ClinicalTrials.gov ID
- NCT03144518
- Acronym / sponsor ID
- 17039
- Conditions
- Vaccination; Infection
- Keywords
- Positive Affect, Positive Mood, Influenza Vaccination, Vaccination, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Northumbria University
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Posted 15 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess whether our intervention can enhance positive affect (mood)
- To collect information regarding likely recruitment, effect sizes, and attrition rates for informing the necessary size of a larger definitive trial
- To examine the practicality and acceptability of delivering the intervention in routine primary care settings
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Positive Affect Intervention, Biological: Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)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. |
| Active Control | Active comparator | Other: Neutral Control Intervention, Biological: Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
- Too physically frail to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Affect InterventionSee Previous Description | Other | Experimental |
| Neutral Control InterventionSee Previous Description | Other | Active Control |
| Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care) | Biological | Active Control, Experimental |
Primary outcome
Mood Outcome Scores [Multiple]
Time frame: Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline).
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.
5 secondary outcomes
Recruitment
Time frame: Baseline
Attrition
Time frame: 4 weeks (post-vaccination), 16 Weeks (post-vaccination)
Secretory IgA Response
Time frame: Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline).
Vaccine Specific IgG Response
Time frame: 4 weeks (post-vaccination), 16 Weeks (post-vaccination)
Health Care Utilization
Time frame: Baseline to 6 months post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18297169Andre 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.
- Background: PubMed 15733718Jefferson 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.
- Background: PubMed 19087431Calder PC, Jackson AA. Undernutrition, infection and immune function. Nutr Res Rev. 2000 Jun;13(1):3-29. doi: 10.1079/095442200108728981.
- BackgroundSimpson R, Spielmann G. Exercise and Immunosenescence. In: Bosch J, Phillips A, Lord J, eds. Immunosenescence. New York: : Springer Science 2013. 159-78.
- Background: PubMed 21697806Centers 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.
- Background: PubMed 15250815Segerstrom 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.
- Background: PubMed 16351329Pressman SD, Cohen S. Does positive affect influence health? Psychol Bull. 2005 Nov;131(6):925-971. doi: 10.1037/0033-2909.131.6.925.
- Background: PubMed 15173834Bryant 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.
- Background: PubMed 16758315Uchino 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.
- Background: PubMed 20210985Coudeville 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.
- Derived from this study: PubMed 31380684Ayling 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Affect Intervention in people with Vaccination; Infection, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood Outcome Scores [Multiple] (time frame: Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03144518, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.