VaccinationFor-MENCT03956329
Flu and Mood in Older Adults
A study testing Standardised Digital Intervention and Individualised Digital Intervention in people with Vaccination and Infection, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. 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?
- Standardised Digital Intervention and Individualised Digital Intervention
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 654 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Aug 2019to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2018/19 season
- Eligible to receive 2019/20 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 2018/19 season
- Ineligible to receive 2019/20 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 12Show 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 video content as intended would be compromised
- Those for whom the collection of blood samples is contraindicated
- Those who have participated previously in the pilot study (NCT03144518).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Nottinghamshire, NG7 2RD
About this study
Official title: Enhancing Influenza Vaccination by Optimising Mood in Older Adults: a Randomised Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Vaccination, Infection
- Being tested
- Standardised Digital Intervention, Individualised Digital Intervention
- Keywords
- Positive Affect, Influenza Vaccination, Positive Mood, Vaccination, Randomised Control 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.
Standardised Digital InterventionOther
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.
Individualised Digital InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care, control arm | No intervention | Usual care in which participants will not see a video intervention. This group will attend their influenza vaccination appointment as usual, without intervention. Participants will receive Northern Hemisphere Influenza Vaccine 2019/20 (Delivered as part of Standard Care). |
| Standardised Digital Intervention | Experimental | 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. Following intervention, participants will receive the Northern Hemisphere Influenza Vaccine 2019/20 (Delivered as part of Standard Care). Receives: Other: Standardised Digital Intervention |
| Individualised Digital Intervention | Experimental | 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. Following intervention, participants will receive the Northern Hemisphere Influenza Vaccine 2019/20 (Delivered as part of Standard Care). Receives: Other: Individualised Digital Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Mood- Affective Slider
Self-reported mood will be measured using three validated patient-reported outcome measures to determine changes in mood from before to after usual care/ intervention arms. One of the three outcome measures includes the Affective Slider (AS), which is a slider scale that is measures a single value on a continuous normalised scale ranging from 0-1, with a central, default thumb position value equal to 0.5, where 0 is low and 1 is high.
Measured: Baseline, immediately post- intervention (15- 20 minutes post baseline)
Self-Reported Mood- Scale of Positive and Negative Experience
The second outcome measure of changes in mood will be the Scale of Positive and Negative Experience (SPANE), where participants rate 12 emotion words from 1 to 5, where 1 is Not at all and 5 is Very. The overall affect is then determined using these scores and can also be divided out into positive and negative feelings scales.
Measured: Baseline, immediately post- intervention (15- 20 minutes post baseline)
Self-Reported Mood- Happy-Sad and Alert-Sleepy Dynamic Visual Analogue Mood Scales
The third and final measure of changes in mood will be the Happy-Sad and Alert-Sleepy Dynamic Visual Analogue Mood Scales (DVAMS), which is a morphing image scale that is gender specific and changes when the participant moves the slider scale. The scale ranges from 0 to 100, where 0 is low and 100 is high. The central, default thumb position value is 50.
Measured: Baseline, immediately post- intervention (15- 20 minutes post baseline)
Secondary outcomes (5)
Influenza vaccination-specific antibody responses- Haemagglutination inhibition assay
Antibody levels specific to antigens contained in the influenza vaccination will be assessed in sera taken immediately prior to vaccination and at 4 weeks post-vaccination. This will be assessed using the haemagglutination inhibition (HAI) assay that allows for the determination of the quantity of influenza virus present based of HAI units by carrying out serial dilutions. A larger number of HAI units equates to a high quantity of influenza virus.
Measured: Baseline, 4 weeks post-vaccination
Influenza vaccination-specific antibody responses- IgG-specific enzyme-linked immunosorbent assay
The concentration of influenza specific antibody will be measured using a IgG- specific enzyme linked immunosorbent assay (ELISA).
Measured: Baseline, 4 weeks post-vaccination
Number of participants who experience flu-like symptoms and self care
Participants who experience cold and flu-like symptoms will a complete flu-like symptoms diary and self-care behaviours for occasions of flu-like illnesses during the 6 months post-vaccination.
Measured: 6 months
Number of participants who do not follow up with trial procedures- Attrition
Loss to follow-up will be noted for participants who do not complete the intervention, do not attend the post-vaccination follow-up, and who do not return flu-like symptom diaries at 6 months post-vaccination.
Measured: Baseline, immediately post- intervention, 4 weeks post-vaccination, 6 months post-vaccination
Recruitment
The number and proportion of participants who consent to participate in the trial from the total number of the population approached.
Measured: From the time of recruitment to the start of the Randomised Control Trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start12 Aug 2019
- Primary completion7 Nov 2019
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for VaccinationStudies 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
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health England
- Responsible party
- Sponsor
- Investigators
- Kavita Vedhara, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956329
- Sponsor's protocol ID
- 19004
- Acronym
- For-ME
- Status last verified
- Sep 2021
- First submitted
- 30 Apr 2019
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ayling K, Fairclough L, Tighe P, Todd I, Halliday V, Garibaldi J, Royal S, Hamed A, Buchanan H, Vedhara K. Positive mood on the day of influenza vaccination predicts vaccine effectiveness: A prospective observational cohort study. Brain Behav Immun. 2018 Jan;67:314-323. doi: 10.1016/j.bbi.2017.09.008. Epub 2017 Sep 18.
PubMed 28923405Andre 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 18297169Goodwin K, Viboud C, Simonsen L. Antibody response to influenza vaccination in the elderly: a quantitative review. Vaccine. 2006 Feb 20;24(8):1159-69. doi: 10.1016/j.vaccine.2005.08.105. Epub 2005 Sep 19.
PubMed 16213065Moynihan JA, Larson MR, Treanor J, Duberstein PR, Power A, Shore B, Ader R. Psychosocial factors and the response to influenza vaccination in older adults. Psychosom Med. 2004 Nov-Dec;66(6):950-3. doi: 10.1097/01.psy.0000140001.49208.2d.
PubMed 15564363Betella A, Verschure PF. The Affective Slider: A Digital Self-Assessment Scale for the Measurement of Human Emotions. PLoS One. 2016 Feb 5;11(2):e0148037. doi: 10.1371/journal.pone.0148037. eCollection 2016.
PubMed 26849361Barrows PD, Thomas SA. Assessment of mood in aphasia following stroke: validation of the Dynamic Visual Analogue Mood Scales (D-VAMS). Clin Rehabil. 2018 Jan;32(1):94-102. doi: 10.1177/0269215517714590. Epub 2017 Jun 27.
PubMed 28653547Ayling K, Brown M, Carlisle S, Bennett R, Buchanan H, Dumbleton J, Hawkey C, Hoschler K, Jack RH, Nguyen-Van-Tam J, Royal S, Turner D, Zambon M, Fairclough L, Vedhara K. Optimizing mood prior to influenza vaccination in older adults: A three-arm randomized controlled trial. Health Psychol. 2024 Feb;43(2):77-88. doi: 10.1037/hea0001267. Epub 2023 Dec 7.
PubMed 38059932
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Influenza Vaccination by Optimising Mood in Older Adults: a Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03956329
- Acronym / sponsor ID
- For-ME / 19004
- Conditions
- Vaccination, Infection
- Keywords
- Positive Affect, Influenza Vaccination, Positive Mood, Vaccination, Randomised Control Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 654 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Public Health England
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care, control arm | No intervention | –Usual care in which participants will not see a video intervention. This group will attend their influenza vaccination appointment as usual, without intervention. Participants will receive Northern Hemisphere Influenza Vaccine 2019/20 (Delivered as part of Standard Care). |
| Standardised Digital Intervention | Experimental | Other: Standardised Digital InterventionVideo 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. Following intervention, participants will receive the Northern Hemisphere Influenza Vaccine 2019/20 (Delivered as part of Standard Care). |
| Individualised Digital Intervention | Experimental | Other: Individualised Digital InterventionSimilar 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. Following intervention, participants will receive the Northern Hemisphere Influenza Vaccine 2019/20 (Delivered as part of Standard Care). |
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 2018/19 season
- Eligible to receive 2019/20 influenza vaccination as part of usual care
- Ability to give informed consent
Key exclusion criteria (12 listed)
- Males and Females aged less than 65 or over 85 years (exclusive)
- Did not receive influenza vaccination for the 2018/19 season
- Ineligible to receive 2019/20 influenza vaccination as part of usual care
- Unable to provide informed consent
- Deemed by health care provider to be:
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 |
|---|---|---|
| Standardised Digital InterventionVideo 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. | Other | Standardised Digital Intervention |
| Individualised Digital InterventionSimilar 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. | Other | Individualised Digital Intervention |
Primary outcome
Self-Reported Mood- Affective Slider
Time frame: Baseline, immediately post- intervention (15- 20 minutes post baseline)
Self-reported mood will be measured using three validated patient-reported outcome measures to determine changes in mood from before to after usual care/ intervention arms. One of the three outcome measures includes the Affective Slider (AS), which is a slider scale that is measures a single value on a continuous normalised scale ranging from 0-1, with a central, default thumb position value equal to 0.5, where 0 is low and 1 is high.
Self-Reported Mood- Scale of Positive and Negative Experience
Time frame: Baseline, immediately post- intervention (15- 20 minutes post baseline)
The second outcome measure of changes in mood will be the Scale of Positive and Negative Experience (SPANE), where participants rate 12 emotion words from 1 to 5, where 1 is Not at all and 5 is Very. The overall affect is then determined using these scores and can also be divided out into positive and negative feelings scales.
Self-Reported Mood- Happy-Sad and Alert-Sleepy Dynamic Visual Analogue Mood Scales
Time frame: Baseline, immediately post- intervention (15- 20 minutes post baseline)
The third and final measure of changes in mood will be the Happy-Sad and Alert-Sleepy Dynamic Visual Analogue Mood Scales (DVAMS), which is a morphing image scale that is gender specific and changes when the participant moves the slider scale. The scale ranges from 0 to 100, where 0 is low and 100 is high. The central, default thumb position value is 50.
5 secondary outcomes
Influenza vaccination-specific antibody responses- Haemagglutination inhibition assay
Time frame: Baseline, 4 weeks post-vaccination
Influenza vaccination-specific antibody responses- IgG-specific enzyme-linked immunosorbent assay
Time frame: Baseline, 4 weeks post-vaccination
Number of participants who experience flu-like symptoms and self care
Time frame: 6 months
Number of participants who do not follow up with trial procedures- Attrition
Time frame: Baseline, immediately post- intervention, 4 weeks post-vaccination, 6 months post-vaccination
Recruitment
Time frame: From the time of recruitment to the start of the Randomised Control Trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Background: PubMed 28923405Ayling K, Fairclough L, Tighe P, Todd I, Halliday V, Garibaldi J, Royal S, Hamed A, Buchanan H, Vedhara K. Positive mood on the day of influenza vaccination predicts vaccine effectiveness: A prospective observational cohort study. Brain Behav Immun. 2018 Jan;67:314-323. doi: 10.1016/j.bbi.2017.09.008. Epub 2017 Sep 18.
- 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 16213065Goodwin K, Viboud C, Simonsen L. Antibody response to influenza vaccination in the elderly: a quantitative review. Vaccine. 2006 Feb 20;24(8):1159-69. doi: 10.1016/j.vaccine.2005.08.105. Epub 2005 Sep 19.
- Background: PubMed 15564363Moynihan JA, Larson MR, Treanor J, Duberstein PR, Power A, Shore B, Ader R. Psychosocial factors and the response to influenza vaccination in older adults. Psychosom Med. 2004 Nov-Dec;66(6):950-3. doi: 10.1097/01.psy.0000140001.49208.2d.
- Background: PubMed 26849361Betella A, Verschure PF. The Affective Slider: A Digital Self-Assessment Scale for the Measurement of Human Emotions. PLoS One. 2016 Feb 5;11(2):e0148037. doi: 10.1371/journal.pone.0148037. eCollection 2016.
- Background: PubMed 28653547Barrows PD, Thomas SA. Assessment of mood in aphasia following stroke: validation of the Dynamic Visual Analogue Mood Scales (D-VAMS). Clin Rehabil. 2018 Jan;32(1):94-102. doi: 10.1177/0269215517714590. Epub 2017 Jun 27.
- Derived from this study: PubMed 38059932Ayling K, Brown M, Carlisle S, Bennett R, Buchanan H, Dumbleton J, Hawkey C, Hoschler K, Jack RH, Nguyen-Van-Tam J, Royal S, Turner D, Zambon M, Fairclough L, Vedhara K. Optimizing mood prior to influenza vaccination in older adults: A three-arm randomized controlled trial. Health Psychol. 2024 Feb;43(2):77-88. doi: 10.1037/hea0001267. Epub 2023 Dec 7.
- 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.
Kavita Vedhara principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardised Digital Intervention and Individualised Digital Intervention in people with Vaccination and 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 12 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 6 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-Reported Mood- Affective Slider (time frame: Baseline, immediately post- intervention (15- 20 minutes post baseline)). The study lists 3 primary outcomes in all. 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 NCT03956329, which also lists 7 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 6 Oct 2021.