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Mood and Influenza Vaccine Response: A Feasibility Trial

NCT03144518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2019-07-15

Study results available
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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

Interventions

OTHER

Positive Affect Intervention

See Previous Description

OTHER

Neutral Control Intervention

See Previous Description

BIOLOGICAL

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

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

Sponsors & Collaborators

  • Northumbria University

    collaborator OTHER

  • University of Nottingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2017-11-01
Completion
2018-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03144518 on ClinicalTrials.gov