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Motivation, Brain Function and Mood in Individuals With Cold and/or Flu

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860169
Recruitment Status : Terminated (Due to GSK concerns that the data collected in this study could not support reliable interpretation of assessments and conclusions on the primary objectives.)
First Posted : August 9, 2016
Results First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study aim to adapt and test a novel indication of motivation in participants with cold & flu using the Picture Surfing Task (PST). The purpose of this task, in both healthy participants and those with cold & flu, will be to provide a measure of: 1) change in general motivation, 2) change in cold and flu-specific motivation, and 3) any change in general tendency to exert force to serve as a control.

Condition or disease Intervention/treatment Phase
Cognition Behavioral: Participants self-administered questionnaire and assessment Not Applicable

Detailed Description:
The study is designed in three parts. The first, Part A, is an online survey to select salient images (cold & flu related) to be used in the motivation task under investigation in Parts B and C. Part B is a pilot investigation of a novel measure of motivation, using a grip force cognitive task (PST, previously used in obesity literature) in a small group of participants with cold and flu compared to a group without. The result of this pilot study will inform task content and sample size for Part C. The final part will investigate the effects of cold and flu on motivation (using the PST), cognitive performance (using the Cambridge Cognition Cognitive Assessments [CANTAB] testing battery) and subjective mood and motivation in participants suffering from C&F and healthy participants.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Cold and/or Flu on Motivation, Mood and Cognitive Performance in Otherwise Healthy Individuals
Actual Study Start Date : March 11, 2016
Actual Primary Completion Date : November 24, 2016
Actual Study Completion Date : November 24, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu

Arm Intervention/treatment
Experimental: Participants with cold and flu
Eligible participants with cold and flu were instructed to answer the self administered questionnaire and participate in the assessment that included Picture Rating, Picture Surfing Task, Questionnaire and VAS scales, Cognitive Function Assessment, RTI, AST, ERT , RVP
Behavioral: Participants self-administered questionnaire and assessment
Participants self-administered questionnaire and assessment includes Picture Rating, Picture Surfing Task, Questionnaire and VAS scales, Cognitive Function Assessment, RTI, AST, ERT , RVP.

Placebo Comparator: Healthy participants
Eligible healthy participants were instructed to answer the self administered questionnaire and participate in the assessment that included Picture Rating, Picture Surfing Task, Questionnaire and VAS scales, Cognitive Function Assessment, RTI, AST, ERT , RVP
Behavioral: Participants self-administered questionnaire and assessment
Participants self-administered questionnaire and assessment includes Picture Rating, Picture Surfing Task, Questionnaire and VAS scales, Cognitive Function Assessment, RTI, AST, ERT , RVP.




Primary Outcome Measures :
  1. Liking Rating on 11 Point Likert Scale (0-10 - 0 = Not at All; 10 = Like Extremely) [ Time Frame: At Screening ]
    Participants will be asked to rate a selection of images relevant to cold and flu on an 11 point Likert scale of "how much do you like this image?" from 0 = "Not at all" to 10 = "Extremely like" (In Part A of the study).

  2. Change in Reaction Time (RTI) Milliseconds (ms) From the Reaction Time Task in Participants Suffering From Cold and Flu Versus Healthy Participants [ Time Frame: Day 1 ]
    Change in RTI will be measured by the five-choice reaction time task. The participant will hold down a button at the bottom of the screen until a yellow spot appears in one of the five circles at the top of the screen. Median from five-choice reaction time (the median duration between the onset of the stimulus and the release of the button) will be measured (In Part B of the study).

  3. Change in Emotional Recognition Task (ERT) Score (Number of Total Hits) in Participants Suffering From Cold and Flu Versus Healthy Participants [ Time Frame: Day 1 ]
    Change in ERT will be measured by displaying Morphed images of real participant's facial features, each showing a specific emotion on the screen for 200ms. The participant will need to decide from 6 options which emotion the face is displaying. Change in ERT (total hits) which is calculated from the number of problems during assessment blocks, on which the participant chose the correct emotion (In Part B of the study).

  4. Change in Rapid Visual Information Processing (RVP) A Prime (RVP A') in Participants Suffering From Cold and Flu Versus Healthy Participants [ Time Frame: Day 1 ]
    RVP A Prime will be measured with the help of a white box appears in the centre of computer screen inside which digits, from 2 to 9, appear in a pseudo-random order, at the rate of 100 digits per minute. Participants are requested to detect target sequences of digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the press pad. RVP A Prime is the signal detection measure of sensitivity to the target, regardless of response tendency (the expected range is 0.00 to 1.00; bad to good). In essence, this metric is a measure of how good the participant is at detecting target sequences (In Part B of the study).

  5. Change in Attention Switching Task (AST) Score (Congruency Cost [ms]) in Participants Suffering From Cold and Flu Versus Healthy Participants [ Time Frame: Day 1 ]
    Change in AST score is a measure of executive attention. The test displays an arrow which can appear on either side of the screen (right or left) and can point in either direction (to the right or to the left). Each trial displays a cue at the top of the screen that indicates to the participant whether they have to press the right or left button according to the "side on which the arrow appeared" or the "direction in which the arrow was pointing". AST congruency cost (median; ms) will be measured as the difference between the median latency of response (from stimulus appearance to button press) on the trials that were congruent versus the trials that were incongruent. Calculated by subtracting the median congruent latency (ms) from the median incongruent latency. Close to zero: less variation in latencies across congruent and incongruent trials. A positive score: participant is faster on congruent trials and a negative score: participant is faster on incongruent trials (in Part C).

  6. Change in Mood and Motivation Visual Analogue Scale (VAS) Change (Millimeter[mm]) in Participants Suffering From Cold and Flu Versus Healthy Participants [ Time Frame: Day 1 ]
    VAS of 100mm line will be used to assess subjective ratings of mood and motivation. For mood participants will be asked to rate their current mood under the headings of alertness, pleasure/displeasure and anxiety. Motivation will be assessed by asking participants to rate their current motivation under six different headings e.g. general motivation, motivation to engage with friends and family and motivation to perform leisure activities (In Part B of the study).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Part A: Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary informed consent confirmed online before completing the online survey.
  • Part B and C: Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
  • Aged between 18 and 65 years inclusive.
  • Participant is male or female.
  • Part A: Healthy adult with no chronic illness and currently free from acute illness.
  • Part B and C: Good general and mental health with, in the opinion of the Investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history. Healthy group: Healthy adult with no chronic illness. Currently free from acute illness.

Exclusion Criteria:

  • Woman who are known to be pregnant or who are intending to become pregnant over the duration of the study or who are breast-feeding.
  • Parts B and C: Current (within 14 days of the start of the study) or regular use of any prescription, OTC and herbal medicine unless it will not interfere with study endpoints as determined by the principal investigator. Vitamin supplements and occasional doses of OTC paracetamol for pain relief/ treatment of cold and flu symptoms are permitted (with the exception of > 24 hours before study visits).
  • Current or in the 30 days prior to dosing use of any drug known to induce or inhibit hepatic drug metabolism (e.g. barbiturates, theophylline, cimetidine, or erythromycin).
  • Current or past use (within 2 years) if antidepressants or other psychoactive medication.
  • Use of over the counter (OTC) analgesics/cold and flu treatments 24 hours prior to assessment visits in all parts of the study.
  • Participant is colour blind.
  • Recent history (within the last 5 years) of alcohol or other substance abuse.
  • Participant must not be regular smokers (as defined - more than 3 per day or equivalent for e-cigarettes, chewing tobacco or pipes).
  • Participant must not consume greater than 21 units of alcohol per week (male) and 14 units per week (female).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860169


Locations
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United Kingdom
GSK Investigational Site
Brentford, Middlesex, United Kingdom, TW8 9DA
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02860169    
Other Study ID Numbers: 205689
First Posted: August 9, 2016    Key Record Dates
Results First Posted: April 11, 2019
Last Update Posted: April 11, 2019
Last Verified: January 2018