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

NCT02860169 | Terminated Results

• 1 other identifier: 205689
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition

Outcome Measures

Primary Outcomes (6)

• Liking Rating on 11 Point Likert Scale (0-10 - 0 = Not at All; 10 = Like Extremely)

  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).

  At Screening

• Change in Reaction Time (RTI) Milliseconds (ms) From the Reaction Time Task in Participants Suffering From Cold and Flu Versus Healthy Participants

  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).

  Day 1

• Change in Emotional Recognition Task (ERT) Score (Number of Total Hits) in Participants Suffering From Cold and Flu Versus Healthy Participants

  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).

  Day 1

• Change in Rapid Visual Information Processing (RVP) A Prime (RVP A') in Participants Suffering From Cold and Flu Versus Healthy Participants

  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).

  Day 1

• Change in Attention Switching Task (AST) Score (Congruency Cost [ms]) in Participants Suffering From Cold and Flu Versus Healthy Participants

  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).

  Day 1

• Change in Mood and Motivation Visual Analogue Scale (VAS) Change (Millimeter[mm]) in Participants Suffering From Cold and Flu Versus Healthy Participants

  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).

  Day 1

Study Arms (2)

Participants with cold and flu

EXPERIMENTAL

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

Healthy participants

PLACEBO COMPARATOR

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

Interventions

Participants self-administered questionnaire and assessment BEHAVIORAL

Participants self-administered questionnaire and assessment includes Picture Rating, Picture Surfing Task, Questionnaire and VAS scales, Cognitive Function Assessment, RTI, AST, ERT , RVP.

Healthy participants; Participants with cold and flu

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Brentford, Middlesex, TW8 9DA, United Kingdom

Location

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Limitations and Caveats

Study was terminated due to GSK concerns that the data collected in this study could not support reliable interpretation of the assessments and conclusions on the primary objectives of the study.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: August 9, 2016
• Study Start: March 11, 2016
• Primary Completion: November 24, 2016
• Study Completion: November 24, 2016
• Last Updated: April 11, 2019
• Results First Posted: April 11, 2019

Record last verified: 2018-01

Locations

GB (1)