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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02860169
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.5
• Patients Per Site Per Month: 13.4

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• 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: Mar 11, 2016
• Actual Primary Completion Date: Nov 24, 2016
• Actual Study Completion Date: Nov 24, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Brentford	Middlesex	United Kingdom	TW8 9DA

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02860169
• Other Study ID Numbers: 205689
• First Posted: Aug 9, 2016
• Last Update Posted: Apr 11, 2019
• Last Verified: Jan 1, 2018

Study Results

Participant Flow

Recruitment Details	Participants were recruited from one center at United Kingdom (UK).
Pre-assignment Detail	This study was divided in 3 parts (A, B and C). Part A was an online survey, Parts B and C. Participants recruited separately for each part of the study based on the inclusion and exclusion criteria of respective part of the study. (46 [part A] + 20 [part B] + 48 [part C] = 114 enrolled in the study)

Arm/Group Title	Overall Participants
Arm/Group Description	The study consisted of three parts A (includes only healthy participants), B and C (both B and C included healthy and cold and flu participants). Recruitment is done separately for each part of the study, based on the inclusion and exclusion criteria set for the respective part of the study.
Period Title: Part A
STARTED	46
Healthy Participants	46
Participants With Cold and Flu	0
COMPLETED	35
NOT COMPLETED	11
Period Title: Part A
STARTED	20
Healthy Participants	10
Participants With Cold and Flu	10
COMPLETED	9
NOT COMPLETED	11
Period Title: Part A
STARTED	48
Healthy Participants	6
Participants With Cold and Flu	42
COMPLETED	47
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Healthy Participants	Participants With Cold and Flu	Total
Arm/Group Description	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 visual analogue scale (VAS), Cognitive Function Assessment, Reaction time (RTI), Attention switching task (AST), Emotional recognition task (ERT) , Rapid visual information processing (RVP).	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	Total of all reporting groups
Overall Participants	62	52	114
Age, Customized (Years) [Mean (Standard Deviation) ]
Mean Age	34.38 (11.01)	31.3 (10.98)	32.91 (5.2)
Sex: Female, Male (Count of Participants)
Female	35 56.5%	25 48.1%	60 52.6%
Male	27 43.5%	27 51.9%	54 47.4%
Race/Ethnicity, Customized (Count of Participants)
White	14 22.6%	28 53.8%	42 36.8%
Asian	1 1.6%	18 34.6%	19 16.7%
Mixed	0 0%	1 1.9%	1 0.9%
Arab	0 0%	1 1.9%	1 0.9%
Black	4 6.5%	1 1.9%	5 4.4%
Not collected (Part A participants)	46 74.2%	0 0%	46 40.4%

Outcome Measures

1. Primary Outcome

Title	Liking Rating on 11 Point Likert Scale (0-10 - 0 = Not at All; 10 = Like Extremely)
Description	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).
Time Frame	At Screening

Outcome Measure Data

Analysis Population Description

No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GlaxoSmithKline (GSK) is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.

Arm/Group Title	Participants With Cold and Flu	Healthy Participants
Arm/Group Description	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	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
Measure Participants	0	0

2. Primary Outcome

Title	Change in Reaction Time (RTI) Milliseconds (ms) From the Reaction Time Task in Participants Suffering From Cold and Flu Versus Healthy Participants
Description	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).
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GSK is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.

Arm/Group Title	Participants With Cold and Flu	Healthy Participants
Arm/Group Description	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	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
Measure Participants	0	0

3. Primary Outcome

Title	Change in Emotional Recognition Task (ERT) Score (Number of Total Hits) in Participants Suffering From Cold and Flu Versus Healthy Participants
Description	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).
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GSK is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.

Arm/Group Title	Participants With Cold and Flu	Healthy Participants
Arm/Group Description	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	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
Measure Participants	0	0

4. Primary Outcome

Title	Change in Rapid Visual Information Processing (RVP) A Prime (RVP A') in Participants Suffering From Cold and Flu Versus Healthy Participants
Description	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).
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GSK is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.

Arm/Group Title	Participants With Cold and Flu	Healthy Participants
Arm/Group Description	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	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
Measure Participants	0	0

5. Primary Outcome

Title	Change in Attention Switching Task (AST) Score (Congruency Cost [ms]) in Participants Suffering From Cold and Flu Versus Healthy Participants
Description	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).
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GSK is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.

Arm/Group Title	Participants With Cold and Flu	Healthy Participants
Arm/Group Description	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	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
Measure Participants	0	0

6. Primary Outcome

Title	Change in Mood and Motivation Visual Analogue Scale (VAS) Change (Millimeter[mm]) in Participants Suffering From Cold and Flu Versus Healthy Participants
Description	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).
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GSK is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.

Arm/Group Title	Participants With Cold and Flu	Healthy Participants
Arm/Group Description	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	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
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	No participant data was analyzed for adverse events in this study as it was terminated early due to concerns relating to procedures for data collection, handling, and transfer that potentially impacted the integrity of the study data.
Arm/Group Title	Participants With Cold and Flu		Healthy Participants
Arm/Group Description	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		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
All Cause Mortality
	Participants With Cold and Flu		Healthy Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Participants With Cold and Flu		Healthy Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Participants With Cold and Flu		Healthy Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.