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

NCT ID: NCT02860169

Last Updated: 2019-04-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-11
• Study Completion Date: 2016-11-24

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.

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.

Conditions

Cognition

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Participants self-administered questionnaire and assessment

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Participants self-administered questionnaire and assessment

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Brentford, Middlesex, United Kingdom

Countries

United Kingdom

Other Identifiers

205689

Identifier Type: -

Identifier Source: org_study_id