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

GlaxoSmithKline (GSK)

Status: Terminated

Conditions: Cognition

Treatments: Behavioral: Participants self-administered questionnaire and assessment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02860169

205689

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups, including a placebo group

Participants with cold and flu

Experimental 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

Treatment:

Behavioral: Participants self-administered questionnaire and assessment

Healthy participants

Placebo Comparator 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 VAS scales, Cognitive Function Assessment, RTI, AST, ERT , RVP

Treatment:

Behavioral: Participants self-administered questionnaire and assessment