Back to resultsEmotional Response in Psychiatric and Control Participants
Primary Purpose
Schizophrenia, Emotions
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
social interaction
food consumption
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- For control participants, you are eligible to participate in this study if you are between 18 and 65 years of age, you are fluent in English, and you have not been clinically diagnosed with a psychiatric disorder.
- For psychiatric patients, you are eligible to participate in this study if you are between 18 and 65 years of age, you are fluent in English, and you have been clinically diagnosed with schizophrenia, schizoaffective disorder, or depression with no recent hospitalization or changes in your psychiatric medications.
Exclusion Criteria:
- For control participants, you are not eligible to participate in the study if you have a history of stroke or a current history of substance or alcohol dependence. You are also not eligible to participate in this study if you have had a diagnosis of substance abuse in the past three months. You are not eligible to participate if you have a current or past history of a major medical illness, significant tremors, a history of a head injury or prolonged unconsciousness.
- For psychiatric patients, you are not eligible to participate in the study if you have had major changes to your psychotropic medications within the last two months, have a history of stroke or a current history of substance or alcohol dependence. You are also not eligible to participate in this study if you have had a diagnosis of substance abuse in the past three months, a current or past history of a major medical illness, significant tremors, or a history of a head injury or prolonged unconsciousness.
Sites / Locations
- Social Ecology 1
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
social interaction
food consumption
Arm Description
Participants will engage in a social interaction with another person
Participants will be offered food stuffs to eat/drink
Outcomes
Primary Outcome Measures
Social Anhedonia Scale
measures social anhedonia
Physical Anhedonia Scale
measures physical anhedonia
EEG activity
physiological parameter
Verbal behavioral rating
how many words are spoken throughout the task
Non-verbal behavioral rating
how many gestures are made throughout the task
International Personality Item Pool questionnaires
measure of personality
Secondary Outcome Measures
Following Affective States test
questionnaire re: how much participants follow or ignore their emotions
AMNART
measure of verbal IQ
MMSE
measure of mental status
Full Information
NCT ID
NCT03056781
First Posted
January 3, 2017
Last Updated
December 12, 2018
Sponsor
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT03056781
Brief Title
Emotional Response in Psychiatric and Control Participants
Official Title
Emotional Response in Psychiatric and Control Participants
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this research is to understand how the emotions of people with different mental health concerns (e.g., people with schizophrenia, people with major depressive disorder) differ from individuals without mental health concerns. A large body of literature suggests that people with mental illnesses have emotional abnormalities compared to healthy individuals, but a number of these abnormalities are not well understood. For example, often people with schizophrenia report on questionnaires that they experience fewer pleasant emotions when talking with other people, but some evidence suggests these individuals report a similar amount of pleasant emotion when they are actually engaged in a pleasant activity. Thus, it is unclear the extent to which reports of emotional abnormalities extend to a more real-world setting. In the tasks in the current proposal, participants will engage in a series of tasks designed to assess their emotional functioning. These tasks involve viewing emotional stimuli on the computer, engaging in social interactions, and consuming small amounts of food. In all tasks, participants will make ratings of their experiences of pleasure (and displeasure). We will then compare the experiences of patient groups to those of healthy individuals to test how emotional ratings might differ across these tasks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Emotions
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
social interaction
Arm Type
Experimental
Arm Description
Participants will engage in a social interaction with another person
Arm Title
food consumption
Arm Type
Experimental
Arm Description
Participants will be offered food stuffs to eat/drink
Intervention Type
Behavioral
Intervention Name(s)
social interaction
Intervention Description
Participants will engage in a social interaction with another person
Intervention Type
Behavioral
Intervention Name(s)
food consumption
Intervention Description
Participants will be offered food stuffs to eat/drink
Primary Outcome Measure Information:
Title
Social Anhedonia Scale
Description
measures social anhedonia
Time Frame
1 day
Title
Physical Anhedonia Scale
Description
measures physical anhedonia
Time Frame
1 day
Title
EEG activity
Description
physiological parameter
Time Frame
1 day
Title
Verbal behavioral rating
Description
how many words are spoken throughout the task
Time Frame
1 day
Title
Non-verbal behavioral rating
Description
how many gestures are made throughout the task
Time Frame
1 day
Title
International Personality Item Pool questionnaires
Description
measure of personality
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Following Affective States test
Description
questionnaire re: how much participants follow or ignore their emotions
Time Frame
1 day
Title
AMNART
Description
measure of verbal IQ
Time Frame
1 day
Title
MMSE
Description
measure of mental status
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For control participants, you are eligible to participate in this study if you are between 18 and 65 years of age, you are fluent in English, and you have not been clinically diagnosed with a psychiatric disorder.
For psychiatric patients, you are eligible to participate in this study if you are between 18 and 65 years of age, you are fluent in English, and you have been clinically diagnosed with schizophrenia, schizoaffective disorder, or depression with no recent hospitalization or changes in your psychiatric medications.
Exclusion Criteria:
For control participants, you are not eligible to participate in the study if you have a history of stroke or a current history of substance or alcohol dependence. You are also not eligible to participate in this study if you have had a diagnosis of substance abuse in the past three months. You are not eligible to participate if you have a current or past history of a major medical illness, significant tremors, a history of a head injury or prolonged unconsciousness.
For psychiatric patients, you are not eligible to participate in the study if you have had major changes to your psychotropic medications within the last two months, have a history of stroke or a current history of substance or alcohol dependence. You are also not eligible to participate in this study if you have had a diagnosis of substance abuse in the past three months, a current or past history of a major medical illness, significant tremors, or a history of a head injury or prolonged unconsciousness.
Facility Information:
Facility Name
Social Ecology 1
City
Irvine
State/Province
California
ZIP/Postal Code
92697-0001
Country
United States
12. IPD Sharing Statement
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Emotional Response in Psychiatric and Control Participants
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