Emotional Response in Psychiatric and Control Participants

• ClinicalTrials.gov Identifier: NCT03056781
• Recruitment Status: Completed
• First Posted: February 17, 2017
• Last Update Posted: December 14, 2018
• Sponsor: University of California, Irvine
• Information provided by (Responsible Party): Elizabeth A. Martin, University of California, Irvine

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Emotions	Behavioral: social interaction; Behavioral: food consumption	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 46 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Emotional Response in Psychiatric and Control Participants
• Actual Study Start Date: February 15, 2017
• Actual Primary Completion Date: August 1, 2018
• Actual Study Completion Date: August 1, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: social interaction; Participants will engage in a social interaction with another person	Behavioral: social interaction; Participants will engage in a social interaction with another person
Experimental: food consumption; Participants will be offered food stuffs to eat/drink	Behavioral: food consumption; Participants will be offered food stuffs to eat/drink

Outcome Measures

Primary Outcome Measures :

1. Social Anhedonia Scale [ Time Frame: 1 day ]
   measures social anhedonia
2. Physical Anhedonia Scale [ Time Frame: 1 day ]
   measures physical anhedonia
3. EEG activity [ Time Frame: 1 day ]
   physiological parameter
4. Verbal behavioral rating [ Time Frame: 1 day ]
   how many words are spoken throughout the task
5. Non-verbal behavioral rating [ Time Frame: 1 day ]
   how many gestures are made throughout the task
6. International Personality Item Pool questionnaires [ Time Frame: 1 day ]
   measure of personality

Secondary Outcome Measures :

1. Following Affective States test [ Time Frame: 1 day ]
   questionnaire re: how much participants follow or ignore their emotions
2. AMNART [ Time Frame: 1 day ]
   measure of verbal IQ
3. MMSE [ Time Frame: 1 day ]
   measure of mental status

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, California

Social Ecology 1

Irvine, California, United States, 92697-0001

Sponsors and Collaborators

University of California, Irvine

More Information

• Responsible Party: Elizabeth A. Martin, Assistant Professor, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT03056781
• Other Study ID Numbers: 2016-2945
• First Posted: February 17, 2017
• Last Update Posted: December 14, 2018
• Last Verified: December 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders