Determining the Role of Social Reward Learning in Social Anhedonia

Psychosis Clinical Trial

— SAMI  

Official title:

Determining the Role of Social Reward Learning in Social Anhedonia in First-Episode Psychosis Using Motivational Interviewing in a Perturbation-Based Neuroimaging Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05617898
• Other study ID #: IRB-300009711
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2023
• Est. completion date: November 2027

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: Junghee Lee, PhD
• Phone: 205-934-8205
• Email: jungheelee[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a clinical trial study that aims to evaluate the specificity of the relationship between reduced sensitivity to social reward and social anhedonia at both behavioral and neural levels. Individuals who recently experienced their first-episode psychosis will be recruited. Participants will be randomized 1:1 to motivational interviewing or a time- and format-matched control probe. At pre- and post-probe, participants will perform two social reward learning tasks in the scanner. With this design feature, we will examine the relationship between sensitivity to social reward and reduced subjective experience of social pleasure at both the behavioral and neural levels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: November 2027
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age 18-35 years
• A first episode of a psychotic illness that began within the past two years
• Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
• Taking 2nd generation antipsychotic medications
• Estimated premorbid IQ not less than 70 as assessed with the Wechsler Test of Adult Reading
• Appropriate for scanning (i.e., no pacemaker or metal implants) and expressed willingness to participate in scanning
• Sufficient fluency in English to comprehend testing procedures
• Corrected vision of at least 20/30

Exclusion Criteria:

• No evidence that substance use makes the diagnosis ambiguous (rule out substance-induced psychosis)
• No evidence of moderate or severe alcohol or substance use disorder in the past 3 months
• No clinically significant disease based on medical history (e.g., epilepsy) or significant head injury
• For females: no current pregnancy
• No sedatives or anxiolytics on the day of assessment
• No medication change 3 weeks prior to enrollment

Related Conditions & MeSH terms

• Anhedonia
• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• Motivational Interviewing
Three motivational interviewing sessions will target sensitivity to social reward, including subjective evaluation of social interaction, socially rewarding stimuli, and events (e.g., interactions with others, feedback from others).
• Nutrition Didactic Training
The Nutrition didactic training will ask participants to discuss pros and cons of healthy eating habits and how to improve their current eating habits.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of California Los Angeles	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Mental Health (NIMH), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Bias	Response bias is defined as the likelihood of making one response, such as the frequently rewarded stimulus, more than the other response during the perceptual social reward learning task	3 weeks
Primary	the number of optimal response	The number of optimal response is defined as the number of responses choosing a stimuli with optimal outcomes (e.g., choosing a good over a neutral machine or choosing a neutral over a bad machine) during the inductive social reward learning task.	3 weeks
Primary	fMRI activation levels	fMRI activation is defined as beta weights from general linear model from key regions of interests including the ventromedial prefrontal cortex, dorsal anterior cingulate cortex and ventral striatum during the perceptual social reward learning task and the inductive social reward learning task.	3 weeks