SAMI: Determining the Role of Social Reward Learning in Social Anhedonia

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05617898
• Collaborator: University of California, Los Angeles (Other), National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 152
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 55
• Patients Per Site: 76
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Psychosis	Behavioral: Motivational Interviewing; Behavioral: Nutrition Didactic Training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 152 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Basic Science
• 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
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2027
• Anticipated Study Completion Date: Nov 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Motivational Interview Intervention This arm involves three 45-minute sessions on motivational interviewing targeting sensitivity to social reward.	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).
Active Comparator: Active Control Intervention This arm involves three 45-minute sessions on didactic training on nutrition.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Response Bias [3 weeks]

   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

2. the number of optimal response [3 weeks]

   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. fMRI activation levels [3 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 (depressed type)

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	University of California Los Angeles	Los Angeles	California	United States	90095

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Junghee Lee, Associate Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT05617898
• Other Study ID Numbers: IRB-300009711
• First Posted: Nov 16, 2022
• Last Update Posted: Jan 25, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Junghee Lee, Associate Professor, University of Alabama at Birmingham: social anhedonia, social reward learning, fMRI, sensitivity to reward
• Additional relevant MeSH terms: Anhedonia; Psychotic Disorders; Mental Disorders

Study Results

No Results Posted as of Jan 25, 2023