Determining the Role of Social Reward Learning in Social Anhedonia (SAMI)

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Psychosis

Treatments: Behavioral: Nutrition Didactic Training; Behavioral: Motivational Interviewing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05617898

IRB-300009711

1R01MH129351-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-35 years
• A first episode of a psychotic illness that began within the past three 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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152 participants in 2 patient groups

Motivational Interview Intervention

Experimental group

Description:

This arm involves three 45-minute sessions on motivational interviewing targeting sensitivity to social reward.

Treatment:

Behavioral: Motivational Interviewing

Active Control Intervention

Active Comparator group

Description:

This arm involves three 45-minute sessions on didactic training on nutrition.

Treatment:

Behavioral: Nutrition Didactic Training