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Recruiting NCT05617898

Determining the Role of Social Reward Learning in Social Anhedonia

No phase Interventional Psychosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Motivational Interviewing, Nutrition Didactic Training.
Who it may be relevant to
Registry conditions: Psychosis. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • 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).
  • 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.

Primary outcome measures

  • Response Bias [Time frame: 3 weeks]
  • the number of optimal response [Time frame: 3 weeks]
  • fMRI activation levels [Time frame: 3 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 2 centers
  • University of Alabama at Birmingham — Birmingham
  • University of California Los Angeles — Los Angeles

Identifiers

NCT: NCT05617898 · IRB-300009711 · 1R01MH129351-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗