Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT05617898

Conditions

Psychosis

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Interventions

Motivational Interviewing

Nutrition Didactic Training

Study Details

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.

Conditions

Psychosis

Study ID

NCT05617898

Start date

Jun 14, 2023

Status verified date

Jul, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Motivational Interview Intervention

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

active comparator: Active Control Intervention

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

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Junghee Lee, PhD

205-934-8205jungheelee@uabmc.edu

Andrew Meddaugh, BA

205-934-8203ajmeddaugh@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Andrew Meddaugh, BA

205-934-8203ajmeddaugh@uabmc.edu

Junghee Lee, PhD

205-934-8205jungheelee@uabmc.edu

Principal Investigator:

Junghee Lee, PhD

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Rebecca Zornitsky, MS

424-225-1779zornitsky@mednet.ucla.edu

Joseph Ventura, PhD

310-206-3142jventura@mednet.ucla.edu

Principal Investigator:

Keith H Nuechterlein, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • social anhedonia, social reward learning, fMRI, sensitivity to reward

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-07-27.