NCT05617898

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Jun 2023Nov 2027

First Submitted

Initial submission to the registry

October 31, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

June 14, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

4.4 years

First QC Date

October 31, 2022

Last Update Submit

July 21, 2025

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Motivational Interview Intervention

EXPERIMENTAL

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

Behavioral: Motivational Interviewing

Active Control Intervention

ACTIVE COMPARATOR

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

Behavioral: Nutrition Didactic Training

Interventions

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).

Motivational Interview Intervention

The Nutrition didactic training will ask participants to discuss pros and cons of healthy eating habits and how to improve their current eating habits.

Active Control Intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Psychotic DisordersAnhedonia

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Junghee Lee, PhD

CONTACT

Andrew Meddaugh, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 16, 2022

Study Start

June 14, 2023

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

July 24, 2025

Record last verified: 2025-07

Locations