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

Primary Purpose

Psychosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Nutrition Didactic Training
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psychosis focused on measuring social anhedonia, social reward learning, fMRI, sensitivity to reward

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • University of California Los AngelesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational Interview Intervention

Active Control Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 31, 2022
Last Updated
July 3, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
University of California, Los Angeles, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05617898
Brief Title
Determining the Role of Social Reward Learning in Social Anhedonia
Acronym
SAMI
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2023 (Actual)
Primary Completion Date
November 2027 (Anticipated)
Study Completion Date
November 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
University of California, Los Angeles, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
social anhedonia, social reward learning, fMRI, sensitivity to reward

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interview Intervention
Arm Type
Experimental
Arm Description
This arm involves three 45-minute sessions on motivational interviewing targeting sensitivity to social reward.
Arm Title
Active Control Intervention
Arm Type
Active Comparator
Arm Description
This arm involves three 45-minute sessions on didactic training on nutrition.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Didactic Training
Intervention Description
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 Information:
Title
Response Bias
Description
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
Time Frame
3 weeks
Title
the number of optimal response
Description
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.
Time Frame
3 weeks
Title
fMRI activation levels
Description
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.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junghee Lee, PhD
Phone
205-934-8205
Email
jungheelee@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Meddaugh, BA
Phone
205-934-8203
Email
ajmeddaugh@uabmc.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Meddaugh, BA
Phone
205-934-8203
Email
ajmeddaugh@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Junghee Lee, PhD
Phone
205-934-8205
Email
jungheelee@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Junghee Lee, PhD
First Name & Middle Initial & Last Name & Degree
Adrienne C Lahti, MD
First Name & Middle Initial & Last Name & Degree
Alison Thomas, PhD
First Name & Middle Initial & Last Name & Degree
Caitlin W Clevenger, PhD
First Name & Middle Initial & Last Name & Degree
Gerhard S Hellemann, PhD
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Zornitsky, MS
Phone
424-225-1779
Email
zornitsky@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Joseph Ventura, PhD
Phone
310-206-3142
Email
jventura@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Keith H Nuechterlein, PhD
First Name & Middle Initial & Last Name & Degree
Michael F Green, PhD
First Name & Middle Initial & Last Name & Degree
Joseph Ventura, PhD
First Name & Middle Initial & Last Name & Degree
Kenneth Subotnik, PhD
First Name & Middle Initial & Last Name & Degree
Amy M Jimenez, PhD
First Name & Middle Initial & Last Name & Degree
Lena M Reddy, PhD

12. IPD Sharing Statement

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Determining the Role of Social Reward Learning in Social Anhedonia

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