PsychosisSAMINCT05617898
Determining the Role of Social Reward Learning in Social Anhedonia
A study testing Motivational Interviewing and Nutrition Didactic Training in people with Psychosis, run by University of Alabama at Birmingham at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Motivational Interviewing and Nutrition Didactic Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jun 2023to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Andrew Meddaugh, BA, 205-934-8203, ajmeddaugh@uabmc.edu
Junghee Lee, PhD, 205-934-8205, jungheelee@uabmc.edu
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Rebecca Zornitsky, MS, 424-225-1779, zornitsky@mednet.ucla.edu
Joseph Ventura, PhD, 310-206-3142, jventura@mednet.ucla.edu
About this study
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
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
- Being tested
- Motivational Interviewing, Nutrition Didactic Training
- Keywords
- social anhedonia, social reward learning, fMRI, sensitivity to reward
- Medical subject headings
- Psychotic Disorders, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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 TrainingBehavioural
The Nutrition didactic training will ask participants to discuss pros and cons of healthy eating habits and how to improve their current eating habits.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview Intervention | Experimental | This arm involves three 45-minute sessions on motivational interviewing targeting sensitivity to social reward. Receives: Behavioral: Motivational Interviewing |
| Active Control Intervention | Active comparator | This arm involves three 45-minute sessions on didactic training on nutrition. Receives: Behavioral: Nutrition Didactic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start14 Jun 2023
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junghee Lee, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617898
- Sponsor's protocol ID
- IRB-300009711
- Other IDs
- 1R01MH129351-01A1
- Acronym
- SAMI
- Status last verified
- Jul 2026
- First submitted
- 31 Oct 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05617898
- Acronym / sponsor ID
- SAMI / IRB-300009711
- Conditions
- Psychosis
- Keywords
- social anhedonia, social reward learning, fMRI, sensitivity to reward
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, National Institute of Mental Health (NIMH)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview Intervention | Experimental | Behavioral: Motivational InterviewingThis arm involves three 45-minute sessions on motivational interviewing targeting sensitivity to social reward. |
| Active Control Intervention | Active comparator | Behavioral: Nutrition Didactic TrainingThis arm involves three 45-minute sessions on didactic training on nutrition. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingThree 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). | Behavioural | Motivational Interview Intervention |
| Nutrition Didactic TrainingThe Nutrition didactic training will ask participants to discuss pros and cons of healthy eating habits and how to improve their current eating habits. | Behavioural | Active Control Intervention |
Primary outcome
Response Bias
Time frame: 3 weeks
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
Time frame: 3 weeks
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
Time frame: 3 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Nutrition Didactic Training in people with Psychosis, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junghee Lee, PhD (205-934-8205, jungheelee@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Bias (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.