USS Training to Improve Social Function in People With Psychosis

October 7, 2025 updated by: VA Office of Research and Development

Understanding Social Situations (USS): Training to Improve Social Function in People With Psychosis

Psychotic spectrum disorders (PSD) are associated with poor social function. By doing this study, the investigators hope to learn which of two different types of 2-month long training courses is more effective in improving day-to-day interactions and quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be randomly assigned to one of the two training courses. All participants will be asked to fill out questionnaires, engage in interviews, and complete paper and pencil tasks at the beginning of the study, at the halfway point of the training course (1 month), and end of the training course (2 months), and another 2 months later. One training focuses on how to make good judgments about what other people may be thinking or feeling in social situations, and why people might act in certain ways in different situations. The other training focuses on different strategies for handling everyday problems and stressors. Both trainings are done in one-on-one sessions with a research staff member. There will be 16-20 training sessions, each about 45-60 minutes long. The investigators will ask participants to attend 2 training sessions per week, so the total training time should be about 2 months.

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516-2770
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Veteran with diagnosis of psychotic disorder (e.g. schizophrenia, schizoaffective disorder, delusional disorder, psychosis NOS, etc);
  • psychiatrically stable (30 or more days since last hospitalization/change in psychiatric medication)
  • fluent in English
  • able to provide legal written informed consent

Exclusion Criteria:

  • current substance use disorder
  • developmental disability
  • severe, uncorrected auditory/visual impairment
  • diagnosis of medical or neurological illness known to impair brain function including dementia, presence of seizures, history of head trauma with loss of consciousness > 1hr, or clear cognitive sequelae from other illness or injury
  • currently enrolled in another treatment study targeting, or expected to impact, functioning.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: USS
social cognitive training
Behavioral: USS
social cognitive training
Active Comparator: MovingForward
problem solving training
Behavioral: MovingForward
problem solving training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Functioning Scale (SFS) Change
Time Frame: Post-testing (2 months) and follow-up (4 months)

The SFS is one of the best known measures of social functioning in schizophrenia, and was one of two social function measures nominated by experts and selected by a RAND panel for a large-scale investigation of measures to assess real-world outcomes based on its psychometric properties, sensitivity to change, relationship to symptoms, and comprehensiveness. The total score ranges from 55 to 135, with a higher score indicates better social functioning.

Score change at post-testing (2 months) and follow-up (4 months) was calculated by subtracting the baseline score, with negative values indicating worse and positive values indicating better social functioning compared to baseline. Mid-testing (1 month) score change was included in the mixed-effects model, but its least square mean was not calculated as it was not a time point of interest.
Post-testing (2 months) and follow-up (4 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Skills Performance Assessment (SSPA) Change
Time Frame: Post-training (2 months) and follow-up (4 months).

SSPA is a role-play measure of social skill ability. It consists of two, 3-minute, structured role plays (tenant meeting a new neighbor; tenant calling landlord to request repair). Each role play is rated between 1 and 5. The total score is calculated by summing up the ratings, and ranges from 2 to 10. A higher score indicates better social skill performance.

Score change at post-testing (2 months) and follow-up (4 months) was calculated by subtracting the baseline score, with negative values indicating worse and positive values indicating better social skill performance compared to baseline.
Post-training (2 months) and follow-up (4 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Joanna M. Fiszdon, PhD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 18, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Estimated)

October 15, 2025

Last Update Submitted That Met QC Criteria

October 7, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3354-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

see below

IPD Sharing Time Frame

Data will be available once primary and secondary study aims have been published.

IPD Sharing Access Criteria

Completely de-identified data will be made available to other investigators, with written request and IRB approval, ideally under a data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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