PsychosisNCT04557124
USS Training to Improve Social Function in People With Psychosis
A study testing USS and MovingForward in people with Psychosis, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis
- What is being tested?
- USS and MovingForward
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychosis
- Being tested
- USS, MovingForward
- Keywords
- psychosis, social function, social cognition
- Medical subject headings
- Psychotic Disorders, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USSBehavioural
social cognitive training
MovingForwardBehavioural
problem solving training
| Study group | Role | What they receive |
|---|---|---|
| USS | Experimental | social cognitive training Receives: Behavioral: USS |
| MovingForward | Active comparator | problem solving training Receives: Behavioral: MovingForward |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Functioning Scale (SFS) Change
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.
Measured: Post-testing (2 months) and follow-up (4 months)
Secondary outcomes (1)
Social Skills Performance Assessment (SSPA) Change
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.
Measured: Post-training (2 months) and follow-up (4 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Dec 2020
- Primary completion30 Sep 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joanna M. Fiszdon, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557124
- Sponsor's protocol ID
- D3354-R
- Status last verified
- Oct 2025
- First submitted
- 14 Sep 2020
- Last updated
- 15 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: see below
Publications
Fiszdon JM, Bell MD, Fulford D, Roberts DL, Dziura J, Parente L, Nasse A, Choi J. Understanding social situations: study protocol for a randomized controlled trial evaluating a novel social cognitive training versus modified problem-solving training for people with psychosis. Front Psychiatry. 2024 Aug 22;15:1440476. doi: 10.3389/fpsyt.2024.1440476. eCollection 2024.
PubMed 39238934
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Social Situations (USS): Training to Improve Social Function in People With Psychosis
- ClinicalTrials.gov ID
- NCT04557124
- Acronym / sponsor ID
- D3354-R
- Conditions
- Psychosis
- Keywords
- psychosis, social function, social cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Posted 12 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| USS | Experimental | Behavioral: USSsocial cognitive training |
| MovingForward | Active comparator | Behavioral: MovingForwardproblem solving training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| USSsocial cognitive training | Behavioural | USS |
| MovingForwardproblem solving training | Behavioural | MovingForward |
Primary outcome
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.
1 secondary outcome
Social Skills Performance Assessment (SSPA) Change
Time frame: Post-training (2 months) and follow-up (4 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39238934Fiszdon JM, Bell MD, Fulford D, Roberts DL, Dziura J, Parente L, Nasse A, Choi J. Understanding social situations: study protocol for a randomized controlled trial evaluating a novel social cognitive training versus modified problem-solving training for people with psychosis. Front Psychiatry. 2024 Aug 22;15:1440476. doi: 10.3389/fpsyt.2024.1440476. eCollection 2024.
- Individual participant dataSharing planned: Yes. see below
Related trials for Psychosis
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
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. This study is not recruiting at the moment.
Joanna M. Fiszdon, PhD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USS and MovingForward in people with Psychosis, run by VA Office of Research and Development at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Functioning Scale (SFS) Change (time frame: Post-testing (2 months) and follow-up (4 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04557124, which also lists 1 linked publication.
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 15 Oct 2025.