USS Training to Improve Social Function in People With Psychosis

NCT ID: NCT04557124

Last Updated: 2025-10-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2025-09-30

Brief Summary

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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

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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

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Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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USS

social cognitive training

Group Type EXPERIMENTAL

USS

Intervention Type BEHAVIORAL

social cognitive training

MovingForward

problem solving training

Group Type ACTIVE_COMPARATOR

MovingForward

Intervention Type BEHAVIORAL

problem solving training

Interventions

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USS

social cognitive training

Intervention Type BEHAVIORAL

MovingForward

problem solving training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanna M. Fiszdon, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Locations

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VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39238934 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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D3354-R

Identifier Type: -

Identifier Source: org_study_id

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