USS Training to Improve Social Function in People With Psychosis

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: Recruiting
• Conditions: Psychosis
• Intervention / Treatment: Behavioral: USS; Behavioral: MovingForward

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 (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joanna M Fiszdon, PhD; Phone Number: 2231 (203) 932-5711; Email: joanna.fiszdon@va.gov

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516-2770
      • Recruiting
      • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
      • Contact: Joanna M Fiszdon, PhD; Phone Number: 2231 203-932-5711; Email: joanna.fiszdon@va.gov
      • Principal Investigator: Joanna M. Fiszdon, PhD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	self-report measure of social functioning	pre-training, mid-training (1 month), post-training (2 months), follow-up (4 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Skills Performance Assessment (SSPA) Change	social interaction skill role-play	pre-training, post-training (2 months), follow-up (4 months)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Joanna M. Fiszdon, PhD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): 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 (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: social cognition; psychosis; social function
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• 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