USS Training to Improve Social Function in People With Psychosis

Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04557124
• Other study ID #: D3354-R
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: Joanna M Fiszdon, PhD
• Phone: (203) 932-5711
• Email: joanna.fiszdon[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• USS
social cognitive training
• MovingForward
problem solving training

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Social Skills Performance Assessment (SSPA) Change	social interaction skill role-play	pre-training, post-training (2 months), follow-up (4 months)