Clinical trial NCT04557124: USS Training to Improve Social Function in People With Psychosis
Official title: Understanding Social Situations (USS): Training to Improve Social Function in People With Psychosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychosis
Keywords: psychosis
social function
social cognition
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-09-21
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Social Functioning Scale (SFS) Change
timeFrame: Post-testing (2 months) and follow-up (4 months)
Secondary outcomes:
measure: Social Skills Performance Assessment (SSPA) Change
timeFrame: Post-training (2 months) and follow-up (4 months).
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Joanna M. Fiszdon, PhD
role: PRINCIPAL_INVESTIGATOR
References: