USS Training to Improve Social Function in People With Psychosis
Primary Purpose
Psychosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
USS
MovingForward
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis focused on measuring psychosis, social function, social cognition
Eligibility Criteria
Inclusion Criteria:
- 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.
Sites / Locations
- VA Connecticut Healthcare System West Haven Campus, West Haven, CTRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
USS
MovingForward
Arm Description
social cognitive training
problem solving training
Outcomes
Primary Outcome Measures
Social Functioning Scale (SFS) Change
self-report measure of social functioning
Secondary Outcome Measures
Social Skills Performance Assessment (SSPA) Change
social interaction skill role-play
Full Information
NCT ID
NCT04557124
First Posted
September 14, 2020
Last Updated
December 2, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04557124
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
psychosis, social function, social cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
USS
Arm Type
Experimental
Arm Description
social cognitive training
Arm Title
MovingForward
Arm Type
Active Comparator
Arm Description
problem solving training
Intervention Type
Behavioral
Intervention Name(s)
USS
Intervention Description
social cognitive training
Intervention Type
Behavioral
Intervention Name(s)
MovingForward
Intervention Description
problem solving training
Primary Outcome Measure Information:
Title
Social Functioning Scale (SFS) Change
Description
self-report measure of social functioning
Time Frame
pre-training, mid-training (1 month), post-training (2 months), follow-up (4 months)
Secondary Outcome Measure Information:
Title
Social Skills Performance Assessment (SSPA) Change
Description
social interaction skill role-play
Time Frame
pre-training, post-training (2 months), follow-up (4 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joanna M Fiszdon, PhD
Phone
(203) 932-5711
Ext
2231
Email
joanna.fiszdon@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna M. Fiszdon, PhD
Organizational Affiliation
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna M Fiszdon, PhD
Phone
203-932-5711
Ext
2231
Email
joanna.fiszdon@va.gov
First Name & Middle Initial & Last Name & Degree
Joanna M. Fiszdon, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
USS Training to Improve Social Function in People With Psychosis
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