NCT04557124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 12, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

3.8 years

First QC Date

September 14, 2020

Results QC Date

January 29, 2025

Last Update Submit

October 7, 2025

Conditions

Keywords

psychosissocial functionsocial cognition

Outcome Measures

Primary Outcomes (1)

  • Social Functioning Scale (SFS) Change

    The SFS is one of the best known measures of social functioning in schizophrenia, and was one of two social function measures nominated by experts and selected by a RAND panel for a large-scale investigation of measures to assess real-world outcomes based on its psychometric properties, sensitivity to change, relationship to symptoms, and comprehensiveness. The total score ranges from 55 to 135, with a higher score indicates better social functioning. Score change at post-testing (2 months) and follow-up (4 months) was calculated by subtracting the baseline score, with negative values indicating worse and positive values indicating better social functioning compared to baseline. Mid-testing (1 month) score change was included in the mixed-effects model, but its least square mean was not calculated as it was not a time point of interest.

    Post-testing (2 months) and follow-up (4 months)

Secondary Outcomes (1)

  • Social Skills Performance Assessment (SSPA) Change

    Post-training (2 months) and follow-up (4 months).

Study Arms (2)

USS

EXPERIMENTAL

social cognitive training

Behavioral: USS

MovingForward

ACTIVE COMPARATOR

problem solving training

Behavioral: MovingForward

Interventions

USSBEHAVIORAL

social cognitive training

USS
MovingForwardBEHAVIORAL

problem solving training

MovingForward

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

West Haven, Connecticut, 06516-2770, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychotic DisordersSocial Adjustment

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSocial BehaviorBehavior

Results Point of Contact

Title
Joanna Fiszdon, Principal Investigator
Organization
VA Connecticut Healthcare System

Study Officials

  • Joanna M. Fiszdon, PhD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 21, 2020

Study Start

December 1, 2020

Primary Completion

September 30, 2024

Study Completion

September 30, 2025

Last Updated

October 15, 2025

Results First Posted

March 12, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

see below

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be available once primary and secondary study aims have been published.
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.

Locations