Creating Live Interactions to Mitigate Barriers

NCT ID: NCT03317769

Last Updated: 2019-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-06-06

Brief Summary

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This study is a validation study to evaluate the acceptability, feasibility and impact of a mobile psychosocial intervention to enhance social functioning in people with schizophrenia.

Detailed Description

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The goal of this study is to employ an innovative and evidence-based mobile intervention that includes a neuroscience-informed computerized social cognition training program, a Health Insurance Portability and Accountability Act-compliant videoconferencing tool that we will use for psychoeducational group therapy, and peer-to-peer secure social networking for individuals with schizophrenia, in a parallel arm, double-blind, randomized, controlled clinical trial to assess feasibility and initial efficacy, to investigate the intervention's effects on symptoms, social cognition, and quality of life, and to prepare for a large-scale efficacy trial in adults with schizophrenia.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Comparator

Commercially-available computerized training for 18 hours and 9 hours of unstructured support group sessions over a 9 week period.

Group Type ACTIVE_COMPARATOR

Commercially available computerized training

Intervention Type OTHER

Training on computerized, casual video games for 2 hours per week.

Unstructured support group sessions

Intervention Type OTHER

Unstructured support group-video calls for 1 hour per week. The Specialist will not engage with participants (eg. providing participants with links to articles and additional support) or provide guidance for the group discussion.

Experimental Treatment

Computerized cognitive training for 18 hours and structured social skills training for 9 hours over a 9 week period.

Group Type EXPERIMENTAL

Computerized Plasticity-Based Adaptive Cognitive Training

Intervention Type OTHER

Training on computerized exercises that targets social cognition for 2 hours per week.

Optimized social skills training

Intervention Type OTHER

Group-video calls with Specialist for 1 hour per week where participants can interact with Specialist individually or as a group. Specialist will provide guidance, support and feedback, and send links and articles about information and topics discussed during the video calls.

Interventions

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Computerized Plasticity-Based Adaptive Cognitive Training

Training on computerized exercises that targets social cognition for 2 hours per week.

Intervention Type OTHER

Commercially available computerized training

Training on computerized, casual video games for 2 hours per week.

Intervention Type OTHER

Optimized social skills training

Group-video calls with Specialist for 1 hour per week where participants can interact with Specialist individually or as a group. Specialist will provide guidance, support and feedback, and send links and articles about information and topics discussed during the video calls.

Intervention Type OTHER

Unstructured support group sessions

Unstructured support group-video calls for 1 hour per week. The Specialist will not engage with participants (eg. providing participants with links to articles and additional support) or provide guidance for the group discussion.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants must have a clinical diagnosis of Schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and confirmed by the Structured Clinical Interview for DSM-5 (SCID)
* Participant must be clinically stable (outpatient status for at least 2 months) at time of screening
* Participants taking psychiatric medications must be on a stable medication regimen for greater than or equal to 4 weeks prior to screening
* Participant must be a fluent English speaker
* Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse
* Participants must be able to use iOS mobile applications

Exclusion Criteria

* Participants with unstable and/or untreated conditions that may affect cognition, including substance abuse/dependence disorders, cardiovascular, endocrine, neurologic disorder, epilepsy, recent hospitalization, ongoing chemotherapy or other cancer treatment
* Participant has a history of mental retardation, pervasive developmental disorder, head trauma, traumatic brain injury, or other neurological disorder that impairs cognition
* Participants who have had psychiatric hospitalizations in the 8 weeks prior to randomization
* Participants had significant medication or clinical status changes, or adjustment in their antipsychotic treatment in the 4 weeks prior to randomization
* Participants with active suicidal ideations and/or behaviors as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Participants showing signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit
* Participants with problems performing assessments or comprehending or following spoken instructions
* Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment that could affect the outcome of this study
* Participant is using computer-based cognitive training programs or has used it within a month of the consent date
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Posit Science Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruno Biagianti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Posit Science Corporation

Locations

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Posit Science Corporation

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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PSC-1013-17

Identifier Type: -

Identifier Source: org_study_id

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