Creating Live Interactions to Mitigate Barriers (CLIMB)

Posit Science

Status: Completed

Conditions: Schizophrenia

Treatments: Other: Optimized social skills training; Other: Commercially available computerized training; Other: Computerized Plasticity-Based Adaptive Cognitive Training; Other: Unstructured support group sessions

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT03317769

PSC-1013-17

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups

Experimental Treatment

Experimental group

Description:

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

Treatment:

Other: Computerized Plasticity-Based Adaptive Cognitive Training

Other: Optimized social skills training

Active Comparator

Active Comparator group

Description:

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

Treatment:

Other: Commercially available computerized training

Other: Unstructured support group sessions