Clinical trial NCT03317769: Creating Live Interactions to Mitigate Barriers
Official title: Creating Live Interactions to Mitigate Barriers (CLIMB): A Mobile Intervention to Improve Social Functioning in People With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-10-23
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Social Functioning utilizing the Social Functioning Scale.
timeFrame: At 9 weeks
measure: Negative Symptoms utilizing the Positive and Negative Syndrome Scale.
timeFrame: At 9 weeks
measure: Quality of Life utilizing the Abbreviated Quality of Life Scale.
timeFrame: At 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Posit Science Corporation
state: California
Study officials:
affiliation: Posit Science Corporation
name: Bruno Biagianti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: