search
Back to results

Creating Live Interactions to Mitigate Barriers (CLIMB)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Plasticity-Based Adaptive Cognitive Training
Commercially available computerized training
Optimized social skills training
Unstructured support group sessions
Sponsored by
Posit Science Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Posit Science Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Treatment

Active Comparator

Arm Description

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

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

Outcomes

Primary Outcome Measures

Social Functioning utilizing the Social Functioning Scale.
Between-group magnitude of change in social functioning utilizing the Social Functioning Scale. The Social Functioning Scale (SFS) was constructed specifically to tap areas of social functioning that are crucial to the community maintenance of individuals with schizophrenia. The 7 domains include: social engagement/withdrawal, interpersonal behavior, pro-social activities, recreation, independence-competence, independence-performance, and employment/occupation. The raw scores for each domain are converted to scaled scores, with a mean of 100 and a standard deviation of 15. Higher scores are indicative of greater social functioning.
Negative Symptoms utilizing the Positive and Negative Syndrome Scale.
Between-group magnitude of change in negative symptoms utilizing the Positive and Negative Syndrome Scale. The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. A rating from 1 to 7 is given to each of the 30 different symptoms. The 7-point rating represents increasing levels of psychopathology: 1= absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, and 7=extreme. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale. The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. Higher scores are indicative of greater symptomatology.
Quality of Life utilizing the Abbreviated Quality of Life Scale.
Between-group magnitude of change in quality of life utilizing the Abbreviated Quality of Life Scale. The Quality of Life Scale (QLS) is a scale commonly used as a measure of functioning in schizophrenia. The Abbreviated QLS (aQLS) includes 7 items representing all four interdependent theoretical constructs of the original 21-item QLS. Behavioral anchors are presented for each item, scored on a 0 (severe impairment) to 6 (high functioning) scale. Higher scores are indicative of greater quality of life.

Secondary Outcome Measures

Full Information

First Posted
October 18, 2017
Last Updated
July 22, 2019
Sponsor
Posit Science Corporation
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT03317769
Brief Title
Creating Live Interactions to Mitigate Barriers
Acronym
CLIMB
Official Title
Creating Live Interactions to Mitigate Barriers (CLIMB): A Mobile Intervention to Improve Social Functioning in People With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
June 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Posit Science Corporation
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Treatment
Arm Type
Experimental
Arm Description
Computerized cognitive training for 18 hours and structured social skills training for 9 hours over a 9 week period.
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Commercially-available computerized training for 18 hours and 9 hours of unstructured support group sessions over a 9 week period.
Intervention Type
Other
Intervention Name(s)
Computerized Plasticity-Based Adaptive Cognitive Training
Intervention Description
Training on computerized exercises that targets social cognition for 2 hours per week.
Intervention Type
Other
Intervention Name(s)
Commercially available computerized training
Intervention Description
Training on computerized, casual video games for 2 hours per week.
Intervention Type
Other
Intervention Name(s)
Optimized social skills training
Intervention Description
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
Intervention Name(s)
Unstructured support group sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social Functioning utilizing the Social Functioning Scale.
Description
Between-group magnitude of change in social functioning utilizing the Social Functioning Scale. The Social Functioning Scale (SFS) was constructed specifically to tap areas of social functioning that are crucial to the community maintenance of individuals with schizophrenia. The 7 domains include: social engagement/withdrawal, interpersonal behavior, pro-social activities, recreation, independence-competence, independence-performance, and employment/occupation. The raw scores for each domain are converted to scaled scores, with a mean of 100 and a standard deviation of 15. Higher scores are indicative of greater social functioning.
Time Frame
At 9 weeks
Title
Negative Symptoms utilizing the Positive and Negative Syndrome Scale.
Description
Between-group magnitude of change in negative symptoms utilizing the Positive and Negative Syndrome Scale. The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. A rating from 1 to 7 is given to each of the 30 different symptoms. The 7-point rating represents increasing levels of psychopathology: 1= absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, and 7=extreme. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale. The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. Higher scores are indicative of greater symptomatology.
Time Frame
At 9 weeks
Title
Quality of Life utilizing the Abbreviated Quality of Life Scale.
Description
Between-group magnitude of change in quality of life utilizing the Abbreviated Quality of Life Scale. The Quality of Life Scale (QLS) is a scale commonly used as a measure of functioning in schizophrenia. The Abbreviated QLS (aQLS) includes 7 items representing all four interdependent theoretical constructs of the original 21-item QLS. Behavioral anchors are presented for each item, scored on a 0 (severe impairment) to 6 (high functioning) scale. Higher scores are indicative of greater quality of life.
Time Frame
At 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Biagianti, MD, PhD
Organizational Affiliation
Posit Science Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Posit Science Corporation
City
San Francisco
State/Province
California
ZIP/Postal Code
94111
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Creating Live Interactions to Mitigate Barriers

We'll reach out to this number within 24 hrs