ClinicalTrials.gg
CompletedNCT03317769CLIMBUpdated Jul 23, 2019

Creating Live Interactions to Mitigate Barriers

An interventional study of Computerized Plasticity-Based Adaptive Cognitive Training and Commercially available computerized training in Schizophrenia, sponsored by Posit Science Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-07-23.

Sponsored by Posit Science Corporation · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,465 studies in Schizophrenia with a site in United States — 148 open to participants now, 166 under way, 22 of them phase 3. Schizophrenia · United States.

Enrollment
977th of 1,319
31 · median 66
Started
2018
with 47 others
No phase
479 of 1,465
71 open now
Registered
1,038th of 1,465
by date

Among the 1,465 studies in Schizophrenia with a site in United States, this one is the 977th largest by enrollment of the 1,319 interventional ones that give a count, is one of 48 that started in 2018, is one of 479 with no phase, and was the 1,038th registered.

Schizophrenia

3,567 studies on the registry are indexed under Schizophrenia; 493 are open to participants now.

Browse Schizophrenia studies →

Open to participants now

148 of the 1,465 studies in Schizophrenia with a site in United States are open now. Recruiting first, the newest first:

143 more — sign in →

All 148 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 332 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 258 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Schizophrenia

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04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must have a clinical diagnosis of Schizophrenia as defined by the (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

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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Experimental Treatment

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

    Other: Computerized Plasticity-Based Adaptive Cognitive Training · Other: Optimized social skills training

  • Active comparator
    Active Comparator

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

    Other: Commercially available computerized training · Other: Unstructured support group sessions

Interventions

  • OtherComputerized Plasticity-Based Adaptive Cognitive Training

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

  • OtherCommercially available computerized training

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

  • OtherOptimized 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.

  • OtherUnstructured 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At 9 weeks

  2. 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.

    Time frame: At 9 weeks

  3. 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.

    Time frame: At 9 weeks

07

Study locations

1 site
  • Posit Science Corporation
    San Francisco, California 94111, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in May 2019, 13 months.

Of 769 interventional studies with no phase under Schizophrenia, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 56. This study's 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2017
First posted
Oct 23, 2017
StartActual
Apr 1, 2018
Primary completionActual
May 31, 2019
CompletionActual
Jun 6, 2019
Last update
Jul 23, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03317769
Responsible party
Sponsor
First posted
Oct 23, 2017
Start date
Apr 1, 2018
Primary completion
May 31, 2019
Completion
Jun 6, 2019
Last update
Jul 23, 2019

Study contacts

Bruno Biagianti, MD, PhD
principal investigator · Posit Science Corporation

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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