SchizophreniaCLIMBNCT03317769
Creating Live Interactions to Mitigate Barriers
A study testing Computerized Plasticity-Based Adaptive Cognitive Training, Commercially available computerized training and Optimized social skills training in people with Schizophrenia, run by Posit Science Corporation at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Computerized Plasticity-Based Adaptive Cognitive Training, Commercially available computerized training and Optimized social skills training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 6 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Posit Science Corporation
San Francisco, California, 94111
About this study
Official title: Creating Live Interactions to Mitigate Barriers (CLIMB): A Mobile Intervention to Improve Social Functioning in People With Schizophrenia
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.
- Conditions
- Schizophrenia
- Being tested
- Computerized Plasticity-Based Adaptive Cognitive Training, Commercially available computerized training, Optimized social skills training, Unstructured support group sessions
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Plasticity-Based Adaptive Cognitive TrainingOther
Training on computerized exercises that targets social cognition for 2 hours per week.
Commercially available computerized trainingOther
Training on computerized, casual video games for 2 hours per week.
Optimized social skills trainingOther
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.
Unstructured support group sessionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | Computerized cognitive training for 18 hours and structured social skills training for 9 hours over a 9 week period. Receives: 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. Receives: Other: Commercially available computerized training; Other: Unstructured support group sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 9 weeks
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.
Measured: At 9 weeks
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.
Measured: At 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start1 Apr 2018
- Primary completion31 May 2019
- Study completion6 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Bruno Biagianti, MD, PhD, Principal investigator, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317769
- Sponsor's protocol ID
- PSC-1013-17
- Acronym
- CLIMB
- Status last verified
- Jul 2019
- First submitted
- 18 Oct 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating Live Interactions to Mitigate Barriers (CLIMB): A Mobile Intervention to Improve Social Functioning in People With Schizophrenia
- ClinicalTrials.gov ID
- NCT03317769
- Acronym / sponsor ID
- CLIMB / PSC-1013-17
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Other: Computerized Plasticity-Based Adaptive Cognitive Training, Other: Optimized social skills trainingComputerized cognitive training for 18 hours and structured social skills training for 9 hours over a 9 week period. |
| Active Comparator | Active comparator | Other: Commercially available computerized training, Other: Unstructured support group sessionsCommercially-available computerized training for 18 hours and 9 hours of unstructured support group sessions over a 9 week period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Plasticity-Based Adaptive Cognitive TrainingTraining on computerized exercises that targets social cognition for 2 hours per week. | Other | Experimental Treatment |
| Commercially available computerized trainingTraining on computerized, casual video games for 2 hours per week. | Other | Active Comparator |
| Optimized social skills trainingGroup-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. | Other | Experimental Treatment |
| Unstructured support group sessionsUnstructured 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. | Other | Active Comparator |
Primary outcome
Social Functioning utilizing the Social Functioning Scale.
Time frame: At 9 weeks
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.
Time frame: At 9 weeks
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.
Time frame: At 9 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Biagianti, MD, PhD principal investigator
Posit Science Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Plasticity-Based Adaptive Cognitive Training, Commercially available computerized training and Optimized social skills training in people with Schizophrenia, run by Posit Science Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Functioning utilizing the Social Functioning Scale. (time frame: At 9 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.