SchizophreniaNCT03623477
Can Cognitive Training Decrease Reactive Aggression?
A study testing Cognitive Remediation (CRT) and CRT+ Social Cognition Training in people with Schizophrenia and Cognitive Deficits, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
The purpose of the study is to examine the effects of cognitive training on emotion regulation, impulse control, and aggression in people with schizophrenia. The study compares a combination of computerized cognitive remediation and social cognition training (CRT+SCT) to cognitive remediation alone (CRT). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Cognitive Deficits, Impulsive Aggression
- What is being tested?
- Cognitive Remediation (CRT) and CRT+ Social Cognition Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Aug 2016to 25 Oct 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
- diagnosis of schizophrenia or schizo-affective disorder
- Age 18-60
- Mini Mental Status Exam score greater/equal to 24 at screening
- Auditory and visual acuity adequate to complete cognitive tests
- At least a score of 5 or more on the Life History of Aggression (LHA) aggression items or one confirmed assault in the past year
- Capacity and willingness to give consent
Who cannot join
- Inability to read or speak English
- Documented significant disease of the Central Nervous System (CNS)
- History of intellectual impairment predating psychosis (e.g., a diagnosis of developmental disability)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Manhattan Psychiatric Center
New York, New York, 10035
NewYork Presbyterian Hospital
White Plains, New York, 10605
About this study
Official title: Can Cognitive Training Decrease Reactive Aggression? The Role of Improved Emotion Regulation, Emotion Awareness, and Impulse Control
The purpose of the study is to examine the effects of cognitive training on emotion regulation, impulse control, and aggression in people with schizophrenia. The study compares a combination of computerized cognitive remediation and social cognition training (CRT+SCT) to cognitive remediation alone (CRT). Study outcomes include multiple measures of aggression, emotion regulation, impulse control, cognition, and symptoms.
Read the detailed description
Neurocognitive and social cognitive impairments are contributors to negative emotionality and impulsive aggression in people with schizophrenia. Impulsive aggression poses several challenges to the care of people with schizophrenia. These include a greater risk of rehospitalization and longer hospital stays, involvement with the criminal justice system, and increased risk of recidivism. The investigators recently found that schizophrenia patients with aggression history experienced improvements in neurocognition as well as decreased hostility/agitation and incidents of verbal and physical aggression after participating in cognitive remediation training (CRT). Based on these findings, it is hypothesized that improving neurocognition through CRT may have enhanced the capacity of schizophrenia patients to inhibit aggression through improved emotion regulation capacity and impulse control. It is also postulated that the addition of Social Cognition Training (SCT) to CRT would provide greater benefits on emotion regulation and impulse control over CRT alone. To test the hypotheses, the investigators will conduct a clinical trial that compares two configurations of cognitive training--CRT plus SCT versus CRT plus control computer games. The goal of the study is to examine the comparative benefits of the two configurations of cognitive training on outcomes that include neurocognition, social cognition, emotion regulation, impulse control, and reactive aggression. Participants assigned to the CRT plus SCT group will complete 24 hours of CRT and 12 hours of SCT. Participants assigned to the CRT only group will complete 24 hours of CRT and 12 hours of control computer activities. Emotion regulation, impulse control, and reactive aggression will be indexed using laboratory-based challenges. The investigators will recruit and characterize 90 study participants on demographic and clinical variables including age, gender, education, aggression history, and medications. Study outcome measures will be administered at baseline and posttreatment to participants randomized to the study groups. In a subsample of 32 patients, the study investigators will further examine changes in the neural network of emotion regulation and impulsivity before and after cognitive training.
- Conditions
- Schizophrenia, Cognitive Deficits, Impulsive Aggression, Emotion, Impulsivity
- Being tested
- Cognitive Remediation (CRT), CRT+ Social Cognition Training
- Keywords
- Cognitive Remediation, Social Cognition Training, Emotion Regulation, Urgency
- Medical subject headings
- Schizophrenia, Cognition Disorders, Impulsive Behavior, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation (CRT)Behavioural
Study compares two configurations of cognitive training--computerized cognitive remediation versus a combination of computerized cognitive remediation and social cognition training. The cognitive remediation therapy group will complete computerized training activities in attention, memory, processing speed, problem solving, and executive functions.
CRT+ Social Cognition TrainingBehavioural
Study compares two configurations of cognitive training--computerized cognitive remediation versus a combination of computerized cognitive remediation and social cognition training. The combined cognitive remediation and social cognition training group will complete computerized training that target neurocognitive functions, facial affect emotion recognition and mentalizing tasks.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Remediation (CRT) | Active comparator | Participants assigned to CRT alone will complete 24 hours of neurocognitive training activities and 12 hours of control computer activities. Receives: Behavioral: Cognitive Remediation (CRT) |
| CRT+ Social Cognition Training | Experimental | Participants assigned to the combination of CRT and SCT will complete 24 hours of computerized neurocognitive training in memory, attention, and processing speed, and 12 hours of computerized social cognition training focused on improving emotion recognition, social perspective taking, and mentalizing abilities. Receives: Behavioral: CRT+ Social Cognition Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aggression
Overt Aggression Scale-Modified (OAS-M); Taylor Aggression Paradigm (TAP); Point Subtraction Aggression Paradigm (PSAP).
Measured: Change from baseline in aggression measures up to the end of intervention at 4 months
Secondary outcomes (4)
Change in cognitive outcomes
MATRICS Consensus Cognitive Battery (MCCB); Emotion Recognition-40 (ER-40); Reading the Mind in the Eyes (Eyes Task)
Measured: Change from baseline in cognition measures up to the end of intervention at 4 months
Change in Emotionality
Positive and Negative Affect Scale (PANAS); Toronto Alexithymia Scale (TAS); Observer Alexithymia Scale (OAS)
Measured: Change from baseline in emotionality measures up to the end of intervention at 4 months
Change in Emotion Regulation Capacity
Picture viewing task completed while peripheral psychophysiological response is obtained
Measured: Change from baseline in measures up to the end of intervention at 4 months
Change in Impulse Control
Behavioral Impulse control tasks including Go-NoGo Task and Emotional Stop Task
Measured: Change from baseline in impulse control measures up to the end of intervention at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start16 Aug 2016
- Primary completion25 Oct 2019
- Study completion25 Oct 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation, National Center for Advancing Translational Sciences (NCATS), Nathan Kline Institute for Psychiatric Research
- Responsible party
- Sponsor
- Investigators
- Anthony O Ahmed, PhD, Principal investigator, Weill Medical College of Cornell UniversityJean-Pierre Lindenmayer, MD, Principal investigator, Manhattan Psychiatric CenterMatthew J Hoptman, PhD, Principal investigator, Nathan Kline Institute for Psychiatric Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623477
- Sponsor's protocol ID
- 1505016194
- Other IDs
- UL1TR000457
- Status last verified
- Feb 2020
- First submitted
- 3 Aug 2017
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Cognitive Training Decrease Reactive Aggression? The Role of Improved Emotion Regulation, Emotion Awareness, and Impulse Control
- ClinicalTrials.gov ID
- NCT03623477
- Acronym / sponsor ID
- 1505016194
- Conditions
- Schizophrenia, Cognitive Deficits, Impulsive Aggression, Emotion, Impulsivity
- Keywords
- Cognitive Remediation, Social Cognition Training, Emotion Regulation, Urgency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation, National Center for Advancing Translational Sciences (NCATS), Nathan Kline Institute for Psychiatric Research
- Study start
- 16 Aug 2016 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 9 Aug 2018 (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.
The purpose of the study is to examine the effects of cognitive training on emotion regulation, impulse control, and aggression in people with schizophrenia. The study compares a combination of computerized cognitive remediation and social cognition training (CRT+SCT) to cognitive remediation alone (CRT). Study outcomes include multiple measures of aggression, emotion regulation, impulse control, cognition, and symptoms.
Detailed description
Neurocognitive and social cognitive impairments are contributors to negative emotionality and impulsive aggression in people with schizophrenia. Impulsive aggression poses several challenges to the care of people with schizophrenia. These include a greater risk of rehospitalization and longer hospital stays, involvement with the criminal justice system, and increased risk of recidivism. The investigators recently found that schizophrenia patients with aggression history experienced improvements in neurocognition as well as decreased hostility/agitation and incidents of verbal and physical aggression after participating in cognitive remediation training (CRT). Based on these findings, it is hypothesized that improving neurocognition through CRT may have enhanced the capacity of schizophrenia patients to inhibit aggression through improved emotion regulation capacity and impulse control. It is also postulated that the addition of Social Cognition Training (SCT) to CRT would provide greater benefits on emotion regulation and impulse control over CRT alone. To test the hypotheses, the investigators will conduct a clinical trial that compares two configurations of cognitive training--CRT plus SCT versus CRT plus control computer games. The goal of the study is to examine the comparative benefits of the two configurations of cognitive training on outcomes that include neurocognition, social cognition, emotion regulation, impulse control, and reactive aggression. Participants assigned to the CRT plus SCT group will complete 24 hours of CRT and 12 hours of SCT. Participants assigned to the CRT only group will complete 24 hours of CRT and 12 hours of control computer activities. Emotion regulation, impulse control, and reactive aggression will be indexed using laboratory-based challenges. The investigators will recruit and characterize 90 study participants on demographic and clinical variables including age, gender, education, aggression history, and medications. Study outcome measures will be administered at baseline and posttreatment to participants randomized to the study groups. In a subsample of 32 patients, the study investigators will further examine changes in the neural network of emotion regulation and impulsivity before and after cognitive training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation (CRT) | Active comparator | Behavioral: Cognitive Remediation (CRT)Participants assigned to CRT alone will complete 24 hours of neurocognitive training activities and 12 hours of control computer activities. |
| CRT+ Social Cognition Training | Experimental | Behavioral: CRT+ Social Cognition TrainingParticipants assigned to the combination of CRT and SCT will complete 24 hours of computerized neurocognitive training in memory, attention, and processing speed, and 12 hours of computerized social cognition training focused on improving emotion recognition, social perspective taking, and mentalizing abilities. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- diagnosis of schizophrenia or schizo-affective disorder
- Age 18-60
- Mini Mental Status Exam score greater/equal to 24 at screening
- Auditory and visual acuity adequate to complete cognitive tests
- At least a score of 5 or more on the Life History of Aggression (LHA) aggression items or one confirmed assault in the past year
Key exclusion criteria (3 listed)
- Inability to read or speak English
- Documented significant disease of the Central Nervous System (CNS)
- History of intellectual impairment predating psychosis (e.g., a diagnosis of developmental disability)
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 |
|---|---|---|
| Cognitive Remediation (CRT)Study compares two configurations of cognitive training--computerized cognitive remediation versus a combination of computerized cognitive remediation and social cognition training. The cognitive remediation therapy group will complete computerized training activities in attention, memory, processing speed, problem solving, and executive functions. | Behavioural | Cognitive Remediation (CRT) |
| CRT+ Social Cognition TrainingStudy compares two configurations of cognitive training--computerized cognitive remediation versus a combination of computerized cognitive remediation and social cognition training. The combined cognitive remediation and social cognition training group will complete computerized training that target neurocognitive functions, facial affect emotion recognition and mentalizing tasks. | Behavioural | CRT+ Social Cognition Training |
Primary outcome
Change in Aggression
Time frame: Change from baseline in aggression measures up to the end of intervention at 4 months
Overt Aggression Scale-Modified (OAS-M); Taylor Aggression Paradigm (TAP); Point Subtraction Aggression Paradigm (PSAP).
4 secondary outcomes
Change in cognitive outcomes
Time frame: Change from baseline in cognition measures up to the end of intervention at 4 months
Change in Emotionality
Time frame: Change from baseline in emotionality measures up to the end of intervention at 4 months
Change in Emotion Regulation Capacity
Time frame: Change from baseline in measures up to the end of intervention at 4 months
Change in Impulse Control
Time frame: Change from baseline in impulse control measures up to the end of intervention at 4 months
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 28 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Anthony O Ahmed, PhD principal investigator
Weill Medical College of Cornell University
Jean-Pierre Lindenmayer, MD principal investigator
Manhattan Psychiatric Center
Matthew J Hoptman, PhD principal investigator
Nathan Kline Institute for Psychiatric Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation (CRT) and CRT+ Social Cognition Training in people with Schizophrenia and Cognitive Deficits, run by Weill Medical College of Cornell University at 2 sites 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 3 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 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in Aggression (time frame: Change from baseline in aggression measures up to the end of intervention at 4 months). 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 28 Feb 2020.