Clinical trial NCT03079024: Minnesota Community-Based Cognitive Training in Early Psychosis
Official title: Minnesota Community-Based Cognitive Training in Early Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Psychosis
Schizoaffective Disorder
Schizophreniform Disorders
Psychosis NOS
Depression Psychotic Feature
Bipolar Disorder With Psychotic Features
Unspecified Psychosis
Keywords: Cognitive Training
First Episode Psychosis
Recent Onset Psychosis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2017-03-14
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether cognitive training exercises can improve cognitive functioning in young patients with recent-onset psychosis who are being treated in community mental health settings using the NAVIGATE model. The investigators will examine the effects of web-based cognitive training exercises delivered on iPads. Participants will be randomized to one of three conditions, and will be assessed at Baseline, Post-Intervention, and 6 Month Follow Up on measures of clinical, neurocognitive, and functional status.

Detailed description: The purpose of this study is to perform a double-blind randomized controlled trial (RCT) in young patients with First Episode Psychosis (FEP) to target improvement in cognitive functioning within real-world treatment settings. This study will be performed in the University of Minnesota Department of Psychiatry; patients will be recruited from local community based mental health care settings that implement a NAVIGATE model for FEP.

All participants will undergo baseline assessment in measures of clinical, neurocognitive, and functional status prior to randomization. Participants will be equally randomized to one of three groups: Targeted Cognitive Training (TCT); General Cognitive Exercises (GCE); or Treatment as Usual (TAU). Participants assigned to a cognitive training group will be loaned an iPad to complete study training at home. They will complete 60 minutes of training 5 times a week over the course of 6 weeks for a total of 30 hours of training. Participants will be allowed up to 12 weeks to complete the full 30 hours. Participants will return after 30 hours of training or 12 weeks, whichever comes first, for Post-Intervention Assessments. Then participants will enter a no-contact follow up period, until it is time for their 6 Month Follow Up assessment.

Specific Aims:

1. Perform a double-blind RCT of web-based, portable computerized cognitive training in young individuals with recent onset psychosis receiving treatment within the University of Minnesota, Department of Psychiatry's First Episode Psychosis Program or other state clinics utilizing the NAVIGATE treatment model.
2. Compare the clinical and cognitive effects of neural system-informed TCT that focuses explicitly and specifically on distributed neural system efficiency in auditory/verbal and social cognitive domains, vs. more non-specific GCE designed to enhance executive functioning and problem-solving, vs. TAU. Determine the durability of these effects and their relationship to functional outcome over a 6 month period.
3. As a secondary aim, investigate the feasibility, tolerability, and acceptability of the intervention by service providers, clients, and caregivers in these real-world treatment centers.

Hypotheses to be tested:

1. TCT subjects will show significantly greater gains in general cognition, verbal learning/memory, and social cognition compared to GCE and TAU subjects. These gains in the TCT group will be sustained at 6-month follow-up.
2. GCE subjects will show improvement in problem-solving and global cognition compared to TAU subjects. At 6 month follow-up, GCE subjects will show lower gains in global cognition and verbal learning/memory than TCT subjects.
3. Gains in general cognition and processing speed, and in social cognition in TCT subjects will correlate with improvements on 6-month measures of occupational and social functioning, respectively, as well as internalized stigma. These associations will be significantly greater in TCT subjects vs. GCE or TAU subjects.
4. Symptom ratings will show improvement in all subject groups at 6 months, with no significant between-group differences.
5. At least 70% of randomized clients will complete \>20 hours of training in the TCT and GCE arms.
6. Participants and clinicians will rate the TCT and GCE interventions as equally feasible, tolerable, and acceptable.

Participants from this study will also be recruited to participate in an adjunct protocol conducted by Dr. Sophia Vinogradov, titled "Is cognitive training neuroprotective in early psychosis?" NCT03049800.

Data from this project will be analysed with a sister protocol conducted by Dr. Rachel Loewy at the University of California San Francisco, titled "Community-Based Cognitive Training in Early Schizophrenia (COTES)," NCT01973270.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder with psychotic features, bipolar disorder with psychotic features, psychosis disorder not otherwise specified, or unspecified schizophrenia spectrum disorder, and started receiving treatment services at a First Episode Psychosis Program within the last two years
* Good general physical health
* Aged between 16 and 35 years (inclusive)
* Fluent in spoken and written English
* No neurological disorder (diagnosis of Autism Spectrum Disorder is allowed)
* Achieved clinical stability, defined as outpatient status for at least one month prior to study participation, stable doses of psychiatric medications for at least one month prior to study participation
* Women who are pregnant or breastfeeding may participate in this study.

Exclusion Criteria:

* Unable to provide informed consent
* Participated in significant cognitive training programs within the last three years
* Clinically significant substance abuse that is impeding the subject's ability to participate fully during recruitment, assessment, or training (is unable to remain sober for assessments and training).
* Prescribed \>0.5mg daily benztropine (Congentin), \>25mg daily diphenhydramine, or high doses of clozapine (\>500 mg po qd) or olanzapine (to be determined on a case by case basis).
* Active suicidal ideation at screening or baseline, or previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 6 months, as indicated by the C-SSRS

Primary outcomes:
measure: Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: baseline
measure: Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 weeks
measure: Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 months followup
measure: Attention From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: baseline
measure: Attention From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 weeks
measure: Attention From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 months followup
measure: Working Memory From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: Basline
measure: Working Memory From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 weeks
measure: Working Memory From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 months followup
measure: Verbal Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: Baseline
measure: Verbal Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 weeks
measure: Verbal Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 months followup
measure: Visual Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: baseline
measure: Visual Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 weeks
measure: Visual Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 months followup
measure: Problem Solving From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: baseline
measure: Problem Solving From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 weeks
measure: Problem Solving From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 months followup
measure: Social Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: baseline
measure: Social Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 weeks
measure: Social Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 months followup
measure: Global Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: baseline
measure: Global Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 weeks
measure: Global Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: 6 months followup
measure: Emotion Recognition From the University of Pennsylvania Computerized Neurobehavioral Test Battery
timeFrame: baseline
measure: Emotional Prosody Identification From the University of Pennsylvania Computerized Neurobehavioral Test Battery Neurobehavioral Test Battery
timeFrame: Baseline
measure: Emotional Prosody Identification From the University of Pennsylvania Computerized Neurobehavioral Test Battery
timeFrame: 6 weeks
measure: Emotion Recognition From the University of Pennsylvania Computerized Neurobehavioral Test Battery
timeFrame: 6 weeks
measure: Emotion Recognition From the University of Pennsylvania Computerized Neurobehavioral Test Battery
timeFrame: 6 months
measure: Emotional Prosody Identification From the University of Pennsylvania Computerized Neurobehavioral Test Battery
timeFrame: 6 months
measure: Faux Pas Test Theory of Mind
timeFrame: Baseline
measure: Faux Pas Test Theory of Mind
timeFrame: 6 weeks
measure: Faux Pas Test Theory of Mind
timeFrame: 6 months followup
measure: Quality of Life Scale-Abbreviated (Functioning)
timeFrame: baseline
measure: Quality of Life Scale-Abbreviated (Functioning)
timeFrame: 6 weeks
measure: Quality of Life Scale-Abbreviated (Functioning)
timeFrame: 6 months followup
measure: Auditory Processing Speed From the Posit Science Sound Sweeps Assessment
timeFrame: Baseline
measure: Auditory Processing Speed From the Posit Science Sound Sweeps Assessment
timeFrame: 6 weeks
measure: Auditory Processing Speed From the Posit Science Sound Sweeps Assessment
timeFrame: 6 months followup
measure: Temporal Experience of Pleasures (TEPS):Reward Sensitivity--Anticipatory Pleasure
timeFrame: Baseline
measure: Temporal Experience of Pleasures (TEPS):Reward Sensitivity--Anticipatory Pleasure
timeFrame: 6 weeks
measure: Temporal Experience of Pleasures (TEPS):Reward Sensitivity--Anticipatory Pleasure
timeFrame: 6 months followup
measure: Temporal Experience of Pleasures (TEPS): Reward Sensitivity--Consummatory Pleasure
timeFrame: Baseline
measure: Temporal Experience of Pleasures (TEPS): Reward Sensitivity--Consummatory Pleasure
timeFrame: 6 weeks
measure: Temporal Experience of Pleasures (TEPS): Reward Sensitivity--Consummatory Pleasure
timeFrame: 6 months followup
measure: Verbal Memory: Delayed Recall From the Hopkins Verbal Learning Test-Revised Version (HVLT-R)
timeFrame: Baseline
measure: Verbal Memory: Delayed Recall From the Hopkins Verbal Learning Test-Revised Version (HVLT-R)
timeFrame: 6 weeks
measure: Verbal Memory: Delayed Recall From the Hopkins Verbal Learning Test-Revised Version (HVLT-R)
timeFrame: 6months followup
measure: Visual Memory: Delayed Recall From the Brief Visuospatial Memory Test-Revised Version (BVMT-R)
timeFrame: baseline
measure: Visual Memory: Delayed Recall From the Brief Visuospatial Memory Test-Revised Version (BVMT-R)
timeFrame: 6 weeks
measure: Visual Memory: Delayed Recall From the Brief Visuospatial Memory Test-Revised Version (BVMT-R)
timeFrame: 6 months followup
Secondary outcomes:
measure: UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity
timeFrame: Baseline
measure: UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity
timeFrame: 6 weeks
measure: UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity
timeFrame: 6 months followup
measure: Social Functioning Scale
timeFrame: Baseline
measure: Social Functioning Scale
timeFrame: 6 weeks
measure: Social Functioning Scale
timeFrame: 6 months followup
measure: Internalized Stigma of Mental Illness (ISMI)
timeFrame: Baseline
measure: Internalized Stigma of Mental Illness (ISMI)
timeFrame: 6 weeks
measure: Internalized Stigma of Mental Illness (ISMI)
timeFrame: 6 months followup
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, Dept of Psychiatry
state: Minnesota
Study officials:
affiliation: University of Minnesota Department of Psychiatry
name: Sophia Vinogradov, MD
role: PRINCIPAL_INVESTIGATOR
References: