Minnesota Community-Based Cognitive Training in Early Psychosis

Schizophrenia Clinical Trial

— Mini-COTES  

Official title:

Minnesota Community-Based Cognitive Training in Early Psychosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079024
• Other study ID #: PSYCH-2017-25503
• Status: Completed
• Phase: N/A
• Start date: May 19, 2017
• Est. completion date: March 26, 2022

Study information

• Verified date: February 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 26, 2022
• Est. primary completion date: March 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder With Psychotic Features
• Depression Psychotic Feature
• Mental Disorders
• Psychosis
• Psychosis NOS
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorders
• Unspecified Psychosis

Intervention

Device:
• Targeted Cognitive Training
Auditory Training Module (20 hours): exercises designed to improve speed and accuracy of auditory processing while engaging working memory and cognitive control. Exercises adjust difficulty level to maintain an ~80% correct performance. Exercises contain stimuli spanning the acoustic organization of speech. In the initial stages, stimuli exaggerate the rapid temporal transitions by increasing amplitude and stretching in time. The exaggeration is gradually removed so that by the end, all stimuli have characteristics representative of real-world speech. Social Cognition Module (10 hours): exercises designed to improve core deficits of social cognition in psychosis. Exercises apply principles of implicit learning to restore capacity to process and utilize socially-relevant information, and includes training to improve perception of affect (visual/vocal) and social cues (faces, gazes, social situations), theory of mind, self-referential style, emotion labeling and working memory.
• General Cognitive Exercises
The GCE will focus on executive dysfunction, as this domain is a significant, functionally important area of deficit in schizophrenia and has been the target of many previous studies. We will train this domain using a suite of engaging, adaptive web-based exercises that target executive function, intelligence, and spatial navigation developed by Posit Science. The exercises will be provide engaging, adaptive training as described in the Targeted Cognitive Training.

Other:
• Coordinated Specialty Care for First Episode Psychosis
Individuals in this study are receiving care from a coordinated specialty care clinic (CSC) for first episode psychosis. These clinics are following the NAVIGATE treatment model for early psychosis.

Locations

Country	Name	City	State
United States	University of Minnesota, Dept of Psychiatry	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Aggregated Feasibility Score	We will measure and compare the feasibility of the cognitive training programs integrated in the EIS through 1) attrition rates and 2) time to completion of training. These items will be aggregated into a feasibility score which will describe the percentage of participants that were able to complete the program as described.	Post-Training (6 weeks)
Other	Acceptability: Patient	At post-training (6 weeks), subjects will complete a Likert-type questionnaire composed of elements of a measure used previously by Brain Plasticity Institute to evaluate acceptability for their cognitive training software, and components of a measure we have used previously to assess acceptability of training in our recent-onset RCT. Items assess user experience and satisfaction with the programs, the web-based administration, and the training schedule.	Post-Training (6 weeks)
Other	Acceptability: Clinician	Clinicians will complete a Likert-type questionnaire that assess their experience in supporting the clients to use the program, perceived impact on the clients, and the likelihood of using the program outside of a research study.	Post-Training (6 weeks)
Primary	Change from Baseline in Neurocognition Scores	Neurocognition will be assessed using the MATRICS Consensus Cognitive Battery [MCCB]. The MCCB assesses the following domains of neurocognitive functioning: 1) Speed of Processing, 2) Attention/Vigilance, 3) Working Memory, 4) Verbal Learning, 5) Visual Learning, 6) Reasoning and Problem Solving; and 7) Social Cognition. We will also assess Verbal Memory (HVLT delayed recall), Visual Memory (BVMT delayed recall), and administer an additional measure of Reasoning and Problem Solving [BACS Tower of London]. In addition to the MCCB measure of social cognition, we will assess the following constructs: affect recognition, emotional prosody [Penn Prosody Identification, and theory of mind [Faux Pas test.7 hours spread over 3 appointments in a 1-2 week period, 5 hours post-training and an additional 5 hours at a 6-month follow-up.	Post-Training (6 weeks)
Primary	Change from Baseline in Functioning Status Scores	The Quality of Life Scale-Abbreviated will be our primary outcome measure of functional status. This measure assesses quality of life using subjective questions regarding life satisfaction and objective indicators of social and occupational functioning.	Post-Training (6 weeks)
Primary	Change from Baseline in Auditory Processing Speed	Early target engagement is the degree to which an individual demonstrates initial performance improvement ("learning") upon exposure to training. Early target engagement will be measured by auditory processing speed during cognitive training exercises.	10 hours of training
Primary	Reward Sensitivity	The Temporal Experience of Pleasure Scale (TEPS) will be used to assess reward sensitivity.	Baseline
Secondary	Change from Baseline in Functional Capacity	Secondary measures of functional capacity/status will include the following MATRICS-recommended measure: The UCSD Performance Based Skills Assessment [UPSA-Brief].	Post-Training (6 weeks)
Secondary	Change from Baseline in Functional Capacity	Secondary measures of functional capacity/status will include the following MATRICS-recommended measure: The UCSD Performance Based Skills Assessment [UPSA-Brief].	6 Month Follow-up
Secondary	Change from Baseline in Social Functioning	Secondary measures of social functioning will include: The Social Functioning Scale.	Post-Training (6 weeks)
Secondary	Change from Baseline in Social Functioning	Secondary measures of social functioning will include: The Social Functioning Scale.	Baseline to 6 Month Follow-up
Secondary	Change from Baseline in Internalized Stigma	In order to measure internalized stigma, a component of recovery, we will use the Internalized Stigma of Mental Illness (ISMI) Scale.	Post-Training (6 weeks)
Secondary	Change from Baseline in Internalized Stigma	In order to measure internalized stigma, a component of recovery, we will use the Internalized Stigma of Mental Illness (ISMI) Scale.	6 Month Follow-up
Secondary	Change from Baseline in Neurocognition Scores	Neurocognition will be assessed using the MATRICS Consensus Cognitive Battery [MCCB]. The MCCB assesses the following domains of neurocognitive functioning: 1) Speed of Processing, 2) Attention/Vigilance, 3) Working Memory, 4) Verbal Learning, 5) Visual Learning, 6) Reasoning and Problem Solving; and 7) Social Cognition. We will also assess Verbal Memory (HVLT delayed recall), Visual Memory (BVMT delayed recall), and administer an additional measure of Reasoning and Problem Solving [BACS Tower of London]. In addition to the MCCB measure of social cognition, we will assess the following constructs: affect recognition, emotional prosody [Penn Prosody Identification], and theory of mind [Faux Pas test]. 7 hours spread over 3 appointments in a 1-2 week period, 5 hours post-training and an additional 5 hours at a 6-month follow-up.	6-Month Follow-up
Secondary	Change from Baseline in Functioning Status Scores	The Quality of Life Scale-Abbreviated will be our primary outcome measure of functional status. This measure assesses quality of life using subjective questions regarding life satisfaction and objective indicators of social and occupational functioning.	Baseline to 6-Month Follow up