Cognitive Training for Serious Mental Illness

Overseen By Abigail A Mack

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance use, Low IQ, Neurological illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 10 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study addresses the critical need for innovative therapeutic interventions in Veterans with serious mental illnesses (SMI) receiving care in VA Psychosocial Rehabilitation and Recovery Centers (PRRCs). The vast majority of individuals with SMI suffer from cognitive impairments, leading to chronic functional disability, and impaired outcomes, causing a significant strain on support networks and the VA healthcare system. This study aims to introduce an innovative mental health therapy, Targeted Cognitive Training (TCT), to Veterans struggling with serious mental illnesses (SMI). TCT works to improve basic sensory information processing and, ultimately, clinical, cognitive, and psychosocial functioning. By using EEG biomarkers to identify Veterans with SMI receiving care within VA Psychosocial Rehabilitation and Recovery Centers who are most likely to benefit from this treatment, and by understanding how best to implement this therapy, the investigators hope to enhance care and improve life quality for Veterans with SMI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is cognitive training safe for people with serious mental illness?

The research does not report any safety concerns for cognitive training in people with serious mental illness, suggesting it is generally safe for use in humans. ^{1 2 3 4 5}

How is Targeted Cognitive Training different from other treatments for serious mental illness?

Targeted Cognitive Training (TCT) is unique because it focuses on improving cognitive functions through structured exercises, often supplemented with social cognition exercises, which can lead to durable cognitive and social benefits. Unlike medication, TCT directly targets cognitive deficits and is delivered through computer-assisted sessions, making it a non-drug, interactive approach to treatment. ^{4 6 7 8 9}

What data supports the effectiveness of the treatment Targeted Cognitive Training for Serious Mental Illness?

Research shows that cognitive training, including computer-assisted programs, can improve cognitive and functional performance in people with severe mental illness. Studies have found that such training can lead to significant improvements in cognitive abilities and social functioning, especially when patients are actively engaged in the training process. ^{1 6 7 8 9}

Who Is on the Research Team?

Gregory Light, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for Veterans with serious mental illnesses like schizophrenia, bipolar disorder, psychosis, or PTSD who are receiving care in VA Psychosocial Rehabilitation and Recovery Centers. It's designed to help those struggling with cognitive impairments due to their conditions.

Inclusion Criteria

I can see clearly from 20 feet what should normally be seen at that distance.

Fluency in spoken and written English

Ability to detect 1000 Hz tones binaurally at a 40-dB sound pressure level

Exclusion Criteria

I am able to understand and give informed consent.

Active substance use other than cannabis within the last 30 days as determined by CPRS review, self-report, or positive urine drug screen (obtained as part of the screening process)

Estimated premorbid IQ below 70, as estimated via the WRAT-4 Reading subtest

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Enrolled patients complete clinical, cognitive and functional measures and candidate EEG biomarkers at baseline

1 week

Treatment

Participants receive 30 hours of Targeted Cognitive Training (TCT) in addition to Treatment as Usual (TAU)

10 weeks

3 visits per week (in-person)

Follow-up

Repeat assessment occurs after TCT session #10, 20, and 30, and again 12 weeks after the cessation of TCT to evaluate the durability of observed gains

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Targeted Cognitive Training

Trial Overview The study tests Targeted Cognitive Training (TCT), a new therapy aimed at improving sensory information processing and overall brain function which may lead to better clinical outcomes and quality of life for Veterans with serious mental illnesses.

How Is the Trial Designed?

Group I: TCT + TAU Active Control 1 Intervention

Subjects will complete 30 hours of Targeted Cognitive Training (TCT) in addition to their Treatment as Usual (TAU)

Group II: TAU Active Control 1 Intervention

Subjects will participate in their standard Treatment as Usual (TAU) PRRC program

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

The computer-assisted cognitive training program (CCTP) significantly improved cognitive performance in patients with Severe Mental Illness (SMI), as evidenced by a notable increase in the Montreal Cognitive Assessment scores after 8 sessions over 8 weeks.

Participants with primary-level education experienced greater improvements in cognitive and functional performance compared to those with higher education levels, highlighting the program's effectiveness in enhancing verbal episodic memory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Assisted Cognitive Training for Patients with Severe Mental Illness: a Retrospective Study. Lau, CM., Tang, WK.[2021]

A study involving 111 participants with schizophrenia spectrum disorders found that both targeted cognitive training with social cognitive exercises (TCT + SCT) and targeted cognitive training alone (TCT) led to lasting improvements in cognition, symptoms, and functional capacity six months after the intervention.

Participants who received TCT + SCT showed greater and more enduring benefits in prosody identification and reward processing compared to those who only received TCT, suggesting that integrating social cognitive training can enhance functional outcomes in individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six month durability of targeted cognitive training supplemented with social cognition exercises in schizophrenia. Miley, K., Fisher, M., Nahum, M., et al.[2022]

In a study of 38 participants with schizophrenia-spectrum disorders, higher attendance in cognitive training sessions and more homework completion were significantly linked to improvements in neurocognition, indicating that active engagement is crucial for effective treatment outcomes.

Homework completion was found to mediate the relationship between session attendance and neurocognitive improvements, suggesting that encouraging participants to complete homework could enhance the effectiveness of cognitive remediation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivation and engagement during cognitive training for schizophrenia spectrum disorders. Best, MW., Milanovic, M., Tran, T., et al.[2022]

Cognitive training for schizophrenic patients led to significant improvements in various psychometric features, including reductions in symptoms of psychosis, irritability, and depression, as well as enhanced social interest.

The study suggests that cognitive training can effectively enhance cognitive adjustment and adaptability in patients, helping them better navigate complex social situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive training in schizophrenic diseases]. Heim, M., Wolf, S., Göthe, U., et al.[2006]

Computerized cognitive training (CCT) using Brain HQ showed significant cognitive improvements in psychiatric rehabilitation clients, with an average increase of 4.4 points in BACS t-scores after about 17 days of training.

Higher engagement in training (measured by levels completed per day) was positively correlated with cognitive gains, suggesting that monitoring engagement can help identify patients who may need additional support to benefit from CCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training engagement, baseline cognitive functioning, and cognitive gains with computerized cognitive training: A cross-diagnostic study. Harvey, PD., Balzer, AM., Kotwicki, RJ.[2020]

A 2-month home-based cognitive retraining program combined with standard treatment (TAU) significantly improved neuropsychological functions in patients with first episode schizophrenia, particularly in areas like divided attention and planning, based on a study of 45 patients.

Despite the promising results, the study had a small sample size, with only 12 patients completing the treatment group and 11 in the control group, indicating a need for further research with larger cohorts and more rigorous methodologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of home-based cognitive retraining to treatment as usual in first episode schizophrenia patients: a randomized controlled study. Hegde, S., Rao, SL., Raguram, A., et al.[2021]

In a study involving 87 participants with schizophrenia, those who underwent targeted auditory training showed significant improvements in cognitive functions such as global cognition, speed of processing, verbal learning, and verbal memory compared to a control group, after 50 hours of training over 10 weeks.

The training also led to a significant increase in serum brain-derived neurotrophic factor (BDNF) levels, which normalized by the end of the training, suggesting that BDNF may be a useful biomarker for the cognitive benefits of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroscience-informed Auditory Training in Schizophrenia: A Final Report of the Effects on Cognition and Serum Brain-Derived Neurotrophic Factor. Fisher, M., Mellon, SH., Wolkowitz, O., et al.[2020]

In a study of 46 patients with schizophrenia, cognitive training improved objective cognitive performance, particularly in verbal learning and memory, but did not lead to significant improvements in patients' subjective perception of their cognitive difficulties.

The lack of perceived cognitive improvement, despite measurable gains, may affect patients' motivation and engagement in treatment, suggesting that providing feedback on performance could enhance their awareness of progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Divergence of subjective and performance-based cognitive gains following cognitive training in schizophrenia. Treichler, EBH., Thomas, ML., Bismark, AW., et al.[2020]

The integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training (CBSST-CCT) significantly reduced negative symptoms in individuals with schizophrenia, particularly improving motivation, as shown in a pilot study with 55 participants over 12.5 weeks.

CBSST-CCT also enhanced verbal learning abilities compared to the Goal-focused Supportive Contact group, with these benefits lasting up to 6 months after treatment, indicating its potential for long-term impact on cognitive performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training for Negative Symptoms of Psychosis: Effects in a Pilot Randomized Controlled Trial. Granholm, E., Twamley, EW., Mahmood, Z., et al.[2022]

Citations

1. China pubmed.ncbi.nlm.nih.gov

Computer-Assisted Cognitive Training for Patients with Severe Mental Illness: a Retrospective Study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Six month durability of targeted cognitive training supplemented with social cognition exercises in schizophrenia. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Motivation and engagement during cognitive training for schizophrenia spectrum disorders. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Cognitive training in schizophrenic diseases]. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Training engagement, baseline cognitive functioning, and cognitive gains with computerized cognitive training: A cross-diagnostic study. [2020]

6. India pubmed.ncbi.nlm.nih.gov

Addition of home-based cognitive retraining to treatment as usual in first episode schizophrenia patients: a randomized controlled study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Neuroscience-informed Auditory Training in Schizophrenia: A Final Report of the Effects on Cognition and Serum Brain-Derived Neurotrophic Factor. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Divergence of subjective and performance-based cognitive gains following cognitive training in schizophrenia. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training for Negative Symptoms of Psychosis: Effects in a Pilot Randomized Controlled Trial. [2022]