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 trial explores a new therapy called Targeted Cognitive Training (TCT) for Veterans with serious mental illnesses such as schizophrenia, bipolar disorder, or PTSD. The goal is to improve sensory information processing, enhancing overall mental and social functioning. Participants will receive either TCT alongside their usual care or just their usual care for comparison. Veterans currently receiving treatment at VA Psychosocial Rehabilitation and Recovery Centers, who experience cognitive challenges due to their mental health condition, might be a good fit.

As an unphased trial, this study offers Veterans the opportunity to potentially benefit from innovative therapy while contributing to valuable research.

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.

What prior data suggests that Targeted Cognitive Training is safe for Veterans with serious mental illnesses?

Research shows that Targeted Cognitive Training (TCT) may benefit individuals with severe mental illness. Although specific safety data for TCT is unavailable, similar cognitive training types have been studied. These studies indicate that such methods can improve thinking skills without causing serious side effects. Generally, participants tolerate these exercises well.

The trial phase is marked as "Not Applicable," indicating that TCT is neither a new drug nor an invasive treatment. It likely resembles therapies safely used in other contexts, suggesting a lower risk of side effects. However, participants should discuss any concerns with the trial team before joining. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Targeted Cognitive Training (TCT) for serious mental illness because it offers a fresh approach to enhancing cognitive functions, which traditional medications like antipsychotics or mood stabilizers don't specifically address. Unlike standard treatments that primarily focus on managing symptoms, TCT aims to improve mental processes such as memory, attention, and problem-solving skills through structured exercises. This method could potentially lead to better overall functioning and quality of life for individuals with serious mental illnesses, providing benefits beyond symptom control.

What evidence suggests that Targeted Cognitive Training is effective for serious mental illness?

Research has shown that Targeted Cognitive Training (TCT) can enhance brain function in individuals with serious mental health issues. This training includes exercises that become more challenging as participants improve, aiding memory and thinking skills. One study found that these improvements in cognitive and daily activities persisted for six months after the training concluded. Approximately 67% of studies reported significant improvements in at least one area of cognitive skills. In this trial, participants will either receive TCT in addition to their Treatment as Usual (TAU) or continue with their standard TAU program. This indicates that TCT can be a promising method to enhance mental processing and overall quality of life for those with serious mental health conditions. ^{3 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

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10698422/

Analysis of the effectiveness of cognitive rehabilitation for ... The meta-analysis showed that cognitive rehabilitation treatment applied to patients with chronic mental illness was effective in improving cognitive function ...

2. mirecc.va.gov mirecc.va.gov/visn22/cognitivetraining.pdf

Cognitive Training in Serious Mental Illness Uses computerized exercises that adapt to user performance, getting harder as performance improves. For example, programs targeting word recall and memory may ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2215001319300204

Six month durability of targeted cognitive training ... Both TCT + SCT and TCT-only result in durable improvements in cognition, symptoms, and functional capacity six months post-intervention.

4. clinicaltrials.gov clinicaltrials.gov/show/NCT01722344

Improving Work Outcome for People With Severe Mental ... The aim of this study is to investigate the effectiveness of IPS in Denmark and compare effects of 1. IPS vs. 2. IPS + cognitive remediation and work-related ...

5. mdpi.com mdpi.com/2077-0383/13/15/4348

A Systematic Review and Narrative Synthesis of Cognitive ... Approximately 67% of studies reported significant improvements in at least one trained domain of cognitive function after CT, and 47% observed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5816728/

Compensatory Cognitive Training for People with Severe ... We conclude that CCT has the potential to improve cognitive performance, psychiatric symptom severity, and quality of life in people with severe mental ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5675044/

A 60-week prospective randomized controlled trial of ... This 60-week, randomized controlled trial assessed TTIM vs. treatment as usual in 200 individuals with serious mental illness and diabetes.

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0304527

Supported employment interventions with people who have ... Primary and review studies show that supported employment interventions showed promise in assisting people with severe mental illness (SMI) ...

9. sciencedirect.com sciencedirect.com/org/science/article/pii/S2291927922000502

The Effectiveness and Safety of Serious Games for ... The results of the experiments were compiled and categorized based on the comparator as follows: control, conventional exercises, conventional cognitive ...