Cognitive Training for Mental Health Conditions

Overseen By Jessica Bomyea, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of California, San Diego

Must be taking: SSRIs

Must not be taking: Psychiatric pharmacotherapy

Disqualifiers: Substance use, Psychotic, Bipolar, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

128 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed project aims to test the cognitive and neural effects of a cognitive training in a sample of individuals seeking treatment for anxiety, depression, or traumatic stress symptoms. Participants will be randomly assigned to one of two groups. Group 1 will receive a computer-based program that is designed as a cognitive training intervention and Group 2 will receive a similar computer-based exercise that researchers think will be less effective in training thinking skills (also known as a control or sham condition). Participants will be compared on cognitive performance and brain response during cognitive tasks from baseline to post-treatment.

Will I have to stop taking my current medications?

If you are taking medications other than SSRIs (a type of antidepressant), you may need to stop, as the trial excludes those currently receiving psychiatric pharmacotherapy except for SSRIs. If you are on SSRIs, you need to have been stable on them for at least 6 weeks.

What data supports the effectiveness of the treatment COGENT, Sham Program for mental health conditions?

Research shows that computerized cognitive training (CCT) can improve cognitive function in people with mental health conditions like depression, bipolar disorder, and schizophrenia. Improvements are linked to how engaged participants are with the training, suggesting that similar cognitive training programs may help improve mental health symptoms. ^{1 2 3 4 5}

Is cognitive training safe for mental health conditions?

Research on computerized cognitive training for mental health conditions, like schizophrenia and depression, shows it is generally safe and well-tolerated by participants. Patients often find the training acceptable and report improvements in cognitive function and well-being. ^{1 2 6 7 8}

How does the COGENT treatment differ from other treatments for mental health conditions?

COGENT, a cognitive training treatment, is unique because it focuses on improving cognitive functions like memory and attention, which can enhance social behavior and mood. Unlike traditional treatments that may focus on medication, COGENT uses structured exercises to improve mental capacity and adaptability, making it a simple yet effective option for mental health conditions. ^{1 2 9 10 11}

Eligibility Criteria

This trial is for individuals seeking treatment for anxiety, depression, or traumatic stress symptoms. Participants should be willing to undergo cognitive training and brain response assessments. Specific eligibility criteria are not provided but typically include age range, mental health status, and absence of conditions that could interfere with the study.

Inclusion Criteria

Own a smartphone

I often find myself stuck in negative thought loops.

I have been on a stable dose of SSRI medication for at least 6 weeks.

Exclusion Criteria

Past year diagnosis of severe alcohol or moderate or greater substance use disorder

Lifetime history of psychotic or bipolar I disorder

Acute suicidality necessitating immediate clinical intervention

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cognitive training intervention or sham training program

16 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• COGENT
• Sham Program

Trial Overview The trial is testing a computer-based cognitive training program called COGENT against a control exercise (Sham Program) thought to be less effective. Participants will be randomly assigned to one of these two groups and their thinking skills and brain responses will be compared before and after the intervention.

Participant Groups

Group I: COGENT - Cognitive Training Intervention Program Experimental Treatment 1 Intervention

Computer-administered cognitive training program. COGENT is a modified working memory capacity task designed to train cognitive functioning. COGENT was designed to contain high interference across trials. By requiring repeated practice with utilization of interference control across trials, COGENT is thought to enhance plasticity of cognitive systems and improve performance. That is, training is based on the premise that learning-based neural changes will occur via repeated exposure to a task demanding cognitive control resources

Group II: Non-Training Program Placebo Group 1 Intervention

The non-training condition requires participants to complete a similar computer task for the same length of time. The non-training is a modified working memory capacity task designed to be inert. The non-training condition was designed to contain relatively less interference demands across trials.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Findings from Research

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]

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]

A structured problem-solving program for 15 patients with severe mental illness led to significant improvements in their symptoms, as measured by the Positive and Negative Syndrome Scale, after completing the training.

Participants also showed enhanced problem-solving abilities and neurocognitive performance, with continued improvements observed six months after the program ended, suggesting lasting benefits from the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem-solving skills for cognitive rehabilitation among persons with chronic psychotic disorders in Italy. Barbieri, L., Boggian, I., Falloon, I., et al.[2018]

The adaptation of Metacognitive Training for patients with Psychosis (MCT) to create MCT-Acute is feasible for use in acute inpatient settings, providing a structured intervention for patients with severe mental illness.

A case report of a patient who participated in MCT-Acute indicated positive outcomes, including improved mood and behavioral changes, suggesting that this adapted intervention can effectively complement traditional treatment plans in acute care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'You are trying to teach us to think more slowly!': Adapting Metacognitive Training for the acute care setting-A case report. Fischer, R., Scheunemann, J., Bohlender, A., 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 71 first episode psychosis patients showed significant improvements in global cognition, particularly in working memory and processing speed, indicating its potential effectiveness in enhancing cognitive function.

Patients without comorbid diagnoses who participated in cognitive training had lower re-hospitalization rates compared to those in other treatment programs, suggesting that cognitive training may improve long-term outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Cognitive Training in an Intensive Outpatient First Episode Psychosis Program. Murray, A., Svendahl, K., Lee, S., et al.[2019]

In a multicenter study involving 64 patients with schizophrenia, a 5-week computer-based cognitive training program (Cogpack) was found to significantly improve cognitive function and was highly accepted by the participants.

Patients reported increased self-esteem and reduced computer anxiety after the training, indicating that not only was the cognitive training effective, but it also positively impacted their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Subjective experience of a computer-assisted cognitive training by patients with schizophrenia]. Bender, S., Dittmann-Balcar, A., Prehn, G., et al.[2018]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

In a study of 14 elderly female patients with cognitive impairments, those who received 15 days of cognitive training showed significant improvements in memory and attention compared to a control group that received nonspecific attention.

Cognitive training not only enhanced cognitive performance but also positively affected social behavior, mood, and motivation, highlighting its importance in rehabilitation for elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive training in psycho-organic syndromes]. Günther, V., Fuchs, D., Schett, P., et al.[2018]

Cognitive training has evolved from primarily focusing on schizophrenia to being applied to various neuropsychiatric disorders, such as ADHD, mood disorders, and substance use disorders, by leveraging the brain's neuroplasticity to improve cognitive functions related to emotion regulation and daily functioning.

While cognitive training shows promise as an effective alternative to pharmacological treatments for cognitive deficits, further research is necessary to clarify its mechanisms, identify predictors of success, and enhance its practical application in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training in mental disorders: update and future directions. Keshavan, MS., Vinogradov, S., Rumsey, J., et al.[2022]

The Strategic Memory Advanced Reasoning Training (SMART) program, when condensed into 6 to 10 hours over 2 to 3 days, significantly improved cognitive performance in military personnel, veterans, and police officers, particularly in areas like integrated reasoning and innovation.

Participants also reported significant improvements in psychological health immediately after training, with some sustained benefits observed in follow-up assessments, indicating that the SMART strategies can be effectively taught and applied in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Cognitive Training When Translated From the Laboratory to the Real World. Young, LR., Zientz, JE., Spence, JS., et al.[2022]

References

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

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

2. Germany pubmed.ncbi.nlm.nih.gov

[Cognitive training in schizophrenic diseases]. [2006]

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

Problem-solving skills for cognitive rehabilitation among persons with chronic psychotic disorders in Italy. [2018]

4. England pubmed.ncbi.nlm.nih.gov

'You are trying to teach us to think more slowly!': Adapting Metacognitive Training for the acute care setting-A case report. [2022]

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

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

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

Effectiveness of Cognitive Training in an Intensive Outpatient First Episode Psychosis Program. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

[Subjective experience of a computer-assisted cognitive training by patients with schizophrenia]. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

[Cognitive training in psycho-organic syndromes]. [2018]

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

Cognitive training in mental disorders: update and future directions. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Efficacy of Cognitive Training When Translated From the Laboratory to the Real World. [2022]