Cognitive Rehabilitation for Schizophrenia and Depression

Overseen By Synthia Guimond, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Royal Ottawa Mental Health Centre

Must not be taking: Anticholinergics, Benzodiazepines

Disqualifiers: Neurological disorders, Substance abuse, others

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

Compensation: Varies

Number of Visits: 4

Duration: 7 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Schizophrenia and depression are among the most disabling disorders in all of medicine. Cognitive deficits play a key role in patients' disability, affecting their capacity to contribute actively to society by sustaining employment or academic activity. Moreover, cognitive difficulties tend to persist even after the stabilization of other clinical symptoms. Verbal memory and emotion regulation are two important cognitive domains that are impaired in schizophrenia and depression and are associated with patients' functional outcomes. In this study, we are using brain imaging to investigate the brain mechanisms underlying these cognitive deficits in these populations.

Will I have to stop taking my current medications?

The trial requires that your medication be stable for more than one month, and you cannot be taking medications with a high anticholinergic burden or benzodiazepines daily. If your current medications meet these criteria, you may not need to stop them.

Is cognitive rehabilitation therapy safe for humans?

Cognitive rehabilitation therapy (CRT) has been studied in patients with schizophrenia, and during a six-month outpatient treatment, serious adverse events occurred in 15.8% of patients, which is similar to rates reported in other studies. This suggests that CRT is generally safe for humans, with a safety profile comparable to other treatments. ^{1 2 3 4 5}

How is cognitive intervention treatment different from other treatments for schizophrenia and depression?

Cognitive intervention treatment is unique because it focuses on improving cognitive skills like attention, memory, and problem-solving, which can help patients better manage their symptoms and improve their daily functioning. Unlike medication, which targets chemical imbalances, this treatment uses exercises and activities to enhance brain function and is often used alongside other therapies. ^{4 5 6 7 8}

What data supports the effectiveness of the treatment Cognitive Rehabilitation for Schizophrenia and Depression?

Research shows that cognitive remediation, a part of cognitive rehabilitation, helps improve thinking skills and daily functioning in people with schizophrenia. This suggests that similar treatments could be beneficial for cognitive issues in other conditions like depression. ^{5 7 9 10 11}

Who Is on the Research Team?

Synthia Guimond, PhD

Principal Investigator

Royal Ottawa Mental Health Centre

Are You a Good Fit for This Trial?

This trial is for adults aged 18-45 with schizophrenia, schizoaffective disorder, or major depression who have been on stable medication for over a month. Participants must have an IQ above 70 and be fluent in English. It's not suitable for those with cognitive impairments from medical conditions, under guardianship due to decisional incapacity, MRI contraindications, recent substance abuse, or taking certain anticholinergic or daily benzodiazepine medications.

Inclusion Criteria

Current Intelligence Quotient (IQ) > 70 as measured by the Wechsler Abbreviated Scale of Intelligence (WASI)

You must be able to speak and read English fluently.

Stable medication for more than one month

Exclusion Criteria

Any magnetic resonance imaging (MRI) contraindications (e.g. metallic head implant, history of seizure, pacemaker)

You have had problems with drugs or alcohol in the past three months.

I have a medical condition that affects my thinking or memory.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments including cognitive and social functioning tests

1 week

1 visit (in-person)

Treatment

Participants undergo cognitive tasks and fMRI scans to assess brain activity and cognitive function

7 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in cognitive and social functioning post-treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active Control Intervention
• Cognitive Intervention

Trial Overview The study tests a cognitive rehabilitation intervention aimed at improving verbal memory and emotion regulation in patients with schizophrenia and depression. The effectiveness will be measured by changes in cognition, brain function, community functioning, symptom severity, and perceived cognitive deficits.

How Is the Trial Designed?

Group I: Cognitive Intervention Experimental Treatment 1 Intervention

Group II: Active Control Intervention Active Control 1 Intervention

Who Is Running the Clinical Trial?

The Royal Ottawa Mental Health Centre

Lead Sponsor

Trials

24

Recruited

2,300+

Published Research Related to This Trial

Cognitive remediation is an effective non-pharmacological treatment for cognitive deficits in schizophrenia, showing moderate improvements in cognitive test performance and daily functioning based on six meta-analytic studies.

The effectiveness of cognitive remediation varies among patients due to factors like their baseline cognitive abilities, the instructional techniques used, and their motivation, which can influence their response to the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive remediation in schizophrenia. Medalia, A., Choi, J.[2021]

In a study involving 90 patients with schizophrenia, both Integrated Psychological Therapy (IPT-cog) and computer-assisted cognitive remediation (CACR) showed significant improvements in symptoms and cognitive functions compared to usual rehabilitative interventions over 24 weeks.

While both methods were effective, IPT-cog was particularly better at enhancing speed of processing, whereas CACR outperformed both IPT-cog and usual care in overall health outcomes, indicating that both approaches can be beneficial in a typical care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of different modalities of cognitive remediation on symptomatological, neuropsychological, and functional outcome domains in schizophrenia: a prospective study in a real-world setting. Vita, A., De Peri, L., Barlati, S., et al.[2018]

The CIRCuiTS program, a new computerized cognitive remediation therapy, showed significant improvements in visual memory and community functioning in 93 individuals with schizophrenia, with 85% adherence to the program.

Improvements in executive functioning were identified as a key predictor of enhanced social functioning, suggesting that targeting executive skills could lead to better outcomes in cognitive remediation for schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new generation computerised metacognitive cognitive remediation programme for schizophrenia (CIRCuiTS): a randomised controlled trial. Reeder, C., Huddy, V., Cella, M., et al.[2022]

Cognitive remediation interventions were successfully integrated into the treatment of 89 individuals with schizophrenia, with 34 participants completing over 20 hours of training, leading to significant improvements in cognitive function as measured by the Brief Assessment of Cognition in Schizophrenia (BACS).

Despite the overall acceptance of the program, the main barrier to participation was a lack of interest, highlighting the need for further research to explore effective strategies for increasing engagement in cognitive remediation among individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful implementation of a cognitive remediation program in everyday clinical practice for individuals living with schizophrenia. John, AP., Yeak, K., Ayres, H., et al.[2019]

Cognitive remediation has shown effectiveness in improving cognitive impairments in adult patients with schizophrenia, particularly in areas like attention, memory, and problem-solving, which can enhance overall functioning.

However, there is limited research on its efficacy during the early stages or prodromal phase of schizophrenia, indicating a need for more studies to confirm its benefits in these critical periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive remediation in the early course of schizophrenia: a critical review. Barlati, S., De Peri, L., Deste, G., et al.[2019]

Outpatient cognitive remediation therapy (CRT) for schizophrenia over six months showed that 58.8% of participants completed more than 80% of their scheduled sessions, indicating good adherence to the treatment.

The safety of outpatient CRT was comparable to existing literature, with serious adverse events occurring in 15.8% of patients, suggesting that this approach is feasible for improving cognitive function in schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of six-month outpatient cognitive remediation in schizophrenia: Experience from the randomized controlled integrated social cognition and social skills therapy study. Schuster, T., Lowe, A., Weide, K., et al.[2023]

In a study involving 62 patients with Schizophrenia Spectrum Disorders, a short computer-based Cognitive Remediation Therapy (CRT) program showed modest improvements in visual memory but did not significantly enhance attention or executive functions.

The CRT consisted of 10 sessions using the Cogpack software, suggesting that while short-term CRT can have some benefits, a longer and more comprehensive rehabilitation approach may be necessary for more substantial cognitive improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Short Course Computer-assisted Cognitive Remediation in Patients with Schizophrenia Spectrum Disorders: A Randomized Clinical Trial. Hatami, S., Mirsepassi, Z., Sedighnia, A., et al.[2022]

Younger individuals with schizophrenia (under 40 years) showed greater benefits from cognitive remediation therapy (CRT) in cognitive flexibility and planning compared to older individuals (40 years and above), although both age groups improved in memory.

Negative symptoms of schizophrenia were more effectively reduced in younger participants undergoing CRT, suggesting that age may influence the effectiveness of this therapy, indicating a need for modifications to better support older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does age matter? Effects of cognitive rehabilitation across the age span. Wykes, T., Reeder, C., Landau, S., et al.[2021]

A clinical trial involving 60 patients with schizophrenia showed that a computer-assisted cognitive remediation program (Cog-trainer) significantly improved attention, concentration, and working memory compared to usual rehabilitation alone after 20 sessions over 3 months.

While the Cog-trainer group demonstrated cognitive improvements that positively affected job functioning, there were no significant changes in the patients' symptoms, indicating that while cognitive rehabilitation can enhance cognitive skills, it may not directly alleviate schizophrenia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of computerized cognitive rehabilitation training on symptomatological, neuropsychological and work function in patients with schizophrenia. Lee, WK.[2018]

Cognitive remediation is an emerging treatment for schizophrenia that aims to improve cognitive functions, social skills, and potentially alleviate symptoms, complementing traditional medication and therapy.

Several cognitive remediation programs have shown efficacy in enhancing neurocognition and functional outcomes, although the long-term benefits after treatment completion need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive remediation: a promising tool for the treatment of schizophrenia. Demily, C., Franck, N.[2018]

Recent studies on cognitive rehabilitation for schizophrenia highlight that improvements in cognitive function are specific to the type of training used, such as neurocognitive or social cognition training, but do not show significant differences in their effects on other cognitive domains or symptoms.

There is a growing emphasis on combining different cognitive remediation methods and tailoring interventions to individual patient needs to enhance the transfer of cognitive skills to real-world functional improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive rehabilitation for people living with schizophrenia - the newest interventions]. Linke, M., Jarema, M.[2018]

Citations

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

Cognitive remediation in schizophrenia. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of different modalities of cognitive remediation on symptomatological, neuropsychological, and functional outcome domains in schizophrenia: a prospective study in a real-world setting. [2018]

3. England pubmed.ncbi.nlm.nih.gov

A new generation computerised metacognitive cognitive remediation programme for schizophrenia (CIRCuiTS): a randomised controlled trial. [2022]

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

Successful implementation of a cognitive remediation program in everyday clinical practice for individuals living with schizophrenia. [2019]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Cognitive remediation in the early course of schizophrenia: a critical review. [2019]

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

Feasibility of six-month outpatient cognitive remediation in schizophrenia: Experience from the randomized controlled integrated social cognition and social skills therapy study. [2023]

7. Iran pubmed.ncbi.nlm.nih.gov

A Short Course Computer-assisted Cognitive Remediation in Patients with Schizophrenia Spectrum Disorders: A Randomized Clinical Trial. [2022]

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

Does age matter? Effects of cognitive rehabilitation across the age span. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

Effectiveness of computerized cognitive rehabilitation training on symptomatological, neuropsychological and work function in patients with schizophrenia. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Cognitive remediation: a promising tool for the treatment of schizophrenia. [2018]

11. Poland pubmed.ncbi.nlm.nih.gov

[Cognitive rehabilitation for people living with schizophrenia - the newest interventions]. [2018]