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?

This trial explores how cognitive interventions can help people with schizophrenia and depression improve their thinking skills. It focuses on enhancing verbal memory and emotion control, which often challenge individuals with these conditions. Participants will receive either the cognitive intervention (also known as cognitive training, cognitive therapy, or cognitive remediation) or join an active control group. People diagnosed with schizophrenia, schizoaffective disorder, or major depression disorder, who have been on stable medication for over a month, might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to understanding cognitive interventions and their potential benefits for mental health.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments aimed at improving thinking skills for people with schizophrenia and depression are generally easy to handle. In one study, more than half of the participants completed their therapy sessions as planned, indicating that many find the treatment manageable. Another study found that computer-based versions of these therapies led to small to moderate improvements in attention, memory, and depression symptoms. These results suggest minimal side effects, as participants continued with the therapy and experienced some benefits. Overall, these treatments appear to be safe and manageable options for enhancing thinking skills in these conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cognitive Intervention for schizophrenia and depression because it offers a fresh approach beyond the typical medication and therapy options. Unlike standard treatments, which often focus on managing symptoms through pharmaceuticals like antipsychotics and antidepressants, this intervention works by enhancing cognitive functions directly. This method targets improving memory, attention, and problem-solving skills, potentially leading to better overall functioning and quality of life for patients. By focusing on cognitive rehabilitation, this treatment could provide a more holistic improvement, addressing not just symptoms but the cognitive deficits that can hinder day-to-day living.

What evidence suggests that this trial's treatments could be effective for schizophrenia and depression?

Research has shown that cognitive exercises, which participants in this trial may receive as part of the Cognitive Intervention arm, can help people with schizophrenia and depression. These exercises improve thinking skills and everyday functioning, which are crucial for daily life. One study involving 4,594 people found significant improvements in various cognitive areas. These benefits were immediate and persisted over time, suggesting that cognitive exercises could address the thinking and memory problems associated with these conditions. Meanwhile, the Active Control Intervention arm will serve as a comparator in this trial to evaluate the specific effects of the Cognitive Intervention. ^{6 7 8 9 10}

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 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]

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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38476043/

Durability of Effects of Cognitive Remediation on ... Cognitive remediation provides substantial improvements in cognitive performance and real-world functioning for people living with schizophrenia.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33772310/

A Meta-analysis of Cognitive Remediation for Schizophrenia The meta-analysis (4594 participants) revealed that CR produced significant small-to-moderate size improvements in all domains of cognition studied.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2215001322000166

Cognitive remediation in schizophrenia: What happens ... These data confirm that the improvements achieved after the CRT/SRT intervention were conserved in the great majority of cognitive abilities 10 years later.

4. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.20230396

Durability of Effects of Cognitive Remediation on ... Cognitive remediation provides substantial improvements in cognitive performance and real-world functioning for people living with schizophrenia.

5. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2778914

Effectiveness, Core Elements, and Moderators of ... In this systematic review and meta-analysis, cognitive remediation was confirmed as effective on both cognitive and functional outcomes and potentially useful ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8870375/

Advances in Cognitive Remediation Training ... Five studies found improvements in verbal working memory, with effect sizes ranging from d = 0.52 to 1.04 [7,14,30] and statistically significant outcomes of (p ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11668788/

Cognitive rehabilitation in schizophrenia research Currently, cognitive remediation approaches for schizophrenia mainly encompass pharmacological treatment (35), physical therapy (36), cognitive ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2215001323000082

Feasibility of six-month outpatient cognitive remediation in ... Results showed that 58.8 % of participants completed the CRT (>80 % of scheduled sessions) and 72.9 % completed at least half the sessions. Predictor analysis ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04123223

Comparing Cognitive Remediation Approaches for ... This research compares the relative efficacy of two empirically-supported, standardized programs of cognitive remediation for treatment of cognitive deficits ...

10. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1363290/full

Effect of computerized cognitive remediation therapy on ... One study found that CCRT had a small to moderate effect on attention, working memory, positive symptoms, and depressive symptoms (13). The ...