Clinical trial NCT06286202: Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE) a Community-Based Cognitive Remediation Trial
Official title: Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE): a Community-Based Cognitive Remediation Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: cognitive remediation
Neuropsychological and Educational Approach to Remediation
Multicontext Treatment Approach
metamotivation
psychiatric rehabilitation
schizophrenia
community mental health
Lead sponsor: Singapore Institute of Technology
Sponsor class: OTHER
Collaborators: name: Singapore Anglican Community Services
First posted: 2024-02-29
Enrollment: 160
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention study model is a parallel randomized controlled trial. There will be two arms. The experimental arm is 'cognitive remediation' and the control arm is 'standard psychiatric rehabilitation'. Participants will be assigned to one of the treatment arms at the beginning of the trial and will continue in that arm throughout the length of the trial. Assignment to the group is done using a computer randomization generator. All eligible participants will be randomly assigned to one of the treatment arms (experimental or control arm) based on a 1:1 treatment allocation. Hence, those who are randomly allocated to the experimental arm will receive cognitive remediation throughout the trial, while those randomly allocated to the control arm will receive standard psychiatric rehabilitation throughout the trial. Both treatment arms will run in parallel.
Primary purpose: TREATMENT

Brief summary: Adults with serious mental illnesses (such as schizophrenia and schizoaffective disorders) often experience a range of cognitive difficulties (such as memory, problem solving difficulties) that affect their ability to lead meaningful life roles. Cognitive remediation is an intervention to address cognitive difficulties in this group of mental health service users. Its implementation in less well-resourced community-based settings is less well-studied.

Therefore, the aims of the study are:

* To investigate the effects of cognitive remediation on various cognitive skills (such as attention, memory, problem-solving, facial expression recognition, taking others' perspectives etc), for participants with schizophrenia or schizoaffective disorders in community mental health settings.
* To investigate if factors such as participants' motivation for engagement and social interaction can affect changes in cognitive skills and functional ability.

Participants in the treatment group will attend computer-based cognitive exercises to improve their cognitive skills. They will also participate in group sessions facilitated by therapists to learn how to utilize strategies learned from the computer sessions in their daily lives. Participants in the control group will attend the usual rehabilitation activities in their respective community-based psychiatric rehabilitation centers.

This research study will compare the differences in their cognitive performance, functional ability and recovery immediately after the intervention and 8 weeks later.

Detailed description: Persons with severe mental illness such as schizophrenia and schizoaffective disorders often have difficulties integrating back to the community and many face the prospect of long-term institutionalisation when families could not manage them. It is assumed that their inability to function is due to their mood and psychotic symptoms such as auditory hallucinations and persecutory delusions and paranoid thoughts. However, evidence has shown that neurocognitive impairment (such as information processing, memory, problem solving) coupled with social cognitive problems (such as difficulty with emotion recognition, perspective taking etc) are the ones with more long-term impact on their functioning (Green et.al., 2000; Tan, 2009).

Cognitive remediation is a form of intervention that addresses cognitive impairments of persons with psychiatric conditions, in order to improve real-world functioning. There are several approaches to cognitive remediation. One of the well-studied cognitive remediation programmes is the Neuropsychological and Educational Approach to Remediation (NEAR), which consists of computer-assisted cognitive exercises, followed by bridging sessions to generalise strategies learnt to daily living. NEAR is conducted in groups of 5-8 clients and is facilitated by 1-2 therapists (Medalia, Revheim and Herlands, 2009). It uses drill-and-practice rehearsal method to improve discrete cognitive skills, as well as strategy-learning method to equip clients with strategies to overcome cognitive challenges in different functional scenarios. NEAR has been implemented in inpatient wards, supported housing settings and outpatient rehabilitation settings in United States and other countries, largely with schizophrenia and schizoaffective disorders clients (Medalia et.al., 2000, 2003, 2019). In Singapore, cognitive remediation has been conducted in early psychosis intervention service with positive results (Chong et.al., 2021).

Meta-analyses of cognitive remediation has shown that while the rehearsal approach improves cognitive performance, the strategy learning approach has a greater effect size on functional outcomes (McGurk et.al., 2007; Wykes et.al., 2011). Deepening strategy learning in cognitive remediation is thus an important ingredient within cognitive remediation. In occupational therapy practice, the Multicontext Treatment Approach has been established as a credible and evidence-based framework on strategy learning (Toglia et.al, 2011, 2020). It utilises an over-arching metacognitive strategy approach that focuses on promoting self-awareness, self-monitoring skills, strategy generation and effective strategy use across a wide range of functional activities. The therapist works closely with the service user to determine single or multiple strategies that can be applied across a broad range of occupations, activities and tasks (Toglia, 2018). Thus, incorporating the Multicontext Treatment Approach as a strategy learning framework within NEAR will enhance skills acquisition for persons with cognitive impairment and may yield better functional outcomes.

In addition, literature over the past decade has highlighted the overlapping constructs between neurocognition, social cognition and negative symptoms in the pathway between symptomatology and functional outcomes (Hajdúk, et.al., 2021; Ventura et.al., 2009). Therefore, integrated neuro and social cognitive remediation have been developed, with some positive findings (DeMare et.al., 2019; Tan et.al., 2018) Such interventions, when contextualised to service users' occupational context, have been shown to improve social functioning and community independence (Mueller et.al., 2015. Furthermore, negative symptoms such as low motivation (ie: avolition) appears to play a significant mediating role in the outcomes of cognitive remediation (Lynch et.al., 2022). Therefore, strategies to enhance motivation, specifically the self-awareness and monitoring of motivation (ie: metamotivation) have also been considered as part of strategy learning.

In light of recent advancement in the research of cognitive remediation, this study attempts to integrate current knowledge in the various therapeutic ingredients of cognitive remediation to deliver an adapted NEAR intervention that meets the needs of community-dwelling persons with schizophrenia and schizoaffective disorders. The adapted NEAR intervention, which comprises of computer-based cognitive exercises and bridging groups, will be implemented in three community psychiatric rehabilitation centers, namely: 1) Anglican Care Center-Hougang; 2) Anglican Care Center-Simei and 3) Anglican Care Center-Bukit Batok.

1. To investigate the effects of cognitive remediation on:

   * neurocognition (measured by Brief Assessment of Cognition)
   * social cognition (measured by Bell Lysaker Emotion Recognition Task)
   * functional outcomes (Social and Occupational Functioning Assessment Scale and Canadian Occupational Performance Measure).
2. To investigate the mediators for change (eg: motivation and negative symptoms) in cognitive performance and functional outcomes.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-V).
* Completed at least ten years of formal education with English as the main instructional language. Participants need to be able to converse in English and understand English instructions, as the cognitive remediation program will be conducted in English.

Exclusion Criteria:

* Known neurological diseases and epilepsy, which affects gains from cognitive remediation.
* Unable to speak and understand English.
* Hospitalized within the past one month.
* Global Assessment of Functioning score of 30 or below, as participants who are too low functioning are unable to benefit from a strategy learning approach.

Primary outcomes:
measure: Brief Assessment of Cognition in Schizophrenia (BACS)
timeFrame: Baseline, post-intervention and 8-week follow-up
measure: Bell Lysaker Emotion Recognition Task (BLERT)
timeFrame: Baseline, post-intervention and 8-week follow-up
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Baseline, post-intervention and 8-week follow-up
measure: Social and Occupational Functioning Assessment Scale (SOFAS)
timeFrame: Baseline, post-intervention and 8-week follow-up
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline, post-intervention and 8-week follow-up
measure: Brief Negative Symptom Scale (BNSS)
timeFrame: Baseline, post-intervention and 8-week follow-up
measure: Brief Regulation of Motivation Scale (BRoMS)
timeFrame: Baseline, post-intervention and 8-week follow-up
measure: Weekly Calendar Planning Activity (WCPA)
timeFrame: Baseline, post-intervention and 8-week follow-up
Other outcomes:
measure: The Global Assessment of Functioning Scale (GAF)
timeFrame: Baseline only, to exclude participants with a score of 30 or lower.
Locations:
city: Singapore
country: Singapore
facility: Anglican Care Center-Bukit Batok
city: Singapore
country: Singapore
facility: Anglican Care Center-Hougang
city: Singapore
country: Singapore
facility: Anglican Care Center-Simei
Study officials:
affiliation: Bhing-Leet Tan
name: Bhing-Leet Tan, PhD
role: PRINCIPAL_INVESTIGATOR
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