Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06286202

Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE) a Community-Based Cognitive Remediation Trial

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anglican Care Center-Bukit Batok, Singapore

Loading trial locations.

About this study

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 five community psychiatric rehabilitation centers, namely: 1) Anglican Care Center-Hougang; 2) Anglican Care Center-Simei; 3) Anglican Care Center-Bukit Batok; 4) Anglican Care Center-Yishun and 5) Anglican Care Center-Pasir Ris.

  • 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).
  • To investigate the mediators for change (eg: motivation and negative symptoms) in cognitive performance and functional outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR)

Behavioral

NEAR consists of computer-assisted cognitive exercises to restore cognitive functioning through rehearsal and strategy learning. Based on the results of the baseline assessments, the therapist will complete the Cognitive Remediation Treatment Plan, to outline targeted cognitive domains and functional goals. During the cognitive games sessions, the Multicontext Treatment Approach will be used, where error patterns are identified. The participants will work on metacognition and use of strategies to overcome challenges faced during the computer games sessions. Bridging groups may include activities for participants to utilize strategies learnt during the computer game sessions to everyday living. Participants will also learn about cognitive impairments and how lifestyle modifications, mood regulation etc can affect cognitive performance. In addition, they will learn about metamotivation and build awareness about their motivation levels through self- reflection and self-monitoring.

Standard Psychiatric Rehabilitation at Anglican Care Centers

Behavioral

Participants in the control arm will attend their usual psychiatric rehabilitation activities. These activities may include vocational training, community living skills training, psychoeducation, social skills training and peer support etc. These activities are also undertaken by participants in the experimental arm.

Primary outcomes

  1. Brief Assessment of Cognition in Schizophrenia (BACS)

    Time frame: Baseline, post-intervention and 8-week follow-up

    The Brief Assessment of Cognition in Schizophrenia (BACS) assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia. This assessment was validated and found to be sensitive and highly correlated with the standard battery composite scores in patients (r = 0.76) and healthy controls (r = 0.90) (Keefe et.al., 2004). BACS was also previously normed in English-speaking adult age Singaporeans (Eng et al., 2014), and had demonstrated good convergent validity with education (Lam et al., 2013) and discriminability between healthy controls and schizophrenia (Lam et al., 2014). BACS is now widely used as an outcome measurement for cognitive remediation for schizophrenia.

  2. Bell Lysaker Emotion Recognition Task (BLERT)

    Time frame: Baseline, post-intervention and 8-week follow-up

    The Bell Lysaker Emotion Recognition Task (BLERT) measures the participants' ability to process and recognize seven emotional states: happiness, sadness, fear, disgust, surprise, anger, or no emotion (Bryson, Bell and Lysaker, 1997). The participants will be presented with 21 video clips of an actor demonstrating facial, voice-tonal and upper-body movement cues, while engaging in work-related monologues. Unlike static photos, this measurement appears to simulate real-world situations better and may approximate real world functional outcomes (Pinkham et.al., 2016). Rating was done by computing the total number of correctly recognized emotions (ranging from 0 to 21).

  3. Canadian Occupational Performance Measure (COPM)

    Time frame: Baseline, post-intervention and 8-week follow-up

    The Canadian Occupational Performance Measure (COPM) is a person-centered tool that measures aspects of functional and personal recovery among clients whose occupational performance and participation are affected by their current psychiatric conditions. Through a semi-structured interview, the clients identify activities in self-care, productivity and leisure that are of personal importance and rate their performance and satisfaction in each activity (Law et.al., 1990). Self-perceived performance and satisfaction are rated on a 10-point Likert scale.

  4. Social and Occupational Functioning Assessment Scale (SOFAS)

    Time frame: Baseline, post-intervention and 8-week follow-up

    The Social and Occupational Functioning Assessment Scale (SOFAS) is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning (Goldman et.al., 1992). It differs from GAF scale by focusing on social and occupational functioning independent of the overall severity of the individual's psychological symptoms. SOFAS has been used as a functional outcome measurement in cognitive remediation trials (Au-Yeung et.al., 2023; Harris et.al., 2022; Hodge et.al., 2010).

Secondary outcomes

  1. Positive and Negative Syndrome Scale (PANSS)

    Time frame: Baseline, post-intervention and 8-week follow-up

    This is a 30-item rating instrument, evaluating the presence and severity of positive, negative and general psychopathology of schizophrenia (Kay, Fiszbein & Opler, 1987). The scale was developed from the Brief Psychiatric Rating Scale (BPRS) and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). PANSS covers positive and negative symptoms associated with schizophrenia, as well as other symptoms (eg aggression, thought disturbance, depression). Its five-factor model structure has also been validated in the Singapore Schizophrenia Chinese population (Jiang, Sim & Lee, 2013). Hence, the PANSS is a sound instrument to be used for symptom measurement.

  2. Brief Negative Symptom Scale (BNSS)

    Time frame: Baseline, post-intervention and 8-week follow-up

    BNSS consists of five domains of negative symptoms (anhedonia, asociality, avolition, blunted affect, and alogia), which could be clustered into two factors - Motivation-Pleasure (MAP) and Emotional Expressivity (EE) (Kirkpatrick et.al., 2011). A local validation study found that BNSS showed good internal consistency and validity (Ang et.al, 2019). In addition, more severe symptoms as shown in BNSS total, avolition and asociality domains are associated with lower scores on the Global Assessment of Functioning (Ang et.al., 2019).

  3. Brief Regulation of Motivation Scale (BRoMS)

    Time frame: Baseline, post-intervention and 8-week follow-up

    BroMS was initially developed to assess college students' regulation of motivation and two factors were identified: regulation of motivation and willpower (Kim et.al., 2018). Subsequently, a study that adapted and validated it for schizophrenia population found it to be acceptable, feasible and internally consistent, with higher BRoMs scores associated with better work-related skills (Lynch et.al., 2022). The adapted BroMs is a structured interview where participants are told to identify three tasks that they have been working on during the past week. The tasks require participants to maintain their effort over hours or days. The participants are then given 12 statements, where they rate on a 4-point scale, from 'Strongly Disagree' to 'Strongly Agree'. These statements are related to awareness and regulation of motivation.

  4. Weekly Calendar Planning Activity (WCPA)

    Time frame: Baseline, post-intervention and 8-week follow-up

    The Weekly Calendar Planning Activity (WCPA) is a performance-based measure of metacognition, that requires the participant to plan and execute a multiple-step activity. It involves scheduling a list of appointments into a weekly calendar while following rules, avoiding conflicts, monitoring time, and inhibiting distractions, thereby evaluating the participant's planning, error recognition, use of strategies and self-monitoring (Toglia, 2015). Besides scoring for accuracy, the WCPA also scores the difference between the participant's estimated performance and his/her actual performance. Hence, it also evaluates the participant's self-awareness (Kaizerman-Dinerman et.al., 2023).

Other outcomes

  1. The Global Assessment of Functioning Scale (GAF)

    Time frame: Baseline only, to exclude participants with a score of 30 or lower.

    This is carried out prior to recruitment to exclude patients who have a score of 30 or lower. It is a numeric scale (0 through 100) used to rate symptom severity and social, occupational and psychological functioning of adults. The scale is indicated as Axis V in the Diagnostic and Statistical Manual of Mental Disorders-IV-TR and guidelines for scoring have been developed (Aas, 2011).

Study contacts

Contact information is provided by the study sponsor or research team.

Bhing-Leet Tan, PhD

CONTACT

[email protected]

+6598422783

Sponsors and collaborators

Lead sponsor

Singapore Institute of Technology

Other

Collaborators

  • Singapore Anglican Community Services

Registry information

Official study title

Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE): a Community-Based Cognitive Remediation Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 29, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.