SchizophreniaNCT06286202
Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE) a Community-Based Cognitive Remediation Trial
A study testing Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR) and Standard Psychiatric Rehabilitation at Anglican Care Centers in people with Schizophrenia and Schizoaffective Disorder, run by Singapore Institute of Technology at 5 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR) and Standard Psychiatric Rehabilitation at Anglican Care Centers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 5 sitesSingapore
- Study dates
- 6 Aug 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Singapore5 sites, 5 recruiting
- Recruiting
Anglican Care Center-Bukit Batok
Singapore
Jonathan Poh, MA, +6592333020, Jonathan_poh@sacs.org.sg
- Recruiting
Anglican Care Center-Hougang
Singapore
Vanessa Koh, BSc (Hons), +6563869338 ext. 101, vanessa_koh@sacs.org.sg
- Not yet recruiting
Anglican Care Center-Pasir Ris
Singapore
Joseph Tee, Master of Psychology, +656584 4633, joseph_tee@sacs.org.sg
- Recruiting
Anglican Care Center-Simei
Singapore
Noel Tan, MA, +6591853094, noel_tan@sacs.org.sg
- Not yet recruiting
Anglican Care Center-Yishun
Singapore
Cindy Low, Master of Counselling, _656753 5311, cindy_low@sacs.org.sg
About this study
Official title: 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:
Read more
- 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.
Read the 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 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR), Standard Psychiatric Rehabilitation at Anglican Care Centers
- Keywords
- cognitive remediation, Neuropsychological and Educational Approach to Remediation, Multicontext Treatment Approach, metamotivation, psychiatric rehabilitation, schizophrenia, community mental health
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR)Behavioural
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 CentersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR) | Experimental | NEAR consists of using carefully selected computer cognitive games to restore cognitive functioning through rehearsal and strategy learning. It will be delivered 3 times a week for 12 weeks at the center. The duration of each session within the week is as follows: 1) First session: 45 min computer-assisted cognitive exercises + 30 min bridging group; 2) Second session: 30 min computer-assisted cognitive exercises + 45 min bridging group; 3) Third session: 45 min computer-assisted cognitive exercises. Computer-assisted cognitive exercises are sessions where participants engage in cognitive games that target different cognitive domains. In addition, the Multicontext Treatment Approach to strategy learning will be carried out. The metacognitive framework of self-evaluation and activity mediation will also be utilized. Bridging groups are conducted twice a week, to aid transfer of learning from the computer game sessions to the participants' everyday life. Receives: Behavioral: Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR) |
| Standard Psychiatric Rehabilitation at Anglican Care Centers | Other | Participants in the control arm will attend their scheduled activities at their respective Anglican Care Centers. The Anglican Care Centers run a variety of activities to provide psychosocial rehabilitation for clients with serious mental illness. These may include vocational training such as training in a retail shop or café, instrumental activities of daily living training (eg: taking public transport, money management), psychoeducation, social skills training etc. Participants in the control arm will not be enrolled into the cognitive remediation. Receives: Behavioral: Standard Psychiatric Rehabilitation at Anglican Care Centers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Assessment of Cognition in Schizophrenia (BACS)
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.
Measured: Baseline, post-intervention and 8-week follow-up
Bell Lysaker Emotion Recognition Task (BLERT)
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).
Measured: Baseline, post-intervention and 8-week follow-up
Canadian Occupational Performance Measure (COPM)
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.
Measured: Baseline, post-intervention and 8-week follow-up
Social and Occupational Functioning Assessment Scale (SOFAS)
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).
Measured: Baseline, post-intervention and 8-week follow-up
Secondary outcomes (4)
Positive and Negative Syndrome Scale (PANSS)
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.
Measured: Baseline, post-intervention and 8-week follow-up
Brief Negative Symptom Scale (BNSS)
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).
Measured: Baseline, post-intervention and 8-week follow-up
Brief Regulation of Motivation Scale (BRoMS)
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.
Measured: Baseline, post-intervention and 8-week follow-up
Weekly Calendar Planning Activity (WCPA)
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).
Measured: Baseline, post-intervention and 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start6 Aug 2024
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Anglican Community Services
- Responsible party
- Principal investigator, Bhing-Leet Tan, Singapore Institute of Technology
- Investigators
- Bhing-Leet Tan, PhD, Principal investigator, Bhing-Leet Tan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286202
- Sponsor's protocol ID
- RECAS-0306
- Status last verified
- Jan 2026
- First submitted
- 22 Feb 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If the IPD is to be shared eventually, the data to be shared will be the treatment allocation (either experimental or control arm) and the corresponding outcome measurements data.
Publications
Aas IH. Guidelines for rating Global Assessment of Functioning (GAF). Ann Gen Psychiatry. 2011 Jan 20;10:2. doi: 10.1186/1744-859X-10-2.
PubMed 21251305Au-Yeung C, Bowie CR, Montreuil T, Baer LH, Lecomte T, Joober R, Abdel-Baki A, Jarvis GE, Margolese HC, De Benedictis L, Schmitz N, Thai H, Malla AK, Lepage M. Predictors of treatment attrition of cognitive health interventions in first episode psychosis. Early Interv Psychiatry. 2023 Oct;17(10):984-991. doi: 10.1111/eip.13391. Epub 2023 Jan 18.
PubMed 36653167Ang MS, Rekhi G, Lee J. Validation of the Brief Negative Symptom Scale and its association with functioning. Schizophr Res. 2019 Jun;208:97-104. doi: 10.1016/j.schres.2019.04.005. Epub 2019 Apr 13.
PubMed 30987926Eng GK, Lam M, Bong YL, Subramaniam M, Bautista D, Rapisarda A, Kraus M, Lee J, Collinson SL, Chong SA, Keefe RS. Brief assessment of cognition in schizophrenia: normative data in an English-speaking ethnic Chinese sample. Arch Clin Neuropsychol. 2013 Dec;28(8):845-58. doi: 10.1093/arclin/act060. Epub 2013 Aug 1.
PubMed 23912998Goldman HH, Skodol AE, Lave TR. Revising axis V for DSM-IV: a review of measures of social functioning. Am J Psychiatry. 1992 Sep;149(9):1148-56. doi: 10.1176/ajp.149.9.1148.
PubMed 1386964Gur RC, Sara R, Hagendoorn M, Marom O, Hughett P, Macy L, Turner T, Bajcsy R, Posner A, Gur RE. A method for obtaining 3-dimensional facial expressions and its standardization for use in neurocognitive studies. J Neurosci Methods. 2002 Apr 15;115(2):137-43. doi: 10.1016/s0165-0270(02)00006-7.
PubMed 11992665Hancock N, Scanlan JN, Honey A, Bundy AC, O'Shea K. Recovery Assessment Scale - Domains and Stages (RAS-DS): Its feasibility and outcome measurement capacity. Aust N Z J Psychiatry. 2015 Jul;49(7):624-33. doi: 10.1177/0004867414564084. Epub 2014 Dec 19.
PubMed 25526940Harris AWF, Kightley M, Williams J, Ma C, Dodds C. Does Adding Social Cognitive Remediation Therapy to Neurocognitive Remediation Therapy Improve Outcomes in Young People With a Severe Mental Illness?-The Advantage Trial. Front Psychiatry. 2022 Mar 14;12:789628. doi: 10.3389/fpsyt.2021.789628. eCollection 2021.
PubMed 35368729Hodge MA, Siciliano D, Withey P, Moss B, Moore G, Judd G, Shores EA, Harris A. A randomized controlled trial of cognitive remediation in schizophrenia. Schizophr Bull. 2010 Mar;36(2):419-27. doi: 10.1093/schbul/sbn102. Epub 2008 Aug 20.
PubMed 18718884Jiang J, Sim K, Lee J. Validated five-factor model of positive and negative syndrome scale for schizophrenia in Chinese population. Schizophr Res. 2013 Jan;143(1):38-43. doi: 10.1016/j.schres.2012.10.019. Epub 2012 Nov 11.
PubMed 23148897Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
PubMed 3616518Keefe RS, Goldberg TE, Harvey PD, Gold JM, Poe MP, Coughenour L. The Brief Assessment of Cognition in Schizophrenia: reliability, sensitivity, and comparison with a standard neurocognitive battery. Schizophr Res. 2004 Jun 1;68(2-3):283-97. doi: 10.1016/j.schres.2003.09.011.
PubMed 15099610Kirkpatrick B, Strauss GP, Nguyen L, Fischer BA, Daniel DG, Cienfuegos A, Marder SR. The brief negative symptom scale: psychometric properties. Schizophr Bull. 2011 Mar;37(2):300-5. doi: 10.1093/schbul/sbq059. Epub 2010 Jun 17.
PubMed 20558531Lam M, Collinson SL, Eng GK, Rapisarda A, Kraus M, Lee J, Chong SA, Keefe RS. Refining the latent structure of neuropsychological performance in schizophrenia. Psychol Med. 2014 Dec;44(16):3557-70. doi: 10.1017/S0033291714001020. Epub 2014 May 22.
PubMed 25066336Lam M, Eng GK, Rapisarda A, Subramaniam M, Kraus M, Keefe RSE, Collinson SL. Formulation of the age-education index: measuring age and education effects in neuropsychological performance. Psychol Assess. 2013 Mar;25(1):61-70. doi: 10.1037/a0030548. Epub 2012 Nov 12.
PubMed 23148648
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE): a Community-Based Cognitive Remediation Trial
- ClinicalTrials.gov ID
- NCT06286202
- Acronym / sponsor ID
- RECAS-0306
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- cognitive remediation, Neuropsychological and Educational Approach to Remediation, Multicontext Treatment Approach, metamotivation, psychiatric rehabilitation, schizophrenia, community mental health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Singapore Institute of TechnologyUniversity, hospital or other
- Collaborators
- Singapore Anglican Community Services
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR) | Experimental | Behavioral: Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR)NEAR consists of using carefully selected computer cognitive games to restore cognitive functioning through rehearsal and strategy learning. It will be delivered 3 times a week for 12 weeks at the center. The duration of each session within the week is as follows: 1) First session: 45 min computer-assisted cognitive exercises + 30 min bridging group; 2) Second session: 30 min computer-assisted cognitive exercises + 45 min bridging group; 3) Third session: 45 min computer-assisted cognitive exercises. Computer-assisted cognitive exercises are sessions where participants engage in cognitive games that target different cognitive domains. In addition, the Multicontext Treatment Approach to strategy learning will be carried out. The metacognitive framework of self-evaluation and activity mediation will also be utilized. Bridging groups are conducted twice a week, to aid transfer of learning from the computer game sessions to the participants' everyday life. |
| Standard Psychiatric Rehabilitation at Anglican Care Centers | Other | Behavioral: Standard Psychiatric Rehabilitation at Anglican Care CentersParticipants in the control arm will attend their scheduled activities at their respective Anglican Care Centers. The Anglican Care Centers run a variety of activities to provide psychosocial rehabilitation for clients with serious mental illness. These may include vocational training such as training in a retail shop or café, instrumental activities of daily living training (eg: taking public transport, money management), psychoeducation, social skills training etc. Participants in the control arm will not be enrolled into the cognitive remediation. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR)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. | Behavioural | Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR) |
| Standard Psychiatric Rehabilitation at Anglican Care CentersParticipants 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. | Behavioural | Standard Psychiatric Rehabilitation at Anglican Care Centers |
Primary outcome
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.
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).
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.
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).
4 secondary outcomes
Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline, post-intervention and 8-week follow-up
Brief Negative Symptom Scale (BNSS)
Time frame: Baseline, post-intervention and 8-week follow-up
Brief Regulation of Motivation Scale (BRoMS)
Time frame: Baseline, post-intervention and 8-week follow-up
Weekly Calendar Planning Activity (WCPA)
Time frame: Baseline, post-intervention and 8-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Background: PubMed 21251305Aas IH. Guidelines for rating Global Assessment of Functioning (GAF). Ann Gen Psychiatry. 2011 Jan 20;10:2. doi: 10.1186/1744-859X-10-2.
- Background: PubMed 36653167Au-Yeung C, Bowie CR, Montreuil T, Baer LH, Lecomte T, Joober R, Abdel-Baki A, Jarvis GE, Margolese HC, De Benedictis L, Schmitz N, Thai H, Malla AK, Lepage M. Predictors of treatment attrition of cognitive health interventions in first episode psychosis. Early Interv Psychiatry. 2023 Oct;17(10):984-991. doi: 10.1111/eip.13391. Epub 2023 Jan 18.
- Background: PubMed 30987926Ang MS, Rekhi G, Lee J. Validation of the Brief Negative Symptom Scale and its association with functioning. Schizophr Res. 2019 Jun;208:97-104. doi: 10.1016/j.schres.2019.04.005. Epub 2019 Apr 13.
- Background: PubMed 23912998Eng GK, Lam M, Bong YL, Subramaniam M, Bautista D, Rapisarda A, Kraus M, Lee J, Collinson SL, Chong SA, Keefe RS. Brief assessment of cognition in schizophrenia: normative data in an English-speaking ethnic Chinese sample. Arch Clin Neuropsychol. 2013 Dec;28(8):845-58. doi: 10.1093/arclin/act060. Epub 2013 Aug 1.
- Background: PubMed 1386964Goldman HH, Skodol AE, Lave TR. Revising axis V for DSM-IV: a review of measures of social functioning. Am J Psychiatry. 1992 Sep;149(9):1148-56. doi: 10.1176/ajp.149.9.1148.
- Background: PubMed 11992665Gur RC, Sara R, Hagendoorn M, Marom O, Hughett P, Macy L, Turner T, Bajcsy R, Posner A, Gur RE. A method for obtaining 3-dimensional facial expressions and its standardization for use in neurocognitive studies. J Neurosci Methods. 2002 Apr 15;115(2):137-43. doi: 10.1016/s0165-0270(02)00006-7.
- Background: PubMed 25526940Hancock N, Scanlan JN, Honey A, Bundy AC, O'Shea K. Recovery Assessment Scale - Domains and Stages (RAS-DS): Its feasibility and outcome measurement capacity. Aust N Z J Psychiatry. 2015 Jul;49(7):624-33. doi: 10.1177/0004867414564084. Epub 2014 Dec 19.
- Background: PubMed 35368729Harris AWF, Kightley M, Williams J, Ma C, Dodds C. Does Adding Social Cognitive Remediation Therapy to Neurocognitive Remediation Therapy Improve Outcomes in Young People With a Severe Mental Illness?-The Advantage Trial. Front Psychiatry. 2022 Mar 14;12:789628. doi: 10.3389/fpsyt.2021.789628. eCollection 2021.
- Background: PubMed 18718884Hodge MA, Siciliano D, Withey P, Moss B, Moore G, Judd G, Shores EA, Harris A. A randomized controlled trial of cognitive remediation in schizophrenia. Schizophr Bull. 2010 Mar;36(2):419-27. doi: 10.1093/schbul/sbn102. Epub 2008 Aug 20.
- Background: PubMed 23148897Jiang J, Sim K, Lee J. Validated five-factor model of positive and negative syndrome scale for schizophrenia in Chinese population. Schizophr Res. 2013 Jan;143(1):38-43. doi: 10.1016/j.schres.2012.10.019. Epub 2012 Nov 11.
- Background: PubMed 3616518Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
- Background: PubMed 15099610Keefe RS, Goldberg TE, Harvey PD, Gold JM, Poe MP, Coughenour L. The Brief Assessment of Cognition in Schizophrenia: reliability, sensitivity, and comparison with a standard neurocognitive battery. Schizophr Res. 2004 Jun 1;68(2-3):283-97. doi: 10.1016/j.schres.2003.09.011.
- Individual participant dataSharing planned: Undecided. If the IPD is to be shared eventually, the data to be shared will be the treatment allocation (either experimental or control arm) and the corresponding outcome measurements data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bhing-Leet Tan, PhD principal investigator
Bhing-Leet Tan
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR) and Standard Psychiatric Rehabilitation at Anglican Care Centers in people with Schizophrenia and Schizoaffective Disorder, run by Singapore Institute of Technology at 5 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bhing-Leet Tan, PhD (+6598422783, bhingleet.tan@singaporetech.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Assessment of Cognition in Schizophrenia (BACS) (time frame: Baseline, post-intervention and 8-week follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06286202, which also lists 45 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.