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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Behavioral: Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR); Behavioral: Standard Psychiatric Rehabilitation at Anglican Care Centers

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 Penn Emotional Recognition Test-ER40 and The Awareness of Social Inference Test, Part 3
   • functional outcomes (Social and Occupational Functioning Assessment Scale, Goal Attainment Scale and Recovery Assessment Scale-Domain and Stages).
2. To investigate the mediators for change (eg: motivation and negative symptoms) in cognitive performance and functional outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bhing-Leet Tan, PhD; Phone Number: +6598422783; Email: bhingleet.tan@singaporetech.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Anglican Care Center-Bukit Batok
    • Contact: Jonathan Poh, MA; Phone Number: +6592333020; Email: Jonathan_poh@sacs.org.sg
  • Singapore, Singapore
    • Anglican Care Center-Hougang
    • Contact: Mingxiu Cai, BSc (Hons); Phone Number: 101 +6563869338; Email: mingxiu_cai@sacs.org.sg
  • Singapore, Singapore
    • Anglican Care Center-Simei
    • Contact: Noel Tan, MA; Phone Number: +6591853094; Email: noel_tan@sacs.org.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-V).
• Able to converse in English and understand English instructions, as the cognitive games and bridging groups will be conducted in English.

Exclusion Criteria:

• Known neurological diseases and epilepsy, which affects gains from cognitive remediation.
• Unable to speak and understand English.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Other: Standard Psychiatric Rehabilitation at Anglican Care Centers; 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.	Behavioral: Standard Psychiatric Rehabilitation at Anglican Care Centers; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, post-intervention and 8-week follow-up
Penn Emotion Recognition Task (ER40)	Penn Emotion Recognition Task (ER-40) requires participants to identify an emotion to 40 photographs depicting 5 emotions (happiness, sadness, anger, fear and neutral), 4 each of low and high intensity (Gur et al., 2002). It has been shown by the Social Cognition Psychometric Evaluation (SCOPE) study to have good test-retest reliability (r=.710), internal consistency (r=.754) and significant association with functional outcomes (Pinkham, Harvey and Penn, 2018).	Baseline, post-intervention and 8-week follow-up
The Awareness of Social Inference Test (TASIT)- Part 3	The TASIT-Part 3 is a test of social perception, social inference and theory of mind, where participants are shown various scenarios for them to infer the speaker's true emotions, beliefs and thinking (McDonald, 2012). Additional information via a visual edit or verbal information via a prologue is provided, to test the participant's perspective taking. Therefore, the participants have to integrate the use of contextual information with the conversation and understand the underlying thinking behind the conversation. Its test-retest reliability ranged from 0.74 - 0.88 and associations with theory of mind and social perception tests were also found (McDonald et.al., 2006; McDonald, 2012).	Baseline, post-intervention and 8-week follow-up
Goal Attainment Scale	The Goal Attainment Scale (GAS) is an individualised measurement tool that involves goal selection and goal scaling by the participant that is standardised in order to calculate the extent to which the participant's goals are met (Kiresuk, et.al. 2014). It has been used to measure the achievement of client's functional goals in cognitive remediation (Wykes et.al., 2023). The participant will identify 3-4 goals, which are incorporated into the single GAS score through the use of a defined formula. The importance and difficulty of the goals are weighted and the extent of the achievement of the goals are also 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).	Baseline, post-intervention and 8-week follow-up
Recovery Assessment Scale-Domain and Stages (RAS-DS)	Recovery Assessment Scale - Domains and Stages (RAS-DS) is a client-centred and self-reported instrument of mental health recovery, to facilitate collaborative and recovery-oriented practice, as well as to chart client's personal recovery milestone (Hancock et.al., 2015). . Rasch analysis showed that the scale had excellent internal reliability and validity and was also sensitive to change (Hancock et.al., 2015; Scanlan et.al, 2018).	Baseline, post-intervention and 8-week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	Baseline, post-intervention and 8-week follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Global Assessment of Functioning Scale (GAF)	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).	Baseline only, to exclude participants with a score of 30 or lower.

Collaborators and Investigators

• Sponsor: Singapore Institute of Technology
• Collaborators: Singapore Anglican Community Services
• Investigators: Principal Investigator: Bhing-Leet Tan, PhD, Bhing-Leet Tan

Publications and helpful links

General Publications

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• Badal VD, Depp CA, Hitchcock PF, Penn DL, Harvey PD, Pinkham AE. Computational methods for integrative evaluation of confidence, accuracy, and reaction time in facial affect recognition in schizophrenia. Schizophr Res Cogn. 2021 Apr 22;25:100196. doi: 10.1016/j.scog.2021.100196. eCollection 2021 Sep.
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• Goldman 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.
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• Hancock 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.
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• Medalia, A., Revheim, N., & Herlands, T. (2009). Cognitive Remediation for Psychological Disorders: Therapist Guide. New York: Oxford University Press.
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Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: schizophrenia; community mental health; cognitive remediation; psychiatric rehabilitation; Neuropsychological and Educational Approach to Remediation; Multicontext Treatment Approach; metamotivation
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders
• Other Study ID Numbers: RECAS-0306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No