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

NCT06286202 | Recruiting DMC

• 1 other identifier: RECAS-0306
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 5

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

cognitive remediation; Neuropsychological and Educational Approach to Remediation; Multicontext Treatment Approach; metamotivation; psychiatric rehabilitation; schizophrenia; community mental health

Outcome Measures

Primary Outcomes (4)

• 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

• 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).

  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.

  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

Secondary Outcomes (4)

• Positive and Negative Syndrome Scale (PANSS)

  Baseline, post-intervention and 8-week follow-up

• Brief Negative Symptom Scale (BNSS)

  Baseline, post-intervention and 8-week follow-up

• Brief Regulation of Motivation Scale (BRoMS)

  Baseline, post-intervention and 8-week follow-up

• Weekly Calendar Planning Activity (WCPA)

  Baseline, post-intervention and 8-week follow-up

Other Outcomes (1)

• The Global Assessment of Functioning Scale (GAF)

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

Study Arms (2)

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.

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.

Behavioral: Standard Psychiatric Rehabilitation at Anglican Care Centers

Interventions

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.

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

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.

Standard Psychiatric Rehabilitation at Anglican Care Centers

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore Institute of Technology: lead
• Singapore Anglican Community Services: collaborator

Study Sites (5)

Anglican Care Center-Bukit Batok

Singapore, Singapore

RECRUITING

Anglican Care Center-Hougang

Singapore, Singapore

RECRUITING

Anglican Care Center-Pasir Ris

Singapore, Singapore

NOT YET RECRUITING

Anglican Care Center-Simei

Singapore, Singapore

RECRUITING

Anglican Care Center-Yishun

Singapore, Singapore

NOT YET RECRUITING

Related Publications (45)

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MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Bhing-Leet Tan, PhD

  Bhing-Leet Tan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bhing-Leet Tan, PhD

CONTACT

+6598422783; bhingleet.tan@singaporetech.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Upon randomization, the co-investigators will indicate the allocated group in a separate spreadsheet from the outcome measurements. The co-investigator who is collecting baseline, post-intervention and 8-week outcome measurements will be blinded to the treatment allocation of each participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Cluster Director

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: August 6, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

SG (5)