protocolSection identificationModule nctId: NCT06286202, orgStudyIdInfo id: RECAS-0306, briefTitle: Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE) a Community-Based Cognitive Remediation Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Singapore Institute of Technology, class: OTHER, collaborators name: Singapore Anglican Community Services, descriptionModule briefSummary: 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., conditionsModule conditions: Schizophrenia, conditions: Schizoaffective Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: 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., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR), interventions name: Standard Psychiatric Rehabilitation at Anglican Care Centers, outcomesModule primaryOutcomes measure: Brief Assessment of Cognition in Schizophrenia (BACS), primaryOutcomes measure: Penn Emotion Recognition Task (ER40), primaryOutcomes measure: The Awareness of Social Inference Test (TASIT)- Part 3, primaryOutcomes measure: Goal Attainment Scale, primaryOutcomes measure: Social and Occupational Functioning Assessment Scale (SOFAS), primaryOutcomes measure: Recovery Assessment Scale-Domain and Stages (RAS-DS), secondaryOutcomes measure: Positive and Negative Syndrome Scale (PANSS), secondaryOutcomes measure: Brief Negative Symptom Scale (BNSS), secondaryOutcomes measure: Brief Regulation of Motivation Scale (BRoMS), otherOutcomes measure: The Global Assessment of Functioning Scale (GAF), eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Anglican Care Center-Bukit Batok, city: Singapore, country: Singapore, contacts name: Jonathan Poh, MA, role: CONTACT, phone: +6592333020, email: Jonathan_poh@sacs.org.sg, geoPoint lat: 1.28967, lon: 103.85007, locations facility: Anglican Care Center-Hougang, city: Singapore, country: Singapore, contacts name: Mingxiu Cai, BSc (Hons), role: CONTACT, phone: +6563869338, phoneExt: 101, email: mingxiu_cai@sacs.org.sg, geoPoint lat: 1.28967, lon: 103.85007, locations facility: Anglican Care Center-Simei, city: Singapore, country: Singapore, contacts name: Noel Tan, MA, role: CONTACT, phone: +6591853094, email: noel_tan@sacs.org.sg, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False