Schizophrenia Clinical Trial
Official title:
Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE): a Community-Based Cognitive Remediation Trial
NCT number | NCT06286202 |
Other study ID # | RECAS-0306 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | July 2027 |
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.
Status | Not yet recruiting |
Enrollment | 160 |
Est. completion date | July 2027 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Singapore | Anglican Care Center-Bukit Batok | Singapore | |
Singapore | Anglican Care Center-Hougang | Singapore | |
Singapore | Anglican Care Center-Simei | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore Institute of Technology | Singapore Anglican Community Services |
Singapore,
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. — View Citation
Ang 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. — View Citation
Au-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. — View Citation
Bryson G, Bell M, Lysaker P. Affect recognition in schizophrenia: a function of global impairment or a specific cognitive deficit. Psychiatry Res. 1997 Jul 4;71(2):105-13. doi: 10.1016/s0165-1781(97)00050-4. — View Citation
Chong NIM, Maniam Y, Chua YC, Tang C. The Implementation and Review of Cognitive Remediation Training for First Episode Psychosis in Singapore. Front Psychiatry. 2021 Nov 30;12:784935. doi: 10.3389/fpsyt.2021.784935. eCollection 2021. — View Citation
De Mare A, Cantarella M, Galeoto G. Effectiveness of Integrated Neurocognitive Therapy on Cognitive Impairment and Functional Outcome for Schizophrenia Outpatients. Schizophr Res Treatment. 2018 Oct 21;2018:2360697. doi: 10.1155/2018/2360697. eCollection 2018. — View Citation
Eng 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. — View Citation
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. — View Citation
Green MF, Kern RS, Braff DL, Mintz J. Neurocognitive deficits and functional outcome in schizophrenia: are we measuring the "right stuff"? Schizophr Bull. 2000;26(1):119-36. doi: 10.1093/oxfordjournals.schbul.a033430. — View Citation
Gur 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. — View Citation
Hajduk M, Penn DL, Harvey PD, Pinkham AE. Social cognition, neurocognition, symptomatology, functional competences and outcomes in people with schizophrenia - A network analysis perspective. J Psychiatr Res. 2021 Dec;144:8-13. doi: 10.1016/j.jpsychires.2021.09.041. Epub 2021 Sep 24. — View Citation
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. — View Citation
Harris 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. — View Citation
Hodge 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. — View Citation
Jiang 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. — View Citation
Kaizerman-Dinerman A, Roe D, Demeter N, Josman N. Do symptoms moderate the association between participation and executive functions outcomes among people with schizophrenia? BMC Psychiatry. 2023 Jan 17;23(1):42. doi: 10.1186/s12888-022-04510-0. — View Citation
Kay 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. — View Citation
Keefe 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. — View Citation
Kim, Y.E., Brady, A.C., Wolters, C.A., 2018. Development and validation of the Brief Regulation of Motivation Scale. Learn. Individ. Differ. 67, 259-265. https://doi.org/ 10.1016/j.lindif.2017.12.010
Kiresuk, T. J., Smith, A., & Cardillo, J. E. (2014). Goal attainment scaling: Applications, theory, and measurement. Psychology Press.
Kirkpatrick 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. — View Citation
Lam 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. — View Citation
Lam 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. — View Citation
Law M, Baptiste S, McColl M, Opzoomer A, Polatajko H, Pollock N. The Canadian occupational performance measure: an outcome measure for occupational therapy. Can J Occup Ther. 1990 Apr;57(2):82-7. doi: 10.1177/000841749005700207. — View Citation
Lynch DA, Brown M, Saperstein A, Stefancic A, Medalia A. Assessing metamotivation in schizophrenia: A pilot study of the Brief Regulation of Motivation Scale (BRoMS). Psychiatry Res. 2022 Nov;317:114799. doi: 10.1016/j.psychres.2022.114799. Epub 2022 Aug 19. — View Citation
McDonald S, Bornhofen C, Shum D, Long E, Saunders C, Neulinger K. Reliability and validity of The Awareness of Social Inference Test (TASIT): a clinical test of social perception. Disabil Rehabil. 2006 Dec 30;28(24):1529-42. doi: 10.1080/09638280600646185. — View Citation
McDonald, S. (2012) New Frontiers in Neuropsychological Assessment: Assessing Social Perception Using a Standardised Instrument, The Awareness of Social Inference Test. Australian Psychologist 47 (2012) 39-48.
McGurk SR, Twamley EW, Sitzer DI, McHugo GJ, Mueser KT. A meta-analysis of cognitive remediation in schizophrenia. Am J Psychiatry. 2007 Dec;164(12):1791-802. doi: 10.1176/appi.ajp.2007.07060906. — View Citation
Medalia A, Dorn H, Watras-Gans S. Treating problem-solving deficits on an acute care psychiatric inpatient unit. Psychiatry Res. 2000 Dec 4;97(1):79-88. doi: 10.1016/s0165-1781(00)00214-6. — View Citation
Medalia A, Erlich MD, Soumet-Leman C, Saperstein AM. Translating cognitive behavioral interventions from bench to bedside: The feasibility and acceptability of cognitive remediation in research as compared to clinical settings. Schizophr Res. 2019 Jan;203:49-54. doi: 10.1016/j.schres.2017.07.044. Epub 2017 Jul 30. — View Citation
Medalia A, Herlands T, Baginsky C. Rehab rounds: Cognitive remediation in the supportive housing setting. Psychiatr Serv. 2003 Sep;54(9):1219-20. doi: 10.1176/appi.ps.54.9.1219. No abstract available. — View Citation
Medalia, A., Revheim, N., & Herlands, T. (2009). Cognitive Remediation for Psychological Disorders: Therapist Guide. New York: Oxford University Press.
Mueller DR, Schmidt SJ, Roder V. One-year randomized controlled trial and follow-up of integrated neurocognitive therapy for schizophrenia outpatients. Schizophr Bull. 2015 May;41(3):604-16. doi: 10.1093/schbul/sbu223. Epub 2015 Feb 22. — View Citation
Pinkham AE, Harvey PD, Penn DL. Social Cognition Psychometric Evaluation: Results of the Final Validation Study. Schizophr Bull. 2018 Jun 6;44(4):737-748. doi: 10.1093/schbul/sbx117. — View Citation
Scanlan JN, Hancock N, Honey A. The Recovery Assessment Scale - Domains and Stages (RAS-DS): Sensitivity to change over time and convergent validity with level of unmet need. Psychiatry Res. 2018 Mar;261:560-564. doi: 10.1016/j.psychres.2018.01.042. — View Citation
Tan BL, Lee SA, Lee J. Social cognitive interventions for people with schizophrenia: A systematic review. Asian J Psychiatr. 2018 Jun;35:115-131. doi: 10.1016/j.ajp.2016.06.013. Epub 2016 Sep 23. — View Citation
Tan BL. Profile of cognitive problems in schizophrenia and implications for vocational functioning. Aust Occup Ther J. 2009 Aug;56(4):220-8. doi: 10.1111/j.1440-1630.2008.00759.x. — View Citation
Toglia J (2018) The dynamic interactional model and the multicontext approach. In: Katz N and Toglia J (eds) Cognition, Occupation, and Participation Across the Lifespan. Bethesda, MD: AOTA Press, 355-385.
Toglia J, Goverover Y, Johnston MV, Dain B. Application of the Multicontextual Approach in Promoting Learning and Transfer of Strategy Use in an Individual with TBI and Executive Dysfunction. OTJR (Thorofare N J). 2011 Winter;31(1):S53-60. doi: 10.3928/15394492-20101108-09. — View Citation
Toglia J, Lee A, Steinberg C, Waldman-Levi A. (2020) Establishing and measuring treatment fidelity of a complex cognitive rehabilitation intervention: The multicontext approach. British Journal of Occupational Therapy. 83(6):363-374. doi:10.1177/0308022619898091
Toglia J. Weekly calendar planning activity: a performance test of executive function. AOTA Press; 2015.
Ventura J, Hellemann GS, Thames AD, Koellner V, Nuechterlein KH. Symptoms as mediators of the relationship between neurocognition and functional outcome in schizophrenia: a meta-analysis. Schizophr Res. 2009 Sep;113(2-3):189-99. doi: 10.1016/j.schres.2009.03.035. Epub 2009 Jul 22. — View Citation
Wykes T, Huddy V, Cellard C, McGurk SR, Czobor P. A meta-analysis of cognitive remediation for schizophrenia: methodology and effect sizes. Am J Psychiatry. 2011 May;168(5):472-85. doi: 10.1176/appi.ajp.2010.10060855. Epub 2011 Mar 15. — View Citation
Wykes T, Stringer D, Boadu J, Tinch-Taylor R, Csipke E, Cella M, Pickles A, McCrone P, Reeder C, Birchwood M, Fowler D, Greenwood K, Johnson S, Perez J, Ritunnano R, Thompson A, Upthegrove R, Wilson J, Kenny A, Isok I, Joyce EM. Cognitive Remediation Works But How Should We Provide It? An Adaptive Randomized Controlled Trial of Delivery Methods Using a Patient Nominated Recovery Outcome in First-Episode Participants. Schizophr Bull. 2023 May 3;49(3):614-625. doi: 10.1093/schbul/sbac214. — View Citation
* Note: There are 44 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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). | Baseline, post-intervention and 8-week follow-up |
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