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

Официальное название

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

Обзор

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.

Подробное описание

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.

1. 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). 2. To investigate the mediators for change (eg: motivation and negative symptoms) in cognitive performance and functional outcomes.

Вмешательства

• Поведенческое 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 t
• Поведенческое 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.

Первичные конечные точки

• Brief Assessment of Cognition in Schizophrenia (BACS) [Срок оценки: Baseline, post-intervention and 8-week follow-up]
• Bell Lysaker Emotion Recognition Task (BLERT) [Срок оценки: Baseline, post-intervention and 8-week follow-up]
• Canadian Occupational Performance Measure (COPM) [Срок оценки: Baseline, post-intervention and 8-week follow-up]
• Social and Occupational Functioning Assessment Scale (SOFAS) [Срок оценки: Baseline, post-intervention and 8-week follow-up]

Вторичные конечные точки (4)

• Positive and Negative Syndrome Scale (PANSS) [Срок оценки: Baseline, post-intervention and 8-week follow-up]
• Brief Negative Symptom Scale (BNSS) [Срок оценки: Baseline, post-intervention and 8-week follow-up]
• Brief Regulation of Motivation Scale (BRoMS) [Срок оценки: Baseline, post-intervention and 8-week follow-up]
• Weekly Calendar Planning Activity (WCPA) [Срок оценки: Baseline, post-intervention and 8-week follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Сингапур · 5 центров

• Anglican Care Center-Bukit Batok — Singapore
• Anglican Care Center-Hougang — Singapore
• Anglican Care Center-Pasir Ris — Singapore
• Anglican Care Center-Simei — Singapore
• Anglican Care Center-Yishun — Singapore

Публикации

• 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. PMID 21251305
• 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. PMID 36653167
• 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. PMID 30987926
• 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. PMID 23912998
• 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. PMID 1386964
• 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. PMID 11992665
• 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. PMID 25526940
• 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. PMID 35368729

Идентификаторы

NCT: NCT06286202 · RECAS-0306

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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