Promoting Cognitive Health in Schizophrenia

Официальное название

Promoting Cognitive Health in Schizophrenia: A National Collaborative Effort to Implement Online Psychological Interventions

Обзор

The goal of this clinical trial is to effectively implement virtually-delivered interventions in mental health institutions nationwide to improve the cognitive health of individuals living with schizophrenia. The main objectives are: * To determine the clinical effectiveness of two virtual cognitive health interventions (i.e., Action-Based Cognitive Remediation or MetaCognitive Training). * To evaluate our implementation strategy involving the virtual delivery of cognitive health interventions combined with a digital learning platform to train mental health practitioners. Participants will be assessed for the severity of symptoms, cognitive performance, and overall functioning before and after receiving the intervention. Qualitative interviews will also be conducted with participants and therapists to evaluate the implementation strategies.

Подробное описание

In Canada, few individuals with psychotic disorders have access to online psychosocial therapies integrated with the care they receive from the public mental health care system. There is thus an urgent need for pragmatic trials, conducted in diversified settings, on the effectiveness and implementation of technology- enabled psychosocial interventions in this population. Even at the respective sites of the investigators, such interventions are predominately offered within the context of research and not as a clinical service. The investigators propose a hybrid effectiveness-implementation trial relying on digital technology to facilitate the rapid adoption of high- quality psychosocial interventions in five distinct care settings (Douglas Institute, Royal Institute of Mental Health Research, Kingston Health Science Centre, Ontario Shores Centre for Mental Health Sciences and Vancouver Coastal Health/UBC). Each site provides a unique environment to promote the uptake of interventions; all have a track-record of integrated clinical infrastructure for psychological interventions and access to large cohorts of potential participants (n\>6000). These sites have all been providing psychological interventions for schizophrenia for several years and have the necessary infrastructure to provide virtual care.

Considering that both proposed cognitive health interventions are well established, the investigators are proposing a hybrid effectiveness-implementation design, Type 2 which is ideal when studying interventions that already have evidence of effectiveness in other settings or populations and that seek to determine feasibility and utility of an implementation strategy. Such designs are now commonly used to move evidence-based behavioral interventions into real care environments as they address the need to confirm clinical effectiveness while targeting the methods and procedures necessary to deliver and sustain such interventions in real-world care settings.

Objective 1: To determine the clinical effectiveness of two virtual cognitive health interventions. The investigators will use a non-randomized concurrent control design (NRCC) in which one intervention (e.g., CR) acts as the active control for the other (e.g., MCT) and vice-versa, on intervention-specific primary outcomes. The investigators hypothesize that participation in CR will specifically improve cognitive capacity (i.e., increase performance on measures of memory, executive functions, attention, etc.) whereas participation in MCT will specifically improve cognitive biases, per the objective standard measures described below. Moreover, participation in either intervention will be associated with improvement in symptomatology, reduced social isolation and greater functioning at post-intervention and maintained at 1 month follow-up. The investigators are also expecting a greater improvement in all those domains when participants are doing both interventions.

Objective 2: To evaluate the implementation strategy involving the virtual delivery of cognitive health interventions combined with a digital learning platform (E-Cog) to train mental health practitioners across multiple care settings. The investigators will assess how this strategy promotes the uptake of these cognitive health interventions across different mental health care settings. More specifically, the investigators will assess:

i) whether the E-Cog digital learning platform represents an effective educational strategy for implementation, ii) the contextual factors influencing the implementation of the two virtual interventions (i.e., potential barriers and facilitators to adoption) across sites, and iii) sustainability, the extent to which these interventions will be maintained within a service setting's ongoing operations.

Вмешательства

• Поведенческое Cognitive remediation
  The goal of this program is to improve performance on cognitive domains known to hinder functioning. It aims to promote positive attitudes towards learning and facilitate the development of independent learning skills to foster competence and confidence. Another aim is to increase patients' awareness of their cognitive strengths and weaknesses and their own problem solving strategies.
• Поведенческое MetaCognitive Training
  The metacognitive training (MCT) program is based on the theoretical foundations of cognitive models of schizophrenia but employs a slightly different focus in its therapeutic approach targeting the specific cognitive biases underlying delusions. The modules aim to raise awareness of these biases and prompts participants to critically reflect on and update their problem-solving repertoire.

Первичные конечные точки

• Change from Baseline Brief version of the Cambridge Neuropsychological Testing Automated Battery (CANTAB) score at the end of the intervention [Срок оценки: Baseline to post (10 weeks)]
• Change from Baseline Wechsler Memory Scale - Logical Memory (LM) subscale score at the end of the intervention [Срок оценки: Baseline to post (10 weeks)]
• Change from Baseline Brief Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS-B) score at the end of the intervention [Срок оценки: Baseline to post (10 weeks)]
• Change from Baseline Cognitive Motivation Scale (CMS) score at the end of the intervention [Срок оценки: Baseline to post (10 weeks)]
• Change from Baseline Davos Assessment of Cognitive Biases Scale (DACOBS) score at the end of the intervention [Срок оценки: Baseline to post (10 weeks)]
• Change from Baseline Beads task score at the end of the intervention [Срок оценки: Baseline to post (10 weeks)]
• Change from Baseline bias against disconfirmatory evidence (BADE) image task score at the end of the intervention [Срок оценки: Baseline to post (10 weeks)]

Вторичные конечные точки (8)

• Change from Baseline Short version of the Positive And Negative Syndrome Scale (PANSS-6) score at the end of the intervention [Срок оценки: Baseline to post (10 weeks)]
• Change from Baseline Brief Negative Symptom Scale (BNSS) score at the end of the intervention [Срок оценки: Baseline to post (10 weeks)]
• Change from Baseline Psychotic Symptom Rating Scales (PSYRATS) score at the end of the intervention [Срок оценки: Baseline to post (10 weeks)]
• Change from Baseline Emotional, and Social Loneliness Scale (OES) score at the end of the intervention [Срок оценки: Baseline to post (10 weeks)]
• Change from Baseline Self-Esteem Rating Scale - Short Form (SERS-SF) score at the end of the intervention [Срок оценки: Baseline to post (10 weeks)]
• Change from Baseline Warwick-Edinburgh Mental Well-being Scale (WEMWBS) score at the end of the intervention [Срок оценки: Baseline to post (10 weeks)]
• Change from Baseline Questionnaire about the Process of Recovery (QRP) score at the end of the intervention [Срок оценки: Baseline to post (10 weeks)]
• Change from Baseline Personal and Social Performance scale (PSP) score at the end of the intervention [Срок оценки: Baseline to post (10 weeks)]

Критерии участия

Критерии включения

• Diagnosis of affective or non-affective psychosis or related disorder;
• Follow-up and treatment by a clinician at one of the services mentioned above;
• Participants symptomatically stable and capable of using the online platforms and participating in intervention groups, as judged by their primary clinicians (i.e., psychiatrist, case manager);
• Participants must have access to a private space (i.e., a room where the participant can be alone) to ensure confidentiality for the group;
• Participants must be able to nominate an emergency contact and to agree to allow researchers to contact their clinician and/or emergency services in the event of an emergency during study procedures.

Критерии исключения

• Intellectual disability;
• Hospitalization at the time of recruitment;
• Inability to speak or read English or French;
• High suicide risk as per evaluation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 5 центров

• Faculty of Medicine, University of British Columbia — Vancouver
• Kingston Health Sciences Centre, Queen's University — Kingston
• Institute of Mental Health Research, University of Ottawa — Ottawa
• Ontario Shoares Centre for Mental Health Sciences, University of Toronto — Toronto
• Douglas Mental Health University Institute — Montreal

Публикации

• Bowie CR, Grossman M, Gupta M, Holshausen K, Best MW. Action-based cognitive remediation for individuals with serious mental illnesses: Effects of real-world simulations and goal setting on functional and vocational outcomes. Psychiatr Rehabil J. 2017 Mar;40(1):53-60. doi: 10.1037/prj0000189. Epub 2016 Apr 21. PMID 27100095
• Moritz S, Woodward TS. Metacognitive training in schizophrenia: from basic research to knowledge translation and intervention. Curr Opin Psychiatry. 2007 Nov;20(6):619-25. doi: 10.1097/YCO.0b013e3282f0b8ed. PMID 17921766
• Mendelson D, Thibaudeau E, Sauve G, Lavigne KM, Bowie CR, Menon M, Woodward TS, Lepage M, Raucher-Chene D. Remote group therapies for cognitive health in schizophrenia-spectrum disorders: Feasible, acceptable, engaging. Schizophr Res Cogn. 2021 Dec 6;28:100230. doi: 10.1016/j.scog.2021.100230. eCollection 2022 Jun. PMID 35242604
• Au-Yeung C, Thai H, Best M, Bowie CR, Guimond S, Lavigne KM, Menon M, Moritz S, Piat M, Sauve G, Sousa AE, Thibaudeau E, Woodward TS, Lepage M, Raucher-Chene D. iCogCA to Promote Cognitive Health Through Digital Group Interventions for Individuals Living With a Schizophrenia Spectrum Disorder: Protocol for a Nonrandomized Concurrent Controlled Trial. JMIR Res Protoc. 2025 Apr 15;14:e63269. doi: 10 PMID 40233365

Идентификаторы

NCT: NCT05661448 · iCogCA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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