Promoting Cognitive Health in Schizophrenia

Schizophrenia Clinical Trial

— iCogCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05661448
• Other study ID #: iCogCA
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: August 31, 2029

Study information

• Verified date: October 2023
• Source: Douglas Mental Health University Institute
• Contact: Karyne Anselmo
• Phone: (514) 761-6131
• Email: karyne.anselmo[@]douglas.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: August 31, 2029
• Est. primary completion date: August 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Intellectual disability;

• Hospitalization at the time of recruitment;

• Inability to speak or read English or French;

• High suicide risk as per evaluation.

Related Conditions & MeSH terms

• Cognition
• Schizophrenia

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre, Queen's University	Kingston	Ontario
Canada	Douglas Mental Health University Institute	Montréal	Quebec
Canada	Institute of Mental Health Research, University of Ottawa	Ottawa	Ontario
Canada	Ontario Shoares Centre for Mental Health Sciences, University of Toronto	Toronto	Ontario
Canada	Faculty of Medicine, University of British Columbia	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Douglas Mental Health University Institute	Canadian Institutes of Health Research (CIHR), McGill University

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline Basic Psychological Need Satisfaction and Frustration Scale (BPNSNF) score at the end of the intervention	this scale aims to assess satisfaction and frustration of the three basic psychological needs: competence, affiliation and autonomy. The items are reported on a scale ranging from 1 (completely disagree) to 7 (completely agree).	Baseline to post (10 weeks)
Other	Change from Baseline Autonomous-Controlled Motivation for Intervention Questionnaire (ACMIQ) score at the end of the intervention	Self-scale assessing motivational factors related to controlled and autonomous motivation.	Baseline to post (10 weeks)
Other	Change from Baseline Health Care Climate Questionnaire (HCCQ) score at the end of the intervention	The 6-item scale assesses motivational factors related to the therapists' perceived attributes (perceived support).	Baseline to post (10 weeks)
Other	Change from Baseline MUSIC Cognitive Training Questionnaire score at the end of the intervention	The MUSIC® Model of Motivation Inventory, Cognitive Training version (MMI-CT) is an 18-item self-report questionnaire that assesses motivation toward cognitive training. The questionnaire is divided into five scales namely empowerment, usefulness, success, interest and caring. Responses range from 1 (Strongly disagree) to 6 (Strongly Agree).	Baseline to post (10 weeks)
Other	Program Sustainability Assessment Tool (PSAT)	A 40-question assessment evaluating the sustainability capacity of a program by exploring 8 sustainability domains.	Baseline to post (10 weeks)
Primary	Change from Baseline Brief version of the Cambridge Neuropsychological Testing Automated Battery (CANTAB) score at the end of the intervention	This brief version of the computerized battery assessing neurocognition provides z-scores (with zero indicating the mean of a group of values) for each MATRICS cognitive subdomain.	Baseline to post (10 weeks)
Primary	Change from Baseline Wechsler Memory Scale - Logical Memory (LM) subscale score at the end of the intervention	In the LM I (maximum score=50), the two narrative stories (story A and story B) are verbally given and the examinee is required to immediately recall the stories as much as he/she can. In the LM II (maximum score=50), free recall of two stories is elicited after a 20 to 30-minute delay. Each correct detail was awarded with one score point. The 30 recognition questions (either yes or no) about the two stories are given subsequently to assess the recognition ability (maximum score=30).	Baseline to post (10 weeks)
Primary	Change from Baseline Brief Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS-B) score at the end of the intervention	The SSTICS-B is a 14-item measure focusing on difficulties associated with core cognitive domains including memory, attention, executive functions and praxia. Each item is rated on a five-point Likert scale ranging from "never" to "very often" with higher scores suggesting more cognitive problems.	Baseline to post (10 weeks)
Primary	Change from Baseline Cognitive Motivation Scale (CMS) score at the end of the intervention	Multidimensional scale for cognitive motivation assessing approach and withdrawal from cognitively challenging activities.	Baseline to post (10 weeks)
Primary	Change from Baseline Davos Assessment of Cognitive Biases Scale (DACOBS) score at the end of the intervention	This questionnaire assesses cognitive biases through 42 items rated on a Likert scale from 1 (strongly disagree) to 7 (strongly agree).	Baseline to post (10 weeks)
Primary	Change from Baseline Beads task score at the end of the intervention	In the beads task, participants see two jars full of beads of two colors. The beads in the jar have equal, but opposite ratios. One jar is chosen at random and kept secret from participants. As beads are drawn one at a time from the "secret" jar, participants must decide from which jar the beads are being drawn, or request to see more beads before deciding.; In this task, the number of beads drawn before the participant makes a decision determines their tendency of "jumping to conclusion". Deciding with minimal "evidence" (less beads, or after the first bead is drawn) would indicate a higher tendency to jump to conclusions.	Baseline to post (10 weeks)
Primary	Change from Baseline bias against disconfirmatory evidence (BADE) image task score at the end of the intervention	In this task, participants see partial line drawings of common objects, food or animals and are asked to whether they believe the full drawing corresponds to a word displayed below the image. The presence of a BADE bias in this task is represented by failing to modify an initial, erroneous hypothesis, once disconfirmatory evidence is provided.	Baseline to post (10 weeks)
Secondary	Change from Baseline Short version of the Positive And Negative Syndrome Scale (PANSS-6) score at the end of the intervention	Through a semi-structured interview, the positive and negative symptomatology of schizophrenia is explored. In this reduced scale, the following symptoms are assessed: delusions, conceptual disorganization, hallucinations, flattened affect, passive social withdrawal, and poverty of speech.	Baseline to post (10 weeks)
Secondary	Change from Baseline Brief Negative Symptom Scale (BNSS) score at the end of the intervention	The Brief Negative Symptom Scale (BNSS) is a 13-item instrument measuring blunted affect, alogia, asociality, anhedonia, and avolition. All the items in the BNSS are rated on a 7-point (0-6) scale, with anchor points generally ranging from the symptom's being absent (0) to severe (6).	Baseline to post (10 weeks)
Secondary	Change from Baseline Psychotic Symptom Rating Scales (PSYRATS) score at the end of the intervention	The PSYRATS is comprised of 17 items inquiring about the specific dimensions of hallucinations and delusions, with each item being rated from 0 (absent) to 4 (severe).	Baseline to post (10 weeks)
Secondary	Change from Baseline Emotional, and Social Loneliness Scale (OES) score at the end of the intervention	It is a self-scale assessing the 3-item emotional loneliness and the 3-item social loneliness, two dimensions of the overarching loneliness concept.	Baseline to post (10 weeks)
Secondary	Change from Baseline Self-Esteem Rating Scale - Short Form (SERS-SF) score at the end of the intervention	The SERS consists of 20 items rated on a 7-point Likert scale, 10 scored positively and 10 negatively.	Baseline to post (10 weeks)
Secondary	Change from Baseline Warwick-Edinburgh Mental Well-being Scale (WEMWBS) score at the end of the intervention	The scale consists of 14 items covering both hedonic and eudaimonic aspects of mental health including positive affect (feelings of optimism, cheerfulness, relaxation), satisfying interpersonal relationships and positive functioning (energy, clear thinking, self acceptance, personal development, competence and autonomy).	Baseline to post (10 weeks)
Secondary	Change from Baseline Questionnaire about the Process of Recovery (QRP) score at the end of the intervention	The QPR is a 22 item self- report measure measuring the process of recovery from a psychotic disorder. The items are rated on a five-point Likert scale ranging from "strongly disagree" to "strongly agree".	Baseline to post (10 weeks)
Secondary	Change from Baseline Personal and Social Performance scale (PSP) score at the end of the intervention	The PSP scale assesses functioning across four dimensions (socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviours) with a maximum score of 100.	Baseline to post (10 weeks)