Clinical trial NCT05661448: Promoting Cognitive Health in Schizophrenia
Official title: Promoting Cognitive Health in Schizophrenia: A National Collaborative Effort to Implement Online Psychological Interventions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Cognition
Keywords: intervention
cognitive remediation
metacognition
psychosis
Lead sponsor: Douglas Mental Health University Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: McGill University
First posted: 2022-12-22
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A non-randomized concurrent control design (NRCC) is proposed and will allow for a comparison between the two interventions using one (e.g., CR) as the active control for the other (e.g., MCT) and vice-versa, on intervention-specific primary outcomes.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Brief version of the Cambridge Neuropsychological Testing Automated Battery (CANTAB) score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline Wechsler Memory Scale - Logical Memory (LM) subscale score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline Brief Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS-B) score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline Cognitive Motivation Scale (CMS) score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline Davos Assessment of Cognitive Biases Scale (DACOBS) score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline Beads task score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline bias against disconfirmatory evidence (BADE) image task score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
Secondary outcomes:
measure: Change from Baseline Short version of the Positive And Negative Syndrome Scale (PANSS-6) score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline Brief Negative Symptom Scale (BNSS) score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline Psychotic Symptom Rating Scales (PSYRATS) score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline Emotional, and Social Loneliness Scale (OES) score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline Self-Esteem Rating Scale - Short Form (SERS-SF) score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline Warwick-Edinburgh Mental Well-being Scale (WEMWBS) score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline Questionnaire about the Process of Recovery (QRP) score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline Personal and Social Performance scale (PSP) score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
Other outcomes:
measure: Change from Baseline Basic Psychological Need Satisfaction and Frustration Scale (BPNSNF) score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline Autonomous-Controlled Motivation for Intervention Questionnaire (ACMIQ) score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline Health Care Climate Questionnaire (HCCQ) score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Change from Baseline MUSIC Cognitive Training Questionnaire score at the end of the intervention
timeFrame: Baseline to post (10 weeks)
measure: Program Sustainability Assessment Tool (PSAT)
timeFrame: Baseline to post (10 weeks)
Locations:
city: Vancouver
country: Canada
facility: Faculty of Medicine, University of British Columbia
state: British Columbia
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre, Queen's University
state: Ontario
city: Ottawa
country: Canada
facility: Institute of Mental Health Research, University of Ottawa
state: Ontario
city: Toronto
country: Canada
facility: Ontario Shoares Centre for Mental Health Sciences, University of Toronto
state: Ontario
city: Montréal
country: Canada
facility: Douglas Mental Health University Institute
state: Quebec
Study officials:
affiliation: Douglas Mental Health University Institute
name: Martin Lepage
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.