Promoting Cognitive Health in Schizophrenia

ConditionsSchizophrenia Cognition

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorDouglas Mental Health University Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Intellectual disability;

Hospitalization at the time of recruitment;

Inability to speak or read English or French;

High suicide risk as per evaluation.

Trial design

Design model

Parallel

Treatments tested in this trial

Cognitive remediation
Behavioral
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
Behavioral
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.

Treatment groups

390 Participants

are divided into 2 treatment groups

Group A: Cognitive remediationExperimental treatment 1 intervention

Group B: MetaCognitive TrainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline to post (10 weeks)

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).

Time frame

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

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.

Time frame

Baseline to post (10 weeks)

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.

Time frame

Baseline to post (10 weeks)

Secondary outcomes

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.

Time frame

Baseline to post (10 weeks)

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).

Time frame

Baseline to post (10 weeks)

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).

Time frame

Baseline to post (10 weeks)

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.

Time frame

Baseline to post (10 weeks)

Other outcomes

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).

Time frame

Baseline to post (10 weeks)

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.

Time frame

Baseline to post (10 weeks)

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).

Time frame

Baseline to post (10 weeks)

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).

Time frame

Baseline to post (10 weeks)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Douglas Mental Health University Institute

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

McGill University

Collaborator

Source ClinicalTrials.gov

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