Clinical trial NCT05017532: Cognitive Remediation for Social Cognition in Schizophrenia and Related Disorders
Official title: Cognitive Remediation for Social Cognition in Schizophrenia and Related Disorders: Acceptability, Feasibility and Preliminary Effects of Remoted RC2S+ (RC2S+ Remote)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychosis
Schizophrenia
Cognitive Impairment
Lead sponsor: Douglas Mental Health University Institute
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate whether the remote administration of the cognitive remediation program RC2S+ acceptable and feasible in people with schizophrenia and related disorders.

Detailed description: Schizophrenia and related psychotic disorders are associated with major functioning difficulties encompassing various areas of everyday life such as social interactions or school and work performance. Cognition, and more particularly social cognition, defined as the mental processes underlying social interactions, is considered as one of the best predictors of functioning in schizophrenia and related psychotic disorders. Social cognitive deficits thus represent a promising treatment target to promote functional recovery. Cognitive remediation (CR) is a behavioural intervention that can improve social cognitive deficits and clinical symptoms and moderate to large effect sizes have been reported. While there is great excitement that such interventions can also improve functioning, very few CR program for social cognition have used a personalized approach to tailor treatment to individual difficulties despite the benefit of personalizing CR treatment in schizophrenia. The program Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+) is a personalized CR treatment targeting social cognition using virtual reality to emulate daily social interactions. Two case studies conducted in France with people with schizophrenia have demonstrated acceptability and feasibility of in-person RC2S+ while providing preliminary evidence for efficacy with the report of significant improvement of social cognitive and functional difficulties. While these preliminary results are encouraging, the program has never been used in Canada. Psychosocial intervention, and particularly those targeting social cognition, need to be culturally adapted. Thus, a preliminary study is necessary to assess if RC2S+ is culturally adapted to the social norms and rules of French and English-speaking Canadians. Further, this study needs to consider the actual context of the COVID-19 pandemic which has highlighted the important vulnerability of people with psychotic disorders and the need to adapt evidence-based interventions such as CR to increase access to mental healthcare services. Online interventions have rapidly developed in the last year in response to COVID-19 and these interventions address important factors that are known to limit access to psychiatric care in people with psychotic disorders. A remote version will however require an acceptability and feasibility assessment.

Our main objective is to assess the acceptability, feasibility, and preliminary effect of the remoted RC2S+. To reach this goal, we will, 1) Translate the RC2S+ program in English and adapt the program for French Canadians and 2) Determine the acceptability, the feasibility and the preliminary effect of the remoted RC2S+.

Twenty-six participants with a diagnosis of schizophrenia and related psychotic disorder aged 18 years or older and who present with at least one social cognitive impairment will be recruited. They will be initially assessed for social cognition as well as clinical outcomes (e.g. symptoms, recovery, functioning). Then, participants will receive 24 biweekly individual sessions of RC2S+ of 1 hour with a therapist. Intra-session questionnaires will be administered at different timepoints to the participants and the therapists to assess therapeutic alliance, motivation toward treatment as well as the satisfaction regarding treatment. At the end of treatment, participants will be reassessed with the similar measures as baseline.

This study will provide the first insight of the preliminary effect of RC2S+ administered remotely, in addition to providing French-Canadian and English version of this novel program. The results of the current study will provide relevant information to improve the program and its delivery for a future efficacy study.

Eligibility criteria: Inclusion Criteria:

1. DSM-5 diagnosis of schizophrenia or a related psychotic disorder
2. Being followed and treated by a clinician of the Douglas Mental Health University Hospital
3. Being 18 or older
4. Having an objective difficulty in social cognition (i.e. emotion recognition, theory of mind, attributional bias, social perception) defined as a performance equal of below 1 standard deviation from the normative group on one of the following measures: Penn Emotion Recognition Task (ER-40; Emotion recognition), Combined Stories Test (COST; Theory of mind), Social Knowledge test (SKT; Social knowledge) or Interpersonal, Personal and Situational Attributions Questionnaire (IPSAQ; Attributional style). This criterion is mandatory since we need to be able to remediate a difficulty during cognitive remediation.
5. Being considered symptomatically stable and capable of using the online platforms, as judged by their primary clinicians (i.e., psychiatrist, case manager, psychologist)
6. Having access to digital technology, Internet and access to a private space (a room where the participant can be alone)
7. Being able to nominate an emergency contact

Exclusion Criteria:

1. Evidence of an organic cause for cognitive difficulties (e.g. neurological disease, history of brain trauma)
2. History of mental retardation or autism spectrum disorder
3. Being hospitalized at the time of recruitment
4. Inability to speak or read French or English

Primary outcomes:
measure: Combined Stories Test (COST)
timeFrame: The administration time is estimated at 30 minutes.
measure: Social Knowledge Test (SKT)
timeFrame: The administration time is estimated at 5 minutes.
measure: Penn Emotion Recognition Task (ER-40)
timeFrame: The administration time is estimated at 10 minutes.
measure: Interpersonal, Personal and Situational Attributions Questionnaire (IPSAQ)
timeFrame: The administration time is estimated at 10 minutes.
Secondary outcomes:
measure: DACOBS: Davos Assessment of Cognitive Biases Scale
timeFrame: The administration time is estimated at 10 minutes.
measure: PANSS-6: Positive and Negative Syndrome Scale
timeFrame: The administration time is estimated at 20 minutes.
measure: Social Interaction Anxiety Scale (SIAS)
timeFrame: The administration time is estimated at 5 minutes.
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: The administration time is estimated at 5 minutes.
measure: First-episode social functioning scale (FESF)
timeFrame: The administration time is estimated at 10 minutes.
measure: The Questionnaire about the process of recovery (QPR)
timeFrame: The administration time is estimated at 5 minutes.
Other outcomes:
measure: NIMH suicide screening questionnaire (NIMH-SSQ)
timeFrame: The administration time is estimated at 5 minutes.
measure: Échelle de repercussions fonctionnelles des troubles de la cognition sociale (ERF-CS)
timeFrame: The administration time is estimated at 10 minutes.
measure: Goal Attainment Scale (GAS)
timeFrame: The administration time is estimated at 5 minutes.
measure: MUSIC® Model of Motivation Inventory, Cognitive Training version (MMI-CT)
timeFrame: The administration time is estimated at 5 minutes.
measure: Working Alliance Inventory Short form (WAI)
timeFrame: The administration time is estimated at 5 minutes.
measure: eTherapy Attitudes and Process questionnaire (eTAP)
timeFrame: The administration time is estimated at 5 minutes.
measure: RC2S+ Acceptability, Usability, Safety, Impact, and Satisfaction Questionnaire (RC2S+-AUSIS-Q)
timeFrame: The administration time is estimated at 5 minutes.
Locations:
city: Montréal
country: Canada
facility: Douglas Mental Health University Institute
state: Quebec
Study officials:
References: