Schizophrenia Clinical Trial
Official title:
Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE): a Community-Based Cognitive Remediation Trial
NCT number | NCT06286202 |
Other study ID # | RECAS-0306 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | July 2027 |
Adults with serious mental illnesses (such as schizophrenia and schizoaffective disorders) often experience a range of cognitive difficulties (such as memory, problem solving difficulties) that affect their ability to lead meaningful life roles. Cognitive remediation is an intervention to address cognitive difficulties in this group of mental health service users. Its implementation in less well-resourced community-based settings is less well-studied. Therefore, the aims of the study are: - To investigate the effects of cognitive remediation on various cognitive skills (such as attention, memory, problem-solving, facial expression recognition, taking others' perspectives etc), for participants with schizophrenia or schizoaffective disorders in community mental health settings. - To investigate if factors such as participants' motivation for engagement and social interaction can affect changes in cognitive skills and functional ability. Participants in the treatment group will attend computer-based cognitive exercises to improve their cognitive skills. They will also participate in group sessions facilitated by therapists to learn how to utilize strategies learned from the computer sessions in their daily lives. Participants in the control group will attend the usual rehabilitation activities in their respective community-based psychiatric rehabilitation centers. This research study will compare the differences in their cognitive performance, functional ability and recovery immediately after the intervention and 8 weeks later.
Status | Not yet recruiting |
Enrollment | 160 |
Est. completion date | July 2027 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 60 Years |
Eligibility | Inclusion Criteria: - A diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-V). - Completed at least ten years of formal education with English as the main instructional language. Participants need to be able to converse in English and understand English instructions, as the cognitive remediation program will be conducted in English. Exclusion Criteria: - Known neurological diseases and epilepsy, which affects gains from cognitive remediation. - Unable to speak and understand English. - Hospitalized within the past one month. - Global Assessment of Functioning score of 30 or below, as participants who are too low functioning are unable to benefit from a strategy learning approach. |
Country | Name | City | State |
---|---|---|---|
Singapore | Anglican Care Center-Bukit Batok | Singapore | |
Singapore | Anglican Care Center-Hougang | Singapore | |
Singapore | Anglican Care Center-Simei | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore Institute of Technology | Singapore Anglican Community Services |
Singapore,
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* Note: There are 44 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The Global Assessment of Functioning Scale (GAF) | This is carried out prior to recruitment to exclude patients who have a score of 30 or lower. It is a numeric scale (0 through 100) used to rate symptom severity and social, occupational and psychological functioning of adults. The scale is indicated as Axis V in the Diagnostic and Statistical Manual of Mental Disorders-IV-TR and guidelines for scoring have been developed (Aas, 2011). | Baseline only, to exclude participants with a score of 30 or lower. | |
Primary | Brief Assessment of Cognition in Schizophrenia (BACS) | The Brief Assessment of Cognition in Schizophrenia (BACS) assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia. This assessment was validated and found to be sensitive and highly correlated with the standard battery composite scores in patients (r = 0.76) and healthy controls (r = 0.90) (Keefe et.al., 2004). BACS was also previously normed in English-speaking adult age Singaporeans (Eng et al., 2014), and had demonstrated good convergent validity with education (Lam et al., 2013) and discriminability between healthy controls and schizophrenia (Lam et al., 2014). BACS is now widely used as an outcome measurement for cognitive remediation for schizophrenia. | Baseline, post-intervention and 8-week follow-up | |
Primary | Bell Lysaker Emotion Recognition Task (BLERT) | The Bell Lysaker Emotion Recognition Task (BLERT) measures the participants' ability to process and recognize seven emotional states: happiness, sadness, fear, disgust, surprise, anger, or no emotion (Bryson, Bell and Lysaker, 1997). The participants will be presented with 21 video clips of an actor demonstrating facial, voice-tonal and upper-body movement cues, while engaging in work-related monologues. Unlike static photos, this measurement appears to simulate real-world situations better and may approximate real world functional outcomes (Pinkham et.al., 2016). Rating was done by computing the total number of correctly recognized emotions (ranging from 0 to 21). | Baseline, post-intervention and 8-week follow-up | |
Primary | Canadian Occupational Performance Measure (COPM) | The Canadian Occupational Performance Measure (COPM) is a person-centered tool that measures aspects of functional and personal recovery among clients whose occupational performance and participation are affected by their current psychiatric conditions. Through a semi-structured interview, the clients identify activities in self-care, productivity and leisure that are of personal importance and rate their performance and satisfaction in each activity (Law et.al., 1990). Self-perceived performance and satisfaction are rated on a 10-point Likert scale. | Baseline, post-intervention and 8-week follow-up | |
Primary | Social and Occupational Functioning Assessment Scale (SOFAS) | The Social and Occupational Functioning Assessment Scale (SOFAS) is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning (Goldman et.al., 1992). It differs from GAF scale by focusing on social and occupational functioning independent of the overall severity of the individual's psychological symptoms. SOFAS has been used as a functional outcome measurement in cognitive remediation trials (Au-Yeung et.al., 2023; Harris et.al., 2022; Hodge et.al., 2010). | Baseline, post-intervention and 8-week follow-up | |
Secondary | Positive and Negative Syndrome Scale (PANSS) | This is a 30-item rating instrument, evaluating the presence and severity of positive, negative and general psychopathology of schizophrenia (Kay, Fiszbein & Opler, 1987). The scale was developed from the Brief Psychiatric Rating Scale (BPRS) and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). PANSS covers positive and negative symptoms associated with schizophrenia, as well as other symptoms (eg aggression, thought disturbance, depression). Its five-factor model structure has also been validated in the Singapore Schizophrenia Chinese population (Jiang, Sim & Lee, 2013). Hence, the PANSS is a sound instrument to be used for symptom measurement. | Baseline, post-intervention and 8-week follow-up | |
Secondary | Brief Negative Symptom Scale (BNSS) | BNSS consists of five domains of negative symptoms (anhedonia, asociality, avolition, blunted affect, and alogia), which could be clustered into two factors - Motivation-Pleasure (MAP) and Emotional Expressivity (EE) (Kirkpatrick et.al., 2011). A local validation study found that BNSS showed good internal consistency and validity (Ang et.al, 2019). In addition, more severe symptoms as shown in BNSS total, avolition and asociality domains are associated with lower scores on the Global Assessment of Functioning (Ang et.al., 2019). | Baseline, post-intervention and 8-week follow-up | |
Secondary | Brief Regulation of Motivation Scale (BRoMS) | BroMS was initially developed to assess college students' regulation of motivation and two factors were identified: regulation of motivation and willpower (Kim et.al., 2018). Subsequently, a study that adapted and validated it for schizophrenia population found it to be acceptable, feasible and internally consistent, with higher BRoMs scores associated with better work-related skills (Lynch et.al., 2022). The adapted BroMs is a structured interview where participants are told to identify three tasks that they have been working on during the past week. The tasks require participants to maintain their effort over hours or days. The participants are then given 12 statements, where they rate on a 4-point scale, from 'Strongly Disagree' to 'Strongly Agree'. These statements are related to awareness and regulation of motivation. | Baseline, post-intervention and 8-week follow-up | |
Secondary | Weekly Calendar Planning Activity (WCPA) | The Weekly Calendar Planning Activity (WCPA) is a performance-based measure of metacognition, that requires the participant to plan and execute a multiple-step activity. It involves scheduling a list of appointments into a weekly calendar while following rules, avoiding conflicts, monitoring time, and inhibiting distractions, thereby evaluating the participant's planning, error recognition, use of strategies and self-monitoring (Toglia, 2015). Besides scoring for accuracy, the WCPA also scores the difference between the participant's estimated performance and his/her actual performance. Hence, it also evaluates the participant's self-awareness (Kaizerman-Dinerman et.al., 2023). | Baseline, post-intervention and 8-week follow-up |
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