PSYCHE Cognitive Remediation & Social Recovery Study
Study Details
Study Description
Brief Summary
This study is a pilot feasibility study embedded in the Early Intervention in Psychosis (EIP) services in Ireland. It explores the feasibility and acceptability of a combined cognitive remediation training and social recovery therapy intervention.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The Cognitive Remediation and Social Recovery in Early Psychosis (CRESTR) study is a feasibility study recruiting participants from the Health Service Executive Early Intervention in Psychosis (EIP) services in Sligo, Meath and Cork and the Adult Mental Heath Service in Galway. This study explores the feasibility and acceptability of a novel, 15-week multicomponent psychosocial intervention which combines cognitive remediation training (CRT) and social recovery therapy (SRT). Primary and secondary outcome measures are described later in this registration. The intervention components include:
Component 1: The CRT programme used in this study is the Computerised Interactive Remediation of Cognition- Training for Schizophrenia (CIRCuiTS). CIRCuiTS is a web-based CRT programme which targets metacognition, specifically strategy use, in addition to massed practice of cognitive functions (attention, memory and executive functioning). Collaborative goal setting related to real-world tasks are integral to the programme with the programme tasks and exercises increasing in difficulty in response to the participant's performance and progress. This will be the primary focus of 1:1 therapy for the first 7 weeks with remote practice sessions occurring between therapy visits. After 7 weeks remote practice will continue and the focus of in-person therapy sessions will bridge to social recovery therapy as detailed below.
Component 2: Social recovery therapy (SRT) focuses on addressing barriers to individuals interacting in their social environment e.g., social anxiety. It is informed by cognitive behavioural theory and addresses individual goals. SRT follows an established protocol. In summary, this consists of therapy delivered in three stages. Stage one will include engagement and formulation with the purpose of identifying a problem list and establishing a therapeutic relationship. Stage two will include preparing for new activities with identification of pathways to activity and collaboration with community stakeholders. Stage three will include engagement in new activities using behavioural experiments to promote social activity. This is the primary focus of in-person therapy sessions from week 8 to 15 alongside remote practice of the CRT programme.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention 15 sessions of the combined cognitive remediation training and social recovery therapy intervention. |
Behavioral: CRESTR Intervention
15 1-hour sessions of CRT + SRT
|
| Active Comparator: Control 15 sessions of social recovery therapy alone. |
Behavioral: CRESTR Control
15 1-hour sessions of SRT alone
|
Outcome Measures
Primary Outcome Measures
- Social and Occupational Functioning Assessment Scale (SOFAS) [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
Social and Occupational Functional Assessment Scale (SOFAS) (Rybarczyk, 2011) is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.
- Global Functioning Scale (GFS) [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
The Global Functioning Scale: Social (GFS) measures social skills and relationships within and outside of the family, and the Global Functioning Scale: Role (GFR) assesses performance in a person's primary role (typically student or worker).
- MIRECC GAF [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
Measures occupational functioning, social functioning, and symptom severity on 3 subscales. 3 subscales scored from 0 to 100, with higher scores indicating better functioning
- Global Assessment of Function (GAF) [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
The GAF scale is a 100-point single-item scale designed to measure the global severity of psychiatric illness on the basis of symptom, social, and occupational functioning combined. The scale is divided into 10 anchor intervals, with descriptions and examples of symptoms and of social and occupational functioning.
- Time Use Survey (TUS) [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
The TUS is a semi-structured interview that enquires about time spent over the past month on work, education, voluntary work, leisure, sports, housework or chores, and child care. Time spent on each of the activities is calculated in terms of the average number of hours per week. The activities are summed to create two scores: constructive economic activity (work, education, voluntary work, housework or chores, and child care) and structured activity (constructive economic activity plus leisure and sports activities). Less than 45 hours of structured activity per week is considered a threshold for being at risk of social disability, less than 30 hours per week is threshold for social disability and indicative of poor social functioning, and less than 15 hours per week is considered to reflect serious social disability.
Secondary Outcome Measures
- The Reading the Mind in the Eyes Task [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
The Reading the mind in the eyes task is a theory of mind task that measures the capacity to understand mental states of others from expressions in the eye region of the face. Participants view 36 photos and choose the most accurate descriptor word from four choices for the thought/feeling that was portrayed. Scores range from 0 to 36 with higher scores indicating better theory of mind ability.
- Emotion Recognition Task (CANTAB ERT) [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
The Emotion Recognition Task (ERT) from the Cambridge Neuropsychological Test Automated Battery (Cambridge Cognition Ltd.)
- The Bell Lysaker Emotion Recognition Task (BLERT) [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
The Bell Lysaker Emotion Recognition Task (BLERT) measures recognition of seven emotional states: happiness, sadness, fear, disgust, surprise, anger, or no emotion. Participants identified the emotion shown in 21 videos of a male actor providing dynamic facial, vocal-tonal, and upper-body movement cues. Performance is indexed as the total number of correctly identified emotions (ranging from 0 to 21).
- Test of Premorbid Functioning (TOPF) [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
Test of Premorbid Functioning estimates an individual's pre-morbid cognitive and memory functioning. A revised and updated version of the Wechsler Test of Adult Reading™, TOPF helps predict pre-injury IQ and memory abilities.
- The matrix reasoning subtest from the Wechsler Adult Scale of Intelligence 3rd edition (WAIS-III) [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
The matrix reasoning subtest from the Wechsler Adult Scale of Intelligence 3rd edition (WAIS-III) (Wechsler, 1997) is a brief, reliable measure of cognitive ability for use in clinical, educational and research settings. Matrix reasoning subtest scores range from 0 - 26 with higher scores reflecting better perceptual organization. Once raw scores are derived they are converted to scaled scores adjusted for age.
- Letter Number Sequencing Task [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
The letter-number sequencing task from the Wechsler Memory scale 3rd edition WMS-III assesses working memory. Scores range from 0-21. Higher scores on the WMS-III subtests indicate better memory function. Raw scores are converted to scaled scores adjusted for age.
- Metacognitive Awareness Scale, Domain Specific (MCAS-DS) [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
Meta-Cognitive Awareness Scale - Domain Specific (MCAS-DS) encourages reflection of task strategy processes. This domain-specific scale was first constructed to measure participants' awareness of their own metacognition linked to Raven's Progressive Matrices (SPM). Following discriminatory index and Exploratory Factor Analysis, a 15-item scale was derived. Exploratory Factor Analysis showed five factors: Awareness of Engagement in Self-Monitoring, Awareness of Own Ability, Awareness of Responding Speed/Time, Awareness of Alternative Solutions and Awareness of Requisite Problem-Solving Resources.
- Scale for the assessment of positive symptoms (SAPS) and negative symptoms (SANS) [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
Assessment of positive and negative symptomology
- PHQ-9 [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
The Patient Health Questionnaire (PHQ-9) is a brief tool used to diagnose and measure severity of depression. The PHQ-9 is shorter than many of the other depression screening instruments and can be self-administered. Adapted from the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), the PHQ-9 is comprised of the same diagnostic symptom criteria used in the DSM-IV: Two cardinal signs of depression (anhedonia and depressed mood); Cognitions (e.g. guilt/worthlessness and suicidality/thoughts of death); and Physical symptoms (e.g. change in appetite, difficulty sleeping and concentrating, feeling tired/slowed down or restless).
- GAD-7 [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
The Generalised Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks.
- DUDIT [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
The DUDIT is an 11-item self-administered screening instrument for drug-related problems, giving information on the level of drug intake and selected criteria for substance abuse/harmful use and dependence according to the ICD-10 and DSM-4 diagnostic systems.
- AUDIT [T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)]
The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviors, and alcohol-related problems.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged between 18 and 60 years of age
-
Within the first 5 years of a diagnosed psychotic disorder
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Community based and clinically stable
-
Ability to give informed consent
Exclusion Criteria:
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History of organic impairment
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IQ< 70
-
History of head injury with loss of consciousness > 5-minute duration
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HSE Early Intervention in Psychosis Service, Cork | Cork | Ireland | ||
| 2 | Adult Mental Health Service, University Hospital Galway | Galway | Ireland | ||
| 3 | HSE Early Intervention in Psychosis Service, Meath | Meath | Ireland | ||
| 4 | HSE Early Intervention in Psychosis Service, Sligo | Sligo | Ireland |
Sponsors and Collaborators
- National University of Ireland, Galway, Ireland
- Health Service Executive, Ireland
- Health Research Board, Ireland
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- NUIRELAND2