An interventional study of CRESTR Intervention and CRESTR Control in Early Psychosis, sponsored by National University of Ireland, Galway, Ireland. Recruiting at 5 sites in Ireland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by National University of Ireland, Galway, Ireland · Not applicable, Interventional, and Treatment
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.
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.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
This study's planned enrollment of 40 is below the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →National University of Ireland, Galway, Ireland is the lead sponsor of 47 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
15 sessions of the combined cognitive remediation training and social recovery therapy intervention.
Behavioral: CRESTR Intervention
15 sessions of social recovery therapy alone.
Behavioral: CRESTR Control
15 1-hour sessions of CRT + SRT
15 1-hour sessions of SRT alone
Social and Occupational Functioning Assessment Scale
Social and Occupational Functional Assessment Scale (Rybarczyk, 2011) is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
The Reading the Mind in the Eyes Task
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.
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
Emotion Recognition Task
The Emotion Recognition Task from the Cambridge Neuropsychological Test Automated Battery (Cambridge Cognition Ltd.) Computer-morphed images derived from the facial features of real individuals, each showing a specific emotion, are displayed on the screen, one at a time. Each face is displayed for 200ms and then immediately covered up to prevent residual processing of the image. The participant must select which emotion the face displayed from 6 options (sadness, happiness, fear, anger, disgust or surprise). The outcome measures for ERT will include number correct, which can be looked at either across individual emotions or across all emotions at once. Higher scores indicate superior emotion recognition ability.
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
The Bell Lysaker Emotion Recognition Task
The Bell Lysaker Emotion Recognition Task 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 i.e. a higher score represents superior emotion recognition ability.
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
Test of Premorbid Functioning
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. Total score is derived from the number of correct items, ranges from 0-70 with a higher score indicating superior ability.
Time frame: 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)
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.
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
Letter Number Sequencing Task
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.
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
Metacognitive Awareness Scale, Domain Specific
Meta-Cognitive Awareness Scale - Domain Specific 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. The total score is the sum of the 15-itm scale with higher scores indicating superior metacognitive awareness.
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
The Scale for the Assessment of Positive Symptoms and the Scale for the Assessment of Negative Symptoms.
The Scale for the Assessment of Positive Symptoms measures positive symptoms on a 24 item scale, this includes 19 negative symptom item ratings, and 5 global factor ratings. Each item is scored on a six point scale from 0-5. The composite total is the sum of the nineteen item ratings. The SANS global total is the sum of the five global ratings. The higher the score the more symptomology or severity of symptoms. The Scale for the Assessment of Negative Symptoms measures negative symptoms on a 25 item, 6-point scale from 0-5. Items are listed under the five domains of affective blunting, alogia, avolition/apathy, anhedonia/asociality, and attention. Total (Composite) score is calculated as the sum of SANS items 1-7, 9-12, 14-16, 18-21, and 23-24, while SANS (Global) Summary score was calculated as the sum of SANS items 8, 13, 17, 22, and 25. The higher the score the more symptomology or severity of symptoms.
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
The Patient Health Questionnaire-9
The Patient Health Questionnaire-9 is a brief tool used to diagnose and measure severity of depression. It is adapted from the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). Scores range from 0 to 27 with higher scores indicating more severe depression. A total score of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
The Generalised Anxiety Disorder Assessment-7
The Generalised Anxiety Disorder Assessment 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. Total scores range from 0 to 21with higher scores indicating a higher level of anxiety. Clinical categorisations of anxiety levels are: 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe).
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
Drug Use Disorders Identification Test
The Drug Use Disorders Identification Test 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. The minimum total score possible is 0, and the maximum total score possible is 44 (i.e. total score range: 0-44). Higher scores reflect higher drug dependence
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
Alcohol Use Disorders Identification Test
The Alcohol Use Disorders Identification Test is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviors, and alcohol-related problems. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
EQ-ED-EL Health Questionnaire
The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each level is rated on scale that describes the degree of problems in that area (i.e. I have no problems walking about, slight problems, moderate problems, severe problems, or unable to walk). This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable.
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
Global Functioning Scale
The Global Functioning Scale: Role: measures performance and amount of support needed in one's specific role (ie, school, work). Social: measures quantity and quality of peer relationships, level of peer conflict, age-appropriate intimate relationships, and involvement with family members. Scale: 1-10, higher scores indicate better functioning.
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
MIRECC Global Assessment of Function
The MIRECC Global Assessment of Function measures occupational functioning, social functioning, and symptom severity on 3 subscales. 3 subscales scored from 0 to 100, with higher scores indicating better functioning.
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
Global Assessment of Function
The Global Assessment of Function 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. Higher scores indicate better functioning.
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
Time Use Survey
The Time Use Survey 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.
Time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
Plan to share: Yes — The full protocol in addition to datasets and statistical code generated during the current study will be available from the corresponding author on reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Access criteria: The full protocol in addition to datasets and statistical code generated during the current study will be available from the corresponding author on reasonable request.
No publications or documents are linked to this record.
Started Mar 2023 (actual). Primary completion is estimated for Jun 2025, 27 months after the start.
Of 455 non-industry interventional studies with no phase under Psychotic Disorders, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 52. This study's planned 27 months is below that.
Counting every sponsor, half of 457 studies reached it within 34 months; a quarter within 19 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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National University of Ireland, Galway, Ireland