Clinical trial NCT04273685: Cognitive Remediation and Social Recovery in Early Psychosis
Official title: Cognitive Remediation and Social Recovery in Early Psychosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychosis
Keywords: Early Psychosis
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: Health Research Board, Ireland
First posted: 2020-02-18
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a feasibility study with a randomised, controlled, outcome-assessor-blind, parallel- group design.
Primary purpose: TREATMENT

Brief summary: This intervention trial explores the feasibility, effectiveness and acceptability of a novel psycho-social intervention for early psychosis based on a combined cognitive remediation training and cognitive behavioural therapy approach focused on social recovery. The impact of the CReSt-R intervention on social cognition as a primary outcome will be explored in addition to secondary outcome measures such as social and occupational functioning ( Detailed further in this registration). Feasibility of the trial design and the acceptability of the CReSt-R intervention to the target group, 16-35 year olds who are within the first 5 years of a diagnosed psychotic illness, are also explored in this trial.

Detailed description: This study is being carried out as part of a collaborative doctoral award program entitled Youth Mental Health Research Leadership (YOULEAD, www.nuigalway.ie/youlead) and is funded by the Health Research Board, Ireland.

It is a multi centre, randomised pilot study based at the National University of Ireland,Galway with ethical approval from the Galway University Hospital ethical committee. The principal investigator is Prof. Gary Donohoe and study lead Ms. Emma Frawley, both based at the School of Psychology, National University of Ireland, Galway.

Across psychosis spectrum disorders, social cognition is strongly linked to functional outcomes and therefore considered an important target for intervention.Social Cognition is reported to mediate the effects of neurocognition on functional outcomes.This suggests better functional outcomes may be achieved if both neurocognition and social cognition are targeted in intervention and that neurocognitive training alone does not result in significant social cognitive improvements.

People living with experience of psychotic illness often experience barriers to socialising. For example, experience of positive symptoms in schizophrenia can result in psychological challenges and reduced opportunities to meet and engage with other individuals in a social context. In a 2012 review of social cognitive interventions it was concluded that in order to impact higher-order social cognitive processes, there needs to be ample opportunity for practice of skills both in a clinical setting as well as in the community. A recent meta- analysis and meta-regression study also concluded early intervention in psychosis, where there is a multi-component treatment approach, is associated with better outcomes across a number of variables including global functioning and involvement in school or work. Exploration of the feasibility of the CReSt-R intervention and its ability to integrate into a multi-component treatment approach, is integral to this research study.

The CReSt-R study is novel in its approach, combining the CIRCuiTS cognitive training programme, informed by a metacognitive model, with Social Recovery Therapy, informed by cognitive behavioural theory and assertive outreach.

Effectiveness of the intervention will be explored with social cognition and social and occupational function as co primary outcomes. Secondary outcomes of general cognition and social and occupational functioning (Detailed further in this registration). Feasibility of the intervention will be assessed using key indicators of rate of enrollment, blinding effectiveness, rate of retention of participants and completion rate of the primary outcome measures. Acceptability of the intervention will be assessed using the Intrinsic Motivation inventory (IMI) administered on completion of the study and a qualitative study.

When a participant is recruited and consented to the study (via the services they attend) they will be randomised to either an intervention or control group.

In the intervention group the participant will receive 1 hour a week of the CReSt-R intervention for 10 weeks. This will include:

1. Cognitive remediation training (CR). Cognitive remediation training "Is a behavioural training-based intervention that aims to improve cognitive processes \[attention, memory, executive function, social cognition, or metacognition\] with the goal of durability and generalisability". The programme used in this study is the Computerised Interactive Remediation of Cognition- Training for Schizophrenia (CIRCuiTS). CIRCuiTS is a web based CR 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 4 weeks with remote practice sessions occurring between therapy visits. After 4 weeks' remote practice will continue and the focus of in-person therapy sessions will bridge to Social Recovery Therapy (SRT) as detailed below.
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. It occurs in three stages as defined by the SRT protocol - Stage one focuses on engagement with the participant and collaborative formulation with the purpose of identifying a problem list and establishing a therapeutic relationship. Stage two prepares the participant for new activities with identification of pathways to activity and collaboration with community stakeholders. Stage three promotes engagement in new activities using behavioural experiments to promote social activity. This is the primary focus of in-person therapy sessions from week 5 to 10 alongside remote practice of the CR programme.

In the control group of the study participants will receive Treatment as Usual (TAU) plus 10 weeks of 1:1 non-directive counselling matching the intervention group for time.

Eligibility criteria: Inclusion Criteria:

* Aged between 16 and 35 years' old
* History of psychosis: within the first five years of a diagnosed psychotic illness (based on time since first contact with mental health services for a psychotic episode)
* Community-based and clinically stable (in opinion of primary treating team)
* Ability to give consent

Exclusion Criteria:

* History of organic impairment
* History of head injury with loss of consciousness \>5-minute duration
* Drug abuse in the preceding 1 month

Primary outcomes:
measure: Social and Occupational Functional Assessment Scale (SOFAS) (change from baseline)
timeFrame: Post study at 12 weeks and follow up 3-5 months post study
Secondary outcomes:
measure: Time Use Survey
timeFrame: Baseline, post study at 12 weeks,follow up 3-5 months post study
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB)- Emotion Recognition Task- change being assessed.
timeFrame: Baseline, post study at 12 weeks and 3-5 months post study
measure: The Reading the mind in the eyes task- change being assessed.
timeFrame: Baseline, post study at 12 weeks,follow up 3-5 months post study
measure: The Hinting Task - change being assessed.
timeFrame: Baseline, post study at 12 weeks,follow up 3-5 months post study
measure: The Bell Lysaker Emotion Recognition Task (BLERT)- change being assessed.
timeFrame: Baseline, post study at 12 weeks,follow up 3-5 months post study
measure: Wechsler abbreviated scale of intelligence- similarities and matrix reasoning subtests
timeFrame: Baseline, post study at 12 weeks,follow up 3-5 months post study
measure: Wechsler Memory scale 3rd edition- logical memory and letter number sequencing subtests
timeFrame: Baseline, post study at 12 weeks,follow up 3-5 months post study
measure: Rey Osterreith Complex Figure (ROCF)
timeFrame: Baseline, post study at 12 weeks,follow up 3-5 months post study
measure: STROOP
timeFrame: Baseline, post study at 12 weeks,follow up 3-5 months post study
measure: The Positive and Negative Symptom Scale (PANSS)
timeFrame: Baseline, post study at 12 weeks,follow up 3-5 months post study
Other outcomes:
measure: The Intrinsic Motivation Inventory (IMI)
timeFrame: post study at 12 weeks,follow up 3-5 months post study
measure: The Need for Cognition Scale (NCS)
timeFrame: Baseline, post study at 12 weeks,follow up 3-5 months post study
measure: Computerised Theory of Mind Task (c-TOM)
timeFrame: Baseline, post study at 12 weeks,follow up 3-5 months post study
Locations:
city: Galway
country: Ireland
facility: National University of Ireland, Galway
Study officials:
affiliation: National University of Ireland, Galway
name: Gary Donohoe
role: PRINCIPAL_INVESTIGATOR
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