Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Psychosis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a feasibility study with a randomised, controlled, outcome-assessor-blind, parallel- group design.Masking: Single (Outcomes Assessor)Masking Description: A randomisation procedure for group allocation will be compiled with an independent statistician. A research assistant, blinded to allocation, will complete outcome assessments at the three time points (Prior to the study commencing, 2 weeks post study completion and follow up at 3 months).Primary Purpose: Treatment

Participation Requirements

Age
Between 16 years and 35 years
Gender
Both males and females

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 single centre, randomised pilot study based at the National University o...

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 single 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 as a primary outcome in addition to 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. 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: 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. 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.

Tracking Information

NCT #
NCT04273685
Collaborators
Health Research Board, Ireland
Investigators
Principal Investigator: Gary Donohoe National University of Ireland Galway