Cognitive Remediation and Social Recovery in Early Psychosis

NCT04273685 | Unknown

• 1 other identifier: NUIreland3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis

Keywords

Early Psychosis

Outcome Measures

Primary Outcomes (1)

• Social and Occupational Functional Assessment Scale (SOFAS) (change from baseline)

  The Social and Occupational Functional Assessment Scale is a global rating of current functioning ranging from 0 to 100.Lower scores represent lower functioning and higher scores represent higher functioning.For example a score of 100 represents superior functioning in a wide range of activities,a score of 50 represents serious impairment in social, occupational or school functioning, a score of 30 represents an inability to function in almost all areas of activity. The minimum value is 0 and the maximum value is 100.

  Post study at 12 weeks and follow up 3-5 months post study

Secondary Outcomes (10)

• Time Use Survey

  Baseline, post study at 12 weeks,follow up 3-5 months post study

• Cambridge Neuropsychological Test Automated Battery (CANTAB)- Emotion Recognition Task- change being assessed.

  Baseline, post study at 12 weeks and 3-5 months post study

• The Reading the mind in the eyes task- change being assessed.

  Baseline, post study at 12 weeks,follow up 3-5 months post study

• The Hinting Task - change being assessed.

  Baseline, post study at 12 weeks,follow up 3-5 months post study

• The Bell Lysaker Emotion Recognition Task (BLERT)- change being assessed.

  Baseline, post study at 12 weeks,follow up 3-5 months post study

Other Outcomes (3)

• The Intrinsic Motivation Inventory (IMI)

  post study at 12 weeks,follow up 3-5 months post study

• The Need for Cognition Scale (NCS)

  Baseline, post study at 12 weeks,follow up 3-5 months post study

• Computerised Theory of Mind Task (c-TOM)

  Baseline, post study at 12 weeks,follow up 3-5 months post study

Study Arms (2)

Intervention Condition

EXPERIMENTAL

Cognitive remediation training, cognitive behavioural therapy, social recovery therapy

Behavioral: Cognitive remediation training, social recovery therapy

Control Condition

ACTIVE COMPARATOR

Treatment as usual (TAU),non-directive counselling

Other: treatment as usual

Interventions

Cognitive remediation training, social recovery therapy BEHAVIORAL

10 weeks cognitive remediation training plus social recovery therapy. One hour face to face contact time with intervention therapist per week. At-home cognitive remediation training completion.

Intervention Condition

treatment as usual OTHER

10 weeks Treatment as usual non directive counselling One hour face to face contact time with intervention therapist per week.

Control Condition

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead
• Health Research Board, Ireland: collaborator

Study Sites (1)

National University of Ireland, Galway

Galway, 00000, Ireland

RECRUITING

Related Publications (18)

• Bora E, Yucel M, Pantelis C. Theory of mind impairment in schizophrenia: meta-analysis. Schizophr Res. 2009 Apr;109(1-3):1-9. doi: 10.1016/j.schres.2008.12.020. Epub 2009 Feb 4.

  PMID: 19195844 BACKGROUND

• Horan WP, Kern RS, Shokat-Fadai K, Sergi MJ, Wynn JK, Green MF. Social cognitive skills training in schizophrenia: an initial efficacy study of stabilized outpatients. Schizophr Res. 2009 Jan;107(1):47-54. doi: 10.1016/j.schres.2008.09.006. Epub 2008 Oct 18.

  PMID: 18930378 BACKGROUND

• Kurtz MM, Richardson CL. Social cognitive training for schizophrenia: a meta-analytic investigation of controlled research. Schizophr Bull. 2012 Sep;38(5):1092-104. doi: 10.1093/schbul/sbr036. Epub 2011 Apr 27.

  PMID: 21525166 BACKGROUND

• Pinkham AE, Penn DL, Green MF, Buck B, Healey K, Harvey PD. The social cognition psychometric evaluation study: results of the expert survey and RAND panel. Schizophr Bull. 2014 Jul;40(4):813-23. doi: 10.1093/schbul/sbt081. Epub 2013 May 31.

  PMID: 23728248 BACKGROUND

• Addington J, Saeedi H, Addington D. Facial affect recognition: a mediator between cognitive and social functioning in psychosis? Schizophr Res. 2006 Jul;85(1-3):142-50. doi: 10.1016/j.schres.2006.03.028. Epub 2006 May 5.

  PMID: 16678388 BACKGROUND

• Fett AK, Viechtbauer W, Dominguez MD, Penn DL, van Os J, Krabbendam L. The relationship between neurocognition and social cognition with functional outcomes in schizophrenia: a meta-analysis. Neurosci Biobehav Rev. 2011 Jan;35(3):573-88. doi: 10.1016/j.neubiorev.2010.07.001. Epub 2010 Jul 8.

  PMID: 20620163 BACKGROUND

• Joseph J, Kremen WS, Franz CE, Glatt SJ, van de Leemput J, Chandler SD, Tsuang MT, Twamley EW. Predictors of current functioning and functional decline in schizophrenia. Schizophr Res. 2017 Oct;188:158-164. doi: 10.1016/j.schres.2017.01.038. Epub 2017 Jan 28.

  PMID: 28139356 BACKGROUND

• Sheridan AJ, Drennan J, Coughlan B, O'Keeffe D, Frazer K, Kemple M, Alexander D, Howlin F, Fahy A, Kow V, O'Callaghan E. Improving social functioning and reducing social isolation and loneliness among people with enduring mental illness: Report of a randomised controlled trial of supported socialisation. Int J Soc Psychiatry. 2015 May;61(3):241-50. doi: 10.1177/0020764014540150. Epub 2014 Jul 7.

  PMID: 25001267 BACKGROUND

• Fiszdon JM, Reddy LF. Review of social cognitive treatments for psychosis. Clin Psychol Rev. 2012 Dec;32(8):724-40. doi: 10.1016/j.cpr.2012.09.003. Epub 2012 Sep 21.

  PMID: 23059624 BACKGROUND

• Reeder C, Pile V, Crawford P, Cella M, Rose D, Wykes T, Watson A, Huddy V, Callard F. The Feasibility and Acceptability to Service Users of CIRCuiTS, a Computerized Cognitive Remediation Therapy Programme for Schizophrenia. Behav Cogn Psychother. 2016 May;44(3):288-305. doi: 10.1017/S1352465815000168. Epub 2015 May 25.

  PMID: 26004421 BACKGROUND

• Fowler D, Hodgekins J, French P. Social Recovery Therapy in improving activity and social outcomes in early psychosis: Current evidence and longer term outcomes. Schizophr Res. 2019 Jan;203:99-104. doi: 10.1016/j.schres.2017.10.006. Epub 2017 Oct 22.

  PMID: 29070442 BACKGROUND

• Reeder C, Huddy V, Cella M, Taylor R, Greenwood K, Landau S, Wykes T. A new generation computerised metacognitive cognitive remediation programme for schizophrenia (CIRCuiTS): a randomised controlled trial. Psychol Med. 2017 Nov;47(15):2720-2730. doi: 10.1017/S0033291717001234. Epub 2017 Sep 4.

  PMID: 28866988 BACKGROUND

• Green MF, Horan WP, Lee J. Nonsocial and social cognition in schizophrenia: current evidence and future directions. World Psychiatry. 2019 Jun;18(2):146-161. doi: 10.1002/wps.20624.

  PMID: 31059632 BACKGROUND

• Green, M. F., & Horan, W. P. (2010). Social Cognition in Schizophrenia. Current Directions in Psychological Science, 19(4), 243-248. https://doi.org/10.1177/0963721410377600

  BACKGROUND

• Reeder C, Wykes T (2010). Cognitive Interaction Remediation of Cognition - a Training for Schizophrenia (CIRCuiTS). King's College London: UK.

  BACKGROUND

• Correll CU, Galling B, Pawar A, Krivko A, Bonetto C, Ruggeri M, Craig TJ, Nordentoft M, Srihari VH, Guloksuz S, Hui CLM, Chen EYH, Valencia M, Juarez F, Robinson DG, Schooler NR, Brunette MF, Mueser KT, Rosenheck RA, Marcy P, Addington J, Estroff SE, Robinson J, Penn D, Severe JB, Kane JM. Comparison of Early Intervention Services vs Treatment as Usual for Early-Phase Psychosis: A Systematic Review, Meta-analysis, and Meta-regression. JAMA Psychiatry. 2018 Jun 1;75(6):555-565. doi: 10.1001/jamapsychiatry.2018.0623.

  PMID: 29800949 BACKGROUND

• CREW (2012). Definition of Cognitive Remediation. Cognitive Remediation Expert Working Group: Florence, Italy.

  BACKGROUND

• Frawley E, Cowman M, Cella M, Cohen D, Ryan E, Hallahan B, Bowie C, McDonald C, Fowler D, Wykes T, Donohoe G. Cognitive Remediation and Social Recovery in Early Psychosis (CReSt-R): protocol for a pilot randomised controlled study. Pilot Feasibility Stud. 2022 May 24;8(1):109. doi: 10.1186/s40814-022-01064-6.

  PMID: 35610711 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Gary Donohoe

  National University of Ireland, Galway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor Gary Donohoe

CONTACT

091 49 5122; gary.donohoe@nuigalway.ie

Emma Frawley

CONTACT

091492801; emma.frawley@nuigalway.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a feasibility study with a randomised, controlled, outcome-assessor-blind, parallel- group design.

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 18, 2020
• Study Start: October 1, 2019
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)