PsychosisCReSt-RNCT04273685
Cognitive Remediation and Social Recovery in Early Psychosis
A study testing Cognitive remediation training, social recovery therapy and treatment as usual in people with Psychosis, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Cognitive remediation training, social recovery therapy and treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- 1 Oct 2019to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- History of organic impairment
- History of head injury with loss of consciousness >5-minute duration
- Drug abuse in the preceding 1 month
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
National University of Ireland, Galway
Galway, 00000
Gary Donohoe, 091495122, gary.donohoe@nuigalway.ie
Emma Frawley, 091492801, emma.frawley@nuigalway.ie
About this study
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.
Read the 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:
- 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.
- Conditions
- Psychosis
- Being tested
- Cognitive remediation training, social recovery therapy, treatment as usual
- Keywords
- Early Psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediation training, social recovery therapyBehavioural
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.
treatment as usualOther
10 weeks Treatment as usual non directive counselling One hour face to face contact time with intervention therapist per week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Condition | Experimental | Cognitive remediation training, cognitive behavioural therapy, social recovery therapy Receives: Behavioral: Cognitive remediation training, social recovery therapy |
| Control Condition | Active comparator | Treatment as usual (TAU),non-directive counselling Receives: Other: treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post study at 12 weeks and follow up 3-5 months post study
Secondary outcomes (10)
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).A higher score indicates superior social functioning, a lower score represents impaired social functioning. 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.
Measured: 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.
This task measures the ability to identify six basic emotions in facial expressions along a continuum of expression magnitude. 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 task takes 6 minutes to complete.
Measured: Baseline, post study at 12 weeks and 3-5 months post study
The Reading the mind in the eyes task- change being assessed.
This task 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. As noted above, definitions of the response choices are embedded in the task. The dependent measure was the total number of correct responses, ranging from 0 to 36
Measured: Baseline, post study at 12 weeks,follow up 3-5 months post study
The Hinting Task - change being assessed.
This task examines the ability to infer the true intent of indirect speech. Ten short passages presenting an interaction between two characters are read aloud. Each passage ends with one of the characters dropping a hint, and participants explain what the character truly meant. If the first response provided was inaccurate, a second hint is delivered, allowing participants to earn partial credit. Total scores range from 0 to 20
Measured: Baseline, post study at 12 weeks,follow up 3-5 months post study
The Bell Lysaker Emotion Recognition Task (BLERT)- change being assessed.
This 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).
Measured: Baseline, post study at 12 weeks,follow up 3-5 months post study
Wechsler abbreviated scale of intelligence- similarities and matrix reasoning subtests
The similarities and matrix reasoning subtests from the Wechsler Adult Scale of Intelligence 3rd edition (WAIS-III) is a brief, reliable measure of cognitive ability for use in clinical, educational and research settings. The similarities subtests scores range from 0 - 33 with higher scores indicating better verbal comprehension. 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.
Measured: Baseline, post study at 12 weeks,follow up 3-5 months post study
Wechsler Memory scale 3rd edition- logical memory and letter number sequencing subtests
The Wechsler Memory Scale 3rd edition, logical memory subtest is used to assess episodic and auditory memory in immediate and delayed conditions.Logical memory immediate scores range from 0-75, and delayed scores range from 0-50.
The letter-number sequencing subtest from the Wechsler Memory Scale 3rd edition is used to assess working memory. Scores range from 0-21.
Higher scores on the Wechsler Memory Scale 3rd edition subtests indicate better memory function. Raw scores are converted to scaled scores adjusted for age.
Measured: Baseline, post study at 12 weeks,follow up 3-5 months post study
Rey Osterreith Complex Figure (ROCF)
The Rey Osterreith Complex Figure is an assessment which measures visual memory by asking the participant to reproduce a complicated line drawing, first by copying it freehand and then drawing from memory (immediate and delayed conditions). Scores range from 0-36 with higher scores indicating better visual memory.
Measured: Baseline, post study at 12 weeks,follow up 3-5 months post study
STROOP
The Stroop test measures a person's sustained attention for word reading and color naming with/without interference. A computerized Stroop task measures mean reaction times (RTs) for congruent and incongruent trials. Four colour words (green, red, yellow, and blue) written in congruent or incongruent colour are randomly presented on screen. The Stroop test detects attentional interference via the measurement of response latency (calculated as mean RT for incongruent trials minus mean RT for congruent trials) when participants are asked to inhibit word meaning and indicate the ink colour of the word. Longer latencies are interpreted as greater interference by word content and lower executive function.
Measured: Baseline, post study at 12 weeks,follow up 3-5 months post study
The Positive and Negative Symptom Scale (PANSS)
The Positive and Negative Syndrome Scale (PANSS) is a 30 item scale used to assess symptom severity which includes positive, negative, and general symptom subscales and total scores. Scores range from 7 to 49 for positive and negative symptoms, 16 to 112 for general symptoms, and 30 to 210 for total score. Higher scores indicate higher symptom severity.
Measured: Baseline, post study at 12 weeks,follow up 3-5 months post study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Oct 2019
- Primary completion1 May 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a feasibility study with a randomised, controlled, outcome-assessor-blind, parallel- group design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Responsible party
- Principal investigator, Gary Donohoe, National University of Ireland, Galway, Ireland
- Investigators
- Gary Donohoe, Principal investigator, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273685
- Sponsor's protocol ID
- NUIreland3
- Acronym
- CReSt-R
- Status last verified
- Mar 2022
- First submitted
- 30 Jan 2020
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19195844Horan 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.
PubMed 18930378Kurtz 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.
PubMed 21525166Pinkham 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.
PubMed 23728248Addington 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.
PubMed 16678388Fett 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.
PubMed 20620163Joseph 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.
PubMed 28139356Sheridan 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.
PubMed 25001267Fiszdon 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.
PubMed 23059624Reeder 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.
PubMed 26004421Fowler 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.
PubMed 29070442Reeder 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.
PubMed 28866988Green 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.
PubMed 31059632Green, 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
Reeder C, Wykes T (2010). Cognitive Interaction Remediation of Cognition - a Training for Schizophrenia (CIRCuiTS). King's College London: UK.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation and Social Recovery in Early Psychosis
- ClinicalTrials.gov ID
- NCT04273685
- Acronym / sponsor ID
- CReSt-R / NUIreland3
- Conditions
- Psychosis
- Keywords
- Early Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a feasibility study with a randomised, controlled, outcome-assessor-blind, parallel- group design.
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Behavioral: Cognitive remediation training, social recovery therapyCognitive remediation training, cognitive behavioural therapy, social recovery therapy |
| Control Condition | Active comparator | Other: treatment as usualTreatment as usual (TAU),non-directive counselling |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- History of organic impairment
- History of head injury with loss of consciousness >5-minute duration
- Drug abuse in the preceding 1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive remediation training, social recovery therapy10 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. | Behavioural | Intervention Condition |
| treatment as usual10 weeks Treatment as usual non directive counselling One hour face to face contact time with intervention therapist per week. | Other | Control Condition |
Primary outcome
Social and Occupational Functional Assessment Scale (SOFAS) (change from baseline)
Time frame: Post study at 12 weeks and follow up 3-5 months post study
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.
10 secondary outcomes
Time Use Survey
Time frame: 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.
Time frame: Baseline, post study at 12 weeks and 3-5 months post study
The Reading the mind in the eyes task- change being assessed.
Time frame: Baseline, post study at 12 weeks,follow up 3-5 months post study
The Hinting Task - change being assessed.
Time frame: Baseline, post study at 12 weeks,follow up 3-5 months post study
The Bell Lysaker Emotion Recognition Task (BLERT)- change being assessed.
Time frame: Baseline, post study at 12 weeks,follow up 3-5 months post study
Wechsler abbreviated scale of intelligence- similarities and matrix reasoning subtests
Time frame: Baseline, post study at 12 weeks,follow up 3-5 months post study
Wechsler Memory scale 3rd edition- logical memory and letter number sequencing subtests
Time frame: Baseline, post study at 12 weeks,follow up 3-5 months post study
Rey Osterreith Complex Figure (ROCF)
Time frame: Baseline, post study at 12 weeks,follow up 3-5 months post study
STROOP
Time frame: Baseline, post study at 12 weeks,follow up 3-5 months post study
The Positive and Negative Symptom Scale (PANSS)
Time frame: Baseline, post study at 12 weeks,follow up 3-5 months post study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Background: PubMed 19195844Bora 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.
- Background: PubMed 18930378Horan 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.
- Background: PubMed 21525166Kurtz 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.
- Background: PubMed 23728248Pinkham 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.
- Background: PubMed 16678388Addington 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.
- Background: PubMed 20620163Fett 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Donohoe principal investigator
National University of Ireland, Galway, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive remediation training, social recovery therapy and treatment as usual in people with Psychosis, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Professor Gary Donohoe (091 49 5122 ext. 5122, gary.donohoe@nuigalway.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social and Occupational Functional Assessment Scale (SOFAS) (change from baseline) (time frame: Post study at 12 weeks and follow up 3-5 months post study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04273685, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.