Condition category
Mental and Behavioural Disorders
Date applied
06/06/2016
Date assigned
06/06/2016
Last edited
21/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Non-affective psychosis is the name given to a group of mental health conditions in which a person suffers from psychosis that is not related to mood. Schizophrenia and delusional disorders are examples of non-affective psychoses. These disorders involve a wide range of symptoms, including seeing or hearing things that are not there (hallucinations), having beliefs that do not reflect reality (delusions) and distinct changes in personality or behaviour. These symptoms can be very difficult for patients to deal with, often affecting the way they live their lives and their ability to work. The extent of cognitive problems (problems with thought, learning and/or memory) in people with these conditions is a good predictor functional recovery (how well someone can function in life), even with the best possible rehabilitation opportunities and medication. A new psychological treatment known as cognitive remediation (CRT) can improve both cognitive and functional recovery, including social relationships, work and studying. The ideal time to provide CRT is when a patient is being seen by the Early Intervention Services (for young people experiencing psychosis for the first time, and during the first three years following this first episode) as it is well known that it is more effective for younger people and may have larger effects on functioning if the intervention happens at the earliest opportunity. The aim of this study is to investigate the best way of putting into effect CRT for people in Early Intervention Services by assessing the degree that participants are able to achieve their personal goals.

Who can participate?
Adults aged between 16 and 35 who have a non-affective psychosis and have been attending an Early Intervention Service for at least six months.

What does the study involve?
Participants are randomly allocated to one of four groups. Those in the first group take part in intensive CRT. This involves receiving twice weekly individual therapy sessions for ten and a half weeks. Each session lasts for 60-180 minutes and involves 20-60 minutes of CRT with the therapist, 20-60 minutes of work learning how to apply CRT strategies to real life, and 20-60 minutes of independent CRT, done by the patient in their own time. Those in the second group take part in group CRT. This involves taking part in hour long sessions three times a week for 14 weeks in groups of four. Those in the third group take part in independent CRT. This involves an initial individual session with a therapist to get started and then taking part in CRT on their own at home. These participants are supported through regular contact with their therapist in the form of telephone calls and drop in sessions. Those in the fourth group take receive standard therapy which involves receiving different therapies as deemed necessary by the treating team. At the start of the study, after the CRT programs are complete and then six months later, participants in all groups complete a number of questionnaires in order to evaluate how effective the treatment that they have received has been.

What are the possible benefits and risks of participating?
Participants benefit from receiving financial compensation for taking part in each of the research assessments (£7 per hour). Additionally, participants will have a 75% chance of being allocated to cognitive remediation therapy that may help their thinking skills and everyday activities. There are no notable risks involved with participating in this study.

Where is the study run from?
South London and Maudsley NHS Foundation Trust and nine other Mental Health NHS Trusts in England (UK)

When is the study starting and how long is it expected to run for?
January 2016 to October 2019

Who is funding the study?
National Institute for Health Research

Who is the main contact?
1. Ms Tjasa Velikonja (public)
tjasa.velikonja@kcl.ac.uk
2. Professor Til Wykes (scientific)
til.wykes@kcl.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Tjasa Velikonja

ORCID ID

Contact details

King's College London
Department of Psychology
Institute of Psychiatry
Psychology and Neuroscience
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 20 7848 0762
tjasa.velikonja@kcl.ac.uk

Type

Scientific

Additional contact

Prof Til Wykes

ORCID ID

Contact details

King's College London
Department of Psychology
Institute of Psychiatry
Psychology and Neuroscience
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 20 7848 0596
til.wykes@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20362

Study information

Scientific title

Building Resilience and Recovery through Enhancing Cognition and quality of LIfe in the early PSychosEs (ECLIPSE)­ Study 9: Implementation of Remediation into Early Intervention Services

Acronym

ECLIPSE

Study hypothesis

Study aim as of 21/07/2016:
The aim of this study is to determine the best CRT implementation method for the majority of people in Early Intervention Services as assessed by the degree to which participants have achieved their personal goals (using the Goal Attainment Scale).

Original study aim:
The aim of this study is to determine the feasibility of implementing cognitive remediation therapy (CRT) into routine NHS early intervention services for psychosis and to establish the optimum implementation mode.

Ethics approval

Camden and Kings Cross REC, 22/01/2016 00:00:00, ref: 15/LO/1960

Study design

Randomised; Interventional; Design type: Not Specified, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Mental Health, Primary sub-specialty: Psychosis - schizophrenia

Intervention

Consenting patients will be randomised in blocks of 15 stratified by research site at week 0, week 14/15 and week 28/30, with randomisation in proportions 4:4:3:4 (group CRT/independent CRT/ intensive CRT/ treatment-as-usual). All CRT interventions (intensive/group/independent) will be carried out using computerised cognitive remediation (CIRCUITS Programme). There will be three regimes with different associated hours of therapist contact but all with 42 treatment hours.

Intensive CRT group: All participants are offered 10.5 weeks of twice weekly individual therapy. The sessions last for around 60-180 minutes and are in 3 parts:
1. 20-60 minutes of CRT with a therapist
2. 20-60 minutes of in vivo transfer work (i.e. putting CRT strategies into real life) with a therapist
3. 20-60 minutes of independent CRT, set up by the therapist on site, and done off-site in the patient’s own time
Each patient receives up to 42 hours of CRT (21 with therapist, 21 independently) and 21 hours of in vivo transfer work (with a therapist).

Group CRT group: All participants attend 14 weeks of three times weekly group therapy (up to 42 hours of CRT in total). The groups have closed membership and include 4 participants per group with one therapist leading the sessions. Each session lasts for 1 hour, with attendance for at least 20 minutes considered have completed a session. Group sessions begin and end with group activities, relating to goal-setting and metacognition. During the rest of the session, patients work independently on CIRCuiTS tasks (at the same time) with the therapist offering help and support to individuals on an as-needed basis.

Independent CRT group: All participants are offered one individual session to get started. Following this, participants are offered up to 41 independent sessions (up to 42 hours of CRT in total). To support the independent sessions, the therapist offers telephone contact and/or attendance at daily drop-in sessions on an as needed basis (estimated average therapist time: 1 hour per fortnight). Drop-in sessions allow participants to attend over a set time period during the day, during which s/he will have access to a work-station, and the therapist will meet with them for about 5 minutes to make sure they have been able to set up a session and have any questions/ problems addressed. The participant then works independently for the rest of the session. Valid sessions last a minimum of 20 and a maximum of 60 minutes.

Treatment as usual group:
Participants receive standard, multi-modal treatment which consists of different therapies as defined as necessary by the treating team.

Beside completing a pre-therapy (baseline) assessment in the 4 weeks prior to randomisation, post-therapy interviews/assessments will be conducted immediately following the 14 week intervention and 6 months after therapy using the same list of cognitive, clinical and other measures.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Achievement of goals is measured using the Goal Attainment Scale at baseline, post-CRT and at 6 months follow up.

Secondary outcome measures

1. Total number of hours of structured activity per week is measured using The Time Use Survey at baseline, post-CRT and at 6 months follow up
2. Costs of health and social care use measured using The Client Service Receipt Inventory at baseline, post-CRT and at 6 months follow up
3. Quality-adjusted life years (QALYs) measured using the EQ-5D at baseline, post-CRT and at 6 months follow up
4. Self-esteem measured using the Rosenberg Self Esteem Scale at baseline, post-CRT and at 6 months follow up

Overall trial start date

01/01/2016

Overall trial end date

01/10/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Attending an Early Intervention Service for at least six months
2. Aged between 16 and 35
3. Research diagnosis of non-­affective psychosis, i.e. schizophrenia, schizo­affective or schizophreniform disorder
4. Ability to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 720; UK Sample Size: 720

Participant exclusion criteria

1. Inability to communicate in English sufficiently to participate in cognitive testing
2. Underlying organic/neurological condition affecting cognition(e.g. traumatic brain injury, seizure disorder)
3. Co­-morbid diagnosis of learning disability

Recruitment start date

24/05/2016

Recruitment end date

24/05/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South London and Maudsley NHS Foundation Trust
Michael Rutter Centre Denmark Hill
London
SE5 8AZ
United Kingdom

Trial participating centre

Camden and Islington NHS Foundation Trust
4th Floor, East Wing St Pancras Hospital 4 St Pancras Way
London
NW1 0PE
United Kingdom

Trial participating centre

North East London NHS Foundation Trust
Goodmayes Hospital 157 Barley Lane
Ilford
IG3 8XJ
United Kingdom

Trial participating centre

East London NHS Foundation Trust
Trust Headquarters 9 Alie Street
London
E1 8DE
United Kingdom

Trial participating centre

Barnet, Enfield and Haringey Mental Health NHS Trust
Block B2 St. Anns Hospital St Ann's Road
London
N15 3TH
United Kingdom

Trial participating centre

Birmingham and Solihull Mental Health NHS Foundation Trust
1, B1 50 Summer Hill Road
Birmingham
B1 3RB
United Kingdom

Trial participating centre

Coventry and Warwickshire Partnership NHS Trust
Wayside House Wilsons Lane
Coventry
CV6 6NY
United Kingdom

Trial participating centre

Sussex Partnership NHS Foundation Trust
Trust Headquarters Arundel Road
Worthing
BN13 3EP
United Kingdom

Trial participating centre

Norfolk and Waveney Mental Health NHS Foundation Trust
Hellesdon Hospital Drayton High Road
Norwich
NR6 5BE
United Kingdom

Trial participating centre

Cambridgeshire and Peterborough NHS Foundation Trust
Cambridge Road Fulbourn
Cambridge
CB21 5HH
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

PO05
Institute of Psychiatry
Psychology & Neuroscience (IoPPN)
De Crespigny Park
London
SE5 8AZ
United Kingdom
+44 20 7848 0251
jennifer.liebscher@kcl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Planned publication in journals aimed at providers and commissioners (HSJ), practitioners (The Psychologist; American Journal of Rehabilitation Practice)
2. Production of a training programme for therapists that is web-accessible and make this freely available together with the tests for good clinical practice

Intention to publish date

01/10/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

21/07/2016: The study hypothesis has been updated. 21/06/2016: Study status verified with principal investigator.