Plain English Summary
Background and study aims
Schizophrenia and other related mental health problems often make it harder for sufferers to concentrate, remember things like appointments, change the way they think about things when they need to (flexibility), and do several things at the same time. This might also make it harder for people to take part in talking therapies like cognitive-behavioural therapy (CBT). We hope to use cognitive remediation (CR) to help people get more out of CBT. CR is a way of training the brain to deal with difficulty in concentration, memory and so on, based on practicing puzzles and other tasks. Other studies have shown it can work to improve these things but have not used it before CBT. This study will assess whether the use of a course of CR before CBT will enhance the effectiveness of the CBT.
Who can participate?
Patients aged 18 - 35 years diagnosed with schizophrenia or a related mental health problem, on a waiting list for CBT.
What does the study involve?
Participants are randomly allocated to receive either 40 hours of CR or 40 hours of social support delivered over 12 weeks. Participants then proceed to CBT for between 12 and 30 weeks. Participants’ symptoms are assessed at the start of the study and when participants have completed CR or social support. During the course of CBT participants will be re-assessed every 6 weeks and at 30 weeks after the start of CBT.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Lancashire Care NHS Trust (UK).
When is study starting and how long is it expected to run for?
January 2009 to July 2010.
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Louise Worrell
louise.worrell@lancashirecare.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Ms Louise Worrell
ORCID ID
Contact details
Lancashire Care NHS Trust
Sceptre Way
Bamber Bridge
Preston
PR5 6AW
United Kingdom
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louise.worrell@lancashirecare.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4755
Study information
Scientific title
HELPER Programme (Cognitive Remediation) - a randomised controlled trial of cognitive remediation in first episodes of schizophrenia
Acronym
Study hypothesis
Many people with Schizophrenia have difficulties with neuropsychological skills (like attention, planning, memory, design and perception). Cognitive Remediation (CR) is a method for improving them, in essence a form of 'brain training', consisting of regular practice on a number of mental puzzles. In clinical trials CR has improved several neuropsychological difficulties, insight into those difficulties, and even delusions and hallucinations. It often works when linked to other forms of rehab or psychological treatment. Cognitive Behavioural Therapy (CBT) is used in addition to medication as a treatment for schizophrenia symptoms but depends on participants having the kind of neuropsychological skills targeted by CR (e.g. attention, memory etc).
The study aims to see whether 3 months of computer-based CR, while on the waiting list for CBT, will improve CBT's results following a first episode of psychosis.
64 patients waiting for CBT after their first episode of schizophrenia, who agree to take part, will be randomly selected either for CR or support from a Support Time and Recovery Worker. They will see either the therapist for 40hrs or the support worker for the same amount of time over 3mths. After this both group will have CBT as part of normal NHS service, for 12 - 30 sessions.
Participant's symptoms and neuropsychological skills will be assessed at recruitment and after 12 weeks by an assessor is blind to which group they are in. They will then have delusions and hallucinations reassessed for every 6 weeks for another 30 weeks, during CBT.
More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=4755
Ethics approval
Bolton Research Ethics Committee, 23/12/2008, ref: 08/H1009/76
Study design
Randomised interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Schizophrenia, Psychosis
Intervention
Consenting patients waiting for CBT for psychosis after their first episode of schizophrenia are randomly allocated to either cognitive remediation (CR) or a time-matched social support comparison group by an independent administrator. The CR group engage in computer based cognitive remediation (with the CIRCUITS virtual reality based CR programme) for a total of 40 hours over 3 months. A CR therapist also supports them face-to-face for at least 1h per week. The social support comparator group are exposed to a support time and recovery worker for a matched period. After this both groups have routine CBT for 12 - 30 sessions delivered by specifically trained, accredited, supervised CBT for psychosis therapists as part of NHS Early Intervention Services.
Participants' symptoms and neuropsychological skills are assessed at recruitment and after 12 and 42 weeks.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
PSYRATS, a measure of delusions and hallucinations. PSYRATS is reassessed every 6 weeks during the 30week CBT envelope (weeks 12-42). A final PSYRATS is completed at 54 weeks.
Secondary outcome measures
1. PANSS
2. Calgary Depression
3. Insight Scale and IPQ attitude scores
4. Time to relapse and readmission
Overall trial start date
19/01/2009
Overall trial end date
31/07/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participants which they have suffered a 1st episode of psychosis that meets DSM IV criteria for schizophreniform disorder, schizophrenia, schizo-affective disorder, delusional disorder, or psychosis Not Otherwised Specified (NOS)
2. Aged 18 - 35 years
3. Receiving standard care from Early Intervention Service
4. Male and female participants
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 64
Participant exclusion criteria
DSM IV criteria for substance misuse or organic brain disease
Recruitment start date
19/01/2009
Recruitment end date
31/07/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Lancashire Care NHS Trust
Preston
PR5 6AW
United Kingdom
Sponsor information
Organisation
Lancashire Care NHS Trust (UK)
Sponsor details
Sceptre Point
Sceptre Way
Walton Summit
Preston
PR5 6AW
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in https://www.ncbi.nlm.nih.gov/pubmed/24172842