Plain English Summary
Background and study aims
Schizophrenia and related psychoses 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). The researchers running this study 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 investigate whetherthe use of a course of Cognitive Remediation (CR) prior to participation in CBT will improve the effectiveness of the CBT. CR is a form of brain-training using a programme of mental puzzles and other tasks which is known to be effective in improving cognitive capacities.
Who can participate?
Patients aged between 16-35 with a mental health disorder that take cannabis.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are given 40 hours of CR over a 12 week period before CBT. Those in group 2 are given 40 hours of social support over a 12 week period before CBT. All participants are given CBT for a period of between 12 and 30 weeks. Each participant is assessed at the start of the study using a wide range of measures including the severity of their symptoms and their cognitive capacities (how well they think). They are assessed again after they have completed CR or social support and every 6 weeks for another 30 weeks after they start their 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 the study starting and how long is it expected to run for?
January 2009 to April 2011
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Ms 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
4756
Study information
Scientific title
HELPER Programme (Substance Misuse) - A phase-specific psychological therapy for people with problematic cannabis use following a first episode of psychosis (ReCAP)
Acronym
HELPER (ReCAP)
Study hypothesis
We are conducting an exploratory trial to evaluate whether a psychological therapy following a first episode of psychosis is effective at reducing cannabis use when compared to usual care. This study will also investigate whether a brief intervention (4.5 months) is as effective as a longer one (9 months). This is a randomised controlled trial with 3 treatment groups, long-term treatment, short-term treatment, and treatment as usual.
Ethics approval
08/H1015/82
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
Psychosis
Intervention
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 40 hrs or the support worker for the same amount of time over 3 months. 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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Cannabis
Secondary outcome measures
No secondary outcome measures
Overall trial start date
05/01/2009
Overall trial end date
20/04/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Meeting DSMIV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychosis not otherwise specified using a checklist of criteria and review of case notes; and confirmation of this diagnosis using the structured clinical interview for DSMIV Axis 1 disorders
2. DSMIV diagnosis of cannabis dependance or abuse using the appropriate sections of the structured clinical interview
3. A history of cannabis use of at least 1 day per week in at least half the weeks in the 3mths prior to assessment (those who are misusing other illict substances or alcohol will not be excluded)
4. Aged 16-35
5. No significant history of organic factors implicated in the aetiology of psychotic symptoms
6. Male & female participants
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 135
Participant exclusion criteria
1. No stable accommodation (i.e. street homeless or roofless)
2. Does not possess sufficient English to reliably complete assessments
3. Not able to give informed consent
Recruitment start date
05/01/2009
Recruitment end date
20/04/2011
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
Federal/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
1. 2014 results in https://www.ncbi.nlm.nih.gov/pubmed/25065535
2. 2014 results in https://academic.oup.com/schizophreniabulletin/article/41/2/382/2526090
3. 2015 interim results in https://www.ncbi.nlm.nih.gov/pubmed/25927125