Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

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

Trial website

Contact information



Primary contact

Ms Louise Worrell


Contact details

Lancashire Care NHS Trust
Sceptre Way
Bamber Bridge
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


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)



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


Study design

Randomised interventional trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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




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



Not Applicable

Drug names

Primary outcome measure


Secondary outcome measures

No secondary outcome measures

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Lancashire Care NHS Trust
United Kingdom

Sponsor information


Lancashire Care NHS Trust (UK)

Sponsor details

Sceptre Point
Sceptre Way
Walton Summit
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


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
2. 2014 results in
3. 2015 interim results in

Publication citations

Additional files

Editorial Notes

11/05/2018: Publication references added. 10/05/2018: Publication reference added. 01/03/2016: No publications found, study status unverified