About this trial
People suffering from psychosis who use cannabis experience more relapses, long and compulsory admissions, with huge costs to the individual, families and health services. The Cannabis Clinic for Psychosis (CCP) was developed to respond to this clinical need. A published review of the CCP's intervention showed its safety and efficacy in supporting people suffering from psychosis with reducing their cannabis use. Nevertheless, for the CCP model of care to be applied widely and benefit a larger clinical population, its intervention needs to be tested in a Randomised Control Trial (RCT). The proposed CCP RCT is a waiting list randomised controlled trial that aims to evaluate the clinical efficacy of the existing CCP intervention. Participants will be adults currently under the care of South London and Maudsley (SLaM) Early Intervention Teams for first onset psychosis, who are dependent on cannabis and who express an intention to reduce or stop their use. The RCT primary outcome will measure changes in all participants' cannabis use. Participants will be randomised to either the intervention group or the waiting list control group receiving Treatment As Usual (TAU). The CCP intervention comprises 12 weekly (+/- 4 weeks) one-to-one sessions, with optional participation in a weekly online peer group. Sessions are delivered by trained clinicians and include evidence-based psychosocial techniques, including Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT), SMART goal settings and support for co-occurring tobacco use. The treatment is non-pharmacological and administered via participant-led approach that accommodates online or face-to-face sessions to meet the patient preference. Qualitative data from the recent CCP proof of concept paper indicate that the flexibility in allowing patients choice on the session's modality (online/face to face, hybrid) increased and maintained engagement.
The study is fully funded by the Maudsley Charity and due to last 30 months from the start of recruitment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
First episode psychosis Community Mental Health teams receiving care under of SLaM Early Intervention for Psychosis Adult Mental Health Teams
CUDIT≥9 (Dependent on Cannabis)
age=18 to 65 years old ( age range of adult psychiatric services)
Capacity to give informed consent, as assessed by clinical teams
Disqualifiers
Lack capacity to consent
High levels of suicidal ideation, judged by clinical team
Participation in any other current intervention trial
In active crises and/or expressing suicidal ideations
Trial design
Parallel
Treatments tested in this trial
CCP Intervention
Other intervention1. one-to-one weekly sessions: offered both face to face and online to meet the patient preference. Patients can change the meeting modality at any point to suit their needs (e.g. transport difficulties, family commitments, or mental state). The CCP intervention uses a combination of evidence-based psychosocial interventions (PSIs) tailored to each patient's needs. Patients are offered on average 12 (SD 4.2) weeks sessions, for a maximum of 60 minutes. 2. an online PEER group is facilitated by a senior member of CCP staff and moderated by two PEER mentors with lived experience of psychosis and cannabis use.
Treatment groups
Trial outcomes
Primary outcomes
Cannabis Use Disorders Identification Test-Revised score (CUDIT-R)
The CUDIT-R is an 8-item self-report tool used to screen for cannabis use and cannabis use disorder. Items assess frequency and dependence. Scores range from 0-32, with higher scores indicating greater risk.
Secondary outcomes
Revised Cannabis Experience Questionnaire (CEQ-mv) combined with the Enhanced cannabis timeline follow back (EC-TLFB)
Self-report to assess retrospective daily cannabis use, recording weekly THC consumption in standardised units based on frequency, quantity, and potency, age of onset, potency, type, experiences and subjective effects of cannabis.
Psychotic Symptom Rating Scales Delusions Subscale (PSYRATS DEL)
6-item scale designed to assess different dimensions of delusions with higher scores indicating greater symptom severity.
State Social Paranoia Scale (SSPS)
10-item measure of recent paranoid thinking in a social situation with higher scores indicating greater levels of paranoia .
Patient Health Questionnaire-9 (PHQ-9)
9-item measure that assesses recent levels of depression, with higher scores indicating greater levels of depression.
Other outcomes
Biological outcome
Saliva cannabis drug screening test
Blood Medication levels : optional
Participants will be invited to provide a sample of blood at start and end of the intervention to test if cannabis use status affects antipsychotics blood levels
Sponsors and contacts
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