Psychotic Disorder Clinical Trial
Official title:
A Randomized Pilot Trial of a Cannabis Harm Reduction e-Intervention (CHAMPS) for Young Adults With Early Psychosis Who Use Cannabis
Cannabis users who experienced a psychosis are particularly vulnerable to cannabis-related harms, which can include worse psychotic symptoms and more hospitalizations. Unfortunately, few psychosocial interventions exist that aim to decrease these harms. Instead, most focus on ceasing cannabis use which is rarely appealing to cannabis users. Furthermore, face-to-face psychotherapy often remains inaccessible to people with psychosis mostly due to lack of trained clinicians. Alternatives such as e-interventions have the potential to increase access to treatment and decrease clinicians' workload. Among cannabis harm reduction approaches are the protective behavioural strategies. These strategies do not encourage nor discourage cannabis use. Instead, they recommend behaviours for safer cannabis use. For example, these strategies include: 1) avoid driving a car under the influence of cannabis, 2) avoid mixing cannabis with other drugs and 3) purchase cannabis only from a trusted source. In the present pan-Canadian study, we will test the first e-intervention called CHAMPS (Cannabis Harm-reducing App for Managing Practices Safely) for cannabis harm reduction adapted for young adult cannabis users who experienced a psychosis. CHAMPS is a smartphone application that includes 17 strategies for safer cannabis use, a personalized consumption goal and a consumption journal. The goals of this study are 1) to confirm whether CHAMPS is acceptable to participants and 2) to test whether it works, notably by positively impacting participants' health and cannabis consumption habits.
This multicentric, two-arm, open-labelled, pilot randomized controlled trial involves 100 young cannabis users who experienced a psychosis and are followed in an early intervention service (EIS) in Canada. Participants will be randomized in a 1:1 ratio to one of two interventions: - CHAMPS and EIS - EIS alone The smartphone application CHAMPS contains six modules (each lasting 15-20 min, weeks 1 to 6) and a booster session (20 min, week 10) based on motivational interviewing and harm reduction approaches. EIS consists of standard of care and psychoeducation material on cannabis use offered in first episode psychosis clinics and administered through in-person visits and/or phone or video calls. All participants will be assessed for a follow-up at weeks 6, 12 and 18. Data on mental health, substance use, cannabis dependence severity, cannabis-related problems, quality of life and health care service utilization will be obtained through questionnaires and medical charts. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02306551 -
Well Being And Resilience: Mechanisms of Transmission of Health and Risk
|
||
Active, not recruiting |
NCT00627029 -
Evaluation of Programs of Coordinated Care and Disease Management
|
N/A | |
Terminated |
NCT00049738 -
Screening for Childhood-Onset Psychotic Disorders
|
N/A | |
Withdrawn |
NCT01724372 -
The Role of Antidepressants or Antipsychotics in Preventing Psychosis
|
N/A | |
Completed |
NCT00716755 -
Minimizing Doses of Antipsychotic Medication in Older Patients With Schizophrenia.
|
N/A | |
Completed |
NCT00498550 -
Treatment of Schizophrenia and Comorbid Cannabis Use Disorder: Comparing Clozapine to Treatment-as-Usual
|
Phase 4 | |
Terminated |
NCT04140773 -
The Effect of D-serine as add-on Therapy in Recent-onset Psychosis
|
N/A | |
Completed |
NCT01473550 -
Mental Health Engagement Network (MHEN)
|
N/A | |
Completed |
NCT01207219 -
Yoga and Aerobic Exercise in Psychosis
|
N/A | |
Completed |
NCT00397033 -
Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.
|
Phase 3 | |
Recruiting |
NCT04945278 -
Study of Self-Recognition and Self/Other Distinction Disorders in Patients With Psychological Vulnerability
|
N/A | |
Completed |
NCT03955250 -
Mobile After-Care Support App: Pilot RCT
|
N/A | |
Completed |
NCT00287352 -
Study of Amantadine for Weight Stabilization During Olanzapine Treatment
|
Phase 1 | |
Completed |
NCT00005658 -
Glycine to Treat Psychotic Disorders in Children
|
Phase 2 | |
Terminated |
NCT00169026 -
Alcoholism and Schizophrenia: Effects of Clozapine
|
Phase 4 | |
Completed |
NCT00001482 -
New Drugs in the Treatment of Mood Disorders
|
Phase 2 | |
Terminated |
NCT03671005 -
Mindfulness-based Group Therapy for Inpatients With Schizophrenia Spectrum Disorders
|
N/A | |
Completed |
NCT00156715 -
Efficacy of Quetiapine in the Treatment of Patients With Schizophrenia and a Comorbid Substance Use Disorder
|
Phase 4 | |
Completed |
NCT00095524 -
Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder
|
Phase 3 | |
Completed |
NCT03667729 -
The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia
|
N/A |