Schizophrenia Clinical Trial
— FMIOfficial title:
Motivational Interviewing and Interaction Skills Training for Carers to Change Cannabis Use in Young Adults With Recent-onset Schizophrenia: Randomised Controlled Trial
Cannabis use by people with schizophrenia is associated with family distress and poor
clinical outcomes. Therefore, an Family Motivational Intervention (FMI) was developed to
help parents to motivate their child with a diagnoses of recent-onset schizophrenia to
reduce cannabis use.
In a single-blind randomised clinical trail with 75 patients with the diagnosis of
schizophrenia, parents will be assigned to either FMI or to routine care. Assessments will
be conducted at baseline and at a 10- and 22-month follow-up. The study hypothesis is that
FMI will be more effective than routine care in reducing (a) cannabis use in patients and
(b) distress and sense of burden in parents.
Status | Enrolling by invitation |
Enrollment | 147 |
Est. completion date | February 2011 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of schizophrenia or psychotic-related disorder - Onset of schizophrenia or related disorder within pervious the 10 years - Cannabis use at least 2 days per week in the 3 months prior to the assessment - Antipsychotic medication in prescribed or indicated - At least 10 hours of contact with the parents each week in the last month Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Academic Medical Center | Amsterdam | North Holland |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
Dekker N, Smeerdijk AM, Wiers RW, Duits JH, van Gelder G, Houben K, Schippers G, Linszen DH, de Haan L. Implicit and explicit affective associations towards cannabis use in patients with recent-onset schizophrenia and healthy controls. Psychol Med. 2010 Aug;40(8):1325-36. doi: 10.1017/S0033291709991814. Epub 2009 Nov 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cannabis use in patients with a diagnosis of recent-onset schizophrenia | Baseline (before the start of the intervention) | No | |
Primary | Cannabis use in patients with a diagnosis of recent-onset schizophrenia | 10-month follow-up (3 months after the intervention has ended) | No | |
Primary | Cannabis use in patients with a diagnosis of recent-onset schizophrenia | 22-month follow-up (15 months after the intervention has ended) | No | |
Secondary | Medication adherence in patients with a diagnosis of recent-onset schizophrenia | Baseline (before the start of the intervention) | No | |
Secondary | Medication adherence in patients with a diagnosis of recent-onset schizophrenia | 10-month follow-up (3 months after the intervention has ended) | No | |
Secondary | Medication adherence in patients with a diagnosis of recent-onset schizophrenia | 22-month follow-up (15 months after the intervention has ended) | No | |
Secondary | Quality of life in patients with recent-onset schizophrenia | Baseline (before the start of the intervention) | No | |
Secondary | Quality of life in patients with recent-onset schizophrenia | 10-month follow-up (3 months after the intervention has ended) | No | |
Secondary | Quality of life in patients with recent-onset schizophrenia | 22-month follow-up (15 months after the intervention has ended) | No | |
Secondary | Stress in parents due to caring for a child with recent-onset schizophrenia | Baseline (before the start of the intervention) | No | |
Secondary | Stress in parents due to caring for a child with recent-onset schizophrenia | 10-month follow-up (3 months after the intervention has ended) | No | |
Secondary | Stress in parents due to caring for a child with recent-onset schizophrenia | 22-month follow-up (15 months after the intervention has ended) | No | |
Secondary | Expressed emotion in parents of patients with recent-onset schizophrenia | Baseline (before the start of the intervention) | No | |
Secondary | Expressed emotion in parents of patients with recent-onset schizophrenia | 10-month follow-up (3 months after the intervention has ended) | No | |
Secondary | Expressed emotion in parents of patients with recent-onset schizophrenia | 22-month follow-up (15 months after the intervention has ended) | No |
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