Clinical trial NCT01167556: Family Motivational Intervention in Schizophrenia
Official title: Motivational Interviewing and Interaction Skills Training for Carers to Change Cannabis Use in Young Adults With Recent-onset Schizophrenia: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cannabis
Schizophrenia
Keywords: Family intervention
Recent-onset schizophrenia
Motivational Interviewing
Cannabis use
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 147
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Cannabis use in patients with a diagnosis of recent-onset schizophrenia
timeFrame: Baseline (before the start of the intervention)
measure: Cannabis use in patients with a diagnosis of recent-onset schizophrenia
timeFrame: 10-month follow-up (3 months after the intervention has ended)
measure: Cannabis use in patients with a diagnosis of recent-onset schizophrenia
timeFrame: 22-month follow-up (15 months after the intervention has ended)
Secondary outcomes:
measure: Medication adherence in patients with a diagnosis of recent-onset schizophrenia
timeFrame: Baseline (before the start of the intervention)
measure: Medication adherence in patients with a diagnosis of recent-onset schizophrenia
timeFrame: 10-month follow-up (3 months after the intervention has ended)
measure: Medication adherence in patients with a diagnosis of recent-onset schizophrenia
timeFrame: 22-month follow-up (15 months after the intervention has ended)
measure: Quality of life in patients with recent-onset schizophrenia
timeFrame: Baseline (before the start of the intervention)
measure: Quality of life in patients with recent-onset schizophrenia
timeFrame: 10-month follow-up (3 months after the intervention has ended)
measure: Quality of life in patients with recent-onset schizophrenia
timeFrame: 22-month follow-up (15 months after the intervention has ended)
measure: Stress in parents due to caring for a child with recent-onset schizophrenia
timeFrame: Baseline (before the start of the intervention)
measure: Stress in parents due to caring for a child with recent-onset schizophrenia
timeFrame: 10-month follow-up (3 months after the intervention has ended)
measure: Stress in parents due to caring for a child with recent-onset schizophrenia
timeFrame: 22-month follow-up (15 months after the intervention has ended)
measure: Expressed emotion in parents of patients with recent-onset schizophrenia
timeFrame: Baseline (before the start of the intervention)
measure: Expressed emotion in parents of patients with recent-onset schizophrenia
timeFrame: 10-month follow-up (3 months after the intervention has ended)
measure: Expressed emotion in parents of patients with recent-onset schizophrenia
timeFrame: 22-month follow-up (15 months after the intervention has ended)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: North Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Gerard Schippers, Prof. dr.
role: STUDY_DIRECTOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Don Linszen, Prof.dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Lieuwe de Haan, Dr.
role: STUDY_CHAIR
References:
citation: 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.