Family Motivational Intervention in Schizophrenia

Schizophrenia Clinical Trial

— FMI  

Official title:

Motivational Interviewing and Interaction Skills Training for Carers to Change Cannabis Use in Young Adults With Recent-onset Schizophrenia: Randomised Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01167556
• Other study ID #: Grant 100003014
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 20, 2010
• Last updated: July 21, 2010
• Start date: March 2006
• Est. completion date: February 2011

Study information

• Verified date: February 2008
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and Development
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cannabis
• Marijuana Abuse
• Schizophrenia

Intervention

Behavioral:
• Family Motivational Intervention
A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	North Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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

Outcome

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