FMI: Family Motivational Intervention in Schizophrenia

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01167556
• Collaborator: (none)
• Enrollment: 147
• Location: 1
• Arms: 2
• Duration (Months): 59.1
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cannabis; Schizophrenia	Behavioral: Family Motivational Intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 147 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Mar 1, 2006
• Anticipated Primary Completion Date: Aug 1, 2010
• Anticipated Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Family Motivational Intervention An intervention provided to parents consisting of 6 sessions of training in Interactions Skills and 6 sessions training in Motivational Interviewing.	Behavioral: Family Motivational Intervention; A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.
Active Comparator: Routine care for parents Routine care for parents consisting of 2 sessions psycho-education and individual support	Behavioral: Family Motivational Intervention; A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.

Outcome Measures

Primary Outcome Measures

1. Cannabis use in patients with a diagnosis of recent-onset schizophrenia [Baseline (before the start of the intervention)]

2. Cannabis use in patients with a diagnosis of recent-onset schizophrenia [10-month follow-up (3 months after the intervention has ended)]

3. Cannabis use in patients with a diagnosis of recent-onset schizophrenia [22-month follow-up (15 months after the intervention has ended)]

Secondary Outcome Measures

1. Medication adherence in patients with a diagnosis of recent-onset schizophrenia [Baseline (before the start of the intervention)]

2. Medication adherence in patients with a diagnosis of recent-onset schizophrenia [10-month follow-up (3 months after the intervention has ended)]

3. Medication adherence in patients with a diagnosis of recent-onset schizophrenia [22-month follow-up (15 months after the intervention has ended)]

4. Quality of life in patients with recent-onset schizophrenia [Baseline (before the start of the intervention)]

5. Quality of life in patients with recent-onset schizophrenia [10-month follow-up (3 months after the intervention has ended)]

6. Quality of life in patients with recent-onset schizophrenia [22-month follow-up (15 months after the intervention has ended)]

7. Stress in parents due to caring for a child with recent-onset schizophrenia [Baseline (before the start of the intervention)]

8. Stress in parents due to caring for a child with recent-onset schizophrenia [10-month follow-up (3 months after the intervention has ended)]

9. Stress in parents due to caring for a child with recent-onset schizophrenia [22-month follow-up (15 months after the intervention has ended)]

10. Expressed emotion in parents of patients with recent-onset schizophrenia [Baseline (before the start of the intervention)]

11. Expressed emotion in parents of patients with recent-onset schizophrenia [10-month follow-up (3 months after the intervention has ended)]

12. Expressed emotion in parents of patients with recent-onset schizophrenia [22-month follow-up (15 months after the intervention has ended)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Academic Medical Center	Amsterdam	North Holland	Netherlands	1066 DP

Sponsors and Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

• Study Director: Gerard Schippers, Prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Principal Investigator: Don Linszen, Prof.dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Study Chair: Lieuwe de Haan, Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT01167556
• Other Study ID Numbers: Grant 100003014
• First Posted: Jul 22, 2010
• Last Update Posted: Jul 22, 2010
• Last Verified: Feb 1, 2008

• Keywords provided by , ,: Family intervention; Recent-onset schizophrenia; Motivational Interviewing; Cannabis use
• Additional relevant MeSH terms: Marijuana Abuse; Schizophrenia

Study Results

No Results Posted as of Jul 22, 2010