Family Motivational Intervention in Schizophrenia

NCT ID: NCT01167556

Last Updated: 2010-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Cannabis Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Family Motivational Intervention

An intervention provided to parents consisting of 6 sessions of training in Interactions Skills and 6 sessions training in Motivational Interviewing.

Group Type EXPERIMENTAL

Family Motivational Intervention

Intervention Type BEHAVIORAL

A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.

Routine care for parents

Routine care for parents consisting of 2 sessions psycho-education and individual support

Group Type ACTIVE_COMPARATOR

Family Motivational Intervention

Intervention Type BEHAVIORAL

A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.

Interventions

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Family Motivational Intervention

A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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AMC

Principal Investigators

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Gerard Schippers, Prof. dr.

Role: STUDY_DIRECTOR

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

Don Linszen, Prof.dr.

Role: PRINCIPAL_INVESTIGATOR

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

Lieuwe de Haan, Dr.

Role: STUDY_CHAIR

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

Locations

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Academic Medical Center

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 19917142 (View on PubMed)

Other Identifiers

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Grant 100003014

Identifier Type: -

Identifier Source: org_study_id

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