NCT01924039

Brief Summary

The investigators are proposing a project that will examine the effectiveness of brief motivational enhancement therapy in a population with concurrent psychotic disorders and substance use disorders. This study will represent an emerging line of inquiry, as best practice interventions with this concurrent disordered (CD) populations are yet to be established.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 16, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 17, 2014

Status Verified

December 1, 2014

Enrollment Period

1.3 years

First QC Date

August 7, 2013

Last Update Submit

December 16, 2014

Conditions

Keywords

PsychosisSubstance UseMotivational Enhancement Therapy

Outcome Measures

Primary Outcomes (1)

  • CD group attendance

    The primary outcome engagement with outpatient CD service as measured by CD group attendance.

    2 weeks

Secondary Outcomes (1)

  • Alcohol Use Scale (AUS)/Drug Use Scale (DUS)

    2 weeks and 3 months

Other Outcomes (1)

  • Working Alliance Inventory

    2 weeks

Study Arms (2)

Brief Motivational Enhancement Therapy

EXPERIMENTAL
Behavioral: Brief Motivational Enhancement Therapy

treatment as usual

OTHER
Behavioral: Brief Motivational Enhancement TherapyOther: treatment as usual

Interventions

The MET intervention consists of two 45 minute one-to-one sessions with a MET-trained therapist. The MET approach assists individuals to move through increasingly higher levels of change towards action (making change) and maintaining change. The MET approach aims to invoke rapid and internally motivated change with respect to substance use.

Brief Motivational Enhancement Therapytreatment as usual

Treatment as usual includes case management as well as psychiatric appointments.

treatment as usual

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 16-65
  • DSM-IV Diagnoses of a psychotic disorder and a substance use disorder (tobacco, alcohol and/or drug)
  • Fluent English speaker
  • Capable of giving written informed consent

You may not qualify if:

  • Any medical or neuropsychiatric condition, illness or disorder (e.g. unstable angina, severe dementia) that could compromise attendance to outpatient appointments.
  • Inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

MeSH Terms

Conditions

Psychotic DisordersSubstance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersChemically-Induced Disorders

Study Officials

  • Yarissa Herman, D.Psych

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

August 7, 2013

First Posted

August 16, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

December 17, 2014

Record last verified: 2014-12

Locations