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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01924039
Other study ID # 055/2013
Secondary ID
Status Terminated
Phase N/A
First received August 7, 2013
Last updated December 16, 2014
Start date June 2013
Est. completion date December 2014

Study information

Verified date December 2014
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


Description:

Motivational enhancement therapy (MET) is grounded in research that explores the process of change. 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.

The Two MET sessions adapted from Sampl and Kadden (2001) are prepared as two individual sessions to reflect the original design of MET, allowing for client's to be met at their respective stage of change. Further, individual sessions allow the treatment to be tailored to client's individual reasons for change and personal coping strategies. The use of the Personalized Feedback Report (PFR) further encourages treatment around client's personal concerns and goals (Ramchand et al., 2011; See appendix 1 for further detail).

In the first treatment session, the therapist provides feedback from the initial CD consultation, using the PFR to stimulate discussion about personal substance use and reasons for change. Rapport building is also a key element to the first session, during which a strong therapeutic alliance is initiated. The second session is aimed at strengthening the commitment to change, exploring goal setting, and preparation for group.

The Centre for Addiction and Mental Health (CAMH) Schizophrenia Division introduced a CD service in 2009. Since the time of its inception, more than 200 consultations have been conducted. Of those consultations, more than 80%recommended attending CD groups offered with the Schizophrenia Program. However, less than 10% have followed those recommendations and attended the CD group.

Based on what is known about challenges surrounding engagement of CD clients in recommended treatments coupled with guidelines for evidence-based treatment with this population (Ledgerwood et al., 2008; Tsuang et al., 2006; Roncero et al., 2011), the purpose of the current study is to explore the ability of MET to increase engagement in CD interventions for clients diagnosed with psychotic and substance use disorders.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date December 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Brief Motivational Enhancement Therapy
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.
Other:
treatment as usual
Treatment as usual includes case management as well as psychiatric appointments.

Locations

Country Name City State
Canada Centre for Addiction and Mental Health Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Working Alliance Inventory A measure of alliance between the participant and the clinician conducting the MET sessions. 2 weeks No
Primary CD group attendance The primary outcome engagement with outpatient CD service as measured by CD group attendance. 2 weeks No
Secondary Alcohol Use Scale (AUS)/Drug Use Scale (DUS) The secondary outcome is change in substance use as measured by the AUS and DUS 2 weeks and 3 months No
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