PsychosisNCT01924039
Brief Motivational Enhancement Therapy for Concurrent Disorders
A study testing Brief Motivational Enhancement Therapy and treatment as usual in people with Psychosis and Substance Use, run by Centre for Addiction and Mental Health at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Psychosis, Substance Use
- What is being tested?
- Brief Motivational Enhancement Therapy and treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Motivational Enhancement Therapy for Individuals With Psychotic Disorders and Concurrent Substance Use Disorders
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.
Read the detailed 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.
- Conditions
- Psychosis, Substance Use
- Being tested
- Brief Motivational Enhancement Therapy, treatment as usual
- Keywords
- Psychosis, Substance Use, Motivational Enhancement Therapy
- Medical subject headings
- Psychotic Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational Enhancement TherapyBehavioural
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.
treatment as usualOther
Treatment as usual includes case management as well as psychiatric appointments.
| Study group | Role | What they receive |
|---|---|---|
| Brief Motivational Enhancement Therapy | Experimental | Not described Receives: Behavioral: Brief Motivational Enhancement Therapy |
| treatment as usual | Other | Not described Receives: Behavioral: Brief Motivational Enhancement Therapy; Other: treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD group attendance
The primary outcome engagement with outpatient CD service as measured by CD group attendance.
Measured: 2 weeks
Secondary outcomes (1)
Alcohol Use Scale (AUS)/Drug Use Scale (DUS)
The secondary outcome is change in substance use as measured by the AUS and DUS
Measured: 2 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionDec 2014
Why it stopped: Not enough study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yarissa Herman, Centre for Addiction and Mental Health
- Investigators
- Yarissa Herman, D.Psych, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924039
- Sponsor's protocol ID
- 055/2013
- Status last verified
- Dec 2014
- First submitted
- 7 Aug 2013
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Motivational Enhancement Therapy for Individuals With Psychotic Disorders and Concurrent Substance Use Disorders
- ClinicalTrials.gov ID
- NCT01924039
- Acronym / sponsor ID
- 055/2013
- Conditions
- Psychosis, Substance Use
- Keywords
- Psychosis, Substance Use, Motivational Enhancement Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough study participants
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Motivational Enhancement Therapy | Experimental | Behavioral: Brief Motivational Enhancement Therapy |
| treatment as usual | Other | Behavioral: Brief Motivational Enhancement Therapy, Other: treatment as usual |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Motivational Enhancement TherapyThe 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. | Behavioural | Brief Motivational Enhancement Therapy, treatment as usual |
| treatment as usualTreatment as usual includes case management as well as psychiatric appointments. | Other | treatment as usual |
Primary outcome
CD group attendance
Time frame: 2 weeks
The primary outcome engagement with outpatient CD service as measured by CD group attendance.
1 secondary outcome
Alcohol Use Scale (AUS)/Drug Use Scale (DUS)
Time frame: 2 weeks and 3 months
Results and safety
The study was stopped early (reason given: Not enough study participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yarissa Herman, D.Psych principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Enhancement Therapy and treatment as usual in people with Psychosis and Substance Use, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough study participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD group attendance (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2014.