Contact information
Type
Scientific
Primary contact
Dr Lisa Vettese
ORCID ID
Contact details
Centre for Addiction and Mental Health
33 Russell Street
Toronto
M5S 2S1
Canada
+1 416 535 8501, ext. 4613
lisa_vettese@camh.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00244699
Protocol/serial number
114858
Study information
Scientific title
A Mindfulness-Based Intervention for Youth With Concurrent Disorders
Acronym
Study hypothesis
The integration of mindfulness-based skills training into a standardised brief substance abuse treatment for youth (i.e. Treatment As Usual [TAU]) will be associated with better treatment outcomes than the standardised treatment (TAU) alone on the following outcomes, including number of substance use days, confidence to resist substance urges, and acquisition of mindfulness skills. Additional analyses will explore the extent to which the experimental treatment condition is related to better outcomes on measures of negative consequences of substance use, psychiatric symptoms, emotion dysregulation, self-compassion, rates of transfer to further treatment, and premature treatment termination. A number of individual differences variables expected to influence treatment responsivity will be examined, including stage of readiness for change, substance use severity, and childhood trauma.
Ethics approval
Ethics approval received from local research ethics committees.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Substance abuse, addiction
Intervention
Intervention:
1. Brief treatment
2. Motivational interviewing
3. Mindfulness-based skills training based on Linehan's dialectical behaviour therapy
Control:
1. Brief treatment (i.e. TAU)
2. Motivational interviewing
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Number of substance use days
2. Confidence to resist urges to use substances
3. Mindfulness skills
Secondary outcome measures
1. Negative consequences of substance use
2. Psychiatric symptoms
3. Emotion dysregulation
4. Self-compassion
5. Rates of transfer to further treatment
6. Premature treatment termination
Overall trial start date
25/10/2005
Overall trial end date
31/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
One or more indicators of problematic substance use over the past 60 days and suitable for brief group treatment for problematic substance use
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 - 50
Participant exclusion criteria
Current active or unmanaged psychosis, bipolar disorder, self-harm or suicidality
Recruitment start date
25/10/2005
Recruitment end date
31/10/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Centre for Addiction and Mental Health
Toronto
M5S 2S1
Canada
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - Postdoctoral Fellowship
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
New Emerging Scientist Grant awarded by the Candian Institutes of Health Research (CIHR) (Canada) University of Western Ontario NET Grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary