Condition category
Mental and Behavioural Disorders
Date applied
18/10/2005
Date assigned
08/11/2005
Last edited
19/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Centre for Addiction and Mental Health (Canada)

Sponsor details

33 Russell Street
Toronto
Ontario
M5S 2S1
Canada

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes