NCT00244699

Brief Summary

The proposed study will evaluate the clinical effectiveness of integrating mindfulness-based skills training into a standardized brief group intervention for youth (ages 16 to 24) identified as having problematic substance use. Forty youth (N = 20 per group) will be randomized to one of two treatment conditions: 1) a standardized 4-week brief treatment for problematic substance use (treatment as usual; TAU) or 2) standardized brief treatment (TAU) augmented with a mindfulness skills training component based primarily on the mindfulness module described in Linehan's (1993b) Dialectical Behavior Therapy skills group training. It is expected that, compared to the TAU, the mindfulness-based group plus TAU will produce superior outcomes on the following primary outcome measures: number of substance use days, confidence to resist urges to use substances, and mindfulness skills. Secondary outcomes that will be examined include severity of consequences of use, general psychiatric symptoms, self-compassion, emotion dysregulation, and transfer to further treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2005

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

May 12, 2009

Status Verified

May 1, 2009

First QC Date

October 25, 2005

Last Update Submit

May 9, 2009

Conditions

Keywords

youthdrug addictionsubstance abusemindfulnessmotivational interviewingbrief treatmentskills traininggroup therapyemotion regulation

Outcome Measures

Primary Outcomes (4)

  • The following will be measured T1 (pre-treatment)to T4(3-month follow-up), as well as at each weekly tx session:

  • number substance use days

  • confidence to resist urges to use substances

  • mindfulness skills

Secondary Outcomes (8)

  • The following will be measured T1 (pre-treatment) to T4(3-month follow-up):

  • negative consequences of substance use

  • psychiatric symptoms

  • difficulties with emotion regulation

  • self-compassion

  • +3 more secondary outcomes

Interventions

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • One or more indicators of problematic substance use over the past 60 days and brief group treatment for problematic substance use is indicated

You may not qualify if:

  • Current active or unmanaged psychosis, bipolar disorder, self-harm or suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

MeSH Terms

Conditions

Substance-Related DisordersEmotional Regulation

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersSelf-ControlSocial BehaviorBehavior

Study Officials

  • Lisa C Vettese, Ph.D.

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 27, 2005

Study Start

October 1, 2005

Study Completion

April 1, 2007

Last Updated

May 12, 2009

Record last verified: 2009-05

Locations