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Integrating Mindfulness-Based Skills Training Into Brief Outpatient Treatment for Substance Abusing Youth

Primary Purpose

Substance Abuse, Drug Addiction

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MI Alone or Plus Mindfulness-Based Skills Training
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring youth, drug addiction, substance abuse, mindfulness, motivational interviewing, brief treatment, skills training, group therapy, emotion regulation

Eligibility Criteria

16 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: One or more indicators of problematic substance use over the past 60 days and brief group treatment for problematic substance use is indicated Exclusion Criteria: Current active or unmanaged psychosis, bipolar disorder, self-harm or suicidality

Sites / Locations

  • Centre for Addiction and Mental Health

Outcomes

Primary Outcome Measures

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 Outcome Measures

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
The following will be measured post-treatment or following drop-out from treatment:
rates of transfer to further treatment
reasons for premature treatment termination

Full Information

First Posted
October 25, 2005
Last Updated
May 9, 2009
Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00244699
Brief Title
Integrating Mindfulness-Based Skills Training Into Brief Outpatient Treatment for Substance Abusing Youth
Official Title
A Mindfulness-Based Intervention for Youth With Concurrent Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

5. Study Description

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.
Detailed Description
For a wide range of clinical conditions (e.g., depression, anxiety, chronic pain, and stress-related health problems), the integration of mindfulness based interventions into clinical treatment has yielded positive benefits (e.g., Kabat-Zinn, 1990; Segal, Williams, & Teasdale, 2002; see Appendix II for a list of references for the study). Recently, researchers have found mindfulness skills training to have a number of beneficial treatment implications for substance abuse in adults (e.g., Alterman, A.I., Koppenhaver, J, Mulholland, E, Ladden, L, & Baime M. (2004); Breslin, Zack, & McMain, 2002; Marcus, 2005; Marlatt, 2005; Marlatt & Kristeller, 1999). Although researchers have recommended that mindfulness be implemented as an adjunctive treatment for addictions, including the early stages of substance use treatment (Breslin et al., 2002; Marcus, 2001; 2003; 2005), few studies have explored whether incorporating mindfulness skills training yields incremental benefits over standard treatments alone, or whether mindfulness skills have clinical utility during the early stages of substance abuse treatment. Moreover, no studies have explored the relative benefits of incorporating mindfulness skills training into the treatment of problematic substance use among transition-age youth, an age group at heightened risk for the development of addiction and mental health problems (Beitchman, Adlaf, Douglas, Atkinson, Young, et al., 2001). The integration of mindfulness into youth substance abuse treatment would be expected to yield beneficial effects given the developmental patterns of impulsivity and emotion dysregulation frequently characterizing this population (Winters, 1999). Researchers using the mindfulness paradigm have proposed that one of the key beneficial mechanisms produced by mindfulness is emotional regulation (e.g., Linehan, 1993a, 1993b; see Roemer, 2003). By increasing mindfulness, and thereby emotion regulation, therapy clients undergoing mindfulness skills training would be expected to experience an enhanced capacity to resist impulses to act on substance use urges (Breslin et al., 2002). Thus, when integrated into treatment as usual, mindfulness skills training would be expected to have positive, incremental effects on clients' abilities to reduce their level of substance use over the course of substance abuse treatment. This study will address the question: Does the integration of mindfulness-based skills training into a standardized brief substance abuse treatment (TAU) for youth enhance treatment outcomes compared to standardized treatment (TAU) alone? Clinical outcomes will be compared for youth randomized to one of two treatment conditions: a) a TAU control condition, consisting of an evidence-based, standardized brief treatment group delivered in approximately 2-hour sessions once per week over four weeks (i.e., the First Contact group; Breslin, Li, Sdao-Jarvie, Tupker, & Ittig-Delan, 2002), and b) an experimental treatment condition, consisting of the TAU enhanced with a mindfulness skills training component based primarily on the mindfulness module described in Linehan's (1993) Skills Training Manual for Treating Borderline Personality Disorder (Linehan, 1993b), and recent adaptations of these skills for substance use problems (McMain, Dimeff, Sayrs, Davis, & Linehan, 2005), and youth populations (Miller, Rathus, Landsman, & Linehan, in press). This study will explore whether, when compared to the TAU, the treatment augmented with mindfulness skills training will have a beneficial impact on clinical outcomes, including the confidence to resist substance use urges, number of substance use days, and the development of mindfulness skills. The primary hypotheses are that, compared to TAU, the group receiving treatment enhanced with mindfulness skills training will report the following: (1) a lower number of substance use days, (2) greater confidence to resist urges to use substances, (3) a higher level of mindfulness skills. Secondary analyses will explore the extent to which the experimental condition is related to beneficial effects on the following: (1) negative consequences of substance use, (2) psychiatric symptoms, (3) difficulties with emotion regulation, (4) self-compassion, (5) rates of transfer to further treatment, and (6) premature treatment termination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Drug Addiction
Keywords
youth, drug addiction, substance abuse, mindfulness, motivational interviewing, brief treatment, skills training, group therapy, emotion regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
MI Alone or Plus Mindfulness-Based Skills Training
Primary Outcome Measure Information:
Title
The following will be measured T1 (pre-treatment)to T4(3-month follow-up), as well as at each weekly tx session:
Title
number substance use days
Title
confidence to resist urges to use substances
Title
mindfulness skills
Secondary Outcome Measure Information:
Title
The following will be measured T1 (pre-treatment) to T4(3-month follow-up):
Title
negative consequences of substance use
Title
psychiatric symptoms
Title
difficulties with emotion regulation
Title
self-compassion
Title
The following will be measured post-treatment or following drop-out from treatment:
Title
rates of transfer to further treatment
Title
reasons for premature treatment termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: One or more indicators of problematic substance use over the past 60 days and brief group treatment for problematic substance use is indicated Exclusion Criteria: Current active or unmanaged psychosis, bipolar disorder, self-harm or suicidality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa C Vettese, Ph.D.
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada

12. IPD Sharing Statement

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Integrating Mindfulness-Based Skills Training Into Brief Outpatient Treatment for Substance Abusing Youth

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