Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244699
Status:
COMPLETED
Last Update Posted:
2009-05-12
First Post:
2005-10-25
Brief Title:
Integrating Mindfulness-Based Skills Training Into Brief Outpatient Treatment for Substance Abusing Youth
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
A Mindfulness-Based Intervention for Youth With Concurrent Disorders
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Linehans 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 eg depression anxiety chronic pain and stress-related health problems the integration of mindfulness based interventions into clinical treatment has yielded positive benefits eg 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 eg Alterman AI 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 eg 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 ie 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 Linehans 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
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 ie 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 Linehans 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None