Substance Abuse Clinical Trial
Official title:
A Mindfulness-Based Intervention for Youth With Concurrent Disorders
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04070521 -
EEG Monitoring in the Emergency Department
|
||
Completed |
NCT00729391 -
Women-Focused HIV Prevention in the Western Cape
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT03129334 -
Preventing Prescription Drug Abuse in Middle School Students
|
N/A | |
Completed |
NCT02733003 -
Implementation Research for Vulnerable Women in South Africa
|
N/A | |
Completed |
NCT02573948 -
Feasibility of Interventions on People Who Inject Drugs in Vietnam
|
||
Completed |
NCT02282306 -
Phone Interview to Prevent Recurring Opioid Overdoses
|
N/A | |
Withdrawn |
NCT01847300 -
cSBI-M for Young Military Personnel
|
N/A | |
Withdrawn |
NCT01523444 -
Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings
|
Phase 3 | |
Completed |
NCT01481428 -
Reducing High Risk Behavior in Treatment Court
|
Phase 1 | |
Completed |
NCT01601743 -
Exercise as a Behavioral Treatment for Cocaine Dependence
|
N/A | |
Completed |
NCT01591239 -
Home-Based Program to Help Parents of Drug Abusing Adolescents
|
N/A | |
Active, not recruiting |
NCT00847548 -
Treatment of Intimate Partner Violence and Substance Abuse in a Forensic Setting
|
N/A | |
Withdrawn |
NCT01228890 -
Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)
|
Phase 3 | |
Completed |
NCT01614015 -
Building Outcomes With Observation-Based Supervision: An FFT Effectiveness Trial
|
Phase 2 | |
Completed |
NCT01621334 -
The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use
|
Phase 1 | |
Completed |
NCT00717444 -
Healthy Activities for Prize Incentives
|
N/A | |
Completed |
NCT00841711 -
Transitions: Linkages From Jail To Community
|
N/A | |
Completed |
NCT01465490 -
Monitoring and Feedback in Substance Abuse Treatment
|
Phase 1/Phase 2 | |
Completed |
NCT00685074 -
Computer-based Brief Intervention for Perinatal Substance Abuse
|
Phase 1/Phase 2 | |
Completed |
NCT01188434 -
Integrating Interventions for Maternal Substance Abuse
|
Phase 1 |