Substance AbuseNCT00244699
Integrating Mindfulness-Based Skills Training Into Brief Outpatient Treatment for Substance Abusing Youth
A study testing MI Alone or Plus Mindfulness-Based Skills Training in people with Substance Abuse and Drug Addiction, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Substance Abuse, Drug Addiction
- What is being tested?
- MI Alone or Plus Mindfulness-Based Skills Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2005to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- One or more indicators of problematic substance use over the past 60 days and brief group treatment for problematic substance use is indicated
Who cannot join
- Current active or unmanaged psychosis, bipolar disorder, self-harm or suicidality
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Substance Abuse, Drug Addiction
- Being tested
- MI Alone or Plus Mindfulness-Based Skills Training
- Keywords
- youth, drug addiction, substance abuse, mindfulness, motivational interviewing, brief treatment, skills training, group therapy, emotion regulation
- Medical subject headings
- Substance-Related Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI Alone or Plus Mindfulness-Based Skills TrainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The following will be measured post-treatment or following drop-out from treatment:
rates of transfer to further treatment
reasons for premature treatment termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startOct 2005
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Lisa C Vettese, Ph.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244699
- Sponsor's protocol ID
- 200/2005
- Status last verified
- May 2009
- First submitted
- 25 Oct 2005
- Last updated
- 12 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness-Based Intervention for Youth With Concurrent Disorders
- ClinicalTrials.gov ID
- NCT00244699
- Acronym / sponsor ID
- 200/2005
- Conditions
- Substance Abuse, Drug Addiction
- Keywords
- youth, drug addiction, substance abuse, mindfulness, motivational interviewing, brief treatment, skills training, group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2005
- Study completion
- Apr 2007
- First posted
- 27 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- One or more indicators of problematic substance use over the past 60 days and brief group treatment for problematic substance use is indicated
Key exclusion criteria (1 listed)
- Current active or unmanaged psychosis, bipolar disorder, self-harm or suicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MI Alone or Plus Mindfulness-Based Skills Training | Behavioural | – |
Primary outcome
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
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa C Vettese, Ph.D. principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI Alone or Plus Mindfulness-Based Skills Training in people with Substance Abuse and Drug Addiction, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The following will be measured T1 (pre-treatment)to T4(3-month follow-up), as well as at each weekly tx session:. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2009.