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					        CTN0031 STAGE-12

Stimulant Abuser Groups to Engage in12-Step:
                An Overview
         Dennis M. Donovan, Ph.D.
                  for the
       STAGE-12 Executive Committee

         STAGE-12 Protocol Training Meeting
                  Bethesda, MD
                December 3, 2007
    National Executive Committee
• Dennis Donovan, Ph.D., Lead Investigator
• Dennis Daley, Ph.D., Co-Lead Investigator
• Greg Brigham, Ph.D., CTP Representative
• Candace Hodgkins, Ph.D., CTP
• Harold Perl, Ph.D., NIDA Liaison

• Anthony Floyd, Ph.D., National Project
   Additional Important People in the
   STAGE-12 Protocol Development

NIDA CCTN           DCRI
• Paul Wakim        • Thomas Barfield
                    • Carl Pieper
EMMES               • Debbie Drosdick
• Carol Wenck       • Norman Edwards
• Amanda Moore      • Gudaye Tasissa
• Kendra Orjada     • Randy Young
  General Background:
Why a Study about 12-Step?
Why Consider 12-Step Approaches?

                  • Why climb a
                    mountain? Because
                    it‟s there.
                  • Why study 12-Step?
                    Because it‟s a
                    mountain in the
                    substance abuse field
                    – because it‟s there.

   Mt. Rainier
   Why Consider 12-Step Approaches?

• 12-step orientation/philosophy is the
  predominant approach found in U.S.
  substance abuse treatment
• 12-step groups represent a readily available,
  no-cost recovery resource
• Millions of substance abusers benefit from
  12-step involvement, with increased evidence
  of its effectiveness
• Consistent with community-based treatment
  program and counselor treatment philosophy
   Why Consider 12-Step Approaches?

• Applicable to a broad range of clients in different
  settings and can augment a wide range of
  standard treatments
• A high priority of the CTN‟s CTP Caucus
• Recent development of efficacious interventions
  to facilitate 12-Step involvement
• Availability of 12-Step Facilitation therapy
  manuals and training materials
Why Consider 12-Step Approaches?

                  • Why climb a
                    mountain? Because
                    it‟s there.
                  • Why study 12-Step?
                    Because it‟s a
                    mountain in the
                    substance abuse field
                    – because it‟s there.

   Mt. Rainier
   Reasons Why 12-Step Facilitation
  (TSF) is Well Suited for a CTN Trial

• Can be trained in a relatively short time
• Can augment a wide range of standard
• Can be used by counselors of varying skill
• Can be sustained in the CTPs
• Allows an examination of “treatment as usual”
  in CTPs vis-a-vis 12-Step approaches

   “If the effectiveness and durability of TSF is
   supported in future research with cocaine-
   dependent groups, it would be most important
   because of the wide clinical use of treatments
   that are consistent with the theoretical
   background of the TSF approach evaluated
   here, as well as data from Project MATCH
   which suggested its effectiveness and
   durability with alcohol-dependent populations.”

Carroll, et al., 2000
Why Focus on Facilitating
 12-Step Involvement?
   Points Derived from Previous Research on
              12-Step Involvement
• AA and NA participation is associated with greater
  likelihood of abstinence, improved social
  functioning, and greater self-efficacy
• 12-Step self-help groups significantly reduce health
  care utilization and costs
• Combined 12-Step and formal treatment leads to
  better outcomes than found for either alone
• Engaging in other 12-Step group activities seems
  more helpful than attending meetings
  Is Involvement in 12-Step Support (AA,
 NA, CA) Related to Improved Outcomes?
• Attendance is not involvement.
• Longitudinal studies usually, although not
  always, find that 12-Step involvement after
  treatment is associated with higher rates of
  abstinence regardless of the kind of treatment
• When AA attendance and AA involvement (e.g.,
  reading 12-step literature, getting a sponsor,
  “working” the steps, or helping set up meetings)
  are both measured, involvement is a stronger
  predictor of outcome.
 Points Derived from Previous Research on
            12-Step Involvement
• Consistent and early attendance/involvement
  leads to better substance use outcomes
• Even small amounts of participation may be
  helpful in increasing abstinence, whereas higher
  doses may be needed to reduce relapse
• Reductions in substance use associated with 12-
  Step involvement are not attributable to
  potential third variable influences such as
  motivation, psychopathology, or severity
  Do People Use 12-Step Support During or
             After Treatment?
• 75% of alcoholics entering residential treatment
  reported they had attended AA meetings previously.
  However, only 16% indicated that they had ever
  worked any of the 12 Steps.
• Despite “strong encouragement” to attend, 30% of
  cocaine abusers receiving outpatient treatment and
  40% of those discharged from inpatient treatment
  reported that they had attended 12-Step groups.
• During the follow-up period in the NIDA
  Collaborative Cocaine Treatment Study 33.6% were
  classified as consistently high attenders, 47.9% as
  consistently low attenders, and 18.5% as
  decreasing attendance.
       Jones would walk through a blizzard to score his
      dope. The question remains: what will he do to get
                       to a meeting?
 Recommendations from Expert VA/CSAT
Consensus Panel on Self-Help Organizations

• Community-based treatment programs, even those
  that label and represent themselves as “12-Step
  oriented,” should evaluate whether their current
  program practices actively support involvement in 12-
  Step self-help groups.
• Programs should examine the methods used by their
  counselors. Typically, when counselors do attempt to
  support 12-Step self-help group involvement, they
  rarely use empirically supported methods.
• When clinicians use empirically validated techniques to
  support mutual help group involvement, it is far more
  likely to occur.
                                                 Humphreys, et al., 2004
           Don‟t We Already Do 12-Step?
 • “Making the case that treatment programs should
   prioritize self-help group involvement can be difficult
   because many treatment providers believe they „do this
   already‟; indeed, that every program does.”
 • “In practice, however, what this often means is that at
   some point during treatment a counselor gives the
   patient a list of local self-help groups and suggests that
   the patient attend a meeting, which is a minimally
   effective clinical practice.”
 • “We therefore encourage treatment providers to use the
   more intensive methods of promoting self-help group
   involvement empirically demonstrated to be effective
   …such efforts will maximize the maintenance of
   treatment gains.”

Humphreys & Moos, 2007
   “It should also be emphasized that TSF is
   formal treatment that seeks to foster an
   enduring relationship by the patient with self-
   help; it should not be concluded that merely
   referring a patient to a self-help group would
   be associated with similar outcomes. Indeed,
   studies evaluating referral to self-help
   compared with formal [12-Step facilitation]
   treatment have suggested that merely
   referring substance-dependent patients to
   self-help groups is often insufficient.”
                                   (emphasis added)
Carroll, et al., 2000
 Don‟t We Already Do 12-Step?
STAGE-12 differs from 12-Step:
  – Manualized therapy approach based on
    previous research
  – Not meetings, but a way to provide a better
    understanding of 12-Step that:
     • Leads to attending more meetings
     • Leads to more involvement in meetings attended
     • Leads to engagement in more 12-Step activities
  – Actively gets participants into first meetings
              "Stop fighting and surrender, Jones. As your
             sponsor, all I ask is that you attend 90 meetings
                                 in 90 days."
The STAGE-12 Protocol:
     An Overview
         What Is STAGE-12?
• Combined group- and individual-based
• Combines elements of Twelve-Step Facilitation
  Therapy and Intensive Referral
• Introduces participants to concepts and
  principles involved in 12-Step groups
• Actively attempts to get participants involved in
  12-Step meetings
    Rationale for Combining Intensive Referral
          with Twelve Step Facilitation
•     Interventions that are effective in increasing
      attendance may be insufficient to ensure active
•     Early attrition from attending meetings may, in part, be
      due to individuals‟ inability to embrace or utilize other
      aspects of the 12-step program (Caldwell &
•     Individuals who are attending 12-step groups but are
      having difficulty embracing key aspects of the program
      may need professional assistance that focuses more
      on 12-step practices and tenets and less on meeting
      attendance (Caldwell & Cutter, 1998)
Twelve-Step Facilitation Therapy
 Project MATCH Twelve-Step Facilitation

• Developed by Nowinski, Baker & Carroll (1992)
  specifically for Project MATCH as an approach which:
• Manual guided, delivered on an individual basis
• Intended to sharply contrast to CBT and Motivational
• Approximated frequently used counseling methods that
  invoked 12-Step recovery
• Sought to facilitate meaningful involvement in self help
• Developed in conjunction with Hazelden Foundation
 What Twelve Step Facilitation Is NOT

• While based on principles of Alcoholics
  Anonymous, TSF is Not 12-Step support group
• TSF is Not equivalent to an AA/NA/CA referral
• TSF is Not equivalent to “treatment as usual”

    TSF is a formal, manualized therapy
           delivered by a counselor
    Focus of Twelve Step Facilitation
•    Emphasis on first 3 Steps and fostering
     involvement in AA
•    Primary Goals of TSF:
      1. facilitate "acceptance"
      2. facilitate "surrender"
      3. facilitate active involvement in 12-Step
         meetings and related activities
Project MATCH Twelve-Step Facilitation Therapy

                                                                                                                  CBT             MET     TSF


    80                                     PDA                        40
P   70                                                                20
e   60                                                                    0
    50                                                                        -2 -1       0       4       5       6       7       8   9 10 11 12 13 14 15
e                                                                                                         CBT             MET           TSF
                                             Mean Number of Drinks
n                                                                    14
t   20                                                               10
    10                                                                6
     0                                                                2
         CBT         MET           TSF                                0
                                                                          -2 -1       0       4       5       6       7       8   9 10 11 12 13 14 15
               Type of Treatment                                                                              Time in Months

     % of Outpatients Attending at Least                                        Outpatient Arm of Project MATCH
     1 Meeting During 12 Month Follow-up
       TSF Therapy for Drug Abuse and Dependence




                                                   TSF          CBT                CM
                                              50         48.7
                                              40                                         33.2
  20                                          35
                                              30                      24.2
  15                                    TSF
   5                                          10
   0                                           0
       Cocaine   Alcohol   Coc+Alc                   TSF                     CBT                CM

% of Cocaine/Alcohol Dependent Clients with   Days of 12-Step Attendance During 12-week
3 or More Consecutive Weeks of Abstinence       Active Treatment and 1-Year Follow-up
      12-Step Salmon Recovery Program

      The Horns of a Dilemma

Individual TSF       Group TSF
 Internal Validity   External Validity
        Most Prior Research on TSF Has Used
       Individual Counseling, but the Balance is
                Beginning to Even Out

                                       Wells, et al., 1994
Project MATCH, 1997                    T.G. Brown, et al.,
Crits-Christoph, et al.,
1999 (CCTS)                            S.A. Brown, et al,
Carroll, et al, 2000
         CTP Survey Results

Which of the following formats would work best for
integrating 12-step facilitation at your CTP so
that you could continue using the intervention after
the study has ended?

      1.6% -- Individual therapy
     39.1% -- Group therapy
     59.4% -- Group therapy plus some individual
        CTP Survey Results

If you were to deliver some or all of a 12-step
intervention in a group format, which type of
group would you most likely use

 4.6% -- “Closed admission group”
95.4% -- “Open-ended or rolling admission group”
    Systematic Encouragement and Community
       Access (SECA) – A “Buddy System”
  • Counselor suggests that patient attend AA or Al-Anon
  • Counselor provides a printed list of meeting times and
  • In-session telephone call to current member of AA, NA
    or CA, who talks to the patient briefly and arranges to
    attend a meeting with him or her
  • Reminder telephone call from the 12-step group member
    the night before the meeting
  • 12-step group member drives the patient to or arranges
    to meet the patient at the meeting

Sisson & Mallams, 1981
                               Intensive Referral to 12-Step Self-Help Groups and
                                   6-Month Substance Use Disorder Outcomes
                                        Standard   Intensive


          % Abstinent





                                Drug    Alcohol        Both

                                        Standard   Intensive

Magnitude of Change



                         0.1                                    % Abstinent from Alcohol & Drugs at Both
                                                                 6-month Follow-ups According to 12-
                                                                           Step Involvement
                                Drug                  Alcohol

                                   ASI Composite Score
  Why This Combination of Group and
       Individual Components?
• Response to requests from treatment community
  to provide a group-based 12-Step facilitative
• Provides active components to help treatment
• Is of a duration that is compatible with IOP
• Is compatible with CTP reimbursement
       Design of the Intervention
Group session topics:
   •   Acceptance*
   •   People, Places & Things* (habits that support
       continued drug use or support recovery)
   •   Surrender*
   •   Getting Active in 12-Step*
   •   Managing Emotions

* These represent “core” sessions in the TSF manual
      Design of the Intervention
Individual sessions:
• Introduce 12-step concepts that are discussed more
  thoroughly in group sessions
• Connect the participant with a 12-step group member
  from the community (like a “buddy system”)
• Have the 12-step member accompany the participant
  to his/her first meeting or act as temporary sponsor.
• Review progress in getting engaged and attending
• Review overall involvement in STAGE-12 and plan for
  post-intervention involvement in 12-Step meetings
  and activities
       Basic Study Questions
• Does STAGE-12 improve substance use
  outcomes in stimulant users compared to

• Does STAGE-12 improve attendance and
  involvement in 12-step groups leading to
  improved substance use outcomes
  compared to treatment-as-usual
         Individual presents to CTP for Tx
         Screen for study eligibility
         Informed consent
         Baseline assessment
        Randomized to condition

Treatment as                                    STAGE-12
Usual (TAU)                                Integrated into TAU

                  During Intervention
                   End of Intervention
               3-, 6-Month Posttreatment
STAGE-12                      Days of
Intervention                  substance

               Attendance &
               in 12-step
                 By The Numbers
• ~ 400 stimulant abusing/dependent participants recruited
• 9 sites across the country in 2 waves of recruitment
   – Wave 1 Sites
       Maryhaven   from the Ohio Valley Node
       ChangePoint   from the Oregon/Hawaii Node
       Recovery Centers of King County from the Pacific
        Northwest Node
• ~ 45 participants per site (20-25 each condition --
  STAGE-12 or TAU)
• 15 months recruitment at each site
• 3 and 6 month follow-up periods
 Issue: STAGE-12 as an Add-On to TAU
• There are tradeoffs with STAGE-12 as either an add-on
  or integrated into treatment as usual
• Integrating it into TAU may displace other treatment
  components, thus modifying “TAU”
• Adding it to TAU produces differential amounts of
• The basic question we are interested in answering is
  “Does integrating STAGE-12 into treatment as it is
  typically delivered lead to better outcomes than TAU?”
• This is also consistent with how CTPs are likely to be
  integrate a 12-step facilitative intervention into their
    Issue: Potential Overlap Between
           TAU and STAGE-12
• Many CTPs incorporate 12-Step philosophy and
  meetings in their programs
• However, this is often unsystematic and varies
  across CTPs and counselors within CTPs
• Referring substance-dependent patients to self-help
  groups is often insufficient
• STAGE-12 is a systematic, manual-guided, formal
  therapy that seeks to foster an enduring relationship
  by the patient with self-help
       “It should be noted that because we evaluated a
       closely supervised, manual-guided, individual
       version of TSF, our TSF treatment is probably
       quite different from that currently used by many
       clinicians. It is not clear whether or how much
       additional training and supervision would be
       required for clinicians in general clinical settings
       to deliver TSF as it was implemented here.”

Carroll, et al., 2000
  Three Ancillary Studies Have Attached to

1. Alcohol Assessment
  AUDIT- C items related to alcohol diagnostic criteria
2. Health Services Research
  Agency organizational influencing intervention adoption by
  CTPs and therapist protocol fidelity as a predictor of
  treatment outcome
3. Cognitive Impairment Associated with Stimulant Abuse
  Impairment and plasma indicators of oxidative stress as
  predictors of outcome
               "Does anyone have a burning desire to share?"


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