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 Representative Harold Perl, Ph.D., NIDA Liaison Anthony Floyd, Ph.D., National Project Director

Additional Important People in the STAGE-12 Protocol Development NIDA CCTN Paul Wakim EMMES Carol Wenck Amanda Moore Kendra Orjada DCRI Thomas Barfield Carl Pieper Debbie Drosdick Norman Edwards Gudaye Tasissa Randy Young

General Background: Why a Study about 12-Step?

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. Why Consider 12-Step Approaches? 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 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. Why Consider 12-Step Approaches? 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 treatments Can be used by counselors of varying skill levels Can be sustained in the CTPs Allows an examination of “treatment as usual” in CTPs vis-a-vis 12-Step approaches 2

“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 received. 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 intensity 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

“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 Don’t We Already Do 12-Step?

“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.” Carroll, et al., 2000 (emphasis added)

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 intervention 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 involvement. 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 & Cutter,1998) 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 Interviewing Approximated frequently used counseling methods that invoked 12-Step recovery Sought to facilitate meaningful involvement in self help groups 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 PDA Outpatient Arm of Project MATCH% of Outpatients Attending at Least 1 Meeting During 12 Month Follow-up

TSF Therapy for Drug Abuse and Dependence % of Cocaine/Alcohol Dependent Clients with 3 or More Consecutive Weeks of Abstinence Days of 12-Step Attendance During 12-week Active Treatment and 1-Year Follow-up

12-Step Salmon Recovery Program

The Horns of a Dilemma Individual TSFGroup TSF Internal ValidityExternal Validity

Most Prior Research on TSF Has Used Individual Counseling, but the Balance is Beginning to Even Out Wells, et al., 1994 T.G. Brown, et al., 2002 S.A. Brown, et al, 2006 Project MATCH, 1997 Crits-Christoph, et al., 1999 (CCTS) 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 counseling

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 locations 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 % Abstinent from Alcohol & Drugs at Both 6-month Follow-ups According to 12- Step Involvement % Abstinent ASI Composite Score Magnitude of Change

Why This Combination of Group and Individual Components? Response to requests from treatment community to provide a group-based 12-Step facilitative approach Provides active components to help treatment engagement Is of a duration that is compatible with IOP programs Is compatible with CTP reimbursement schedules

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 meetings 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 treatment-as-usual? 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 Usual (TAU) STAGE-12 Integrated into TAU End of Intervention Assessment 3-, 6-Month Posttreatment Follow-ups During Intervention Assessment

STAGE-12 Intervention Attendance & Involvement in 12-step Groups Days of substance use

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 treatment 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 program

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 STAGE 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?"