The results of the current trial present mixed findings with respect to the impact of integrating the STAGE-12 intervention into an intensive outpatient drug treatment program on the stimulant use of individuals with stimulant use disorders. STAGE-12 involvement was associated with significantly increased odds of abstinence from stimulant drug use over the duration of the active treatment phase. The odds of abstinence for STAGE-12 participants relative to TAU ranged from 3.34 times greater from baseline to mid-treatment and 2.44 between mid-treatment and end-of-treatment. Although the odds ratios still favored STAGE-12 out to the 6 -month post-randomization follow-up, they were no longer significant. However, an unexpected finding showed that if a participant was not abstinent, then the rate of stimulant use was significantly greater for those in STAGE-12 than in TAU during the active treatment phase; this relationship reversed during the follow-up periods.
The pattern of these findings suggests a complex dynamic: the STAGE-12 intervention, as incorporated into existing intensive outpatient treatment, facilitates the initiation and probability of stimulant abstinence, but is not particularly effective for those who are unable to achieve or maintain abstinence. A possible explanatory hypothesis for this pattern can be drawn from the Abstinence Violation Effect (AVE) proposed by Marlatt and colleagues (Marlatt, 1985
; Marlatt & Gordon, 1985
) as part of their cognitive-behavioral relapse model . The AVE suggests that if an individual is strongly committed to abstinence as a goal but is unable to achieve or maintain abstinence, the likelihood of continued use is increased. It may be that STAGE-12’s systematic and intensive focus on 12-step principles increased the salience of abstinence as a goal; as a result those who were unable to achieve this goal were more vulnerable to continued heavy use. The original construct of the AVE was posited to be mediated by a sense of self-blame and internal attributions to oneself as a failure in one’s inability to maintain abstinence (e.g., “Once an addict, always an addict”), with resultant guilt, and a decrease in perceived self-efficacy. However, results of later studies with substance abusers suggested that the heavy use associated with the AVE may be related more to low levels of self-efficacy than to either attributions of self-blame or guilt (Birke, Edelmann, & Davis, 1990
; Kirchner, Shiffman, & Wileyto, 2011
; Ross, Miller, Emmerson, & Todt, 1988 -1989
; Walton, Castro, & Barrington, 1994
). The STAGE-12 intervention may need to be modified to specifically address such emotional reactions of patients when they feel they are not achieving their abstinence goals. For example, this issue could be addressed specifically in one of the individual sessions, discussed as a possible phenomenon during the group session on managing negative emotions and the HALT relapse precipitants, or emphasized as something to write about while journaling with follow-up discussion in sessions.
Alternatively, as has been found with other behavioral treatments with substance abusers, there may be subgroups for whom the STAGE-12 intervention is clinically effective while others for whom there is no effect or even clinical deterioration (Ilgen & Moos, 2005
). Two factors of particular relevance in this regard are treatment exposure and the initial, early achievement of abstinence. Kaskutas (Kaskutas, et al., 2009
) found a significant linear trend between the number of sessions of a group-based 12-step facilitation intervention attended and the percent of participants substance free at 12-month follow-up. Three-quarters of STAGE-12 participants reached an a priori
criterion of a therapeutic dose of the intervention by having attended two or more individual sessions plus three or more of the group sessions. It may be that the smaller subgroup of STAGE-12 “non-completers” accounts for the observed increased rates of stimulant use. Similarly, in addition to the predictive utility of entering treatment stimulant-free (Ahmadi et al., 2009
; Peirce et al., 2009
), the early attainment of abstinence among cocaine dependent individuals in clinical trials is one of the best predictors of later abstinence (McKay, et al., 2001
; Plebani, Kampman, & Lynch, 2009
). As McKay and colleagues note, continued participation in mutual support groups and the early achievement of cocaine abstinence appear to be important factors in longer term outcomes.
Despite the higher self-reported rates of stimulant use among the non-abstinent STAGE-12 group members during the active treatment phase, there was a significant difference favoring STAGE-12 with respect to the ASI Drug Use Composite score at the 3-month follow-up period. Similarly, STAGE-12 participants significantly reduced their scores on this measure from baseline to the 3-month follow-up while TAU participants did not. The Composite score is based on drug use across a number of different substances, perceived drug-related problems, and perceived need for drug treatment during the 30-days preceding the interview. The results suggest that at the 3-month follow-up the STAGE-12 participants, as a group, reported less drug use and perceived themselves as having fewer substance-related problems and less need for treatment than those who had been in TAU. This finding is consistent with the fact that the odds of abstinence at that point, although not significant, still favored STAGE-12 and the rate of use among non-abstinent individuals was comparable between conditions and thereafter began favoring STAGE-12.
A secondary study focus was to determine the impact of STAGE-12 on increasing 12-step meeting attendance and engagement in 12-step activities. Two different measures were used to assess this variable. The Substance Use Calendar results demonstrated no differences between the conditions with respect to either the odds of attending meetings or the number of days on which meetings were attended. However, the Self-Help Activities Questionnaire (SHAQ) data demonstrated that the STAGE-12 group had a significantly higher rate of meeting attendance from baseline to the mid-treatment point and a nearly significant rate from the mid-point to the end of treatment than did the TAU group. The reason for the divergence in these two measures is not clear, although their respective methodologies are somewhat different. Specifically, the SUC asks about meeting attendance on a day-to-day basis on a calendar and has demonstrated intervention effects for a facilitative intervention to increase AA attendance by alcohol dependent individuals. The SHAQ (Weiss, et al., 1996
) asks individuals to estimate the number of days in a 30 day window in which they attended AA, CA, NA, and other 12-step and non-12-step (e.g., Secular Organization for Sobriety, Rational Recovery) self-help meetings as well as the number of days of engaging in 12-step recovery activities and service . Previous versions of the SHAQ have been found to have a high degree of internal consistency and predictive validity, have been used to describe mutual support related behaviors, to evaluate differential changes in these behaviors as a function of the type of treatment received, and to compare the relationship between 12-step attendance and participation with subsequent drug use outcomes (Weiss, Griffin, Gallop, Luborsky, et al., 2000
; Weiss, Griffin, Gallop, Onken, et al., 2000
; Weiss, et al., 2005
; Weiss, et al., 1996
). Measures similar to the SHAQ, in which participants are asked to estimate the number or frequency of 12-step meetings attended and the frequency of other 12-step activities and indicators of affiliation, have been used extensively in prior 12-step research and have demonstrated predictive utility (Humphreys, Kaskutas, & Weisner, 1998
; McKellar, et al., 2003
; Morgenstern, et al., 1996
; Tonigan, Connors, & Miller, 1996
). It is of note that the difference between groups on the SHAQ was found over the first four weeks of the intervention period, the time during which the intensive referral process might have been most likely to have led to the arranged 12-step meeting attendance with the community volunteer in the STAGE-12 condition.
The SHAQ results more clearly indicate that individuals in STAGE-12 had higher rates of 12-step related activities throughout both the active treatment phase and the entire 6-month follow-up period than did those in TAU. Furthermore, the rate ratios of the number of days of service at meetings (e.g., setting up, making coffee, cleaning up) for subjects in STAGE-12 was significantly greater, increasing from 1.61 times that for those in TAU between mid- and end-of-treatment and increasing to a rate of 2.38 for the 30 days preceding the 6-month follow-up assessment. This is of particular note since a number of studies have shown that involvement in 12-step activities and service often increase over time (whereas meeting attendance may decline) and is a more important indicator of engagement, a better predictor of subsequent outcome, and the potential mediator of change associated with 12-step mutual support groups (Kaskutas, 2009
; Owen, et al., 2003
; Subbaraman, et al., 2011
; Weiss, et al., 2005
). Consistent with this, data derived from the SHAQ in the NCCTS demonstrated that 12-step meeting attendance did not predict drug use or ASI Drug Use Composite scores among cocaine dependent individuals while indicators of 12-step service and activities predicted both (Weiss, et al., 2005
The present study has a number of limitations. First, although TAU counselors were instructed not to utilize components or distribute materials from the STAGE-12 intervention, no specific assessments were conducted to determine if and to what extent there might have been contamination or “bleed” from the STAGE-12 condition to TAU. Second, while information about group and individual counseling sessions was available from the Treatment Services Review for both conditions during the 8-week period over which the STAGE-12 intervention was delivered, data concerning drop-out/completion rates for the overall CTP intensive outpatient program that participants were attending is lacking. Third, there was considerable variability across CTPs in both the length/duration and the number of hours per week of the IOP into which STAGE-12 was integrated; the relative impact of STAGE-12 may vary depending on these characteristics of the clinical program.
In summary, STAGE-12, compared to TAU, contributed to a greater likelihood of abstinence from stimulant drugs over the active treatment phase, although it was associated with more days of use among those not achieving abstinence during this period. Relative to TAU, STAGE-12 was also associated with a significant reduction in, and a lower level of, substance use problems as measured by the ASI Drug Use Composite score at the 3-month follow-up. STAGE-12 participants also engaged in significantly more 12-Step activities and meeting-related service than did those in TAU. Subsequent analyses are planned to explore treatment exposure and early achievement of abstinence as well as other variables that might predict and differentiate subgroups having differential outcomes in STAGE-12. Subsequent analyses also will examine the relative predictive value of measures of 12-step attendance versus participation with respect to both substance use and psychosocial outcomes among stimulant abusers.