1 Title: Non-attendance at counselling therapy in cocaine using methadone maintained patients: Lessons learnt from an abandoned randomised controlled trial. 2 Abstract Background: Recently, the authors commenced a randomised controlled trial to study the effectiveness of cognitive behavioural coping skills (CBCS) to reduce cocaine usage in methadone maintained patients’ in a clinical setting by assessing attendance at treatment sessions and outcomes in terms of cocaine use. However, recruitment into the study stopped when it became apparent that attendance at counselling sessions was poor. Aims: The aim of the current study was to determine the reasons for both non attendance and attendance from a patient’s perspective at counselling sessions. Methods: A cross sectional design was employed whereby participants who were recruited for the original study were interviewed utilising a semi-structured interview format. Results: Motivational inconsistencies were most frequently cited as the reason for dropping out of counselling, whereas a good relationship with staff was cited by attenders as the most important factors which aided their attendance at counselling sessions. Conclusions: Selecting opiate dependent methadone maintained cocaine abusers on the basis of their urine toxicology and offering them counselling as a way of reducing their harmful drug use did not prove efficacious. Attempting to address cocaine misuse within this cohort may need require a more stepped approach including brief interventions such as motivational interviewing, or other enhancers of motivation before we can test the effectiveness of CBCS in this population. Key words: Non-attendance; counselling; cocaine users; methadone; cognitive behavioural coping skills 3 Introduction The prevalence of cocaine use in Ireland increased dramatically from 2000 onwards (1). In a 2002-2003 drug prevalence survey, the lifetime prevalence of cocaine use for Ireland was 3% (2) whereas in a 2006-2007 survey lifetime prevalence of cocaine use rose to 5% for the adult population (3). There has been a 177% increase of cases treated for cocaine as a main problem drug, from 954 in 2002 to 2,643 in 2007. Also the number of people reporting cocaine as an additional problem drug increased 128%, from 826 in 2002 to 1,885 in 2007 (1). Recent evidence suggests that crack cocaine is an increasing problem for polydrug users in Dublin (4). Studies concerning the treatment of addictive behaviour have shown that engagement in treatment is one of the strongest predictors of both good therapeutic results and better long-term prognosis (5–8). The efficacy of cognitive behavioural therapy (CBT) for improving treatment outcomes among cocaine-using populations has been documented (9–13). Cognitive behavioural coping skills (CBCS), which is a particular form of CBT, has shown promising results in reducing number of days taking cocaine (14). The central component of CBCS is to train patients in coping skills that include avoidance, refusing, negotiation and communicating skills, as well as general coping mechanisms. Despite the evidence of the efficacy of CBCS in some populations there are doubts about its effective delivery within applied clinical settings like drug treatment clinics (15). A problem in the treatment of substance abuse is the large number of dropouts, with rates ranging from 60 to 80 per cent overall (16–18). With respect to CBT, dropout rates range from 33 to 64 percent (19). Early attrition has been shown to not only increase the likelihood of relapse but also to exacerbate health, financial, and legal consequences (20–23). Early attrition is also associated with reduced cost-effectiveness (24) and can create clinical and morale problems for practitioners (25). The reasons for both non attendance and attendance from a client’s perspective are relatively understudied areas. We wished to examine the uptake and effectiveness of CBSC in relation to cocaine use in a cohort of methadonemaintained opiate users. 4 We commenced a randomised controlled trial to study the effectiveness of cognitive behavioural coping skills (CBCS) in reducing cocaine usage in methadone maintained patients in a clinical setting, by assessing attendance at treatment sessions and outcomes in terms of cocaine use. The definition of cocaine misuse for entry into the study was “50% of four or more urine samples testing positive for cocaine over a three month period”. This cut-off was used to identify patients who had a significant cocaine problem outlining chronic use and not sporadic use of cocaine and therefore warranting an intervention. Clients who were misusing cocaine were randomised to one of two options, to either continue to receive ‘treatment as usual’ (TAU; control arm) or to receive CBCS (intervention arm). Both groups were linked with counsellors, the control group with a counsellor that was not trained in CBCS and the intervention group with a CBCS trained counsellor. Both groups were invited to attend counselling sessions for a twelve week period. The attendance at these sessions for both groups was low. Theoretically a participant could attend a minimum of zero sessions and a maximum of twelve counselling sessions. We recruited forty-five participants into the study before we stopped recruitment. The consort flow diagram is given in Figure 1. The average attendance at sessions for the CBCS arm of the study was 25%; with the TAU group the rate of attendance was 13%. As a result of poor attendance at counselling sessions for both arms of the RCT, recruitment into the study was stopped, as it was obvious that participants were not being exposed to the treatment effect. We subsequently designed a study to determine why participants did not attend counselling sessions available to them. Method Participants All 45 of the original cohort from the aborted RCT were invited to participate. Of the eight participants not included, three were deceased, one refused, one was in prison, one had moved to a different country and two clients had left their treatment setting. Thirty-seven (N=37/45; 82%) of the original participants were available to be interviewed (male = 22; mean age 34.5 years, 5.7 SD). Design 5 A cross sectional design was employed whereby participants who were recruited for the original RCT were interviewed utilising a semi-structured interview format. The objective of this study was to investigate the reasons for both attendance and non-attendance at counselling sessions. Outcome measure The outcome measure was an adapted version of the ‘Reasons for Leaving Treatment’ questionnaire (26) which has been found to be reasonably reliable for predicting dropout from treatment for a drug and alcohol addicted cohort (26). Adaptation was necessary as the original questionnaire was referring to dropout from the whole programme while this study was focusing on dropout from counselling sessions specifically. Two versions of the questionnaire were designed to facilitate questions aimed at those that did attend their counselling session and for those that did not attend. The questionnaire consisted of twenty-five items with scales covering client, programme and external dimensions, such as motivational inconsistencies (Cronbach’s = 0.63), staff conflicts (Cronbach’s = 0.86), boundary concerns (Cronbach’s = 0.74), outside influences (Cronbach’s = 0.46), programme expectations (Cronbach’s = 0.80), problem severity (Cronbach’s = 0.74) and logistical problems (Cronbach’s = 0.53). Procedure All participants who had been recruited into the original trial were invited to take part in a semi-structured interview performed by a researcher (SOC) who was not involved in the RCT and was therefore in a more neutral position to elicit their reasons for attending or not attending counselling sessions. All participants gave their informed consent to be interviewed. Results Reasons for attendance and non-attendance An ‘attender’ was anyone who attended four or more counselling sessions (either TAU counselling or CBCS counselling sessions). Table 1 lists the adapted Reasons for Leaving Treatment Questionnaire (26) with individual items, their endorsement frequency and corresponding scales for non-attenders (N=27/37; 73%). 6 Items within the “motivational inconsistencies” scale were most frequently endorsed as a reason for dropping out of counselling, with “staff conflicts” being the least cited as reasons for not attending sessions. (Table 1 about here) Table 2 lists the adapted Reasons for Leaving Treatment Questionnaire scales with individual items, their endorsement frequency, and corresponding scales for attenders (N=10/37; 27%). “Good relationship with staff” was cited by attenders as the most important factor which aided their attendance at sessions, as opposed to “boundary concerns” which proved to be the least important factor for attenders. (Table 2 about here) Discussion Forty-five cocaine dependent methadone maintained patients were recruited into a study which planned to test the feasibility of delivering a new type of psychosocial intervention aimed at reducing cocaine use. Participants and counsellors were matched according to treatment condition and procedures were put into place to monitor attendance at counselling sessions. Attendance at counselling sessions was low, with the average attendance being 25% for CBCS sessions and 13% for TAU sessions. We followed up this cohort to ascertain reasons for either attending or not attending their assigned counselling session. Motivational inconsistencies was the most cited reason for participants not attending their counselling session, while having a good relationship with staff was the most cited reason for attending counselling. Conflicts with staff were the least cited category by the non- attenders, while positive staff relationships were highly endorsed by attenders. These results are in contrast to results in previous studies which show that therapeutic alliance may play only a small role in predicting the outcome of therapy for cocaine dependence (27), and in another trial of cocaine dependence, alliance also did not predict outcome in cognitive therapy (28). 7 The findings of the current research raise an important issue to consider concerning client motivation. The most frequently quoted reason for non-attendance was loss of hope. Hopelessness has been cited as an important facet of patients’ struggle in recovery from mental illness (29) and perhaps hopelessness has a mediating effect on motivation and a moderating effect on ambivalence on attendance for treatment in addiction counselling. The Carroll et al (10) study recruited participants who were motivated to change their behaviour into the CBCS programme, whereas in our RCT we attempted to recruit opiate dependent methadone patients who were persistently testing cocaine positive, regardless of their intrinsic motivation to change. Perhaps a motivational enhancement technique such as brief interventions or motivational interviewing (30,31) or motivational enhancement therapy (32) or contingency management (CM) may be best used as a preparatory step in engaging substance misusers in psychosocial interventions. CM treatments are interventions in which participants receive tangible reinforcers for objective evidence of behaviour change such as treatment retention and drug abstinence (33). In a recent eight site trial, it was found that stimulant abusers receiving CM in addition to usual care remained in treatment longer, attended more counselling sessions and were significantly more likely to achieve four, eight and twelve week’s of continuous abstinence from drugs than participants in the ‘usual care’ option (34). CM could possibly provide the mechanism required to increase attendance at psychosocial treatment sessions. It is of interest to note that more participants attended for the follow-up interview with the researchers than accessed either CBCS or TAU counselling. This may have been for a number of reasons. Firstly, perhaps it was because they did not feel ready to engage in treatment for their cocaine abuse and they were in the precontemplation stage of behavioural change (35). Secondly, they may have felt that CBCS was not an acceptable form of treatment or thirdly, that simply the voucher remuneration which was given for attending the follow-up interview with researchers was motivation to attend in contrast to the absence of a financial incentive to attend their counselling sessions. Two previous studies have demonstrated that CBCS effects are durable and that continuing improvements may occur even after the end of treatment (10,36). However both studies excluded participants 8 who were addicted to opiates. A recent large scale cohort study in the UK reported that a higher proportion of users of either heroin and crack cocaine abstained than did users of both drugs in response to a psychosocial intervention (37). Patients in the current study were methadone maintained opiate and cocaine dependent clients who were only eligible to participate if 50% or more of the urine samples provided over a period of three months tested positive for cocaine. Therefore, the sample that Carroll et al recruited were arguably less chaotic than the sample in the present study. The therapists who delivered the treatment in the Carroll et al studies were either post-doctoral level or master level psychologists or psychiatrists. Therefore, the therapists who delivered the interventions in the Carroll studies would be considered elite and not typically found in standard drug clinics. The findings from this current pragmatic study suggest that it is still to be determined whether CBCS can be transferred to and administered effectively in opiate treatment settings, at least when the clients have not identified themselves as motivated to change their cocaine using pattern. For this reason it is not recommended by the National Institute of Clinical Excellence in the UK (38) as first line treatment for cocaine users. 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