Alcohol and Alcoholism Advance Access originally published online on September 18, 2007
Alcohol and Alcoholism 2007 42(6):604-609; doi:10.1093/alcalc/agm062
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Compliance with aftercare treatment, including disulfiram, and effect on outcome in alcohol-dependent patients
Centro Regional de Alcoologia do Sul, CRAS, Parque de Saúde de Lisboa, Av. do Brasil, 53 A. 1749-006 Lisbon, Portugal
* Author to whom correspondence should be addressed at: Centro Regional de Alcoologia do Sul, CRAS, Parque de Saúde de Lisboa, Av. do Brasil, 53 A. 1749-006 Lisbon, Portugal. Tel: +351 21 7961807; +351 21 7958030; Fax: +351 21 7940427; E-mail: dneto{at}mail.telepac.pt
Received 23 January 2007; first review notified 26 June 2007; ; accepted 2 July 2007
| ABSTRACT |
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Aim: To delineate the features of treatment compliance which predicted outcome during aftercare treatment in a series of patients that completed an inpatient program at the Lisbon Regional Alcohology Centre (CRAS). Methods: Seventy-four alcohol dependent patients, sequentially admitted to the inpatient treatment of CRAS, were followed over 6 months after discharge. This study focused on the predictive value of the aftercare therapies, which included: attending Alcoholics Anonymous (AA) meetings, attending aftercare groups (AG), attending outpatient consultations with the medical assistant. Disulfiram was prescribed to 83.3% of the patients. At the end of the 6-months follow-up period, the patients and their significant others (co-responsible persons) were interviewed on the telephone by an independent interviewer. The data collected for analysis consists of information from the interviews, and also of data from the patient clinical files. Results: Survival analysis revealed that, after 6 months of follow-up, 39.2% of the patients had attained total abstinence of alcohol ingestion; 71% of the relapses on alcohol consumption occurred within the first 3 months. The median number of days taking disulfiram was significantly related to the number of days of abstinence. Demographic variables, pre-treatment variables, attendance at AA meetings, AGs and outpatient appointments were not significant predictors of outcome. Conclusions: Consistently taking disulfiram is associated with good outcome, but this may reflect committment to abstinence as well as a treatment effect.
| Introduction |
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The year following inpatient treatment for substance abuse constitutes a crucial phase for patient's evolution. Recovery programs encourage patients to attend aftercare services to ease the transition from more intensive involvement in treatment, to provide ongoing support and help to prevent relapse.
Several studies have described some of the factors that can influence a patient's success in his/her efforts not to relapse. Waisberg (1990
) points out the importance of psychological and demographic characteristics, of the level of alcohol dependency, the motivation for treatment, coping styles, and of beliefs about abstinence, on the observable differences of patients evolution after the inpatient period, every patient is given an aftercare plan of 2 years, which includes the following prescriptions: (i) outpatient psychiatric appointments with their medical assistant at CRAS, once a month; (ii) attending AA meetings, (iii) taking part fortnightly in aftercare groups (AG); (iv) when there were no medical contraindications, taking disulfiram, supervised by the person accepted by the patient and by the staff as his/her co-responsible person. And not At the end of the inpatient period, every patient is given an aftercare plan of 2 years, which includes the following prescriptions: (i) outpatient psychiatric appointments with their medical assistant at CRAS, once a month; (ii) attending AA meetings, (iii) taking part fortnightly in aftercare groups (AG); (iv) when there were no medical contraindications, taking disulfiram, supervised by the person accepted by the patient and by the staff as his/her co-responsible person.
Ellis and McClure (1992
) studied a set of variables predictive of a better evolution at 6 months and 1-year follow-ups, for a sample of 75 patients previously treated in an inpatient program. After 6 months, the abstinence rate was 66% for the men and 45% for the women, and at the end of 1 year, 53 and 39%, respectively. The non-relapsing rate for both sexes was associated with attendance of Alcoholics Anonymous (AA) meetings. Furthermore, poor outcome at 1 year was associated with a lack of involvement of the general practitioner in aftercare and failure to provide alcohol counselling in the community.
Other studies suggest that the participation in therapy sessions and counselling groups of the 12-step type also predicted a good evolution at 3 and 12 months (McKay et al., 1998
; Staines et al., 2003
).
Bottlender and Soyka (2005
) studied the predictors of abstinence in a sample of 103 alcohol-dependent outpatients, and found that 64% of the patients were abstinent after a 6-month follow-up evaluation. The severity of the dependence (measured by its duration, the number of previous treatments and by craving intensity) and a high index of depression and anxiety were predictors of a higher number of relapses.
Other studies had already shown that the severity of the psychiatric co-morbidity, in particular of depression, predicted a worse outcome in the aftercare period (McLellan et al., 1983
; Rounsaville et al., 1987
; Glenn and Parsons, 1991
).
Randomized controlled studies of supervised disulfiram treatment have shown that this treatment improves outcome (Chick et al., 1992
; Brewer, 1993
; O'Farrell et al., 1995
; De Sousa and De Sousa, 2004
, 2005
).
| Method |
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Participants
The sample consists of 74 alcohol-dependent patients, according to criteria of the DSM-IV-TR (APA, 2000
Inclusion and exclusion criteria
Patients included in the study fulfilled DSM-IV criteria for alcohol dependence and ended the inpatient programme during the period of the collection of data. We excluded patients who had continued the aftercare program in controlled environment such as a residential rehabilitation centre.
Treatment program
The CRAS inpatient program is based on the Minnesota Model, but it is modified in the sense that it emphasizes the family and community approach, and recommends supervised disulfiram. It is structured to last for a minimum of 4 weeks and a maximum of 5 weeks.
Following detoxification from alcohol (as well as from any other substances, when appropriate), a psychotherapeutic program lasts until the end of the inpatient period. In the first week, each patient is assessed taking into consideration medical, psychological, and family factors. The program prescribes attendance of AA meetings three times a week, and the patients are requested to work on the first three AA steps.
During the inpatient program, the patients take part in therapeutic groups four times a week. Family assessment and brief counselling are given particular attention. Whenever possible, every patient chooses his/her co-responsible person, usually a spouse or parent, who helps with the main issues of the aftercare treatment and who accompanies the patient to the medical meetings. Patients sign a consent to take disulfiram in the presence of this co-responsible person, voluntarily attributing to him/her supervisory functions.
At the end of the inpatient period, every patient is given an aftercare plan of 2 years, which includes the following prescriptions: (i) outpatient psychiatric appointments with their medical assistant at CRAS, once a month; (ii) attending AA meetings, (iii) taking part fortnightly in aftercare groups (AG); (iv) when there were no medical contraindications, taking disulfiram, supervised by the person accepted by the patient and by the staff as his/her co-responsible person.
Disulfiram was prescribed to the 60 (83.3%) of the 72 patients who had no medical contraindications. It was not possible to get information about a prescription of disulfiram in two patients.
Measures
The outcome information was collected by telephone interviews. An independent researcher, who was unfamiliar with CRAS's treatment procedures, interviewed the patients and their co-responsible persons. The interview consisted of a 6-item structured interview, which covered the following areas:
- Number of outpatient psychiatric appointments attended.
- Number of AA meetings attended.
- Number of AG attended.
- Period of disulfiram intake.
- Number of days abstinent from alcohol during the study period.
- Number of days until the first relapse. The ingestion of any amount of alcohol was considered a relapse. Number of days of any drinking.
Checking of the patients clinical files, which included a record of AG attendance and outpatient medical appointments during the study period completed the information gathered from the telephone interviews.
Statistical analysis
The effect on outcomes measures of the treatment prescriptions was examined. Data were analysed using SPSS (Statistical Package for the Social Sciences) version 14.0. For this study, a level of P
0.05 was considered to be statistically significant. The statistical tests used for the numerical variables were the Mann–Whitney U test (analysis of the median) and the qui-square test for categorical variables (analysis of percentages).
Survival analysis (Kaplan–Meier) was used to assess both the time between discharge and the first relapse, and the percentage of patients who remained abstinent during the study period.
Cox Multiple Regression Analysis was used to estimate the effect of the time of use of disulfiram (120 days or less vs 121–180 days) adjusted for the number of AA sessions, AG and medical consultations).
By analogy with the intention to treat principle (ITT; Gillings and Koch, 1991
), any patient who finishes his/her interment is eligible for statistical analysis. In accordance with this principle, it was assumed that the patient had relapsed when there was no information for the 6-month evolution period.
| Results |
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Patients' characteristics at admission
Of the 74 patients, 62 were males and 12 females. The mean age of patients was 45 (±8.1) years. The mean educational level was 5 years (±3.7). Patients who were married or in stable relationships accounted for 51.4%; 30% lived with their parents; 59.5% were unemployed or retired; 24.3% of the patients were involved in court proceedings; 94.6% had someone who was willing to be the co-responsible person for their treatment; 18.9% had already been admitted on inpatient treatment at CRAS. Patients who had contacts with drugs in the past were 32.4%; 13.6% were consuming benzodiazepines, cannabis and heroin during the period of their admission; 66.2% had elevations in serum liver enzymes The average duration of the inpatient treatment was 34 days (±5.3) (Table 1).
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Outcome
During the 180 days of the aftercare period, 29 patients (39.2%) were abstinent. It was assumed that the six patients who were not contactable had relapsed, making a total of 45 relapsed patients (60.8%). The mean days of continuous abstinence from alcohol during the study period was 123.6 (±63.4) (Table 2).
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Using the Kaplan–Meier method, which looks at the relapse event and the time until the first relapse, it is possible to estimate the survival/abstinence curve shown in Table 3 and Fig. 1. The survival analysis (Kaplan–Meier) gives a median time until the first relapse of 120 days. Over the 180-day period, the abstinence rate went from 81.1% in the first 30 days to 39.2%. The results also show that most relapses occurred within the first 90 days of the aftercare period (71% of relapses on the first 90 days vs 29% on the last 90 days).
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In order to assess possible associations of some demographic variables with abstinence, a chi-square test was run, considering gender, marital status, and employment status. However, no significant differences were found. Nevertheless, our results show that the abstinence rate for men is higher (41.9%) than for women (25%) and divorced and persons living alone tend to relapse more than married or cohabiting patients.
Our analysis also investigated if there was some relationship between the abstinence at the end of the follow-up period and previous inpatient treatments at CRAS. Of the 14 patients who had repeated the inpatient treatment, only four (28.4%) patients were abstinent at the end of the 180 days. However, this difference from the relapse rate for the whole sample was not statistically significant (Table 4).
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As to the therapeutic recommendations for the aftercare period, 47.3% of the patients had not met the medical assistant, 20.3% had not frequented the AGs, and 33.8% had not gone to AA sessions. A closer inspection of the patients who had adhered to the prescriptions found that there was no significant relation between the frequency of AA sessions, frequency of the AG, and frequency of medical consultations; and the outcome variables (relapse/abstinence) (Table 5). Of the 60 patients to whom disulfiram was prescribed, 55 had effectively taken it.
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Using the Mann–Whitney U test, we found that the more days the patient has taken disulfiram, the greater number of days of abstinence (median number of days of disulfiram intake by patients who relapsed = 111; median number of days of disulfiram intake by patients who remained abstinent = 180; P < 0.001) (Table 5). To clarify the importance of the disulfiram intake variable as a predictive factor of a good outcome, a survival analysis of Kaplan–Meier was used to compare two classes of patients: class 1, the ones that had taken disulfiram for 120 days or less (N = 23); class 2, 121 days or more (N = 32). It was observed that the increased number of days of intake of disulfiram is associated with an increase in the number of days of abstinence (P < 0.001). Fig. 2 and Table 6.
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In order to clarify the predictive value of disulfiram intake against the effect of confounding variables, Cox regression was used to examine the effect of taking disulfiram, adjusted for the other supposed predictive variables: AA, AG sessions and consultations with the medical assistant. The predictive value of disulfiram was not influenced by the other variables analysed. Patients who took disulfiram for 121 days or more had a reduction of 72.5% of the relative risk of relapse (Table 7).
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| Discussion |
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These results indicate that 180 days after the inpatient treatment at CRAS, 39.2% of the patients were abstinent. The largest percentage of relapses occurred in the first 3 months after the inpatient period. These results are consistent with the critical period of relapses found in other studies (Lash, 1998
Attendance of AG sessions, and of self-help groups (AA), are two therapeutic modalities frequently used in programs of relapse prevention (McKay et al., 1998
; Staines et al., 2003
). Patient compliance with these types of programs is associated with a good social stability and with a cognitive and psychological balance that in turn leads to a better outcome. However, our study did not show a favourable impact on the outcome of the group which attended them, nor did attendance at meetings with the medical assistant at CRAS. There was low compliance with the aftercare plan, which helps explain the weak predictive value of these prescriptions in the present study.
According to Waisberg (1990
), psychological, socio-family, demographic characteristics, and motivation for treatment, can play a part in remaining abstinent. The present study indicates that some factors can hinder better results in attaining abstinence: being unemployed, retired or having short-term contracts (59.5% of the patients), average age (in our sample 45 years old), living with their parents at that age (in 30% of cases), and not being married, or in co-habitation (in 48.6% of the cases). The life conditions of these patients made them akin to dependent adults, and many of them had no realistic hope of getting a house or a job in the near future. The female patients had a worse outcome than the males (75% had relapsed after 6 months, as opposed to 58.1% of the males)—a result that is in agreement with Ellis and McClure (1992
) and might be related to the difficulty women may face in overcoming the same factors considered above. However, this conclusion could not be validated statistically, given the small number of women in the sample group. The importance of this variable requires further research, which can promote adaptations in the therapeutic programme to gender related issues.
Finally, we found that a longer period of disulfiram intake was statistically associated (P < 0.05) with improved rates of abstinence (Tables 5 and 6). This study, without a control group, cannot demonstrate the clinical effectiveness of disulfiram, but it demonstrates a statistical association with a better evolution of the patients. The success of this medication can be related to the importance that CRAS team and the patients attach to involving the co-responsible person and to a pragmatic family approach. The patient starts taking it during the inpatient period, under a written contract, and with careful advice on its side effects and necessary dietary precautions. When he is discharged he allows his co-responsible person to observe his ingestion of disulfiram.
| The Study's Limitations and Suggestions for Further Research |
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The economic limitations of the country and the characteristics of our service prevented us from organizing a more intensive and structured aftercare programme. We had to choose for less intensive contacts with the patients and for what seemed to be better in terms of cost-benefits.
The assessment of the variable abstinence over the 6-month period was based exclusively on telephone conversations with the patients and their co-responsible persons, and on the information gathered from their post-discharge files and outpatient appointments. Future studies will require the patients to be recruited before inpatient treatment and to be followed up on a real-time basis, both throughout the inpatient period and after discharge. They will require a more structured outpatient programme, and the means to detect drop-outs sooner. Additionally, the research-plan employed in this study did not include the use of biological markers at follow up.
Psychological symptoms presented by the patients and their motivation for abstinence, were not evaluated, which did not allow the study of these factors as predictors of evolution.
| ACKNOWLEDGEMENTS |
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We thank Dr. Pedro Aguiar for his help with the statistical analysis, Dr. David Neto, Dr. Nuno Otero and Dr. Nuno Torres for revisions of the text.
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