|
Article Excerpt
THERE IS CONSIDERABLE EVIDENCE that lack of compliance (also termed "adherence") limits the effectiveness of treatment for many disorders. For example, O'Brien and McLellan (1996) reported that compliance with medication regimens for diabetes mellitus, hypertension, and alcohol dependence is 50% or less. Moreover, compliance with the behavioral recommendations associated with the treatment of these disorders (weight loss, diet change, reduction in alcohol consumption) was even poorer than compliance with medications. The rates of compliance with treatment of alcohol dependence are lower than those for medical disorders such as diabetes and hypertension (Volpicelli et al., 1997). Poor treatment adherence compromises the efficacy of treatment, is associated with poorer prognosis, compromises the assessment of the effectiveness of treatments (Hughes et al., 2001; Volpicelli et al., 1997) and, in many circumstances, contributes to life years lost or diminished quality of life, which could otherwise have been preventable (Horwitz et al., 1990). Factors known to adversely affect treatment adherence include characteristics of the patient, the treatment, the treatment provider and the treatment setting. Some examples of such factors include comorbidity, long waiting times, side effects of medications, and a poor understanding of the nature of the proposed treatment (Rohsenow et al., 2000).
A number of interventions have been devised to increase treatment compliance; for example, contingency management (such as provision of vouchers for drug abstinence or medication adherence) has been found to increase abstinence (Higgins et al., 2000) and adherence to naltrexone in opioid-dependent patients (Carroll et al., 2001). Yet, overall, meta-analytic reviews have revealed that, despite the range of interventions examined--for example, educational (teaching seminars, educational videos, pamphlets, and books), behavioral (specific packaging, contingency management, diaries, contracts, and reminder calls) or counseling/supportive interventions (Roter et al., 1998)--overall increases in adherence to treatment are small and no one intervention appears to be superior (McDonald et al., 2002). A contributing factor to the difficulty in assessing the effectiveness of interventions to improve adherence is the lack of randomized controlled studies (Haynes et al., 2002).
A motivational interviewing-based intervention has been shown to increase treatment adherence for patients with mental illness (Kemp et al., 1996). This "compliance therapy" is a brief intervention of four to six sessions specifically aimed at targeting problems that can affect treatment compliance, such as ambivalence about pharmacotherapy, poor attitudes or misperceptions about medications, and a lack of insight into the illness. Compliance therapy borrows extensively from motivational interviewing (Miller and Rollnick, 2002) and cognitive behavioral principles. A randomized controlled trial involving subjects with schizophrenia or bipolar disorder found that this intervention substantially increased medication adherence and improved attitudes toward medication and insight into the disorders compared with nonspecific counseling (Kemp et al., 1996). Moreover, many of these gains were maintained both at the 6- and 18-month follow-up (Kemp et al., 1998).
Such results suggest that an intervention that identifies and specifically targets the factors that compromise treatment adherence may have a role in improving treatment across a broad range of disorders or problems. With the advent of the pharmacotherapies acamprosate (Campral) and naltrexone (Revia) for the treatment of alcohol dependence (Baltieri and De Andrade, 2004; Volpicelli et al., 1992) and the problems associated with poor compliance with these medications (Rohsenow et al., 2000), we hypothesized that compliance therapy may have an important role in the treatment of alcohol dependence. The aim of the present study was to examine, in a randomized controlled trial, the extent to which compliance therapy is effective in increasing treatment adherence in the pharmacological treatment of alcohol dependence.
Method
We conducted a randomized controlled trial of compliance therapy in addition to usual medical care in the treatment of alcohol dependence with acamprosate. All participants were prescribed acamprosate for 4 months. This study was approved by the Human Ethics Review Committee of Central Sydney Area Health Service (RPAH zone).
Subjects
Subjects were recruited from and treated at a hospital-based drug and alcohol treatment service. To enhance recruitment, advertisements in local health and medical centers and newspapers were also placed. Inclusion criteria were a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV; American Psychiatric Association, 1994), diagnosis of alcohol dependence, abstinence from alcohol for 3-21 days with resolution of any withdrawal symptoms, willingness to participate in continuing treatment with the aim of achieving abstinence from alcohol, willingness to be treated with acamprosate, ages between 18 and 65 years, sufficient English comprehension skills to provide informed consent and complete questionnaires, and willingness to provide written informed consent. Exclusion criteria were contraindication to the use of acamprosate, advanced liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy), any other drug dependence (other than tobacco) or severe current psychiatric disorder associated with psychosis and significant suicide risk. Women were excluded from involvement if they were pregnant (they were offered a test if unsure) or breastfeeding. All subjects were compensated Aus. $20 for baseline and follow-up assessments.
Procedure
The treatment procedure and frequency of assessments were explained to all eligible individuals and a study information sheet was provided. Before entry to the study, alcohol withdrawal (detoxification) treatment was offered if clinically indicated according to New South Wales detoxification clinical practice guidelines (New South Wales Health, 1999). Acamprosate was begun at a dose of 1,998 mg/day (two 333-mg tablets thrice daily) when subjects had been abstinent for a minimum of 3 days (maximum of 21 days). This treatment was provided according to approved local clinical guidelines and costs; each prescription for acamprosate provided 30 days worth of medication, and included one repeat prescription for another 30 days without return to the doctor.
Participants were randomly assigned into groups to receive usual medical care only (UC) or usual medical care plus compliance therapy (CT). Randomization was performed by placing a shuffled series of cards labeled with the two study groups into consecutively numbered envelopes. The usual medical care all subjects received...
|
