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12‐step type programmes and Alcoholics Anonymous for alcohol dependence

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To assess the effectiveness of attendance of Alcoholics Anonymous programs versus other psychosocial interventions in reducing alcohol intake, obtaining abstinence, maintaining abstinence, improving the quality of life of affected people and their families, reducing alcohol associated accidents and health problems. The following interventions will be compared:

Twelve‐Steps programmes versus no intervention
Twelve‐Steps programmes versus other intervention (Motivational Enhancement Therapy (MET), Cognitive‐behavioural coping skills training (CBT), Relapse Prevention Therapy (RPT))
Twelve‐Steps programmes variants (Alcoholics anonymous spiritual, alcoholics anonymous non‐spiritual, alcoholics anonymous professionally led and alcoholics anonymous lay‐led) compared in separate analysis.

Background

Alcohol consumption is declining in most developed countries and rising in many of the developing countries, Central and Eastern Europe. Alcohol's abuse significantly contributes to the global burden of disease and in parts of Central and Eastern Europe alcohol abuse has been linked to an unprecedented decline in male life expectancy (WHO 2001). Alcohol dependence one‐year prevalence is around 7% and its life‐time prevalence rates are 14% in the general population (Kessler 1994, Regier 1993). Alcohol dependence (also called alcoholism) is a condition that involves four main symptoms: craving (a strong need to drink); uncontrolled behaviour (after the first drink is impossible to stop); physical dependence (if one do not drink enough, experiences withdrawal symptoms such as nausea, sweating, shakiness and anxiety); and tolerance (the need to increase the amount of alcohol intake to feel satisfied) (NIAA 2003). Substance dependence is defined by the DSMIV as a "cluster of cognitive, behavioural, and physiological symptoms indicating that the individual continues using a substance despite significant substance‐related problems". Dependence on alcohol is characterised by tolerance and withdrawal symptoms. Tolerance is a progressive reduction in the susceptibility to the effects of a substance, resulting from its continued administration. It is present when a person must use an increasing quantity of a given substance, to achieve the same perceived effect as time passes (Gitlow 2001). Tolerance is also experienced when the person notices a decreased sensation with similar doses of a substance over time. Tolerance can be measured objectively a person with high alcohol level in blood who can still perform given tasks such as walking in line, shows sign of tolerance. Withdrawal symptoms are physiological and psychological symptoms associated with withdrawal from a substance after prolonged administration or habituation. Withdrawal is present when a characteristic physiological pattern associated to a certain substance is experienced, or when the person uses the substance to avoid or reduce specific symptoms (Gitlow 2001). People compulsively using alcohol may devote substantial time to obtain and consume alcoholic beverages and continue to use alcohol even if they experience severe psychological and physical consequences such as depression, blackouts, liver disease or other sequel (DSMIV 1994).

There is no unique and known cause of alcohol dependence and several factors may play a role in its development: familiarity, genetic factors, psychological such as high anxiety, ongoing depression, unresolved conflicts within relationship or low self‐esteem, and social factors such availability of alcohol, social acceptance and promotion of the use of alcohol, peer pressure and demanding lifestyle (A.D.A.M. 2002). Risk factors studies conducted on animals suggest that genetic vulnerability to alcohol dependence is multigenic. In humans, evidences about the genetic vulnerability is provided by studies involving monozygotic and dizygotic adult twins, which suggested that alcohol dependence is due in two thirds of cases to genetic factors and one third to environmental factors, without gender differences (Heath 1997). Alcoholic dependence syndrome is is three to four times higher in the relatives of alcoholic dependent people compared with the general population (DSMIV 1994). Stress and emotional problems can play a role in the development of alcohol abuse (NIAA 2000).

Remission is spontaneous in about 20% of people with alcohol dependence. Gender and age do not substantially affect prognosis. Positive prognostic factors are good social functioning (employment, family relationship, absence of legal problems) and good health status. Retention in treatment for at least one month increases the likelihood of remaining abstinent for one year. Psychiatric comorbidity is a negative prognostic factor. The health, social and economic consequences of alcohol abuse are usually devastating. Although many individuals do achieve long‐term sobriety with treatment, others continue to relapse and deteriorate despite multiple courses of treatment. Alcohol dependence contributes to accidents, violent behaviours, suicide, loss of working days, work related accidents and low productivity. Mortality and morbidity are increased in people with alcohol dependence (Hales 1999).

Attendance of self‐help groups is often suggested to people with a diagnosis of alcohol dependence. Participation to self‐help organization meetings can be an adjunct to professional treatment, or a treatment in itself in particular for long periods. Alcoholics Anonymous (AA) is a self‐help groups international organization composed of recovering alcoholics that offers emotional support and an effective model of abstinence for people recovering from alcohol dependence(Alcoholics Anonymous). The practice of AA is the so called Twelve Step Facilitation (TSF), an intervention based on the assumption that substance dependence is a spiritual and a medical disease (Nowinksi 1992). TSF consists of brief, structured, manual‐driven approach to facilitating recovery from alcohol abuse, and it is intended to be implemented on individual basis in 12 to 15 sessions. There are many different types of interventions based on 12‐step type programmes some of them include a spiritual approaches and others do not, some are led by a professional and others are led by former patients.

The aim of the present review is to identify the different types of programmes and to assess the experimental basis for such a frequently prescribed intervention. Besides lots of non‐scientific (mainly spiritual) literature, there is one review which compares studies of heterogeneous design and quality and one large trial (Project MATCH) conducted in the States in the late 90's with the aim of identifying the predictors of success in different non‐pharmacological interventions for alcohol dependence. The present review will consider the results of that trial and any other available experimental studies on the effectiveness of 12‐step based programmes.

Objectives

To assess the effectiveness of attendance of Alcoholics Anonymous programs versus other psychosocial interventions in reducing alcohol intake, obtaining abstinence, maintaining abstinence, improving the quality of life of affected people and their families, reducing alcohol associated accidents and health problems. The following interventions will be compared:

Twelve‐Steps programmes versus no intervention
Twelve‐Steps programmes versus other intervention (Motivational Enhancement Therapy (MET), Cognitive‐behavioural coping skills training (CBT), Relapse Prevention Therapy (RPT))
Twelve‐Steps programmes variants (Alcoholics anonymous spiritual, alcoholics anonymous non‐spiritual, alcoholics anonymous professionally led and alcoholics anonymous lay‐led) compared in separate analysis.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials comparing twelve‐steps and /or Alcoholics Anonymous program to other psychological treatment or no treatment. Where available observational studies with control groups will be considered and separately analysed.

Types of participants

Adults (>18) with alcohol dependence attending Alcoholic Anonymous programs, studies on patients coerced to participate will be enclosed and results will be considered separately from those of studies on voluntary participation.

Types of interventions

Experimental Interventions
Twelve‐step programmes and/or Alcoholic Anonymous for encouraging meeting attendance, reducing drinking, remaining abstinent, and reducing social problems related to alcohol consumption.

Control interventions
Twelve‐Steps programmes variants (Alcoholics anonymous spiritual, alcoholics anonymous non‐spiritual, alcoholics anonymous professionally led and alcoholics anonymous lay‐led) compared in separate analysis.

(1) No treatment

(2) Other psychological interventions: Motivational Enhancement Therapy (MET) based on the principles of cognitive and social psychology the MET seeks to evoke the clients motivation for change the harmful use of drugs. Each clients is helped by a Counsellor to set their own goals and plan (Miller 1996); Cognitive‐behavioural coping skills training (CBT) a treatment which goal is abstinence from use of substances through identification of high risk situations for substance use and the implementation of effective coping strategies (Marlatt 1995); Relapse Prevention Therapy (RPT) is a cognitive‐behavioral approach to the treatment of addictive behaviours that specifically addresses the nature of the relapse process and suggest coping strategies useful in maintaining change (Marlatt 1995; Parks 2001).

(3) Twelve‐Steps programmes variants (Alcoholics anonymous spiritual, alcoholics anonymous non‐spiritual, alcoholics anonymous professionally led and alcoholics anonymous lay‐led.

Types of outcome measures

(1) Addiction severity measured with a questionnaire (ASI a semi‐structured interview protocol used to assess a spectrum of addiction‐related behaviours and consequences (McLellan 1980)
(2) Drop out from treatment, measured as the absolute number of patients at the end of the follow‐up
(3) Reduction of drinking, self‐reported
(4) Abstinence, self reported
(5) Severity of impact of alcohol abuse measured with a questionnaire (Drinking Inventory Consequences (DrInC): is a self‐administered 50‐item questionnaire designed to measure the consequences of alcohol abuse in five domains: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. Each scale provides a lifetime and past 3 months measures of adverse consequences, and scales can be combined to assess total adverse consequences (NIAA 2003)

Search methods for identification of studies

We will search the Cochrane Drugs and Alcohol Group trials register, the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE 1966 to present day; EMBASE 1980 to present day; CINHAL 1982 to present day; PsychINFO 1967 to present day. .

No language or time restriction will be applied.

Self‐helps groups (MESH)
self‐help (text word)
ALCOHOLICS ANONYMOUS (MESH)
(alcoholic next anonymous) (text word)
(alcoholics next anonymous) (text word)
ALCOHOLIC INTOXICATION CHRONIC (MESH)
ALCOHOLISM (MESH)
alcoholism (text word)

Data collection and analysis

Study Selection
One reviewer will inspect the search hits by reading the titles and the abstracts. We will resolve any uncertainty through discussion. We will obtain the full article of each potentially relevant article located in the search and two reviewers will independently assess for inclusion.

Assessment of the methodological quality of Randomised Controlled Studies
Study quality will be assessed according to the criteria indicated in the Cochrane Reviewers' Handbook 4.1.4 (Alderson 2004). Studies will be classified as A (low risk of bias), B (moderate risk of bias) and C (high risk of bias) (Alderson 2004a).

For the observational controlled studies the quality will be assessed against the scales developed by the Scottish Intercollegiate Guidelines Network (SIGN 2004).The quality of studies will be discussed along with the presentation of results.

We will consider: randomisation, allocation concealment and follow‐up. As indicated below we will indicate the adopted gold standard methods for each of them (the methods are ordered for preference). If the preferred method was applied for all three domains the study was categorised as 'A'; if two out of three, it was categorised as 'B'; if no information was reported the study was categorised as 'C' and the authors were contacted for details. The results will be described in the "Characteristics of included studies'" table.

Randomisation method
Computer generated list, random number table, coin toss etc.
date of birth, number of hospital records, etc.
double randomised consent design (seeJadad 1998).

Allocation concealment
methods described and affordable (see Cochrane Reviewers' Handbook) : centralised (e.g. allocation by a central office unaware of participants subject characteristics) or pharmacy‐controlled randomisation; pre‐numbered or coded identical containers which are administered serially to participants; on‐site computer system combined with allocations kept in a locked unreadable; computer file that can be accessed only after the characteristics of an enrolled participant have been entered; sequentially numbered, sealed, opaque envelopes;
other methods
no description

Follow‐up
information on people who left the study for any reasons clearly reported (Greenhalgh 1997).

The quality evaluation was not used as a criterion for exclusion and inclusion but any anticipated findings are described and discussed below in "Statistical analysis'"

Data extraction
Data will be extracted in double by the reviewers.

Statistical analysis
If possible, we will calculate the relative risks using Review Manager . The types of intervention considered will involve heterogeneity due to social context, political organization (for instance in the legal consequences of dependence related problems, access to social services etc.); therefore we will adopt the random effects model. Considering the varieties of approaches included under the 12‐steps programme, we will perform separate analysis based on the characteristics of the interventions. The main groups will be: the use of the standardized procedures for the conduction of groups; the spiritual approach, the professional led groups, the former patients led groups. We may include other subgroups and the reasons for their inclusion will be explained in the review.