ANNEXURE - II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS. / DR MURALIDHARA K A
POSTGRADUATE STUDENT
#176, VIVEK HOSTEL, KIMS CAMPUS
VIDYANAGAR, HUBLI -580022
2. / NAME OF THE INSTITUTION. / KARNATAKA INSTITUTE OF MEDICAL
SCIENCES, HUBLI
3. / COURSE OF STUDY AND SUBJECT / M.D. (PSYCHIATRY)
4. / DATE OF ADMISSION / 31/05/2013
5. / TITLE OF THE TOPIC / “ A PROSPECTIVE STUDY OF
CLINICALPARAMETERS,
PSYCHOSOCIALFACTORS,
DEMOGRAPHIC VARIABLES
CONTRIBUTINGTO RELAPSE AND
MAINTAINANCE OF ABSTINENCE IN
PATIENTS UNDERGOING ALCOHOL
DEADDICTION THERAPY IN KIMS,
HUBLI ”
6. / BRIEF RESUME OF INTENDED WORK:
6.1 NEED FOR THE STUDY:
The harmful use of alcohol is a global problem which compromises both individual and social development. It results in 2.5 million deaths each year. It also causes harm far beyond the physical and psychological health of the drinker. It harms the well-being and health of people around the drinker. An intoxicated person can harm others or put them at risk of traffic accidents or violent behavior , or negatively affect co-workers, relatives, friends or strangers. Thus, the impact of the harmful use of alcohol reaches deep into society1.
Harmful drinking is a major determinant for neuropsychiatric disorders, such as alcohol use disorders and epilepsy and other noncommunicable diseases such as cardiovascular disease , cirrhosis of the liver and various cancers. The harmful use of alcohol is also associated with several infectious diseases like HIV/AIDS, tuberculosis and sexually transmitted infections (STIs). This is because alcohol consumption weakens the immune system and has a negative effect on patients’ adherence to antiretroviral treatment1.
A significant proportion of the disease burden attributable to harmful drinking arises from unintentional and intentional injuries, including those due to road traffic accidents, violence, and suicides. Fatal injuries attributable to alcohol consumption tend to occur in relatively younger age groups1.
The degree of risk for harmful use of alcohol varies with age, sex and other biological characteristics of the consumer. In addition the level of exposure to alcoholic beverages and the setting and context in which the drinking takes place also play a role. For example, alcohol is the world’s third largest risk factor for disease burden; it is the leading risk factor in the Western Pacific and the Americas and the second largest in Europe. Furthermore, 320000 young people between the age of 15 and 29 die from alcohol-related causes, resulting in 9% of all deaths in that age group. Alcohol consumption by an expectant mother may cause fetal alcohol syndrome and pre-term birth complications, which are detrimental to the health and development of neonates1.
In India Pure alcohol consumption among adults (age 15+) in litres per capita per year are as follows Recorded(2003-2005) -0.55,Unrecorded ( calculated using empirical investigations and expert judgments)-0.20,total(2003-2005)-0.75, beer(2011)-0.06, wine(2011) -0.02,spirit(2011)-0.052.
Following deaddiction therapy for alcohol dependence syndrome many patients relapse and only a few patients maintain abstinence.
An episode of relapse will be defined as the person meeting ICD 10
classification of mental and behavior disorders diagnostic criteria for research (ICD
– 10- DCR)13 for Alcohol dependence for a minimumperiod of 1 month
DSM 5 defines Early remission in Alcohol use disorder :
After full criteria for alcohol use disorder were previously met , none of the criteria for alcohol use disorder have been met for atleast 3 months but for less than 12 months ( with the exception that criterion A4 craving or a strong desire or urge to use to alcohol may be met ) .
DSM 5 defines Sustained remission in Alcohol use disorder:
After full criteria for alcohol use disorder were previously met , none of the criteria for alcohol use disorder have been met at any time durig a period of 12 months ( with the exception that criterion A4 craving or a strong desire or urge to use to alcohol ” may be met ) .
The factors related to relapse and maintainance of abstinence following alcohol
deaddiction therapy are as follows
a)Clinical parameters comprising of Age of onset of drinking (yr) , Duration of
Drinking (yr) , Time to develop dependence (yr) ,Age of onset of dependence (yr)
Duration of dependence (yr) , No. of previous relapses , No. of hospitalizations ,
Duration of last hospitalisation (days) , Family history of substance use , Family history of Alcohol dependence, Earlier/current disulfiram therapy and its compliance,Earlier /current anticraving medications and their compliance.Etc
b)Demographic variables comprising of Age (yr) , Marital status , Years of Schooling,
OccupationEmployed/unemployed, Income (Rupees/month), Residence ;Urban /Rural, Etc
c)Psychosocial factors comprising of social support , family support, peer pressure, coping strategies, motivation levels, undesirable life events. Etc.
Some of these factors are modifiable some are unmodifiable. By identifying these factors one can prevent further episodes of relapse in a relapsed patient , in case of a patient maintaining abstinence one can further consolidate on these factors to further maintain abstinence.
Many studies have been done with regard to these factors in India and world wide. The quantum of patients getting admitted to our hospital with Alcohol dependence syndrome for deaddictiontherapy is quite high . So by conducting this study I will be able to identify factorsresponsible for relapse and maintainance of abstinence in this population after undergoing deaddiction treatment. The results of this study can also be used for identification of relapse precipitants , coping strategies ,motivation levels in patients getting admitted to our hospital in future for alcohol deaddiction therapy.
6.2 REVIEW OF LITERATURE:
In a study about the factors influencing the short-term outcome of alcohol one year after the alcohol deaddiction treatment. Positive outcome was noted in 55%, negative in 35%; and 10% were lost to follow up at the end ofone year. However the negative outcome group were younger and they achieved many mile-stones of drinking career like onset of day drinking, development of dependence, diagnosis of dependence earlier. They also had higher psychosocial problem index,family history ofalcoholism, more follow-up days using the mental healthservices.They also did not come for follow up as quickly as the abstinent group after initiation of pathological drinking3.
A naturalistic, uncontrolled follow up study was carried out -in 60 cases of alcohol
dependence syndrome, at the end of one year, 32.5% of patientscould he classified
under abstinent and non problem drinker category. 35% continued to drink hut showed
improvement in social and occupational functioning. 32.5% remained in the unimproved
group. None of thepretreatment variables could differentiate patients with favourable
outcome from those with unfavourable. The duration of disulfiram use was the only
treatment variable studied. The duration of disulfiramwas found to be strongly
associated with a favourableoutcome (p <0.001).This indicates that longer theduration
of disulfiram use, better the chances of afavourable outcome at the end of one year. This
ispossibly explained on the basis of better motivation,which is pointed out as an
important factor behindgood outcome4
One study successfully identified a range of factors that served to support abstinent or
responsible drinking choices of young Pacific people living in New Zealand including:
parental influence; historical factors; church/religious/spiritual influences,
personal factors, and peer influences this study provides additional information specific
to the Pacific population. This suggests that many protective factors may be consistent
across cultures; however, the way in which they play out may differ. There may also be
some protective factors that are specific to particular cultures5
A study about Psychosocial factors associated with relapse in men with alcohol or
opioid dependence revealed (i) Patients who had relapsed were significantly more likely
to have a positivefamily history of substance use and higher number of previous relapses
(ii). Patientswith alcohol/opioid dependence who remained abstinent tended to use
Significantly more number of coping strategies including adaptive strategies such as
positive thinking’, andscored significantly higher on all measures of self-efficacy while
those who had relapsed used maladaptive strategies such as ‘negative thinking’more
often.; (iii) to have been exposed to a higher total number of ‘high risk’ situations;
(iv) have experienced ahigher number of undesirable life events6
Psychiatric illnesses are frequent among relapse cases,so family members have got a
definite roleinproviding support and care to the relapse cases.The findings of lower
relapse cases amongmembers of joint families and married personsrather than nuclear
families anddivorced or separatedpersons give support to this view. Financial securityin
the form of employment is critical for recoveryand social rehabilitation of relapse cases. It
is observedthat regular follow up care of patients is needed, aswith regular follow up
patients with lesser relapsefind confidence and allows better commitment totherapy7.
Remission from alcoholdependence was associated withbeing female, older, and married;
an earlierage of onset of alcohol dependence;and self-reported depression symptoms
from drinking. Absence of remission wasassociated with continuing to drink despite
knowing one had medical problemsfrom drinking and self-reported anxietysymptoms
from drinking8
According to one study during 6 months of outpatient treatment, longer adherence to
Disulfiram and consultationsas well as more phases in a consultation involving
necessarily a co-responsible predict a good outcome independently ofpatient features at
admission9
In one study aboutDeterminants of relapse and re-admission among alcohol abusers after
intensive residential treatmentSignificant reductions in the severity of alcohol and psychologicalproblems were observed, but six months after the initial treatment episode more than half ofof all respondents (54%) had been using alcohol regularly. The domains ‘psychiatric problems’ and ‘patients’ personal per-spectives’ were the best predictors of relapse and readmission. Also,‘patients’ living situations’ predicted relapse. Specific variables that independently predicted relapse were ‘satisfaction with day activities’ and ‘number of days with problems due to alcohol’. Less se-vere psychiatric problems at the start of treatment and more severe psychiatric problems and negative feelings of wellbeing at the time of follow-up were independent predictors of readmission10.
Natural remission may be followed by a high likelihood of relapse; thus, preventiveinterventionsmay be indicated to forestall future alcohol problems among individuals who cut downtemporarily on drinking on their own11.
In one study out of 341 cases, 146 patients were reviewed after six months, 57 after one year, 50 after one and half years and 88 werereviewed at 2 years and above. When a total was made about the number of relapses, partial improvement and abstinent cases, itwas found that 33.16% had relapses, 35.49% cases showed partial improvement and 31.35% cases were abstinent12
In one study ontreatment setting and follow-up in alcohol dependence,86 of 134 chose the inpatient program and 48 the outpatient program. Overall, 58 maintained total abstinence, and 11 had significantly reduced alcohol consumption at six months follow up. The inpatient group did marginally better than the outpatient group. More severely dependent patients, those with greater physical and psychosocial consequences opted for an inpatient program, and did well. Less severely dependent patients did favourably with outpatient intervention alone Improvements made within the first three months tended to influence subsequent treatment compliance The observation that less severely dependent individuals who opted for outpatient services did favourably suggests that extensive treatment may be required only for those with more severe dependence or greater psychosocial consequences13
One study indicated that there is a high degree of dropout ofpatients in the initialmonthsfollowingdetoxification.First of all, the majority of clients have started consuming alcohol earlybefore they sought treatment. At the time ofcontact, they showed a high level of dependence.Further, the majority of the clients seek treatment to gain relief from acutewithdrawal and physical symptoms, and with thesubsidence of withdrawal symptoms, themotivation to attend follow-up might be lost. In clients from the low socio economic class, whoconstitute the majority of the patients, and areespecially likely to suffer from financial stress,and unemployment. Manual labourers who returnto their jobs immediately after treatment resumealcohol consumption to relieve bodily pain aftera hard day's work. The guilt that follows mayprevent them from seeking help again. Inaddition, those who give up alcohol in a protectedenvironment may succumb to a fear of peer pressure14
Follow-up support and continued care appear to significantly improve longer-term recovery in alcohol dependents15.
Because relapse is common in people with dual disorders,researchers should identify and test relapse prevention strategies and interventions for this population.age,therapeutic residential programming,and,to a lesser degree,employment appear to be factors to consider in the development of relapse prevention models16.
In one study both the patients and their families listed items related to 'reduced cognitive vigilance' as the most common relapse precipitants. Reasons pertaining to external situations and euphoric states as well as unpleasant mood states were also frequently reported by them.There was a high degree of concordance between the patients and their family members regarding beliefs about precipitants of alcoholic relapse17.One study demonstrated that the relapse rates were higher in the first six months afterundergoing detoxification therapy thanin the later follow up period. Anticravingmedication was in no way superior to a structured psychotherapy sessions in relapse prevention18.
DRP (dyadic relapse prevention patient with familymember)consistently performed better than TAU (treatment as usual) on all of the outcomes (reduction in quantity of alcohol, drinking days, and number of days with dysfunction in family, occupational, and financial dimensions) also reported a significant reduction in the quantity of alcohol, drinking days, and family problems,compared with IRP19.
One study showed disulfiram was well tolerated and had lesser dropout rate. The reason for dropouts includeseasy availability of alcohol, failure of supervision and deceleration of motivation.Disulfiram asan unsupervised domiciliary therapy for the larger part of 6 the months therapy is a cause for concern as there is a point where deceleration in motivation, overwhelming temptation and easy availability crack the de-addiction course leading to relapse. Supervised domiciliary therapy for a 6-month period along with active participation at psychosocial and alcoholic anonymous meetings is advocated20
Given that alcoholism is a chronic, context-dependent disorder, it is not surprising that short-term interventions have little long-term impact. Social and community resources that are readily available for long periods are more likely to have a lasting influence on the long term course of alcoholism21
One study showed clients initially stating a preference for abstinence showed a better outcome than those stating a preference for non-abstinence. This superior outcome was clearer at 3 months’ follow-up but still evident at 12 months’ follow-up. The better outcome consisted almost entirely in a greater frequency of abstinent days, with only a modest benefit in drinking intensity for goal abstainers that disappeared when baseline covariates of goal preference were controlled for. Type of successful outcome (abstinence/non-problem drinking) was related to initial goal preference, with clients preferring abstinence more likely to obtain an abstinent outcome and those preferring non-abstinence a non-problem drinking outcome22.
An abstinence rate of >50% in one 9-year study strongly supports the concept of comprehensive, long-term outpatient treatment of alcoholics. Supervised, guided in take of Alcohal Deterrants(AD), also over extended periods, can be used as a predominantly psychologically acting ingredient of successful alcoholism therapy23
In one study differences between abstainers and non-abstainers were found for number of previous detoxifications, and number of patients attempted suicides. In addition, female gender and a higher number of prior treatments predicted negative treatment outcome24.
Factors significantly associated with relapse to alcohol use included severity of alcohol use and craving for alcohol at intake and the age of onset of alcohol drinking. Identifying factors thatare associated with relapse after alcohol dependence treatment is likely to improve the effectiveness of treatment and prevent relapse in persons at risk25.
The above studies have revealed the importance of clinical parameters,psychosocial factors,demographic variables in relapseand maintainance of abstinence in patients after undergoing alcohol deaddiction treatment.
So one can infer that “the clinical parameters,psychosocial factors,demographic variables play a indispensible role in predicting a positive or negative outcome following alcohol deaddiction therapy.” So these factors need to be studied at most importance in relapsed patients and those patients maintaining abstinence following alcohol deaddiction therapy.
6.3 OBJECTIVES OF STUDY:
1.To assess the clinical parameters, demographic variables, psychosocial factors
contributing to relapse and maintainance of abstinence in patients undergoing
alcoholdeaddiction treatment in KIMS, Hubli.
2.To study the influence of clinical parameters, demographic variables ,psychosocial
factors on relapse and maintenance of abstinence in patients undergoing alcohol
deaddictiontreatment in KIMS, Hubli .
7. / MATERIALS & METHODS:
7.1 SOURCE OF DATA:
The sample will consist of minimum of 100 discharged consecutively consented
patients with diagnosis Alcohol use disorder ( as per DSM 5 diagnostic
criteria) after undergoing alcohol deaddiction treatment in Department of
Psychiatry KIMS, Hubli.
7.2 METHODS OF COLLECTION OF DATA:
This will be a prospective study of 1 year duration ( January to December 2014 ) .
100 discharged and consecutively consented patients with diagnosis of Alcohol use
disorder ( as per DSM 5 diagnostic criteria ) after undergoing Alcohol deaddiction
treatment in Department of Psychiatry, KIMS, Hubli will constitute the study population.
The sample collection will start from January 2014 and will end by September 2014 .The patients getting discharged during September 2014 will be evaluated for abstinenceduring December 2014 for maintenance of abstinence.
The comprehensive evaluation of data will be done by the end of December 2014.
Statistical tests used are -t-test, chi square test, and other appropriate statistical tests .