Psychosocial Intervention For Domiciliary Alcohol Detoxification
NCT ID: NCT05563740
Last Updated: 2022-10-03
Study Results
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Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2020-01-01
2020-12-31
Brief Summary
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Detailed Description
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According to World Health Organization (WHO) estimates, total adult alcohol per capita consumption (APC, in liters of pure alcohol) in India has rapidly increased from 2.3 liters (2000) to 5.5 liters (2018), with further rises anticipated until 2025, thus making alcohol use disorders an important public health issue which needs urgent attention from all stakeholders.
A considerable proportion of persons in India with Alcohol Use Disorder (AUD) do not have access to treatment for their alcohol-related disorders, resulting in an 86 percent treatment gap. Community based care options being limited; treatment for AUD is largely dependent upon institutional care, which is both limited and strained. AUD encompasses a broad range of drinking behaviors, however for the purpose of this study the term AUD will refer to drinking behavior needing clinical attention.
Detoxification is the initial stage in therapy for AUD. It can take place in the community or in an inpatient facility; the option is based on the degree of the alcohol use. Evidence suggests that community detoxification is preferable to inpatient detoxification in terms of overall success, cost-effectiveness, feasibility, treatment gap reduction, and client acceptability.
Domiciliary alcohol detoxification is a process where the management of detoxification is advised at the level of patient's home, where an alcohol dependent patient is safely detoxified without admission to an inpatient unit. Whereas in assisted domiciliary alcohol detoxification additional monitoring is provided while the patient undergoes detoxification in the community. The implementation of Mental Health Care Act 2017 recommends treatment of the patient in the community, thus domiciliary detoxification is a step in that direction.
The aim of this study was to trail an intervention that assisted a randomly assigned group of patients undergoing domiciliary detoxification. The assistance was through daily phone call monitoring until successful detoxification with brief intervention sessions on two occasions; with the outcome measured as successful detoxification and abstinence at the end of one month.
Methodology:
Study setting: This study was based at the out-patient department of a tertiary care psychiatry hospital in Goa, India.
Study Design: Randomised Control Trial Sample and sample size: 100 consenting male patients aged between 18-65 years who presented in alcohol withdrawal state and were advised Domiciliary Detoxification by treating doctor were included in the study. The sample size was a pragmatic estimate based on feasibility.
Procedure: Eligible patients were approached and written consent was obtained after detailed explanation of the study. Baseline assessment of all participants was done using a) Severity of Alcohol Dependence Questionnaire (SAD-Q) for severity of alcohol dependence. The SAD-Q has been extensively used in a number of studies in India b) Readiness to Change Questionnaire, treatment version (RCQ-TV) for motivation to quit alcohol. This scale is based on Prochaska and DiClemente's stages of change model, for assignment of excessive drinkers to Precontemplation, Contemplation, and Action stages. Researchers throughout the world have used this questionnaire as a simple mean to assess the stage of motivation of an individual and c) Clinical Institute Withdrawal Assessment of Alcohol scale, Revised (CIWA-Ar) for severity of withdrawal. A cut-off of 8 was considered for intake as scores below 8 usually do not need medical management. A vernacular version of the scales was generated using the translation-back translation method. Predesigned semi-structured questionnaire was used to assess the socio-demographic variables and drinking related variables.
Randomisation: Following baseline assessment, randomisation was carried out using pre-randomised and sealed envelopes to assign the subject either into intervention or control group. Randomisation was done by third party not involved in any way with the study. No blinding could be carried out as it was a single investigator study however steps to avoid bias were taken by doing the baseline assessment prior to randomisation.
Both groups (Intervention and Control) received care for alcohol withdrawal state as is routinely provided at the centre by their respective treating doctors and followed up as directed. All treatment and follow up decisions were made by the respective treating doctors. Study team did not have any role in it.
Intervention: The intervention group in addition received a session (approx. 15 min) of Brief Intervention (BI) for alcohol, at the time of recruitment and again after completing detoxification. The BI session was delivered on structured lines based on psychoeducation and personalised feedback. It focussed on making patient aware of the potential harm if alcohol was continued, mainly in terms of medical, social, financial aspects and encouraged abstinence. BI model was selected to keep the intervention simple and feasible. Further, patient or designated caregiver received daily phone calls and Information was provided regarding any queries related to their withdrawal or detoxification process. Adverse outcomes such as sedation, seizure, confusion were enquired for and records were kept. Patient was encouraged to continue the treatment and report back for scheduled follow ups and in case of any adverse outcomes patient was asked to report back to the treating doctor and an appointment was facilitated. Phone calls were discontinued once detoxification (CIWA \< 8) was complete.
Outcome assessment: Outcome measurement for successful detoxification was done at every follow up for both groups. A CIWA score of less than 8 was considered as successful completion of detoxification. Similarly, outcome assessment for abstinence at one month was done using the Time Line Follow Back Method after one month of detoxification either in person or by phone call. The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking. People give retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date using a calendar. This method has been used across wide settings.
Data analysis and interpretation: Data was analysed using the Statistical Package for Social Sciences (SPSS) for Windows software (version 22.0; SPSS Inc., Chicago). Descriptive statistics such as mean and standard deviation (SD) for continuous variables and frequencies and percentages for categorical Variables were calculated. Association between study group and other categorical variables were analysed using chi-square test of independence and unpaired t-test for continuous variables. Level of significance was set at p\<0.05.
Ethical considerations: The study received ethical clearance from the Institutional Ethics Committee at The Goa Medical College, Goa. Written Informed consent was obtained after thorough description of the study to the participants in their own vernacular. All data was kept confidential and privacy was ensured. All relevant information was shared with the treating doctor with consent of the patient. Patients in the control group received the same care as is routinely provided at the hospital. Those patients who had resumed drinking at the end of the trial period received brief counselling regarding drinking and were directed to visit for further assistance.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention Group
All received care for alcohol withdrawal state as is routinely provided at the centre by their respective treating doctors and followed up as directed. All treatment and follow up decisions were made by the respective treating doctors. Study team did not have any role in it.
In addition all received a session of Brief Intervention (BI) for alcohol, at the time of recruitment and again after completing detoxification. Further, patient or designated caregiver received daily phone calls and Information was provided regarding any queries related to their withdrawal or detoxification process. Adverse outcomes such as sedation, seizure, confusion were enquired for and records were kept. Patient was encouraged to continue the treatment and report back for scheduled follow ups and in case of any adverse outcomes patient was asked to report back to the treating doctor and an appointment was facilitated. Phone calls were discontinued once detoxification (CIWA \< 8) was complete.
Psychosocial
Daily telephone calls with two sessions of Brief Interventions for alcohol
Control Group
All participants received care for alcohol withdrawal state as is routinely provided at the centre by their respective treating doctors and followed up as directed. All treatment and follow up decisions were made by the respective treating doctors. Study team did not have any role in it.
No interventions assigned to this group
Interventions
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Psychosocial
Daily telephone calls with two sessions of Brief Interventions for alcohol
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
MALE
No
Sponsors
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Dr Sneha B Suresh
OTHER
Responsible Party
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Dr Sneha B Suresh
Principle Investigator
Principal Investigators
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Anil Rane
Role: PRINCIPAL_INVESTIGATOR
IPHB
Locations
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Institue of Psychiatry & Human Behaviour
Bambolim, Goa, India
Countries
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References
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National Collaborating Centre for Mental Health (UK). Alcohol-Use Disorders: Diagnosis, Assessment and Management of Harmful Drinking and Alcohol Dependence. Leicester (UK): British Psychological Society (UK); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK65487/
GBD 2016 Risk Factors Collaborators. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1345-1422. doi: 10.1016/S0140-6736(17)32366-8.
4. Hammer JH, Parent MC, Spiker DA, World Health Organization. Global status report on alcohol and health 2018 [Internet]. Vol. 65, Global status report on alcohol. 2018. 74-85 p. Available from: http://www.who.int/substance_abuse/publications/global_alcohol_report/msbgsruprofiles.pdf%0Ahttp://www.ncbi.nlm.nih.gov/pubmed/29355346
Rastogi A, Manthey J, Wiemker V, Probst C. Alcohol consumption in India: a systematic review and modelling study for sub-national estimates of drinking patterns. Addiction. 2022 Jul;117(7):1871-1886. doi: 10.1111/add.15777. Epub 2022 Jan 10.
Nadkarni A, Velleman R, Bhatia U, Fernandes G, D'souza E, Murthy P. Home-detoxification and relapse prevention for alcohol dependence in low resource settings: An exploratory study from Goa, India. Alcohol. 2020 Feb;82:103-112. doi: 10.1016/j.alcohol.2019.08.006. Epub 2019 Aug 29.
Nemlekar S, Gaonkar P, Rane A. Domiciliary alcohol detoxification outcomes: a study from Goa, India. J Addict Dis. 2021 Jan-Mar;39(1):105-108. doi: 10.1080/10550887.2020.1826103. Epub 2020 Oct 20.
8. The Mental Health Care Act 2017. Available from: http://www.prsindia.org/uploads/media/Mental%20Health/Mental%20Healthcare%20Act,%202017.pdf
D'Souza PC, Mathai PJ. Motivation to change and factors influencing motivation in alcohol dependence syndrome in a tertiary care hospital. Indian J Psychiatry. 2017 Apr-Jun;59(2):183-188. doi: 10.4103/psychiatry.IndianJPsychiatry_262_15.
Johnson PR, Britto C, Sudevan KJ, Bosco A, Sreedaran P, Ashok MV. Resilience in Wives of persons with Alcoholism: An Indian exploration. Indian J Psychiatry. 2018 Jan-Mar;60(1):84-89. doi: 10.4103/psychiatry.IndianJPsychiatry_271_14.
Baby S, Murthy P, Thennarasu K, Chand PK, Viswanath B. Comparative outcome in patients with delirium tremens receiving care in emergency services only versus those receiving comprehensive inpatient care. Indian J Psychiatry. 2017 Jul-Sep;59(3):293-299. doi: 10.4103/psychiatry.IndianJPsychiatry_260_17.
Gupta A, Murthy P, Rao S. Brief screening for cognitive impairment in addictive disorders. Indian J Psychiatry. 2018 Feb;60(Suppl 4):S451-S456. doi: 10.4103/psychiatry.IndianJPsychiatry_41_18.
Gulati P, Chavan BS, Sidana A. Authors' reply to commentary on "Gulati P, Chavan BS, Sidana A. Comparative efficacy of baclofen and lorazepam in the treatment of alcohol withdrawal syndrome". Indian J Psychiatry. 2019 Nov-Dec;61(6):652-653. doi: 10.4103/psychiatry.IndianJPsychiatry_325_19. No abstract available.
Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.
Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38.
18. Waters AF. Readiness to change and smoking expectancies among adult male substance users currently in substance use treatment by. 2020;(December).
Timko C, Below M, Schultz NR, Brief D, Cucciare MA. Patient and program factors that bridge the detoxification-treatment gap: a structured evidence review. J Subst Abuse Treat. 2015 May;52:31-9. doi: 10.1016/j.jsat.2014.11.009. Epub 2014 Dec 3.
Sarkar S, Pakhre A, Murthy P, Bhuyan D. Brief Interventions for Substance Use Disorders. Indian J Psychiatry. 2020 Jan;62(Suppl 2):S290-S298. doi: 10.4103/psychiatry.IndianJPsychiatry_778_19. Epub 2020 Jan 17. No abstract available.
Hjorthoj CR, Hjorthoj AR, Nordentoft M. Validity of Timeline Follow-Back for self-reported use of cannabis and other illicit substances--systematic review and meta-analysis. Addict Behav. 2012 Mar;37(3):225-33. doi: 10.1016/j.addbeh.2011.11.025. Epub 2011 Nov 26.
Other Identifiers
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GMC121019
Identifier Type: -
Identifier Source: org_study_id
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