Psychosocial Intervention For Domiciliary Alcohol Detoxification

September 28, 2022 updated by: Dr Sneha B Suresh

Assisted vs Unassisted Domiciliary Alcohol Detoxification: A Randomised Control Trial

Alcohol Use Disorders (AUD) form a major public health issue in India. In a densely populated country with limited mental health resources, it is challenging to treat those with AUD appropriately. Detoxification is the first step in dealing with clinically significant AUD. Institution based detoxification is not universally available and home based detoxification is mired with poor outcomes with people resuming drinking behaviour. This trail therefore aimed to study the effect of a psychosocial intervention to improve the outcome of domiciliary alcohol detoxification. The intervention involved Brief Interventions for alcohol and daily telephone monitoring and psychosocial support of patients undergoing home detoxification.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Alcohol use is a major contributor to the worldwide disease burden. Alcohol consumption has dropped in high-income nations over the last decade, whereas it has increased in some low- and middle-income countries in Southeast Asia, including India, where alcohol use resulted in 3.4 million deaths and 14.7 million disability-adjusted life years for the year 2019.

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Goa
      • Bambolim, Goa, India, 403202
        • Institue of Psychiatry & Human Behaviour

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria: Consenting male patients aged between 18-65 years who presented in alcohol withdrawal state and were advised Domiciliary Detoxification by treating doctor.

-

Exclusion Criteria:

  • Nil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: Psychosocial
Daily telephone calls with two sessions of Brief Interventions for alcohol
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Succesful Detoxification
Time Frame: Up to four weeks
Proportion of participants successfully completing detoxification as indicated by CIWA score of less than 8
Up to four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence at one month
Time Frame: One month
Total duration in days abstinent from alcohol at one month from detoxification measured on Time Line Follow Back method.
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Sneha B Suresh

Investigators

  • Principal Investigator: Anil Rane, IPHB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

September 23, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (ACTUAL)

October 3, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMC121019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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