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Effectiveness of inpatient alcohol detoxification and psychotherapeutic

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DOI: 10.4103/2542-3932.263670

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RESEARCH ARTICLE

Effectiveness of inpatient alcohol detoxification and

psychotherapeutic support program: a prospective
self-controlled study at a tertiary hospital in Nepal
Suraj Shakya*, Jug Maya Chaudhary, Pramesh Man Pradhan, Saroj Prasad Ojha, Mita Rana
Department of Psychiatry & Mental Health, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal

*Correspondence to: Suraj Shakya, PhD scholar, surajshakya@iom.edu.np.

orcid: 0000-0002-4276-0142 (Suraj Shakya)

Abstract
Background and objectives: Alcohol use disorder is prevalent or common and associated with a range of physical and mental sequelae.
Treatment gap exists in low and middle income countries. This study aims to evaluate effectiveness of inpatient detoxification with con-
comitant psychotherapeutic support in terms of readiness to change and abstinence maintenance.
Subjects and methods: This prospective self-controlled study included 109 patients admitted for alcohol use disorder (age: 42.5 ± 9.3 years;
male: 90.8%) in a tertiary level hospital (inpatient unit at Department of Psychiatry and Mental Health at Tribhuvan University Teaching
Hospital in Kathmandu). They underwent 10–14 days of inpatient detoxification and psychotherapeutic support program. Baseline assess-
ments were done during admission, and follow-ups were done just prior to discharge, 2 weeks and 3 months after discharge. After 3 months,
63 participants were contacted through phone. Primary outcome measures were readiness for change, reflected in scores on The Stages of
Change Readiness and Treatment Eagerness Scale, and status of abstinence maintenance. Ethical approval was taken from Institutional
Review Board, Institute of Medicine, Tribhuvan University on December 29, 2017.
Results: Results showed statistically significant reduction in “ambivalence,” and improvement in “taking steps” during discharge as well
as 2 weeks after discharge in comparison to the baseline measures (P < 0.001). However, there was no significant change in “recognition.”
In the 3-month follow-up, 73% of the participants were in complete abstinence; 6.3% had few drinks (up to three drinks) on a couple of
occasions; and 20.6% relapsed.
Conclusion: Brief inpatient treatment, incorporating pharmacological detoxification as well as psychotherapeutic support helps in enhanc-
ing readiness to change as well as maintaining alcohol-free lifestyle. Scaling up such packages to reduce treatment gap in low and middle
income countries like Nepal is highly needed.
Trial registration: This trial was registered in ClinicalTrials.gov (NCT03988478).

Key words: alcohol treatment; inpatient detoxification; motivation; psychotherapy; psychosocial; relapse; self-controlled study

doi: 10.4103/2542-3932.263670
How to cite this article: Shakya S, Chaudhary JM, Pradhan PM, Ojha SP, Rana M (2019) Effectiveness of inpatient alcohol detoxification
and psychotherapeutic support program: a prospective self-controlled study at a tertiary hospital in Nepal. Asia Pac J Clin Trials Nerv Syst
Dis 4(3):66-71.

INTRODUCTION Key messages:

Alcohol use disorder, which includes alcohol dependence and
harmful use, is one of widespread mental health and psycho-
social problem. In Nepal, 12-month prevalence estimates of
alcohol use disorder are 3.4% in general (Dahal et al., 2019),
3.1% among males and 0.6% among females; while alcohol
attributable years of life lost is 2 years (WHO, 2018).
A recent study on treatment gap in a district of Nepal reports
that only 5.1% of people with alcohol use disorder sought
treatment in past 12 months (Luitel et al., 2017). The barri-
ers to treatment were mostly reported as affordability issues,
being unsure where to go to get mental health care, stigma of
being seen as “crazy,” perceived risk in applying for jobs and
concern of being perceived as weak. Similarly, another study
on use of alcohol treatment facilities in Kathmandu reports
that traditionally alcohol non-using castes and people with
higher socioeconomic status were over-represented in treat-
ment centers (Neupane and Bramness, 2014).
Two major treatment modalities are gaining popularity in
• Brief inpatient detoxification, together with psycho-
therapeutic support, is effective.
• Follow-up even after discharge is necessary compo-
nent to maintain treatment outcome.
• Readiness to change and motivational aspects are
main components for psychosocial aspects.
helping a person with alcohol use disorder in Nepal. One mo-
dality is residential rehabilitation centers which run three or
more months of non-pharmacological management program.
Most of these centers incorporate 12-step programs, besides
infrequent visits of physicians, psychiatrists, psychologists
and counselors. The other modality is a pharmacological de-
toxification program, run by hospitals and clinics on inpatient
or outpatient basis.
Inpatient settings offer constant medical care and supervision

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Shakya et al. / Asia Pac J Clin Trials Nerv Syst Dis
by professional staff, which is an advantage over outpatient
or other modalities of care (Hayashida, 1998) for easy avail-
ability of treatment for serious complications. In addition, such
settings prevent patient access to alcohol and offer separation
from the substance-using environment. Similarly, psycho-
therapeutic interventions are of great relevance for treatment
outcome, and hence integration of psychotherapeutic “moti-
vational” elements into detoxification program is suggested
by various guidelines (Soyka and Horak, 2004).
One aspect of how psychotherapeutic intervention (e.g.,
motivational interview) works is that it helps in person’s
change talk, motivation and self-efficacy, enhancing overall
treatment outcome. For instance, non judgemental atmosphere
in session may provide unique opportunity for the clients to
reflect on their reasons for change in behavior, and they can
verbalize the discrepancy between their current alcohol use
and longer-term life goals (Feldstein Ewing et al., 2011a).
Evidences from translational researches provide hints on how
psychotherapeutic intervention help in inhibiting activation
in brain regions that respond to the salience of alcohol cues
(Feldstein Ewing et al., 2011b). Within the therapy, a skillful
therapist behavior and client change talk is mediated by the
relational reasoning network, which is function of certain
prefrontal cortical structure (e.g., rostrolateral & dorsolateral
prefrontal cortex), the emotional learning/memory network
(e.g., posterior cingulate cortex & precuneus areas) and the
incentive reward network (Feldstein Ewing et al., 2011a).
Feldstein Ewing et al. (2011b) further elaborate on how such
in-session processes continue outside the therapy session and
help in maintaining treatment gains. In addition, these sessions
help in utilizing social bonds (social control theory), alterna-
tive rewards other than alcohol (behavior economics/choice
theory) and social reinforcement/learning by observing others
(social learning theory) (Moos, 2007a).
In context of low and middle income countries like Nepal,
one challenge is awareness on availability of treatment mo-
dalities for alcohol use disorder among general population.
In addition, effectiveness of such treatment modalities for
alcohol use disorder in Nepalese setting is not publicized.
In this context, we report data of an inpatient alcohol de-
toxification and psychotherapeutic support program run in a
tertiary level hospital. This paper is a part of a dissertation
project by one of the author (JMC), when she was trained
as a clinical psychologist at a teaching hospital. The project
focused on studying motivational status of patients being
treated for alcohol use disorder; details on these aspects are
reported elsewhere. The aim of the current paper is to evalu-
ate effectiveness of such treatment as usual (detoxification
with concomitant psychotherapeutic approach) in terms of
improvement in motivation to stay abstinent and status of
drinking in 3-month follow-up.
SUBJECTS AND METHODS
Study design
This was a prospective self-controlled study design. It was
conducted at inpatient unit at Department of Psychiatry and
Mental Health at Tribhuvan University Teaching Hospital in
Asia Pacific Journal of Clinical Trials: Nervous System Diseases  ¦  July ¦  Volume 4  ¦  Issue 3
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Kathmandu, Nepal. This is a tertiary level teaching hospital,
with integrated psychiatric and clinical psychological services.
Ethical approval was taken from Institutional Review Board,
Institute of Medicine, Tribhuvan University on December 29,
2017 (Additional file 1). This trial was registered in Clinical-
Trials.gov (NCT03988478). Informed consent of the study pro-
cedure was obtained from all participants (Additional file 2).
Non probability purposive sampling method was used.
Data were collected for nine months targeting all the patients
aged 18 years above, meeting criteria of alcohol dependence
syndrome according to International Classification of Diseases
10th revision (WHO, 1992). Data were collected once patient
or one close relative attending patient at the inpatient unit
consented for it. Patients with other psychiatric comorbidity
(e.g., schizophrenia, mood disorders), medical co-morbidity
and multiple substance use in past 6 months were excluded.
Interventions
Department of psychiatry and mental health at Tribhuvan
University Teaching Hospital has been running inpatient
detoxification program since its establishment, but separate
inpatient unit for substance related disorders started in 2000
(Sharma, 2013). Since then detoxification as well as psy-
chotherapeutic interventions has been integrated by team of
consultant psychiatrists, clinical psychologists and residents
(MD psychiatry and MPhil Clinical psychology). This has been
summarized in a guideline “Alcohol Detoxification Protocol,”
which was drafted at the department (Sharma et al., 2012). The
objectives of inpatient detoxification and psychotherapeutic
intervention are:
• To ensure that a person can cease alcohol use without ex-
periencing a potentially hazardous withdrawal state;
• Help a person stay away from hazardous effect of excessive
alcohol consumption;
• Diagnose and treat co-morbid medical and psychiatric
conditions;
• Help through harm reduction procedures and initiate referral
for ongoing treatment, relapse prevention and rehabilitation.
Medical and pharmacological managements
Immediate medical support of patients with complicated
withdrawal is the first priority. Medical team also looks after
management of fluid, electrolyte and supplementation of thia-
mine and other multivitamins. Once immediate management
is done, short-term management for inpatient care is the main
component of detoxification program. The management itself
differs for uncomplicated or complicated cases. Pharmaco-
logical management ranges from use of chlordiazepoxide or
lorazepam or diazepam. Injectable haloperidol is also used,
if needed, for addressing aggression or sleep. The doses are
titrated according to the severity of withdrawal features and
they are tapered gradually in 10 to 14 days. Once short-term
management is done, long-term therapy starts with the main
aim of relapse prevention. Disulfiram is an option to be used
as deterent. For anticraving therapy Naltrexone is also an op-
tion decided collaborately with the patients and their family
members. The average hospital stay is two weeks, and usually
less than a month.
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Psychotherapeutic and psychosocial managements
This is an integrated approach which involves consultants and
residents in clinical psychology or psychiatriy together with
nursing staff and all the staff of the detoxification team. Psy-
chosocial intervention aims to enhance and maintain motiva-
tion or readiness to change and overall psychological growth
and development. Ongoing assessment (using motivation level
questionnaire, different rating scales and psychological test-
ing as required) as well as assessment of individual strength,
interpersonal and environmental issues are done. Interventions
can be grouped into three levels as below:
A) Individual level: At individual level the following steps are
considered:
• Psychosocial assessment
• Motivational interviewing for 1 to 3 sessions
• Optional-supportive psychotherapy, cognitive behavior
therapy or other forms of psychotherapy (involve patients
before deciding any therapy)
• Awareness program regarding self-help group, anti-abuse/
anti-craving agents, drinking habits, coping skills and sleep
hygiene
B) Group level: It includes:
• Group session once a week during the stay at hospital, with
other clients with similar problem of alcohol and drug
• Introduction to self-help group
• Family therapy, if indicated
C) Primary support group: It includes sessions with primary
support group like guardians, family members, close friends
or legal guardians of client. They are chief sources of infor-
mation; hence they have a key role in assessment. Minimum
of two sessions with primary support group is targeted,
focusing on psychoeducation and supportive psychotherapy
as per the need.
Long-term management and relapse prevention
For long-term management and relapse prevention, patients
are encouraged to join self-help group meetings (like AA).
They can continue supportive psychotherapy or other sorts
of psychotherapy.
Besides this medical and psychosocial management, ongoing
assessment, diagnosis and treatment of co-morbid medical and
psychiatric condition are also done accordingly.
Outcome measures
For the purpose of study, effectiveness of intervention was
measured by two primary outcome measures; one through
measure in readiness to change or motivation and the
other with 3-month follow-up for status of abstinence and
relapse. For readiness for change, 19-itemed version of The
Stages of Change Readiness and Treatment Eagerness Scale
(SOCRATES) (Miller and Tonigan, 1996) was used. The au-
thors of SOCRATES reported three relatively unrelated factors
that were stable across rotations: Recognition, Ambivalence,
and Taking Steps, with cronbach alphas of 0.91, 0.90 and
0.60 respectively. Nepali translated version of SOCRATES
(Adhikari, 2017), which has been already used in previous
study in the same department, has been used.
Regarding the maintenance of abstinence and relapse,
68 Asia Pacific Journal of Clinical Trials: Nervous System Diseases  ¦  July ¦  Volume 4  ¦  Issue 3
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several definitions exists on what is relapse (Potgieter et al.,
1999). For current study, three criteria were chosen: if partici-
pants maintain complete abstinence, they were categorized as
maintaining well; if they had one or two drinks in a setting,
for not more than two or three days, they were categorized as
occasionally drinking; if they drank more than occasionally,
they were categorized in relapse status.
Other measures
The original research used objective rating scales for severity
of alcohol dependence and withdrawal symptoms during time
of admission. In-depth interviews were also done with patients
during and after discharge. These data will be reported else-
where. A sociodemographic proforma with sociodemographic
details and information regarding alcohol use was also used.
Procedure
Author JMC initiated the project as a part of her dissertation
research project. Initially, all the residents in Psychiatry (n
= 11) and Clinical Psychology (n = 5) were re-oriented on
treatment as usual for inpatient detoxification and psycho-
therapeutic support. They were under constant supervision
of the faculties. Primary data collection was done by JMC.
Eligible participants were approached for data collection
after they were oriented to time, place or person, and when
they were able to communicate. During baseline assessment,
interview on sociodemographic detail was followed with rating
on withdrawal and severity of alcohol dependence together
with ratings on SOCRATES. Each patient underwent the
procedure as per the Usual Treatment Protocol. Post test data
were gathered from patients just prior to discharge (usually
in 2 weeks) and 2 weeks after discharge using SOCRATES.
Totally 63 patients were followed up through phone contact
after 3 months of discharge. Patients and their family members
were enquired on status of abstinence maintenance.
Data analysis
Data were initially entered in MS Excel. Final analysis was
done in IBM SPSS Statistics for Windows, version 20 (IBM,
Armonk, NY, USA). Descriptive statistics were calculated.
Scores on SOCRATES were skewed and hence medians
were reported. Friedman test, as a non-parametric test, was
used to compare baseline and follow-up assessments. When
these changes were statistically significant, a post hoc analysis
was done using Wilcoxon signed-rank test, with Bonferroni
adjustment.
RESULTS
Participant characteristics
Of 135 participants screened for alcohol use disorder between
January and September 2018, only 109 (age 42.5 ± 9.3 years;
male = 90.8%) were enrolled for the study. Totally 26 partici-
pants were excluded as they were having psychiatric and major
medical co-morbidity or using multiple substance use. Patient
characteristics are summarized in Table 1. Most of them were
married (91.1%) with age range between 25 till 67. Most stud-
ied till tenth (28.3%) or twelfth standard (25.4%) and were
from agriculture (31.7%) or service/sales profession (28.6%).
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Similarly, out of 109 enrolled for study, only 63 could be follow-ups starting from the baseline.
followed till 3 months. Most of them were residing outside
Kathmandu Valley and they could not be contacted even Ambivalence
through phone. Sociodemographic details of these 63 partici- There was a decline in scores in ambivalence at successive
pants have also been summarized in Table 1. follow-ups than the baseline and this was statistically signifi-
cant, χ2 = 9.7, P = 0.008. Post hoc analysis with Wilcoxon
Outcome signed-rank tests was conducted with a Bonferroni correction,
Primary outcome measure was pre and post measure reflected with significance level set at 0.017. Median scores were 16,
in SOCRATES. The baseline scores and follow-up scores in 13 and 12 respectively. There were significant differences
SOCRATES are summarized in Table 2. between the baseline and other two post-tests, i.e., prior to
discharge and 2 weeks after discharge (Z = –5.0, P = 0.000
Recognition and Z = –3.0, P = 0.003).
There was no significant change in scores for recognition of
problem, as reflected in median scores of each successive Taking steps
There was statistically significant improvement in scores
for taking steps, χ2 = 13.1, P = 0.001. Post hoc analysis with
Table 1: Baseline sociodemographic characteristics of Wilcoxon signed-rank tests was conducted with a Bonfer-
patients roni correction applied, with significance level set at 0.017.
Cases followed till 3 Median scores were 37, 39 and 40 respectively. There were
Total (n = 109) months (n = 63) significant differences between prior to discharge and 2 weeks
Age (year)a 42.5±9.3 (25–67) after discharge (Z = –4.0, P = 0.000 and Z = –2.1, P = 0.036).
Sexb
Male 99 (90.8) 56 (88.9) Three-month status of abstinence
Female 10 (9.2) 7 (11.1) After 3 months, 63 participants were contacted through phone.
Marital statusb Information was taken from participants and their family mem-
Unmarried 4 (3.7) 2 (3.2) bers regarding alcohol intake (Figure 1). Among them, 73%
Married 97 (89) 59 (93.7) of the participants were in complete abstinence, and 6.3% had
Divorced 5 (4.6) 1 (1.6) one to three drinks on one or two occasions. Similarly, 20.6%
Widow 3 (2.8) 1 (1.6) of the participants relapsed, meaning that they either took more
Educationb than four drinks or started drinking regularly.
Literate 13 (11.9) 11 (17.5)
Primary 18 (16.5) 9 (14.3) DISCUSSION
Secondary 24 (22.0) 15 (23.8) Alcohol use disorder is prevalent, and researches show that
H-Secondary 32 (29.4) 16 (25.4) treatment gap exists (Rathod et al., 2016; Luitel et al., 2017).
University 22 (20.2) 12 (19.0) National Mental Health Policy (MoHP, 1997) reflects com-
Occupationb mitment for access to treatment for all. However, it is neces-
Agriculture 28 (25.7) 20 (31.7) sary to prove that these available treatments are effective.
Service and sales 36 (33.0) 18 (28.6) The present study sought to evaluate an inpatient detox and
Others 45 (41.3) 25 (40.7) psychotherapeutic support program at Tribhuvan University
Teaching Hospital in Kathmandu. The findings hint the fact
Note: aData are expressed as the mean ± SD (range). bData are expressed as n(%).
that the short-term inpatient detoxification and psychothera-
peutic support program has significant impact on enhancing
Table 2: SOCRATES measures at baseline and follow-up readiness for change, and maintaining alcohol free life style.
Measure Time n Median Mode Range The baseline and follow-up results indicate that there is
significant improvement in ambivalence towards drinking as
Recognition Baseline 96 30 29 13–35
At discharge 96 29 27 16–35
2 weeks on 41 28 28 18–35
discharge
Ambivalence Baseline 96 16 16 6–20
At discharge 96 13 12* 6–20
2 weeks on 41 12 10* 4–20 Relapse
discharge 21%
Occasional
Taking steps Baseline 96 37 40 21–40 drinking 6% Well
At discharge 96 39 40* 22–40 maintaining
73%
2 weeks on 41 40 40* 30–40
discharge

Note: *Statistically significant change from baseline. SOCRATES: The Stages of

Change Readiness and Treatment Eagerness Scale. Figure 1: Status of abstinence in 3-month follow-up.

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Shakya et al. / Asia Pac J Clin Trials Nerv Syst Dis
problem and taking steps in either reducing alcohol or staying
alcohol free at least for 3 months. These aspects of motiva-
tion are suggested by Miller and Tonigan (1996) and has
highlighted on the role of motivational variable on treatment
entry, compliance, and outcome of treatment (Miller, 1985).
This is also related to self-efficacy and scores on “taking
steps” is associated with the expectancy to cope successfully
with high-risk situations (Demmel et al., 2004). Regarding
the “recognition” variable on SOCRATES, there has not been
significant improvement, despite improvement in other two
aspects of motivation. One hypothesis to explain this insignifi-
cant change in recognition factor is that most of the patients are
brought to inpatient detoxification after withdrawal features
and life threatening complications; and hence recognition or
awareness of the problem caused by heavy drinking (Demmel
et al., 2004), is already present during baseline assessment,
which implies less change afterwards. Another possibility
is about factor nature of SOCRATES in given population.
Several researchers have proposed two-factor model, merg-
ing recognition factor and ambivalence factor (Maisto et al.,
2003; Bertholet et al., 2009) according to their field studies.
Hence, even in Nepalese population, the three-factor structure
originally proposed by Miller and Tonigan (1996) needs to
be evaluated.
Regarding relapse and abstinence maintenance, in current
study 73% were maintaining well with complete abstinence
after the intervention. This result is comparable or even bet-
ter than other reports (Monahan and Finney, 1996; Bradizza
et al., 2006). As cited in Bradizza et al. (2006), “at 3 months
post-treatment, 40–60% of individuals in treatment for alcohol
problems relapse to a first drink…” There are several predic-
tors of relapse or remission in alcohol treatment. A previous
study shows that in comparison to individuals who obtained
help, those who did not were less likely to achieve remission
and subsequently were more likely to relapse (Moos and
Moos, 2007b).
Limitation of this research includes lack of suitable control,
and methodological concerns in single group pre- and post-test
research designs (Marsden and Torgerson, 2012). Similarly,
several predictor variables for motivation and relapse, for
instance, nature of alcohol habit, amount of alcohol intake, or
types of complication after drinking and other psychosocial
variables are not analyzed in this paper. Future work needs
to incorporate these variables in the design itself. Generally,
abstinence is generally achieved during the early days and
weeks of treatment, but the majority of patients return to heavy
drinking within 3 to 6 months after treatment begins (Low-
man et al., 1996; Bradizza et al., 2006). Hence longitudinal
designs even extending 6 months to few years are necessary.
Similarly, the professionals and clinicians in addiction treat-
ment would benefit from the analysis of specific components
of treatment, that is more efficient and the overall underlying
mechanism of change of the treatment modality, whether it be
underlying biological mechanism, or psychological or social
etiology underlying the modality. Besides these limitations and
future research implications, this study in general, reiterates
the message that people with alcohol use disorder need help
and current treatment modalities facilitate healthy lifestyle.
70 Asia Pacific Journal of Clinical Trials: Nervous System Diseases  ¦  July ¦  Volume 4  ¦  Issue 3
www.actnjournal.com
Scaling up such treatment modalities and making it more cost
effective is necessary.
Additional files
Additional file 1: Institutional Review Board Approval.
Additional file 2: Informed Consent Form.
Acknowledgement
We would like to acknowledge all the faculties and residents at Depart-
ment of Psychiatry and Mental Health, Maharajgunj Medical Campus,
Tribhuvan University Teaching Hospital for supporting this project.
Author contributions
Concept and design of study protocol: SS, JMC, SPO and MR; data
collection and analysis, drafting of the manuscript: SS and JMC;
editing of the manuscript: SS, JMC, PMP, SPO and MR. All authors
approved the final manuscript for publication.
Conflicts of interest
The authors have no conflicts of interest to declare.
Financial support
None.
Institutional review board statement
Ethical approval was taken from Institutional Review Board, Institute
of Medicine, Tribhuvan University on December 29, 2017. This study
was performed according to the Declaration of Helsinki, and informed
consent of the study procedure was obtained from all participants.
Declaration of participant consent
The authors certify that they have obtained all appropriate participant
consent forms. In the forms, the participants have given their consent
for their images and other clinical information to be reported in the
journal. The participants understand that their names and initials will
not be published and due efforts will be made to conceal their identity.
Reporting statement
This study followed the Recommendations for the Conduct, Reporting,
Editing and Publication of Scholarly Work in Medical Journals
developed by the International Committee of Medical Journal Editors.
Biostatistics statement
The statistical analysis of this study was performed by the first author
SS and approved by the other authors.
Copyright license agreement
The Copyright License Agreement has been signed by all authors
before publication.
Data sharing statement
Individual participant data that underlie the results reported in this
article, after deidentification (text, and tables), will be available upon
request. Data will be available immediately following publication, no
end date for anyone who wishes to access the data. In order to gain
access, data requestors will need to sign a data access agreement.
Proposals should be directed to surajshakya@iom.edu.np.
Plagiarism check
Checked twice by iThenticate.
Peer review
Externally peer reviewed.
Open access statement
This is an open access journal, and articles are distributed under
the terms of the Creative Commons Attribution-NonCommercial-
ShareAlike 4.0 License, which allows others to remix, tweak, and
build upon the work non-commercially, as long as appropriate credit
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Received: June 19, 2019
Accepted: July 15, 2019
P-Reviewer: Zhao P; C-Editors: Zhao M, Li JY; S-Editor: Li CH;
L-Editors: Qiu Y, Wang L; T-Editor: Jia Y
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INFORMATION SHEET AND INFORMED CONSENT FORM

MODEL INFORMED CONSENT FORM IN ENGLISH

Department of ____________________________________________ ,
Tribhuvan University Institute of Medicine, Kathmandu, Nepal,
Study Title:
Study Number: Subject’s Initials: _______________
Subject’s Name:_______________
Date of Birth / Age: _________________

Please do initial in box (Subject)

(i) I confirm that I have read and understood the information sheet and [ ]
consent form dated ___ for the above study and have had the opportunity
to ask questions.
(ii) I understand that my participation in the study is voluntary
[] and that I am
free to withdraw at any time, without giving any reason, without my
medical care or legal rights being affected.
(iii) I understand that the researchers and the IRB and other regulatory [ ]
authorities will not need my permission to look at my health records both
in respect of the current study and any further research that may be
conducted in relation to it, even if I withdraw from the trial. I agree to this
access. However, I understand that my identity will not be revealed in any
information released to third parties or published.
I agree not to restrict the use of any data or results that arise from this [ ]
study provided such a use is only for scientific purpose(s)
(v) I agree to take part in the above study. [ ]
Signature (or Thumb impression) of the Subject/Legal Guardian:
_____________
Date: _____/_____/______ Signatory’s Name: _____/_____/______
______________________________________________________
Signature of the Investigator: ____________________________ Date:
_____/_____/______ Study Investigator’s Name:
__________________________________________________ Signature of the Witness
______________________ Date:_____/_____/_______
Name of the Witness:
_______________________________________________________
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