Psychological distress and quality of life among Opioid Agonist Treatment service users with a history of injecting and non-injecting drug use: A cross-sectional study in Kathmandu, Nepal

Sagun Ballav Pant; Suraj Bahadur Thapa; John Howard; Saroj Prasad Ojha; Lars Lien

doi:10.1371/journal.pone.0281437

. 2023 Feb 6;18(2):e0281437. doi: 10.1371/journal.pone.0281437

Psychological distress and quality of life among Opioid Agonist Treatment service users with a history of injecting and non-injecting drug use: A cross-sectional study in Kathmandu, Nepal

Sagun Ballav Pant ^1,^2,^*, Suraj Bahadur Thapa ^1,^2,³, John Howard ⁴, Saroj Prasad Ojha ², Lars Lien ^5,⁶

Editor: Eleni Petkari⁷

PMCID: PMC9901755 PMID: 36745666

Abstract

Background

Opioid use disorder is a serious public health problem in Nepal. People who use opioids often experience psychological distress and poor quality of life. Opioid agonist Treatment (OAT) is central in managing opioid dependence. This study aimed to examine factors associated with quality of life and serious psychological distress among OAT service users in the Kathmandu Valley, Nepal and compare those who had injected opioids prior to OAT and those who had not.

Methods

A cross-sectional study with 231 was conducted using a semi-structured questionnaire, the Nepalese versions of the Kessler 6 psychological distress scale and World Health Organization Quality of Life scale (WHOQOL-BREF). Bivariate and multivariate analyses were undertaken to examine factors associated with quality of life and serious psychological distress.

Results

Most participants were males (92%) and about half had injected opioids before initiating OAT. Serious psychological distress in the past four weeks was significantly more prevalent among participants with a history of injecting (32.2%) than those who did not inject (15.9%). In the adjusted linear regression model, those who had history of injecting were likely to have lower physical quality of life compared to non-injectors. Those self-reporting a past history of mental illness were more than seven times and those with medical comorbidity twice more likely to have serious psychological distress over last four weeks. Lower socioeconomic status and a history of self-reported mental illness in the past were found to be significantly associated with lower quality of life on all four domains.

Conclusion

Those who had history of injecting were younger, had frequent quit attempts, higher medical comorbidity, lower socioeconomic status and remained longer in OAT services. Alongside OAT, the complex and entangled needs of service users, especially those with a history of injecting drugs, need to be addressed to improve quality of life and lessen psychological distress.

Background

Globally, an estimated 62 million people use opioids for non-medical reasons. This use of opioids accounted for 70 per cent of the 18 million healthy years of life lost due to disability and premature death attributed to drug use disorders in 2019. More than half of the estimated global number of opioid users reside in Asia [1]. In Nepal, opioids were the second most commonly used substance, according to the Drug Users survey-2020 [2]. Most people who use opioids in Nepal are either smoking/inhaling heroin, injecting opioids like buprenorphine and heroin, or using high doses of tramadol orally in combination with other substances [2–4]. Injecting drug users (IDU) in Nepal usually inject a combination of opioids, benzodiazepines and antihistamines called the “South Asian Cocktail”, and the use of this mixture has increased health, social, economic and legal hazards in this population [5].

Opioid Agonist Treatment (OAT), primarily use of methadone, buprenorphine and buprenorphine- naloxone combination, is an evidence-based harm reduction initiative for people with opioid use disorder (OUD) that has been increasingly used in order to decrease the health, economic, and social consequences of substance use and to improve quality of life (QoL) [6]. The National Center for AIDS and STD Control (NCASC) implements OAT programs at 12 sites across 10 districts of Nepal with the help of eight Government hospitals and four Non-government organizations (NGO) where both methadone and buprenorphine are dispensed on a daily basis under the supervision of a trained health professional [7]. Nepal has been implementing a ‘low threshold’ OAT program, that is not exclusively for IDUs but anyone with OUD who gives informed consent and has no contraindications [8].

Several factors such as age, employment, duration of OUD, psychiatric diagnoses and psychopharmacological medication have been associated with improved health related QoL amongst those receiving OAT. However, even when improvement is observed for physical health, it has been noted that OAT service users demonstrate more psychological distress and poorer QoL compared to general population [9]. Moreover, facets of mental health and QoL are often overlooked, neglected or receive minimal attention in many harm reduction interventions [10]. This is of concern, as psychiatric co-morbidities contribute to increased mortality and morbidity among those with OUD and in OAT, with higher levels of depressive, anxiety and antisocial personality disorders being the most common [11–14]. Likewise, OUD can lower QoL via impacts on all four domains (psychological, physical, social, and emotional), [15–17] and higher levels of perceived stigma and discrimination, especially in relation to injection drug use, are also associated with higher psychological distress, unhealthy behaviors and significantly poorer QoL [18–21].

In addition to physical and mental health concerns, IDUs often have instability in many aspects of life in addition to high prevalence of infectious disease and mental disorders, such as crime, violence, and lack of stable housing [22, 23]. Resource poor settings often face greater difficulties in addressing the diverse but entangled needs of persons with OUD, due to competing health needs and other priorities.

Nepal, was one of the first South-Asian countries to introduce harm reduction interventions for IDUs, with a needle and syringe program commencing in 1991, and OAT in 1994 [24]. However, Nepal is still not able to provide sustainable, comprehensive health and psychosocial care for people who use drugs [3]. There are relatively few studies in South-Asian settings examining psychological distress and QoL among OAT service users and its association with socio-demographic characteristics and other related variables [25–27]. The study aims to detect any differences in QoL and serious psychological distress (SPD) between OAT service users with histories of injecting and non-injecting drug use and examine the factors associated with QoL and SPD.

Methods

Study setting and design

A cross-sectional study among service users across five OAT sites was conducted from January, 2021 to August, 2021 in three districts in the Kathmandu valley [Kathmandu and Lalitpur two each, and Bhaktapur one]. All OAT sites providing service in Kathmandu were selected for the study. Among them, two were government hospital-based and three community based- Non-Governmental Organization run sites. The Kathmandu Valley has a population of about 2.5 million [28]. Kathmandu valley was chosen on convenience as it has the highest number of OAT sites and highest cumulative OAT service users. The center in Kathmandu represents remaining OAT sites in other cities, as all other centers are also urban based and operating as per the same treatment protocol [8].

Sample size determination and sampling procedure

Sample size was calculated by using single population proportion formula for finite population and the selection of OAT service users based on probability sampling using simple random sampling techniques [29].

Required minimum sample size (n) = [z²p (1-p)/e²])/ [1+ {z²p (1-p)/e²N}]

A total of 477 service users across all the OAT sites in Kathmandu valley were taking service during the study period and were used as a finite population. The proportion (p) was considered 50% in the absence of previous similar studies, with margin error at 5%, and standard normal deviation (Z) at a confidence limit of 95% [30]. The total sample size was 247 with the anticipation of 15% non-response rate to the calculated sample size.

For the required sample size of 247 OAT service users were proportionately allocated to five OAT sites and were selected randomly through computer generated random numbers after listing potential participants in each OAT site. With the response rate of 93.5%, there were 231 study OAT service users in the study (213 male and 18 female).

Eligible OAT service users were aged 18 to 60 years. Those in the first two weeks of initiation in OAT or with any organic mental disorders such as dementia, delirium and amnestic syndromes were excluded due to likely difficulties in giving a reliable history.

Measures and instruments

A face-to-face structured interview was conducted. Information regarding the study was explained to the participants by the core study team members, and written informed consent was obtained. The Nepalese version of the Kessler-6 psychological distresses scale (K-6) and the World Health Organization Quality of Life (WHOQOL-BREF) were used to assess psychological distress and QoL across various domains respectively. Pretesting was done with 20 service users of the estimated sample size, and the questionnaires were reviewed and revised.

Socio-demographic questionnaire

A semi-structured socio-demographic questionnaire was developed to assess the sociodemographic variables and OAT related information. The sociodemographic information included age, gender, education, caste, employment status, marital status, family structure, previous attempt to quit substance, presence of co-morbid medical conditions, past history of mental illness and socio-economic status (SES). SES assessment was based on the modified Kuppuswami’s scale for socio-economic status [31]. Information on ethnicity was first collected based on classification of ‘Caste, Ethnic and Regional Identity in Nepal’, [32] which was later grouped into three categories–Brahmin and Chettris, Janajatis, Dalits and others. Co-morbid medical conditions included non-communicable diseases like tuberculosis, diabetes mellitus, hypertension and blood borne infections like HIV, Viral hepatitis (B and C), injection related thrombosis and abscess. Information on first use of illicit opioids and OAT history related information were also obtained through the questionnaire.

World Health Organization Quality of Life (WHOQOL-BREF)

The internationally validated WHOQOL-BREF comprises 26 items in four domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). The two remaining WHOQOL-BREF items separately rate overall perception of QoL and overall perception of the health of an individual [33]. The WHOQOL-BREF has been validated among OAT service users [34] and translated into Nepali language and used in research in Nepal [35, 36]. It has good discriminant validity, content validity, and test-retest reliability [33, 37]. The physical health domain of WHOQOL-BREF explores activities of daily living, energy and fatigue, mobility, pain and discomfort, sleep and rest, and work capacity. The psychological domain focuses on the ability to concentrate, self-esteem, body image, spirituality and the frequency of positive or negative feelings. The social relationship domain includes personal relationship, social support, and sexual activity. The environment domain includes safety and security, home and physical environment satisfaction, financial security, health/social care availability, information and leisure activity accessibility and transportation satisfaction. The mean scores of items in each domain were used to calculate the domain score, and higher the domain score the higher the QoL.

Kessler-6 psychological distresses scale (K-6)

The K-6 is a standardized, validated screening tool with 6 items that screen for a global measure of possible serious psychological distress (SPD) over last four weeks [38] which can be indicative of a serious mental illness [39]. Each of the following 6 questions are scored from 0 (none of the time) to 4 (all of the time): feeling nervous; hopeless; restless; that everything was an effort; was so sad that nothing could cheer him/her up; or felt worthless. Scores of 0–12 indicate not having significant psychological distress while the score of 13–24 indicate probably having serious psychological distress (SPD) over the last four weeks [38, 40]. This scale has been translated into Nepali language and used in Nepal [41, 42].

Statistical analysis

Data was entered in SPSS version 27 for data analysis [43]. Descriptive statistics from the data such as mean and standard deviations were calculated for the continuous variables and absolute numbers and percentages for the categorical variables. The normal distribution of the continuous variables was checked by using visual inspection, assessment of skewness and kurtosis and Kolmogorov-Smirnov test [44]. Bivariate analyses were done using Chi square and independent sample t tests, which were used to compare categorical variables and means for continuous variables, respectively. The Mann-Whitney U-test was used for not- normally distributed continuous variable. Multivariate analyses were performed with linear and logistic regression models. SPD as a dependent variable was categorized as binary into no and yes (having SPD) included in the final logistic model, where history of use of injectables, age, gender, education, employment, marital status, past history of self-reported mental illness, previous substance quit attempt, being in custody after OAT enrollment, medical co-morbidity, ethnicity, SES and duration since OAT enrollment were kept as dependent variables. The dependent variables were selected based on their statistical and clinical significance. For the liner regression, QoL continuous scores (in four domains- physical, psychological, environmental and social) were kept as dependent variable and the same factors as above were retained as independent variables. Standardized Beta was reported for linear and adjusted odds ratio for logistic regression. For both liner and logistic regression model independent variables were checked for confounding and those only with variation inflation factor less than 2 were included in the final model. The level of significance for all statistical analysis was set at p< 0.05.

Ethical consideration

Ethical approval for this study was obtained from the ethical review board of the Nepal Health Research Council (Ref. no: 1698). Additional ethical approval was obtained from Regional Committees for Medical and Health Research Ethics in Norway (Ref. no: 154194). Permission was also obtained from each of the OAT sites and written informed consent from the study participants.

Results

Among the 231 service users, 113 had never used opioids via injection (non-IDU) and 118 injected opioids before enrollment into OAT. As can be seen in Table 1, there was a significant difference for age, with mean age of non-IDU service users being 32.1± 6.3 years and 35.3 ± 7.9 years for the IDU. There were few women in either group and non-IDU were better educated. Significantly more IDU were separated or divorced and less than half non-IDU had attempted to quit substance use before OAT initiation. About one- third of non-IDU had co-morbid medical conditions which was significantly less for IDUs, and had higher SES.

Table 1. Socio-demographic characteristics of non-injecting (non-IDU) and injecting drug users (IDU).

Characteristics	Non- IDU		IDU		p-value
N = 231	n	%	n	%
^* Age in years, mean ± SD	32.1 ± 6.3		35.3 ± 7.9		0.001
Gender
Male	102	90.3	111	94.1	0.405
Female	11	9.7	7	5.9
Education
Primary and lower	7	6.2	16	13.6	0.021
Secondary	72	63.7	82	69.5
University and above	34	30.1	20	16.9
Ethnicity ^a
Brahmin/Chhetri	46	40.7	40	33.9	0.752
Janajati	59	52.2	69	58.5
Dalit and others	8	7.1	9	7.6
Employment status
Employed	32	28.3	41	34.8	0.216
Unemployed	25	22.1	32	27.1
Self-employed	56	49.6	45	38.1
Marital status
Married	64	56.6	64	54.2	0.004
Unmarried	45	39.8	35	29.7
Separated/ divorced	4	3.6	19	16.1
Types of family
Nuclear	54	47.8	65	55.1	0.328
Extended	59	52.2	53	44.9
Previous attempt to quit substance use
Yes	49	43.4	88	74.6	0.001
No	64	56.6	30	25.4
Presence of Co-morbid medical conditions
Yes	35	32.4	73	67.6	0.001
No	78	63.4	45	36.6
Past history of self-reported mental illness
Yes	15	13.3	23	19.5	0.273
No	98	86.7	95	80.5
SES
Upper class	70	61.9	54	45.8	0.014
Lower class	43	38.1	64	54.2

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Footnote:

*Independent sample t-tests for continuous variables and chi-square test for categorical variables

^a-Brahmin and Chhetri are the highest ethnic group, Janajati are an indigenous group, while Dalits are underprivileged, lowest ethnicity in Nepal

SD: Standard Deviation

Methadone was the most used current OAT modality compared to buprenorphine among both groups. Less non-IDU service users were arrested or taken into police custody after OAT enrollment than IDU. The median duration of OAT use was significantly less for non- IDU service users. (Table 2).

Table 2. Comparison of Opioid Agonist Treatment related characteristics between non-injecting and injecting drug users.

Characteristics	Non-IDU		IDU		p-value
N = 231	n	%	n	%
Current OAT modality
Methadone	91	80.5	82	69.5	0.053
Buprenorphine	22	19.5	36	30.5
Provision of ‘take away’ OAT (Last month)
Yes	21	18.6	22	18.6	0.991
No	92	81.4	96	81.4
Arrested or taken into custody after OAT enrollment
Yes	10	8.8	31	26.3	0.001
No	103	91.2	87	73.7
	n	Median (IQR)	n	Median (IQR)
Duration since OAT enrollment^* (months)	113	7 (2–18)	118	24 (10–60)	0.001

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Footnote:

* Mann-Whitney U-test for continuous variables and chi-square test for categorical variables

SD: Standard Deviation

IQR: Interquartile range

Statistically significant differences can be observed in Table 3 for all QoL domains and the overall QoL with lower mean scores for all four domains in IDU compared to non-IDU and overall QoL. The highest mean difference was observed in the environmental domain. Likewise, presence of SPD over last four weeks was higher among IDUs and the median K-6 score was significantly lower for non-IDUs.

Table 3. Difference in Quality of Life (QoL) and psychological distress among non IDU and IDUs.

	Non IDU		IDU
Variables (N = 231)	Mean	SD	Mean	SD	p-value
Physical QoL^*	26.8	4.5	24	4.7	0.001
Psychological QoL	22	3.6	20.1	4.8	0.001
Social QoL	10.4	2.6	9.3	2.9	0.004
Environmental QoL	28.4	3.9	27	5.1	0.014
Overall QoL	94.4	12.2	86.7	16.2	0.001
	n	%	n	%
No Serious psychological distress (SPD)	95	84.1%	80	67.8%	0.004
Serious psychological distress (SPD)	18	15.9%	38	32.2%
	n	Median (IQR)	n	Median (IQR)
K-6 score^**	113	2 (0–7)	118	5 (0–14)	0.005

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Footnote:

*Independent sample t-tests for continuous variables and chi-square test for categorical variables

**Mann-Whitney U-test

SD: Standard Deviation

IQR: Interquartile range

As seen in Table 4, using the adjusted logistic regression model, IDU status did not show significant association with the SPD. Those having history of self- reported mental illness in the past were more than seven times more likely to have SPD within the last four weeks. Likewise, those with history of medical comorbidity also were around 2.28 times more like to have SPD within the last four weeks than those who did not.

Table 4. Factors associated with Serious psychological distress (SPD).

Variables (N = 231)	Unadjusted OR (95% CI)	Adjusted OR (95% CI)
IDU (vs. Non-IDU)
Yes	2.51 (1.32, 4.73) ^**	2.02 (0.89, 4.6)
Age	1.01 (0.97, 1.05)	0.98 (0.92, 1.04)
Gender (vs. Male)
Female	1.63 (0.58, 4.66)	2.1 (0.56, 7.9)
Education (vs. Primary and lower)
Secondary	0.87 (0.46, 1.64)	0.76 (0.23, 2.51)
University and above	0.99 (0.49, 2.01)	0.68 (0.15,3.02)
Employment (vs. Employed)
Unemployed	1.93 (0.45, 8.32)	2.13(0.35, 13.01)
Self-employed	1.40 (0.76, 2.60)	1.1 (0.52, 2.28)
Marital status (vs. Married)
Unmarried	0.86 (0.46, 1.64)	0.67 (0.28, 1.61)
Separated/ divorced/ widowed	0.86 (0.30, 2.42)	0.46 (0.13, 1.76)
Family type (vs. Nuclear)
Extended	0.92 (0.51, 1.69)	1.1 (0.53, 2.30)
Ethnicity (vs. Brahmin and Chettri)
Janajati	0.91 (0.5,1.66)	0.66 (0.32,1.4)
Dalit and others	0.65 (0.18–2.4)	0.36(0.08,1.64)
Past history of self-reported mental illness (vs. No)
Yes	6.43 (3.06, 13.52) ^***	7.5 (3.15, 17.85) ^***
Tried quitting substance use (vs. no)
Yes	1.62 (0.86, 3.06)	0.99 (0.46, 2.12)
Been in custody after enrollment in OAT (vs no)
Yes	1.83 (0.88, 3.79)	1.19 (0.49, 2.9)
History of comorbidity (vs. no)
Yes	2.85 (1.52, 5.36) ^***	2.28 (1.04, 4.97) ^*
SES (vs. Lower class)
Upper class	1.35 (0.76, 2.43)	0.81 (0.36, 1.82)
Duration since OAT enrollment	1.01 (1,1.01)	1.00 (0.99,1.01)

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Footnote:

*p-value <0.05

** p-value <0.01

*** p-value < 0.001

OR: Odds Ratio

CI: Confidence interval In the linear regression models for different domains of QoL

IDU were likely to have lower physical QoL compared to non-IDU as seen in Table 5. Age was also positively associated with better physical and social QoL. A history of self-reported mental illness in the past was associated with lower QoL on all four domains of QoL and previous quit attempt was also associated with lower QoL on physical, psychological and environmental domains.

Table 5. Factors associated with Quality of life (QoL).

	Physical QOL	Psychological QOL	Social relationships QOL	Environmental QOL
Variables (N = 231)	Beta (95% CI)	Beta (95% CI)	Beta (95% CI)	Beta (95% CI)
IDU (vs. non-IDU)
Yes	-0.14 (-3.00, -0.34) ^*	-0.09 (-2.46, 0.91)	-0.07 (-1.48, 0.75)	-0.02 (-1.96, 1.68)
Age	0.17 (0.01, 0.21) ^*	0.14 (-0.02, 0.56)	0.19 (0.02, 0.13) ^*	0.08 (-0.50, 0.15)
Gender (vs. Male)
Female	-0.07 (-3.54, 0.92)	-0.08 (-3.33, 0.75)	-0.06 (-1.97, 0.74)	-0.05 (-3.09, 1.33)
Education (vs. Primary and lower)
Secondary	0.20 (-0.06, 4.04)	0.19 (-0.19, 3.56)	0.07 (-0.81, 1.67)	0.21 (0.02, 4.09)
University and above	0.07 (-1.62, 3.31)	0.12 (-0.97, 3.54)	-0.03 (-1.69, 1.3)	0.20 (-0.26, 4.62)
Employment (vs. Employed)
Unemployed	-0.09 (-5.59, 0.65)	-0.19 (-5.37, 0.33)	0.04 (-1.32, 2.45)	-0.09 (-5.27, 0.83)
Self-employed	-0.06 (-1.75, 0.66)	-0.05 (-1.51, 0.69)	-0.07 (-1.14, 0.32)	-0.05 (-1.63, 0.76)
Marital status (vs. Married)
Unmarried	0.07 (-0.67, 2.08)	0.01 (0.01, 0.14)	0.01 (-0.77, 0.89)	0.04 (-1.02, 1.70)
Separated/ divorced/ widowed	0.02 (-1.70, 2.30)	0.07 (-0.80, 2.81)	-0.07 (-1.9, 0.52)	0.05 (-1.16, 2.81)
Family type (vs. Nuclear)
Extended	0.06 (-0.57, 1.80)	0.09 (-0.32, 1.85)	0.02 (-0.59, 0.83)	0.10 (-0.26, 2.10)
Ethnicity (vs. Brahmin and Chettri)
Janajati	-0.10 (-2.13, 0.24)	-0.02 (-1.26, 0.91)	0.05 (-0.42, 1.01)	-0.06 (-1.69, 0.66)
Dalit and others	-0.01 (-2.43, 2.14)	0.09 (-0.58, 3.60)	0.09 (-0.39, 2.38)	-0.01 (-2.41, 2.12)
Past history of self-reported mental illness (vs. No)
Yes	-0.30 (-5.42, -2.30) ^***	-0.23 (-4.12, -1.27) ^***	-0.26 (-2.94, -1.05) ^***	-0.21 (-4.19, -1.09) ^***
Tried quitting substance use (vs. no)
Yes	-0.15 (-2.67, -2.50) ^*	-0.18 (-2.65, -0.43) ^*	-0.12 (-1.43, -0.04)	-0.14 (-2.49, -0.09) ^*
Been in custody after enrollment in OAT (vs no)
Yes	-0.05 (-2.22, 0.89)	-0.01 (-1.51, 1.33)	-0.02 (-1.12, 0.76)	-0.03 (-1.87, 1.21)
History of comorbidity (vs. no)
Yes	-0.05 (-1.77, 0.75)	-0.12 (-2.17, 0.14)	-0.10(-1.33, 0.19)	-0.02 (-1.43, 1.07)
SES (vs. Lower class)
Upper class	0.14 (0.08, 2.62) ^*	0.20 (0.56, 2.92) ^**	0.28 (0.78, 2.35) ^***	0.31 (1.51, 4.08) ^***
Duration since OAT enrollment	-0.89 (-0.03, 0.01)	-0.11 (-0.03, 0.01)	-0.02 (-0.01, 0.01)	0.01 (-0.02, 0.02)

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Footnote:

*p-value <0.05

** p-value <0.01

*** p-value < 0.001

CI: Confidence interval

Likewise, those with upper SES were more likely to have a better QoL compared to those with lower SES with higher QoL score across all four domains of QoL.

Discussion

This study appears to be one of the first that explored and compared psychological distress and QoL among OAT service users with injecting and non-injecting histories. It is well recognized that QoL and psychological distress are influenced by multiple and entangled factors which can exacerbate each other and produce further complexity. Some arise from genetic predispositions associated with physical and mental health outcomes, others are associated with social and structural determinants of health [45].

Non-IDUs in this study were slightly younger compared to IDUs but the mean age of both groups was similar to people with OUD in India. Similarly, service users were predominantly male as in many countries, including neighboring India which shares cultural similarities [19, 25]. The possible reasons for the gender differences may be due to higher level of perceived stigma, and barriers in access to health care facilities and treatment including OAT for females [46]. As expected, IDUs had significantly more medical co-morbidities, lower SES and were more commonly taken into police custody despite being in OAT. Similar observations have been observed in developed settings [47].

In this study the estimated prevalence rate of SPD among non IDUs and IDUs were lower compared to global scenario [46] and regional studies form Asia [48, 49]. A study among male IDUs from needle and syringe program in Delhi, India found extremely high rates of participants with depressive (84%) and anxiety (71%). Their study population was considerably more socially disadvantaged than the present study, with high proportions being illiterate, homeless and living on a very low income/being dependent on scavenging [50].

The current study demonstrated that despite many months in OAT, both IDU and non-IDUs showed high SPD over last four weeks. Left untreated, the risk of poor health outcomes, of relapse after treatment, workplace productivity loss and even premature mortality [51].

The study also examined the pattern of impairments in different QoL domains among OAT service users and explored the relationship between different sociodemographic and clinical variables and various domains of QoL. The findings from previous studies showed that heroin-dependent participants had poorer QoL than controls in the general well-being items, physical, psychological, environmental and social relationship domains and total WHOQoL scores [16, 52–54]. However, the current study demonstrate that QoL scores were significantly lower in the IDU group across all the domains in a bivariate analysis, but on multivariate analysis this was only significant for the physical domain. This may be due to the higher level of physical health comorbidity in our sample.

Given the importance of QoL and psychological distress among both injecting and non-injecting users, the findings demonstrate that QoL was lower in the IDU group compared to non-IDUs in the physical domain and IDUs had spent more time in OAT compared to non-IDUs. With the passage of time, it was expected that the benefits accumulated overtime would lead to better QoL [26]. Despite this, IDU fared poorly on most domains of QoL.

Past attempts to quit substance use was associated with poor QoL. While this was an interesting observation, no similar studies were identified. It is well known that OUD has high prevalence of relapse and previous research has shown that stressful life situations, negative mood persisting over time and failed attempts at quitting substance use may reinforce a sense of ‘failure’ and hence negatively impact QoL [55].

A self-reported past history of mental illness was associated with lower QoL in all four domains in IDU (physical, psychological, social and environment). Studies in South Asia and the Middle East show high lifetime prevalence of psychiatric disorders, especially depression and anxiety, psychological distress and lower QoL among opioid users [12, 15, 56–62], consistent with numerous studies from Europe, Nepal, Australia, the US, Slovakia, Taiwan and Vietnam [48, 63–68]. Effectively addressing mental health issues is crucial, and the studies reveal that QoL of people with opioid dependence improves with OAT and provision of interventions addressing their individual and complex needs [25, 54].

In the current study, the upper SES OAT service users had better QoL than those with lower SES, highlighting well recognized health inequalities. The Scott et al. study demonstrated substantially lower personal well-being and related psychological stress and SES over time in a population of IDUs, but that housing and health services could make a difference [64]. Further research might explore potentially direct and indirect impacts of a broader range of social and structural variables that appear to be associated with QoL and SPD, such as the role of perceived stigma and self-stigma [20, 21, 69]. This research would benefit from quantitative, qualitative, longitudinal, and intervention studies.

Implications

Much of what is canvassed above is not new to OAT services, but how to respond to build optimism, resilience, and agency in service users to improve QoL and reduce psychological distress is challenging, especially in resource poor settings. Sites of OAT programs must be more than a ‘clinic’ where service users merely attend, get dosed, have minimal contact with staff, and depart. Ideally, OAT staffing with a diversity of professional and ex-consumer/peer could better respond to this complexity; such as psychiatrists, nurses, psychologists, social workers, occupational therapists, peer educators. This can however have funding implications in low resource settings. Consequently, the development of functional ongoing links to appropriate and accessible ancillary services would be essential, guided and promoted via policy reforms.

Strengths and limitations

This study provides novel evidence accentuating the distinct needs of people on OAT who injected opioids. Reliability of data was assured as data were collected using standardized and validated tools/instruments. However, there are some limitations. The cross-sectional study design limits establishing causation when considering the association between SPD and QoL and factors associated with them. The study might be subjected to recall bias as some of the questions depend on subjective memory. Additionally, the impact of opioid use at baseline was not assessed. The study was undertaken in OAT sites from Kathmandu Valley; hence it might be difficult to generalize findings to all service users in OAT in Nepal or elsewhere. However, it can provide some guidance for further research to inform policy and guidelines for the development of evidence-informed interventions for OAT programs.

Conclusion

Service users in OAT programs in this study reported high levels of SPD within last four weeks and low QoL especially among IDUs. A history of self-reported past mental illness affected both SPD and QoL. It is well recognized that more than pharmacotherapy is required to better meet the multiple, entangled and complex needs of OAT service users, and focus on health, wellbeing and quality life would assist. To identify more clearly key and modifiable contributing factors, and which approaches and interventions are the most efficient and effective in buffering the onerous impacts of psychological distress and low QoL particularly among people who inject drugs in resource-poor settings.

Supporting information

S1 Dataset

(SAV)

Click here for additional data file.^{(406.5KB, sav)}

Acknowledgments

We would like to express our gratitude to all the OAT sites of the Kathmandu valley. We are very grateful to Dr. Rolina Dhital and Dr. Richa Shah for statistical inputs and Mr. Suvash Nayaju and Dr. Dipesh Bhattarai for reviewing and proof reading the manuscript.

Data Availability

All relevant data are within the paper and its Supporting Information files.

Funding Statement

The research is funded by the “Collaboration in Higher Education in Mental Health between Nepal and Norway- the COMENTH/NORPART project” https://www.med.uio.no/klinmed/english/research/projects/comenth/ The funding institution was not involved in data collection, analysis and manuscript writing and finalization.

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PONE-D-22-23448Psychological distress and quality of life among Opioid Agonist Treatment service users with histories of injecting and non-injecting: A cross-sectional study in Kathmandu, NepalPLOS ONE

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The study entitled “Psychological distress and quality of life among Opioid Agonist Treatment service users with histories of injecting and non-injecting: A cross-sectional study in Kathmandu, Nepal” can be improved with the following considerations.

1. Briefly describe different types of Opioid Agonist Treatment (OAT) in the Introduction, such as Methadone Maintenance Treatment (MMT).

2. The statement “OUD can lower QoL via impacts on all four domains (psychological, physical, social, and emotional), [14] and higher levels of perceived stigma and discrimination, especially in relation to injection drug use, are also associated with higher psychological distress, unhealthy behaviors and significantly poorer QoL [15,16]” can also be supported by the following relevant publications.

Lin, C.-Y., Chang, K.-C., Wang, J.-D., & Lee, L. J.-H. (2016). Quality of life and its determinants of heroin addicts receiving methadone maintenance program: comparison with matched referents from general population. Journal of the Formosan Medical Association, 115(9), 714-727.

Chang, K.-C., & Lin, C.-Y. (2015). Effects of publicly-funded and quality of life on attendance rate among methadone maintenance treatment patients in Taiwan: an 18-month follow-up study. Harm Reduction Journal, 12, 40.

Cheng, C.-M., Chang, C.-C., Wang, J.-D., Chang, K.-C., Ting, S.-Y., & Lin, C.-Y. (2019). Negative impacts of self-stigma on the quality of life of patients in methadone maintenance treatment: the mediated roles of psychological distress and social functioning. International Journal of Environmental Research and Public Health, 16, 1299.

Saffari, M., Chen, H.-P., Chang, C.-W., Fan, C.-W., Huang, S.-W., Chen, J.-S., Chang, K.-C., & Lin, C.-Y. (2022). Does sleep quality mediate the associations between problematic internet use and quality of life in people with substance use disorder? BJPsych Open, 8, e155.

Chang, C.-W., Chang, K.-C., Griffiths, M. D., Chang, C.-C., Lin, C.-Y., Pakpour, A. H. (2022). The mediating role of perceived social support in the relationship between perceived stigma and depression among individuals diagnosed with substance use disorders. Journal of Psychiatric and Mental Health Nursing, 29(2), 307-316.

Chang, C.-C., Chang, K.-C., Hou, W.-L., Yen, C.-F., Lin, C.-Y., & Potenza, M. N. (2020). Measurement invariance and psychometric properties of Perceived Stigma toward People who use Substances (PSPS) among three types of substance use disorders: heroin, amphetamine, and alcohol. Drug and Alcohol Dependence, 216, 108319.

Chang, K.-C., Lin, C.-Y., Chang, C.-C., Ting, S.-Y., Cheng, C.-M., & Wang, J.-D. (2019). Psychological distress mediated the effects of self-stigma, psychological distress, and quality of life in opioid-dependent individuals. Plos One, 14(2), e0211033.

3. When introduction the WHOQOL-BREF (i.e., line 174), please also mention that the WHOQOL-BREF has been validated among heroin users.

Chang, K.-C., Wang, J.-D., Tang, H.-P., Cheng, C.-M., & Lin, C.-Y. (2014). Psychometric evaluation using Rasch analysis of the WHOQOL-BREF in heroin-dependent people undergoing methadone maintenance treatment: further item validation. Health and Quality of Life Outcomes, 12, 148.

4. Please do not use p=<0.001. This presentation is confusing as no one know if it means p=0.001 or p<0.001.

5. The Results section is lengthy and has redundancy between text and tables. The authors are suggested to report concise results in text and refer the readers to read the details in tables.

6. The authors have defined QoL as quality of life. Then, they should adhere to using this abbreviation. However, the authors sometimes still use quality of life (e.g., line 316; quality of life among OAT service users).

7. The Discussion may discuss the QoL and psychological distress issues among people with OAT are related to stigma among this population. The authors may consult the references I mentioned earlier. The authors may also encourage future studies to know the stigma levels (including perceived stigma and self-stigma) among this population given that valid instruments have been developed (e.g., Chang et al., 2020; Fan et al., 2022).

Fan, C.-W., Chang, K.-C., Lee, K.-Y., Yang, W.-C., Pakpour, A. H., Potenza, M. N., & Lin, C.-Y. (2022). Rasch Modeling and Differential Item Functioning of the Self-Stigma Scale-Short Version Among People with three different Psychiatric Disorders. International Journal of Environmental Research and Public Health, 19, 8843.

Reviewer #2: Psychological distress and quality of life among Opioid Agonist Treatment service users with histories of injecting and non-injecting: A cross-sectional study in Kathmandu, Nepal

Thank you for the opportunity to review this paper. The manuscript is well written, the topic is interesting, and the results provide important information for improving the effectiveness of the OAT program, but there is still the need to address some shortcomings.

Specific comments:

- In the title, emphasize that it is about drug use when it comes to the division of participants into injecting and non-injecting “Psychological distress and quality of life among Opioid Agonist Treatment service users with a history of injecting and non-injecting drug use: A cross-sectional study in Kathmandu, Nepal”

- In the introduction, the problem is nicely and chronologically explained, but the introduction should be a little more concise or shorter.

- In the methodology, it is necessary to briefly explain why you choose 5 out of the 12 cities where the OAT programs were implemented, and whether the programs in those cities differ from the others in terms of content. This is important because of the external validity of the study and the generalizability of the results.

- It is not recommended to start sentences with abbreviations

- Have you used the Kolmogorov - Smirnov test to test the normality of the data distribution, in case the data distribution is not normal it is necessary to use non-parametric tests.

- Start the results with a description of the sample, not with the sentence "Table 1 summarizes the socio-demographic characteristics of the OAT service user……". This sentence should be placed after the textual description of the contents of Table 1.

- In the tables, it is necessary to express one p-value for comparing the value of one independent categorical variable between injecting and non-injecting drug users, for example, for the variable education we have three p-values instead of one. It is necessary to check that the same error is not repeated in the tables below. P value is expressed to three decimal places, and values less than 0.001, e.g. 0.000 is displayed as 0.001

- In line 231, explain the abbreviation SD.

- In line 240 the sentence "Regarding SES 70 (61.9%) belonged to upper SES as 241 compared to 54(45.8%) non IDU (p=0.014)" is not clear.

- A cross-sectional study design does not allow the use of words such as predictor or risk factor because we cannot prove causality, but instead the construct "factor associated with" can be used.

- In line 325 “The possible reasons for the gender differences may be due to higher level of perceived stigma, and barriers in access to health care facilities and treatment including OAT for females”…. Are there other gender differences that could be the cause of the obtained results, maybe differences in employment, income...what do other studies say.

- In the discussion, the data from the results are often repeated, the discussion should be based more on the comparison with the results from other studies for a potential explanation of them.

**********

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Reviewer #1: No

Reviewer #2: No

**********

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PLoS One. 2023 Feb 6;18(2):e0281437. doi: 10.1371/journal.pone.0281437.r002

Author response to Decision Letter 0

16 Jan 2023

Reviewer #1:

Comment 1: Briefly describe different types of Opioid Agonist Treatment (OAT) in the Introduction, such as Methadone Maintenance Treatment (MMT).

Our response: Thank you for your comment. Opioid Agonist Treatment (OAT) includes taking opioid agonist medications like methadone, buprenorphine and buprenorphine- naloxone combination.

We have added a sentence mentioning different types of OAT modalities in line 83-84, Page 4 “Opioid Agonist Treatment (OAT), primarily use of methadone, buprenorphine and buprenorphine- naloxone combination, is an evidence-based harm reduction initiative.”

Additionally, we also thought the reviewer wanted us to mention OAT modalities used in Nepal, for that we have mentioned that both methadone and buprenorphine are provided on a daily basis by a trained health professional.

Line 87-91, page 4,now reads as:

“The National Center for AIDS and STD Control (NCASC) implements…….. Non-government organizations (NGO) where both methadone and buprenorphine are dispensed on a daily basis under the supervision of a trained health professional.”

Comment 2: The statement “OUD can lower QoL via impacts on all four domains (psychological, physical, social, and emotional), [14] and higher levels of perceived stigma and discrimination, especially in relation to injection drug use, are also associated with higher psychological distress, unhealthy behaviors and significantly poorer QoL [15,16]” can also be supported by the following relevant publications.

Our response: Thank you for the suggestions of excellent papers. We have read all of the papers you suggested and have decided to cite ‘four’ articles out of them to support our statements in the introduction.

Articles by Lin, C.-Y, et.al, Chang, K.-C. et. al, are cited along with Karow A. et.al in line 106, page 5 and article by Cheng, C.-M., et. Chang, K.-C. et.al are cited along with Couto E Cruz C et. al, and Singh S. et al in line 108, page 5.

As reviewer 2, advised to reduce the size of introduction, we decided not to add additional text but only contextualize references which supports the statements made in the introduction through line 103-108, page 5.

Comment 3: When introduction the WHOQOL-BREF (i.e., line 174), please also mention that the WHOQOL-BREF has been validated among heroin users.

Our response: Thank you for this very valuable input. We accept your suggestion and have added this reference in line 189-190, page 8.

The WHOQOL-BREF has been validated among OAT service users and translated into Nepali language and used in research in Nepal.

Comment 4: 4. Please do not use p=<0.001. This presentation is confusing as no one know if it means p=0.001 or p<0.001.

Our response: Thank you for pointing out this issue. It was a typing error and it actually is p<0.001, which can now be seen corrected in Table 2.

Comment 5: The Results section is lengthy and has redundancy between text and tables. The authors are suggested to report concise results in text and refer the readers to read the details in tables.

Our response: Thank you for your comment. We have formatted the result section to reduce redundancy and highlighted the major findings from each table. We have removed repetition of numbers from tables and referred to respective tables where ever appropriate. You can follow the changes in result section from line 241-255, 260-266, 276-287, 296-304 and 311-329 of through pages 10-20 (Results section) in the “revised manuscript with track changes.”

Comment 6: The authors have defined QoL as quality of life. Then, they should adhere to using this abbreviation. However, the authors sometimes still use quality of life (e.g., line 316; quality of life among OAT service users).

Our response:

Thank you for your important comment. We have made changes in line 100 (page 5), line167 (page 7), line 188 (page 8), line 337 (page23), line 397 (page 25), line 431 and 438 in Page 27

Comment 7: The Discussion may discuss the QoL and psychological distress issues among people with OAT are related to stigma among this population. The authors may consult the references I mentioned earlier. The authors may also encourage future studies to know the stigma levels (including perceived stigma and self-stigma) among this population given that valid instruments have been developed (e.g., Chang et al., 2020; Fan et al., 2022).

Our response:

Thank you for your inputs in regards to stigma. We did not discuss in detail about stigma in this paper because our focus of study was psychological distress and QoL. Furthermore, we are working in a follow-up manuscript evaluating stigma among OAT service users; hence it was not much addressed in this paper. However, we have taken your recommendation and made statement for need of further studies to know about perceived and self-stigma among OUD and OAT service users, citing relevant references suggested by you.

Line 401-405, Page 25-26 reads as:

Further research might explore potentially direct and indirect impacts of a broader range of social and structural variables that appear to be associated with QoL and SPD, such as the role of perceived stigma and self-stigma. This research would benefit from quantitative, qualitative, longitudinal, and intervention studies.

Reviewer #2:

Comment 1

Our response: Thank you for your comment. We have addressed the issue as suggested by you. The title (line 1-4, Page 1) now reads as:

“Psychological distress and quality of life among Opioid Agonist Treatment service users with a history of injecting and non-injecting drug use: A cross-sectional study in Kathmandu, Nepal”

Comment 2

In the introduction, the problem is nicely and chronologically explained, but the introduction should be a little more concise or shorter.

Our response:

Thank you for emphasizing the need for making a more concise and shorter introduction. We have a deleted sentences from line 109-113 (page 5) and line 117-119 (page 5).

The new condensed paragraph now reads as:

In addition to physical and mental health concerns, IDUs often have instability in many aspects of life in addition to high prevalence of infectious disease and mental disorders, such as crime, violence, and lack of stable housing. Resource poor settings often face greater difficulties in addressing the diverse but entangled needs of persons with OUD, due to competing health needs and other priorities.

Comment 3

- In the methodology, it is necessary to briefly explain why you choose 5 out of the 12 sites where the OAT programs were implemented, and whether the programs in those cities differ from the others in terms of content. This is important because of the external validity of the study and the generalizability of the results.

Our response:

Thank you for your comments. Kathmandu valley has three districts – Kathmandu, Lalitpur and Bhaktapur. Kathmandu valley has a total of 5 OAT centers and each of these sites were included in the study. Kathmandu valley was chosen on convenience, as it has 5 out of 12 cites, and caters more than half of all OAT service users from all over the country. The other OAT centers are also situated across major cities (urban area) and the service users are managed by the same guiding protocol and organogram. Hence, we believe that the five centers represent OAT service users from the over country.

We have added the following sentences to address your valid concerns for generalizability and external validity

Line: 136-137 (page 6)- All OAT sites providing service in Kathmandu were selected for the study.

Line 139-143 (page 6)- Kathmandu valley was chosen on convenience as it has the highest number of OAT sites and highest cumulative OAT service users. The center in Kathmandu represents remaining OAT sites in other cities, as all other centers are also urban based and operating as per the same treatment protocol.

Comment 4

- It is not recommended to start sentences with abbreviations

Our response:

Thank you for your comments. We have scanned the document in detail and found some places where sentences started with abbreviations. We have addressed the issue as per your suggestion.

Line 87-88 (page 4) … “OAT programs are”……, has been paraphrased to “The National Center for AIDS and STD Control (NCASC) implements OAT programs at 12 sites”

Line 409 (page 26) …”OAT programs must be”….. has been paraphrased to “Sites of OAT programs…”

Line 431 (page 27) “OAT service users in this…” has been paraphrased to “ Service users in OAT programs in this….”

Comment 5

Have you used the Kolmogorov - Smirnov test to test the normality of the data distribution, in case the data distribution is not normal it is necessary to use non-parametric tests.

Our response:

Thank you for your comment and important observation. When we worked on the manuscript, test for normality was based on histogram observation and examination using skewness and kurtosis.

In a manuscript by Kim HY, 2013, the author mentions for medium sized samples (50<n<300), the null hypothesis is rejected at an absolute z-value +/- 3.29. This was the basis of our testing for Normal distribution. From this test, all the variables were deemed to be normally distributed hence we progressed with the parametric test.

• Kim HY. Statistical notes for clinical researchers: assessing normal distribution (2) using skewness and kurtosis. Restor Dent Endod. 2013 Feb;38(1):52 54.

https://doi.org/10.5395/rde.2013.38.1.52)

From the manuscript

“For medium-sized samples (50 < n < 300), reject the null hypothesis at absolute z-value over 3.29, which corresponds with a alpha level 0.05, and conclude the distribution of the sample is non-normal.”

In recent times, other interesting publications have also highlighted using parametric test for non- normal distribution in medical research. We want to highlight two publications which has taken this discussion forward:

• Cessie S le, Goeman JJ, Dekkers OM. Who is afraid of non-normal data? Choosing between parametric and non-parametric tests. Eur J Endocrinol. 2020 Feb 1;182(2):E1–3.

In this manuscript the authors mention,

“In many papers the Methods’ section reads like: ‘for non-normally distributed data, non-parametric tests were used’. And indeed, many papers apply non-parametric tests, such as Mann–Whitney test or Wilcoxon test, to compare groups, when the data do not seem completely normally distributed. However, the use of parametric methods, like the t-test, has a clear advantage compared to non-parametric tests: where a non-parametric test will only produce a P value, a t-test will also produce the observed mean difference between the groups, with a 95% confidence interval (CI)…….”

• Wadgave U, Ravindra Khairnar M. Parametric test for non-normally distributed continuous data: For and against. Electron Physician. 2019 Feb 25;11(2):7468–70.

In this manuscript authors mention,

“The existing evidence from simulation studies suggests that parametric methods are preferred over non-parametric in most situations while analysing non-normally distributed continuous data. Even though non-parametric tests are independent of normality assumption, they depend on equal shape and variance of the two distributions [homoscedasticity] (12). So, non-parametric tests should only be considered for the continuous data when the distribution is highly skewed and log transformation cannot change it to normal distribution and when normality of these data cannot be assumed from reports of these data elsewhere (16). Considering the limitation of normality tests’ application to both large and small sample sizes, it is advised to assess the magnitude of skewness of data distribution with graphical methods…”

However, despite considering the above inferences using references, we welcome and support the comment of the Reviewer # 2 and Associate Editor and reapproached using Kolomogorov- Smirnov test, and decided to use non-parametric test- “The Mann-Whitney U-test” for variable “Duration since OAT enrolment (months)” in Table 2 (page 14-15) and “K-6 score” in Table 3 (page 16) since these two variables were heavily skewed.

Also, the following addition has been made in the Statistical analysis section:

Lines 215-217 Page 9: The normal distribution of the continuous variables was checked by using visual inspection, assessment of skewness and kurtosis and Kolmogorov-Smirnov test.

Lines 219-220 Page 10: The Mann-Whitney U-test was used for not normally distributed continuous data.

Comment 6

Our response:

Thank you for this important observation. We have amended the result section as per your suggestion. Now all the result section starts with a description of the sample.

Comment 7

In the tables, it is necessary to express one p-value for comparing the value of one independent categorical variable between injecting and non-injecting drug users, for example, for the variable education we have three p-values instead of one. It is necessary to check that the same error is not repeated in the tables below. P value is expressed to three decimal places, and values less than 0.001, e.g. 0.000 is displayed as 0.001

Our response:

Thank you, for your suggestion. We have changed to one p-value to for one independent categorical variable between injecting and non-injecting drug users. In table 1 (Page 11-13), the p-values for the following variables have been re-analysed and changed: Education (p=0.021), Ethnicity (p=0.752), employment status (p=0.216), marital status (p= 0.004).

Like you suggested, p value <0.001 has been kept as 0.001, in Table 2 (Page 14-15) (Duration since OAT enrolment), Table 3 (Page 16) (Physical QoL, Overall QoL).

Comment 8

- In line 231, explain the abbreviation SD.

Our response:

Thank you, SD stands for standard deviation which is labelled in Table 1. So, its deleted from the text portion in the paragraph.

Comment 9

- In line 240 the sentence "Regarding SES 70 (61.9%) belonged to upper SES as 241 compared to 54(45.8%) non IDU (p=0.014)" is not clear.

Our response:

We have clarified the text with simple sentence.

About one- third of non-IDU had co-morbid medical conditions which was significantly less for IDUs, and had higher SES. (line 253-255, page 11)

Comment 10

A cross-sectional study design does not allow the use of words such as predictor or risk factor because we cannot prove causality, but instead the construct "factor associated with" can be used.

Our response:

Thank you for your comment. We have changed predictor variables to independent variables (Line 230, page 10, Statistical analysis)

Comment 11

Our response:

Thank you for this important observation. In our study gender difference was not obvious in socio-demographic variables like employment, income etc. The statement made in line 346-348 Page 23, “The possible reason…..including OAT for females” was mostly to highlight the fact that females drug users don’t access treatment as common as men in settings like Nepal. Even in this study the female population (IDU and non-IDU combined) was just 18 out of 231.

As suggested by the reviewer, we examined if there were differences in regards various socio-demographic variables in regards to gender, but did not find any. Additionally, we have added a reference from a recent systematic review and meta-analysis (Santo Jr, T, et al, 2022) to support our statement in the discussion

Comment 12

In the discussion, the data from the results are often repeated, the discussion should be based more on the comparison with the results from other studies for a potential explanation of them.

Our response:

Thank you, we have taken that into consideration and taken out results and redundancy from our discussions.

Academic Editor (Eleni Petkari)

Comment : Both Reviewers find that the work is original and well written in general terms. However, a more concise results section is needed, and the execution of the Kolmogorov Smirnoff test is necessary to decide whether to proceed with parametric or not parametric analyses.

Based on the Reviewers' suggestions, the discussion should also be amended, to provided thorough evidence-based explanations of the results.

Our response: Thank you for your comments. We have made the result more concise with deletion of repetition of findings and statistical inferences already evident on the tables. The discussion has also been amended with removal of redundant repetition from results and addition of five new references to support of discussion and observations.

About the use of Kolmogorov Smirnoff test and use of parametric or non-parametric test, we have responded to that in detail comment 5, Pages 10-12 in ‘Response to reviewer #2’.

We have reapproached using Kolmogorov- Smirnov test, and used non-parametric test- The Mann-Whitney U-test was used for variable “Duration since OAT enrollment” in Table 2 and “Kessler-6 score” in Table 3. (See above comment 5 Pages 10-12)

Thank you once again for the opportunity to revise and resubmit our manuscript. I would also want to emphasize that the final ‘manuscript’ meets PLOS ONE’s style requirements, including file naming. We look forward to hearing from you.

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PLoS One. doi: 10.1371/journal.pone.0281437.r003

Decision Letter 1

Eleni Petkari

24 Jan 2023

Psychological distress and quality of life among Opioid Agonist Treatment service users with a history of injecting and non-injecting drug use: A cross-sectional study in Kathmandu, Nepal

PONE-D-22-23448R1

Dear Dr. Pant,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Eleni Petkari

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Dear Authors,

the Reviewers are happy with the modifications you provided to the manuscript. I am please to inform you that your article can be accepted for publication.

Please make sure to address a final comment by Reviewer 2, as follows:Table 2 for the variable "Provision of 'take away' OAT (Last month)" to correct the p value, more precisely to be rounded to 3 decimal places during the proofreading process of the publication.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

Reviewer #1: Yes

Reviewer #2: Yes

**********

6. Review Comments to the Author

Reviewer #1: The authors have taken all my previous comments seriously to revise their contribution. The revised manuscript is much improved and I am happy with it. I have no more comments on it now.

Reviewer #2: The authors corrected everything requested of them and improved the manuscript. It is additionally necessary in Table 2 for the variable "Provision of 'take away' OAT (Last month)" to correct the p value, more precisely to be rounded to 3 decimal places.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

**********

PLoS One. doi: 10.1371/journal.pone.0281437.r004

Acceptance letter

Eleni Petkari

26 Jan 2023

PONE-D-22-23448R1

Psychological distress and quality of life among Opioid Agonist Treatment service users with a history of injecting and non-injecting drug use: A cross-sectional study in Kathmandu, Nepal

Dear Dr. Pant:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

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on behalf of

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Data Availability Statement

All relevant data are within the paper and its Supporting Information files.

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PERMALINK

Psychological distress and quality of life among Opioid Agonist Treatment service users with a history of injecting and non-injecting drug use: A cross-sectional study in Kathmandu, Nepal

Sagun Ballav Pant

Suraj Bahadur Thapa

John Howard

Saroj Prasad Ojha

Lars Lien

Roles

Abstract

Background

Methods

Results

Conclusion

Background

Methods

Study setting and design

Sample size determination and sampling procedure

Measures and instruments

Socio-demographic questionnaire

World Health Organization Quality of Life (WHOQOL-BREF)

Kessler-6 psychological distresses scale (K-6)

Statistical analysis

Ethical consideration

Results

Table 1. Socio-demographic characteristics of non-injecting (non-IDU) and injecting drug users (IDU).

Table 2. Comparison of Opioid Agonist Treatment related characteristics between non-injecting and injecting drug users.

Table 3. Difference in Quality of Life (QoL) and psychological distress among non IDU and IDUs.

Table 4. Factors associated with Serious psychological distress (SPD).

Table 5. Factors associated with Quality of life (QoL).

Discussion

Implications

Strengths and limitations

Conclusion

Supporting information

Acknowledgments

Data Availability

Funding Statement

References

Decision Letter 0

Eleni Petkari

Roles

Author response to Decision Letter 0

Decision Letter 1

Eleni Petkari

Roles

Acceptance letter

Eleni Petkari

Roles

Associated Data

Supplementary Materials

Data Availability Statement

ACTIONS

PERMALINK

RESOURCES

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