Accuracy of the Arabic HCL - 32 and MDQ in detecting patients with bipolar disorder.

BACKGROUND: Studies about the two most used and validated instruments for the early detection of Bipolar Disorder (BD), the 32 - item Hypomania Checklist (HCL - 32) and the Mood Disorder Questionnaire (MDQ), are scarce in non-Western countries. This study aimed to explore the reliability, factor structure, and criterion validity of their Arabic versions in a sample of Tunisian patients diagnosed with mood disorders. METHODS: The sample included 59 patients with BD, 86 with unipolar Major Depressive Disorder (MDD) and 281 controls. Confirmatory factor analysis was applied to show that a single global score was an appropriate summary measure of the screeners in the sample. Receiver Operating Characteristic analysis was used to assess the capacity of the translated screeners to distinguish patients with BD from those with MDD and controls. RESULTS: Reliability was good for both tools in all samples. The bifactor implementation of the most reported two-factor model had the best fit for both screeners. Both were able to distinguish patients diagnosed with BD from putatively healthy controls, and equally able to distinguish patients diagnosed with BD from patients with MDD. CONCLUSION: Both screeners work best in excluding the presence of BD in patients with MDD, which is an advantage in deciding whether or not to prescribe an antidepressant.

Clinical predictors of response to clozapine in Tunisian patients with treatment resistant schizophrenia.

INTRODUCTION: Treatment resistant schizophrenia (TRS), affecting approximately one-third of patients with schizophrenia, is associated with a serious impairment in global psychosocial functioning. Clozapine is the only licensed drug for TRS. However its prescription remains limited by its side effects requiring mandatory monitoring. The need to identify clinical factors associated with good response to clozapine in TRS has been established. The presence of ethnic differences in these factors and the scarcity of data on the Tunisian or more generally the North-African population warrants the conduct of a clinical study on the subject. The aim of this study was to investigate demographic, clinical, and biochemical patient characteristics as potential predictors of response to clozapine. METHODS: This is a cross-sectional and retrospective study, at the "F and A psychiatry departments" of Razi Hospital in Manouba, Tunisia. All patients, with DSM 5 diagnosis of schizophrenia in its resistant form, on clozapine for at least 12 months and who consulted from June 1, 2018 to November 30, 2018 were included. We investigated premorbid functioning by the premorbid adjusment scale, demographic and clinical characteristics, and clozapine plasma level as potential clozapine response predictors. The response to clozapine was defined by a total BPRS score of 35 or less. RESULTS: Sixty-three patients were included in the study. The mean age at clozapine introduction was 30,84 ±9,25 years. The mean duration of clozapine treatment was 7,22 ± 4,02 years. There were 16 clozapine responders (25%) who had BPRS total scores below or equal to 35 and 47 non-responders (75%). A higher premorbid social functioning in childhood (p = 0,018) and early adolescence (p = 0,024) was associated with better response to clozapine. A delay clozapine initiation shorter than 7 years(p = 0,036), one atypical antipsychotic trial (p = 0,029) and schizophrenia paranoid subtype (p< 0.01) were found to be significantly predictive of good clozapine response. None of the demographic factors or biochemical characteristics were associated with clozapine response. CONCLUSIONS: Our work is consistent with previous studies suggesting the need for clinicians to be aware of the clinical predictors of a good response to clozapine to overcome their reluctance to prescribe it. It also highlighted the major prognostic role of premorbid adjustment in the clinical response to treatment. However, prospective studies including therapeutic drug monitoring would be very useful to better delineate the sub-group of patients to whom clozapine would benefit the most and to improve prescription modalities.

Prevalence of Mood Disorders and Associated Factors at the Time of the COVID-19 Pandemic: Potocol for a Community Survey in La Manouba Governorate, Tunisia.

Aims: The present survey aims to assess the overall mood disorder prevalence and identify associated socio-demographic and clinical factors in a Tunisian community sample, with special attention to the COVID-19 pandemic. Background: Mood disorders are one of the leading causes of all non-fatal burdens of disease, with depression being at the top of the list. The COVID-19 pandemic may have increased the prevalence of mood disorders, especially in Low and Middle-income countries (LMICs) and in vulnerable populations. Objective: 1/ Assess point and lifetime prevalence of depressive and bipolar disorders as well as subthreshold bipolarity in a representative population sample of La Manouba governorate and assess treatment patterns for these disorders; 2/Study socio-demographic and clinical correlates of mood disorders 3/ Assess the association between mood disorders and quality of life 4/ Study the impact of the COVID-pandemic on the prevalence of mood disorders 5/ Assess coping mechanisms to the COVID-pandemic and whether these mechanisms moderate the appearance of mood disorders or symptoms since the beginning of the pandemic. Methods: This is a household cross-sectional observational survey to be conducted in La Manouba Governorate in a sample of 4540 randomly selected individuals aged ≥ 15 years. Data collection will be carried out by trained interviewers with clinical experience, through face-to-face interviews and the use of the computer assisted personal interviewing approach (CAPI). The following assessment tools are administered. Results: Structured clinical Interview for DSM IV-TR (Mood disorder section and Screening questions on Anxiety), Mood Disorder Questionnaire (MDQ), Suicide Behaviors Questionnaire-Revised (SBQ), 12-item Short Form Survey (SF-12), the Brief-COPE, and a questionnaire about a headache. In addition, socio-demographic and clinical data will be collected. Conclusion: This will be one of the very few household surveys in a general population sample to assess mental health problems and COVID-19-related variables since the beginning of the pandemic. Through this research, we aim to obtain an epidemiological profile of mood disorders in Tunisia and an estimation of the impact of the COVID-19 pandemic on their prevalence. Results should contribute to improving mental health care in Tunisia.

Women's mental health: acute impact of COVID-19 pandemic on domestic violence.

The coronavirus disease 2019 (COVID-19) pandemic created a situation of general distress. Although the focus has been initially more on the physical health during the pandemic, mental health concerns linked to the lockdown have quickly risen. This study aims to assess the effect of the COVID-19-related lockdown on Tunisian women's mental health and gender-based violence. An online survey was conducted, using the Depression Anxiety and Stress Scales (DASS-21) and the Facebook Bergen Addiction Scale (FBAS). We chose a female-exclusive social group on Facebook and used the snowball sampling method. A total of 751 participants originating from all the Tunisian regions completed the questionnaire. More than half of the participants (57.3%) reported extremely severe distress symptoms, as per the DASS-21. Those who had a history of mental illness and who were allegedly abused during lockdown were found to have more severe symptoms of depression, anxiety, and stress. Around 40% of women reported problematic social media use. Violence against women also reportedly increased significantly during the lockdown (from 4.4 to 14.8%; p < 0.001). Psychological abuse was the most frequent type of violence (96%). Women who had experienced abuse before the lockdown were at an increased risk of violence during lockdown (p < 0.001; OR = 19.34 [8.71-43.00]). To our knowledge, this is the first study that evaluates the acute impact of COVID-19 on mental health and violence against women in Tunisia, Africa, and the Arab world. It may be a sound basis for developing a more effective psychological intervention aimed at women in these regions.

The Factor Structure of the Mood Disorder Questionnaire in Tunisian Patients.

BACKGROUND: The Mood Disorder Questionnaire (MDQ) is a frequently used screening tool for the early detection of Bipolar Disorder (BD), which is often unrecognized or misdiagnosed at its onset. In this study, data from Tunisia has been used to evaluate the psychometric properties of the Arabic MDQ. METHODS: The sample included 151 patients with a current major depressive episode. The Arabic adapted version of the Structured Clinical Interview for DSM-IV-TR was used to formulate a diagnosis, yielding 62 patients with BD and 89 with unipolar Major Depressive Disorder (MDD). Principal component analysis with parallel analysis was used to establish the spontaneous distribution of the 13 core items of the MDQ. Confirmatory Factor Analysis (CFA) was used to check the available factor models. Receiver Operating Characteristic (ROC) analysis was used to assess the capacity of the MDQ to distinguish patients with BD from those with MDD. RESULTS: Cronbach's α in the sample was 0.80 (95%CI: 0.75 to 0.85). Ordinal α was 0.88. Parallel analysis suggested two main components, which explained 59% of variance in the data. CFA found a good fit for the existing unidimensional, the two-factor, and the three-factor models. ROC analysis showed that at a threshold of 7, the MDQ was able to distinguish patients with BD from those with MDD with extraordinary negative predictive value (0.92) and a positive diagnostic likelihood ratio of 3.8. CONCLUSION: The Arabic version of the MDQ showed good measurement properties in terms of reliability, factorial validity and discriminative properties.

Staff Perception of Respect for Human Rights of Users and Organizational Well-being: A Study in Four Different Countries of the Mediterranean Area.

BACKGROUND: The perception by mental health service staff of respect for users' rights is a fundamental component of organizational well-being. The objective of this work is to examine how cultural differences and the working context can influence the perception of respect for users' rights in mental health professionals in the Mediterranean area. METHODS: An observational survey carried out in four different mental health networks in four countries of the Mediterranean area (Tunisia, North-Macedonia, Italy, Palestine). Each invited participant fulfilled a format on socio-demographic information and coded the Well-Being at Work and Respect Right Questionnaire (WWRR). All data were encrypted and analysed using the Statistical Package for Social Sciences (SPSS) version 20. The Games-Howell post-hoc test was used to assess differences between countries. The Games-Howell test does not assume equal variances and sample sizes. Eta-squared (η2) was used as a measure of effect size in the ANOVA (η2 around 0.01, 0.06, and 0.14 are considered small, medium, and large, respectively). RESULTS: The sample included 590 professionals working in the mental health field. The four countries showed statistically significant differences with regards to the quality rights assessment tool. Participants from Italy reported, on average, the highest scores across the questions. There were also differences across the countries about the perception of the impact of available resources on the effectiveness of care (η2 = 0.106). CONCLUSION: Our findings offer a useful insight into the perception of the quality of mental health services, especially from a users' rights point of view.

Principal Component Analysis of the Well-Being at Work and Respect for Human Rights Questionnaire (WWRRR) in the Mediterranean Region.

BACKGROUND: The Well-Being at Work and Respect for human Rights Questionnaire (WWRR) was conceived based on the hypothesis that the perception of respect for users' rights is an essential element of well-being in the workplace in healthcare. The objective of the study is to examine the principal components of the WWRR. METHODS: A random sample representative of a set of professionals working in three different healthcare networks in Tunisia, North-Macedonia, and Italy was enrolled (n=426). Each professional completed a questionnaire on sociodemographic data and the WWRR. The WWRR consists of six items on beliefs about: satisfaction at work, users' satisfaction, organization at work, respect of users' and staff human rights, adequacy of resources. A seventh item assesses the perceived needs of personnel. Correlation between the items was evaluated by analysing the principal components with Varimax rotation and Kaiser normalization (which included all components with an Eigen value> 1). RESULTS: A single factor covered over 50% of the variance, all the items of the questionnaire were closely related and compose a single factor. Tunisia presented some differences regarding the item about the human rights of staff. CONCLUSION: Satisfaction with the respect for the rights of users is strongly correlated with the other factors that are part of the concept of the organizational well-being of health care providers. The WWRR provides a means of measuring this important and often neglected dimension.

Screening for Depression using the PHQ-9 questionnaire: a study for Tunisian individuals consulting in the primary health care centers.

INTRODUCTION: Depression is considered a global public health problem especially in the developed countries, where depression is the leading cause of morbidity. OBJECTIVES: To determine the point prevalence and the severity of depression in primary health care, to define the profile of patients suffering from depression and consulting in primary health care. To identify risk factors for depression, in particular chronic co-morbid conditions. METHODS: Our study was a descriptive and analytical cross-sectional study of 1000 patients aged over 18 years consulting in ten primary care structures. It took place during a period of six successive days from 8 to 13 April 2012. Depression was assessed by the 9-item-Patient Health Questionnaire (PHQ-9). RESULTS: In our sample, the average age was 42,4 years ranging from 18 to 89 years. Females were predominant with 66,6 %. According to the PHQ-9, the prevalence of major depressive episode (MDE) was 12,1 %. It was higher among women (13,5%) compared with men (9,3%) with an odds ratio of 1,5. The highest prevalence of MDE (19%) was noted in the age group of 45-54 years. The most prevalent clinical signs found in our population were sleep disorders (29,7%) and suicidal ideation (28,4%). Among patients with MDE, only 10% were followed up for depression. Major depressive disorder was significantly associated with comorbid chronic diseases (p < 0,001), especially diabetes (p = 0,043, OR = 2,1), musculoskeletal diseases (p = 0,028, OR = 2,1) and pulmonary diseases (p = 0,001 , OR = 5,5). Having one comorbid chronic condition multiplied the risk of having a MDE by 2,2. This risk was 3,2 for two or more comorbid chronic conditions. CONCLUSION: Depression in primary care remains a largely underdiagnosed and undertreated condition. Patients with chronic disorders are particularly vulnerable.

Depression during the COVID pandemic in La Manouba Governorate, Tunisia: A community survey.

BACKGROUND: It is difficult to quantify the impact of the COVID-19 pandemic on mental health as many community surveys have limited quality, rely on screening tests to measure mental health conditions and distress, and often use convenience samples. Moreover, robust surveys come mainly from high-income countries. AIM: To measure the prevalence of depressive disorders with onset during the pandemic in a community of a Lower-Middle-income country (LMIC)-Tunisia. METHODS: Clinical semi-structured face-to-face interviews were carried out during the pandemic (September-December 2021) by medical doctors among a representative sample of the general population in the governorate of La Manouba, Tunisia. Psychiatric diagnoses were established according to DSM-IV. RESULTS: The prevalence of Major Depressive Disorder (MDD) started or recurred after the pandemic was 5.66%. The factors associated with MDD were loss of job and considerably diminished income due to the pandemic (OR = 2.1, 95% CI [1.5, 2.9]) and the perception of having the family's financial situation below the Tunisian average (OR = 2.3, 95% CI [1.7, 3.2]). Female sex, marital status as separated/divorced, and having a COVID-19 infection were associated with MDD only in the overall sample and urban areas, but not in rural areas. Age and having loved ones who passed away due to COVID-19 were not associated with MDD. CONCLUSION: In Tunisia, the pandemic seems to have increased the risk of depression in people experiencing a precarious financial situation, also due to the pre-existing economic crisis. Specific local level factors, such as not establishing a rigid lockdown for an extended period, may have protected young people and allowed for better mourning in families suffering the loss of a loved one.

Hyperactivity and Risk for Dysregulation of Mood, Energy, and Social Rhythms Syndrome (DYMERS): Standardization of a Simple One-Item Screener versus the Mood Disorder Questionnaire (MDQ).

Background: This study aims to verify the accuracy of item 10 on the energy level of the Short-Form Health Survey (SF-12) in an item screening according to Mood Disorder Questionnaire (MDQ) results, providing a measure of hyper-energy. Methods: Regression techniques were employed in a dataset comprising 4093 records of respondents to test both linear and nonlinear relationships between predictor and outcome variables (energy level and symptoms considered in the MDQ). We examined the relationship of energy level with cases identified using MDQ with a cut-off of 7. Results: Levels of energy, as rated on item 10 of the SF-12, were related to the MDQ score with sensitivity = 0.72 and specificity = 0.70. In linear regression, the associations were stronger with MDQ items on excessive energy or activity, showing a medium effect size and an explained variance of 10% or higher. A greater association was observed for items on excessive energy and activity, as expected, as well as for items concerning self-confidence, sociability, and talkativeness. Conclusions: This result may have implications for the research on risk factors and the pathogenesis of the dysregulation of mood, energy, and social rhythms syndrome (DYMERS), a syndrome that is hypothesized to occur in stressful conditions like those shown under the COVID-19 pandemic.

"To fast or not to fast?" Ramadan and religiosity through the eyes of people with bipolar disorder: an exploratory study.

Background: The month of Ramadan, due to its changes in social rhythms, can seriously affect the course of bipolar disorder (BD). Therefore, psychiatrists sometimes find it necessary to discourage Ramadan practices, especially fasting, although taking part in this practice can give a sense of belonging and accomplishment to patients. Research on this subject is limited. Aim: The aim of the present work was to explore: (i) religious practices with special attention to Ramadan before and after the onset of BD, (ii) the perceptions and behaviors related to not fasting during Ramadan in patients with BD and their families' attitudes, (iii) religiosity and self-stigmatization and their relationships with religious practices, and (iv) the doctor-patient relationship around fasting. Methods: We conducted a retrospective, cross-sectional and descriptive study in clinically stabilized patients with BD in a public mental hospital and in a private psychiatric practice in Tunis, Tunisia. Socio-demographic and clinical data, as well as data related to general religious practices and Ramadan practices were collected using a self-established questionnaire. We assessed (i) religiosity of the patients with the Duke University Religion Index and (ii) self-stigma using the Internalized Stigma of Mental Illness scale. Results: Our sample consisted of 118 patients of whom 65.3% were fasting regularly before BD onset. More than half had stopped this practice following BD onset. Of the patients who did not fast, 16% felt guilty about this and 4.9% reported receiving negative remarks from their surroundings. High self-stigma scores were observed in 11% of the patients. Self-stigma was associated significantly with negative perception of not fasting, negative remarks regarding not fasting and taking both meals at regular times during Ramadan. The decision whether to fast or not was taken without seeking medical advice in 71.2% of the sample, and 16.9% of the sample reported that their psychiatrist had spontaneously approached the issue of Ramadan fasting. Conclusion: Religiosity and more specifically the practice of Ramadan remains an important point that should be considered when treating patients with psychiatric problems. It seems necessary that healthcare professionals should integrate the positive and the negative side of fasting into their reflections. Our results remain exploratory and encourage further work on the subject.

Accuracy of the Personal Economic Distress Index Among Arabic Unemployed.

Objectives: Studies about The Index of Personal Economic Distress (IPED) in Arab countries since the onset of the COVID-19 pandemic have been alarming. This study aimed to explore the reliability, factor structure, and criterion validity of the Arabic IPED in a sample of unemployed Tunisians during the past 6 months. Methods: The Arabic version of the IPED and the validated Hospital Anxiety and Depression Scale (HADS) were administered to a total of 2011 unemployed people originating from all Tunisian regions. Principal component analysis (PCA) with confirmatory factor analysis (CFA) was used to establish the spontaneous distribution of the 8 items and possible factors of the IPED. Receiver operating characteristic (ROC) analysis was conducted to assess the ability of the IPED to distinguish between unemployed individuals with no economic distress and those in distress. The correlation between the IPED and the HADS were explored. Results: The reliability of the Arabic version of the IPED was adequate. The PCA suggested two main components of the Arabic version of the IPED: the first component including five items focused on financial responsibilities towards state structures and the second dimension containing three items focused on well-being. A statistically significant association (p = 0.01; r = 0.05) was found between the well-being dimension of the IPED and the Anxiety subscale of HADS. Conclusion: This validated version of the IPED is an important tool to study the impact of economic crises on the mental health of unemployed people, as demonstrated in the link found in this study between economic distress and anxiety.

Arabic validation of the "Mental Health Knowledge Schedule" and the "Reported and Intended Behavior Scale".

Objectives: Mental illness affects one in eight people in the world according to the WHO. It is a leading cause of morbidity and a major public health problem. Stigma harms the quality of life of people with mental illness. This study aimed at validating the Arabic version of the Mental Health Knowledge Schedule (MAKS) and the Reported and Intended Behavior Scale (RIBS) in a sample of Tunisian students and determining socio-demographic and clinical factors correlated with stigma. Methods: This cross-sectional study was conducted on 2,501 Tunisian students who filled in the MAKS, the RIBS, and a sociodemographic and clinical questionnaire. The validation of the questionnaires in Arabic was carried out using the validity criteria: face and content validity, reliability, and construct validity. Next, the associations between stigma and sample characteristics have been studied using multivariate linear regression. Results: Face and content validity of the measures MAKS and RIBS were satisfactory, with adequate internal consistency. There were significant positive correlations between the items and scales, and test-retest reliability was excellent. The internal validity showed that the items were well-aligned with the intended factors, and the external validity revealed a significant positive relationship between the MAKS and RIBS. Besides, gender, the field of study, psychiatric history, and contact with someone with a mental illness were all contributing factors to mental illness stigma. Additionally, men performed better than women in terms of behavior toward people with mental illness, while women had a greater level of knowledge about mental health. Conclusion: The Arabic versions of the MAKS and RIBS have appropriate psychometric properties, making them effective tools for evaluating mental illness stigma. With multiple factors contributing to this issue, these instruments can help focus anti-stigma efforts and promote a more inclusive society.

Antineuronal autoantibodies induced paraneoplasic syndrome in schizophrenia spectrum disorders: case report.

Secondary psychiatric symptoms are usually suspected when there is an atypical presentation of the symptoms or a lack of response to psychotropic medication. Case presentation: Our case is about a woman aged 62 years old, with a history of mental disorder who presented psychiatric symptomatology after years of being stabilized by antipsychotics. She was later investigated due to a mass in her breast. Carcinoma was diagnosed, and her psychiatric symptomatology was resolved after the tumerectomy. Discussion: The therapeutic difficulty is the major problem of psychic disorders in the context of paraneoplastic syndrome. Several literature review have suggested a relationship between schizophrenia and antineuronal antibodies in the context of paraneoplastic syndrome. Treating the tumor can solve psychiatric symptoms better than psychotic treatment. Conclusions: The aim of our study is to highlight the importance of a complete medical evaluation to identify the psychiatric presentations of organic disorders associated with psychiatric manifestation and to ensure an early diagnosis.

Incidence of treatment-resistant depression during the first mood depressive episode.

INTRODUCTION: In spite of several approaches and therapeutic measures, treatment-resistant depression (TRD) continues to inflict serious, individual and collective consequences. Therefore, there is a persistent need to scrutinize the concept of TRD in order to adapt the therapeutic strategies. AIM: To estimate the incidence of TRD in patients with a first major depressive episode (MDD), and study factors associated with resistance. METHODS: A descriptive prospective longitudinal study of outpatients with a first MDD, was conducted. Patients with a history of subthreshold hypomania were excluded. Eligible patients were put on a selective serotonin reuptake inhibitor (SSRI), either fluoxetine or sertraline. Participants were followed regularly until they had a therapeutic response or they met the criteria for TRD. RESULTS: The study involved 82 adults. The incidence of treatment-resistant depression was 19.4% CI95%=[5.5-33.3]. Among the sociodemographic and clinical factors, family history of psychosis (p=0.038) and chronic respiratory comorbidities (p=0.016) were associated with TRD. The small size of the sample is a potential limitation of this study. Besides, the use of only two SSRIs could influence the results. CONCLUSION: In this study, the incidence of TRD was at the lower limit of the rates reported in clinical studies. Clinical factors associated with TRD suggest the relevance of genotype analysis to identify patients with TRD. Furthermore, our results highlight the importance of heeding comorbidities to optimize care. Larger multicenter studies are needed to generalize.

Psychiatric disturbances in idiopathic epilepsy.

INTRODUCTION: The relationship between epilepsy and psychiatric disorders has been highlighted for a long time. Idiopathic epilepsy is known to have a benign course in most cases. However, the association of psychiatric disturbances could worsen the disease outcome. AIM: To study the frequency of psychiatric symptoms in patients with idiopathic epilepsy, and to assess the determinant factors in the patient group with these manifestations. METHODS: In one-year prospective study, consecutive patients diagnosed with idiopathic epilepsy were included. Those with a known psychiatric follow-up or with post ictal psychiatric disturbances were excluded. Psychiatric symptoms were evaluated with the Neurological Disorders Depression Inventory for Epilepsy, the Generalized Anxiety Disorder - 7 and the Neuropsychiatric Inventory Scale. Demographic and clinical data were collected and analyzed. RESULTS: Among 101 consecutive patients with idiopathic epilepsy, psychiatric symptoms were diagnosed in 61% of them. Anxiety (36.6%), psychotic features (21%) and depression (15.8 %) were the most commonly found psychiatric manifestations. Female gender (p < 10-3) and longer duration of epilepsy (p = 0.046) were significantly associated with occurrence of psychiatric disturbances. Patients under Carbamazepine and Valproic acid showed a lower frequency of depression (respectively p = 0.018 and p = 0.003). CONCLUSIONS: Occurrence of psychiatric disturbances was frequent in idiopathic epilepsy, with psychotic manifestations and anxiety being the most common of them. Female gender and long disease course were the main determining factors of psychiatric manifestations and should be considered in management of idiopathic epilepsy.

Reducing stigma and improving access to care for people with mental health conditions in the community: protocol for a multi-site feasibility intervention study (Indigo-Local).

Background: Stigma and discrimination towards people with mental health conditions by their communities are common worldwide. This can result in a range of negative outcomes for affected persons, including poor access to health care. However, evidence is still patchy from low- and middle-income countries (LMICs) on affordable, community-based interventions to reduce mental health-related stigma and to improve access to mental health care. Methods: This study aims to conduct a feasibility (proof-of-principle) pilot study that involves developing, implementing and evaluating a community-based, multi-component, public awareness-raising intervention (titled Indigo-Local), designed to reduce stigma and discrimination and to increase referrals of people with mental health conditions for assessment and treatment. It is being piloted in five LMICs - China, Ethiopia, India, Nepal and Tunisia - and includes several key components: a stakeholder group workshop; a stepped training programme (using a 'Training of Trainers' approach) of community health workers (or similar cadres of workers) and service users that includes repeated supervision and booster sessions; awareness-raising activities in the community; and a media campaign. Social contact and service user involvement are instrumental to all components. The intervention is being evaluated through a mixed-methods pre-post study design that involves quantitative assessment of stigma outcomes measuring knowledge, attitudes and (discriminatory) behaviour; quantitative evaluation of mental health service utilization rates (where feasible in sites); qualitative exploration of the potential effectiveness and impact of the Indigo-Local intervention; a process evaluation; implementation evaluation; and an evaluation of implementation costs. Discussion: The outcome of this study will be contextually adapted, evidence-based interventions to reduce mental health-related stigma in local communities in five LMICs to achieve improved access to healthcare. We will have replicable models of how to involve people with lived experience as an integral part of the intervention and will produce knowledge of how intervention content and implementation strategies vary across settings. The interventions and their delivery will be refined to be acceptable, feasible and ready for larger-scale implementation and evaluation. This study thereby has the potential to make an important contribution to the evidence base on what works to reduce mental health-related stigma and discrimination and improve access to health care.