Lesbian, Gay, Bisexual, Transgender, Intersex, Queer, Asexual, and other sexually or gender diverse (LGBTIQA+) communities in many countries face high levels of mental health problems compared to the general population. This is often due to discrimination, being excluded, abuse, and unfair treatment. In many low- and middle-income countries, including Nepal, the mental health needs of LGBTIQA+ people are not met, and the violence they experience is often ignored because they are seen as breaking gender norms. The low number of trained mental health specialists in a country like Nepal imply that any short-term effort to alleviate the mental health problems among LGBTIQA+ must rely on other type of support workers such as peers. There is growing evidence that help from community members-such as counselling given by non-professionals-can improve mental well-being. Considering that discrimination of LGBTIQA+ is common also within the health services, this study will look at whether peer counselling-support provided by trained LGBTIQA+ community members-can work well in Nepal. We have improved a counselling program called 'Problem Management Plus' (PM+), developed by the World Health Organization, by adding new parts that focus on reducing the risk of some of the contributing causes of mental distress, namely violence, marginalisation and loneliness. The added components include safety planning, counselling that builds confidence and strength, and goal setting strategies to help study participants use the skills they learn and reach the desired impact. In addition, peer-led monthly group meetings will be conducted to enhance social cohesion, strengthen interpersonal networks, and reduce feeling of loneliness. The study uses a community based participatory research approach, meaning LGBTIQA+ people are invited to give inputs throughout the study from study design to being involved as peer advocates to deliver the counselling. The trial will recruit at least 960 LGBTIQA+ individuals aged 18 to 55 years living in seven districts of Nepal. Study participants will be randomly allocated to one of three arms: one arm receiving individual augmented PM+ counselling with six weekly sessions; one arm receiving the individual augmented PM+ counselling followed by 11 monthly group sessions; and one control arm. There will be a one year follow-up to examine whether the peer support helps improve mental health and reduce exposure to violence among LGBTIQA+ people. The study findings will help guide programmes to improve the mental health of LGBTIQA+ in other low- and middle-income countries where they also experience discrimination, exclusion, and violence.

Sexual and gender minorities, including Lesbian, Gay, Bisexual, Transgender, Intersex, Queer, Asexual and other sexually or gender diverse (LGBTIQA+) individuals, disproportionately experience social stressors such as discriminatory attitudes, violence, prejudice, and stigmatization. This environment leads to negative health outcomes, including physical ailments and risky health-related behaviors (e.g., smoking, drug abuse, and inconsistent condom usage), as well as mental health problems, ultimately impacting the overall well-being of these vulnerable groups. LGBTIQA+ individuals often anticipate rejection and discrimination from the majority population, which leads to constant vigilance, identity concealment, and self-stigma. These factors negatively affect self-acceptance and exacerbate psychological distress. Despite the high burden of violence and mental illness, LGBTIQA+ individuals tend to use health services less frequently than the majority population in many countries. This is due to fears of discrimination also from health professionals and prior experiences of disrespectful treatment and poor communication. To meet the violence prevention and mental health needs of LGBTIQA+ individuals in low- and middle-income countries (LMICs) and reduce health inequalities, culturally relevant, low-cost interventions that do not require highly trained professionals are needed.

The overall objective of this trial is to evaluate the effectiveness of a multicomponent intervention (SAATHI) in reducing exposure to violence and psychological distress among LGBTIQA+ people in Nepal. This project utilizes a mixed-method research design, and the trial had been preceded by formative research with qualitative interviews and focus group discussions with key stakeholders to evaluate the feasibility and acceptability of the intervention package. The three-armed randomized controlled trial will be implemented in seven districts across two provinces in Nepal. A qualitative process evaluation will be conducted during the intervention delivery.

We will enroll at least 960 LGBTIQA+ participants in the trial. The inclusion criteria are: age 18-55 years, history of surviving violence in the previous 12 months, and a score of ≥3 on the General Health Questionnaire indicating psychological distress.

The participants allocated to the two intervention arms will receive six weekly 90-minute counseling sessions covering multiple topics. The counselling aims to mitigate the psychological effects of trauma and moderate the impacts of a stressful, coercive, and threatening environment by altering individuals' appraisal of stressful events, modify coping patterns, and promote self-regulation, self-esteem, and positive feelings about LGBTIQA+ identity. In one of the intervention arms the participants will also be invited to 11 monthly group sessions after the individual counselling to enhance social support and social cohesiveness. The counselling and the group sessions will be offered by peer advocates who have received a 10-day training in counselling and group facilitation.

The trial participants will be followed up for one year to assess changes in exposure to violence and mental health status. The primary outcome will be GHQ-12 score. The effectiveness analysis will be based on intention-to-treat principles. The intervention effects on outcomes will be assessed using mean differences for continuous outcomes and risk ratios and absolute risk differences for binary variables.

The qualitative analysis of data from the formative research and intervention delivery will be based on Reflexive Thematic Analysis, grounded in critical realist/contextualist ontology, where interviewees' experiences are understood as lived realities produced and existing within broader social contexts.

By addressing mental health distress, discrimination and violence through a culturally sensitive and community-driven approach, this study aims to contribute to the reduction of health disparities and the improvement of health and well-being among LGBTIQA+ individuals in Nepal.

Inclusion Criteria:

• Self-identify as a member of the LGBTIQA+ community
• Aged 18 to 55 years
• Have a history of exposure to any form of violence (physical, sexual, or psychological) within the past 12 months
• Exhibit psychological distress, defined as a score of more than or equal to 3 on the General Health Questionnaire (GHQ-12)

Exclusion Criteria:

• Express current suicidal ideation or plans to end their life
• Meet diagnostic criteria for substance use disorders, including alcohol or drug dependence
• Have severe functional impairment due to a mental, neurological, or developmental disorder (e.g., severe intellectual disability, dementia, or psychosis)
• Decline or are unable to provide informed consent
• Intend to relocate from the study districts or move outside the country within the next few months

This study evaluates the effectiveness of a psychosocial intervention among a highly vulnerable and marginalized population-sexual and gender minorities-who experience daily abuse, discrimination, and marginalization in Nepalese society. The study collects sensitive data, including mental health status, exposure to violence, and related psychosocial factors.

To protect participants privacy, a de-identified dataset will be shared only after the publication of findings related to primary and secondary outcomes. The shared dataset will exclude identifying variables such as age, study district, and gender identity.

January 2031-December 2031

Collaborators and qualified independent researchers may request access to the de-identified individual participant data and supporting documentation (e.g., codebooks and analysis plan) by submitting reasonable written request to the principal investigator (PI). Contact information will be provided in the scientific publications associated with the study.

The outcome assessors will be independent from the intervention team and will not be involved in delivering the intervention. They will be masked to participant's group assignment in order to reduce bias, ensure objective data collection, and minimize measurement bias during the assessment of study outcomes.