NCT06979193

Peer Counselling to Reduce Psychological Distress and Exposure to Violence Among Sexual and Gender Minorities

Effectiveness of Peer Counseling in Addressing Psychological Distress and Exposure to Violence Among LGBTIQA+ Population in Nepal: A Three-arm Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 960 (estimated)
• Sponsor: Public Health and Environment Research Centre (PERC), Nepal · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Mental Health
• Psychological Distress
• Secondary Violence Reduction
• Discrimination
• Sexual and Gender Minorities
• Minority Groups
• Homosexuality
• Domestic Violence
• Gender Based Violence

Interventions

Type	Name	Description
BEHAVIORAL	SAATHI intervention (Augmented PM+ counseling)	Study participants in this arm will attend six weekly peer-led sessions, each approximately 90-minutes in length, designed to empower them to make decisions about their lives and build resilience. PM+ is a psychological intervention developed by the World Health Organization, based on principles of cognitive behavioural therapy. It includes components such as understanding adversity and psychoeducation on mental health, managing stress, problem-solving, behavioural activation, and strengthening social support. The PM+ model in this study is augmented with additional elements, including self-empowerment strategies, motivational interviewing, psychoeducation on intimate partner and community violence, mindful meditation and safety planning. Participants will also be introduced to best practices and lessons learned that support danger assessments and avoidance of risk of future violence. The intervention aims to improve participants' overall circumstances and mental well-being.
BEHAVIORAL	SAATHI intervention with Peer-Led Group Meetings	These 11-monthly peer-led group sessions are designed to enhance social support, build resilience, and reinforce the application of augmented PM+ strategies in daily life. They provide a safe space for reflection and mutual encouragement among study participants. The group sessions focus on managing stress, strengthening self-regulation, building self-esteem, fostering social connectedness, and promoting positive identity development. Group sessions involve identifying and discussing the barriers and facilitators related to practicing slow breathing techniques, problem-solving strategies, maintaining physical activity, navigating intimate partner and community violence, understanding social support networks, and planning for safety in various situations faced by sexual and gender minorities.

Timeline

• Start date: 2025-05-20
• Primary completion: 2026-12-31
• Completion: 2027-04-30
• First posted: 2025-05-18
• Last updated: 2026-02-18

Locations

6 sites across 1 country: Nepal