Clinical trial NCT06979193: Peer Counselling to Reduce Psychological Distress and Exposure to Violence Among Sexual and Gender Minorities
Official title: Effectiveness of Peer Counseling in Addressing Psychological Distress and Exposure to Violence Among LGBTIQA+ Population in Nepal: A Three-arm Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health
Psychological Distress
Secondary Violence Reduction
Discrimination
Sexual and Gender Minorities
Minority Groups
Homosexuality
Domestic Violence
Gender Based Violence
Keywords: Problem Management Plus
LGBTIQA+
Mental Health Services
RCT
Nepal
Peer Counseling
Violence Prevention
Psychological Support
Participatory Research
Lead sponsor: Public Health and Environment Research Centre (PERC), Nepal
Sponsor class: OTHER
Collaborators: name: Department of Global Public Health and Primary Care, University of Bergen
name: Blue Diamond Society, Nepal
name: Sahayatri Samaj, Parsa
name: Friends Hetauda, Makwanpur
name: Pahichan Nepal, Sarlahi
name: Manab Sachet Samaj, Chitwan
name: Sunaulo Bihani Samaj, Dhanusha
name: CruiseAIDS Nepal, Kathmandu
name: Parichaya Samaj, Lalitpur
First posted: 2025-05-18
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants will be randomly assigned to one of the three arms. The control arm (Arm 1) will receive standard care, whereas the second intervention arm (Arm 2) will receive six weekly counselling sessions (approximately 90 minutes each) on Problem Management Plus strategies, safety planning, and empowerment-based counselling. The third intervention arm (Arm 3) will receive the same counseling as Arm 2, along with 11 additional monthly group meetings to enhance social support. Participants will be followed for one year to assess the outcomes of interest.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: General Health Questionnaire (GHQ-12)
timeFrame: Baseline Assessment; Follow up 1 at one-week post-counselling (7 weeks after baseline); Follow up 2 at 12 weeks post-counselling (18 weeks after baseline); Follow up 3 at 47 weeks after PM+ counselling completion (53 weeks after baseline assessment).
measure: Experience of violence
timeFrame: Baseline Assessment; Follow up 1 at one-week post-counselling (7 weeks after baseline); Follow up 2 at 12 weeks post-counselling (18 weeks after baseline); Follow up 3 at 47 weeks after PM+ counselling completion (53 weeks after baseline assessment).
Secondary outcomes:
measure: Post-Traumatic Stress Disorder Symptoms (PCL-5)
timeFrame: Baseline Assessment; Follow up 1 at one-week post-counselling (7 weeks after baseline); Follow up 2 at 12 weeks post-counselling (18 weeks after baseline)
measure: Daily functioning (WHODAS 2.0- 12-item version)
timeFrame: Baseline Assessment; Follow up 1 at one-week post-counselling (7 weeks after baseline); Follow up 2 at 12 weeks post-counselling (18 weeks after baseline)
measure: Modified Collective Self-Esteem Scale
timeFrame: Baseline Assessment; Follow up 1 at one-week post-counselling (7 weeks after baseline); Follow up 2 at 12 weeks post-counselling (18 weeks after baseline); Follow up 3 at 47 weeks after PM+ counselling completion (53 weeks after baseline assessment).
measure: Neff's Self-Compassion Scale (Short- form)
timeFrame: Baseline Assessment; Follow up 1 at one-week post-counselling (7 weeks after baseline); Follow up 2 at 12 weeks post-counselling (18 weeks after baseline); Follow up 3 at 47 weeks after PM+ counselling completion (53 weeks after baseline assessment).
measure: MOS Modified Social Support Survey- Five Item Version (MSSS-5)
timeFrame: Baseline Assessment; Follow up 1 at one-week post-counselling (7 weeks after baseline); Follow up 2 at 12 weeks post-counselling (18 weeks after baseline).
measure: Modified Safety Planning Checklist
timeFrame: Baseline Assessment; Follow up 1 at one-week post-counselling (7 weeks after baseline); Follow up 2 at 12 weeks post-counselling (18 weeks after baseline); Follow up 3 at 47 weeks after PM+ counselling completion (53 weeks after baseline assessment).
measure: Use of Community Resources
timeFrame: Baseline Assessment; Follow up 1 at one-week post-counselling (7 weeks after baseline); Follow up 2 at 12 weeks post-counselling (18 weeks after baseline); Follow up 3 at 47 weeks after PM+ counselling completion (53 weeks after baseline assessment).
Other outcomes:
measure: Perceived feasibility and acceptability of SAATHI intervention (Augmented PM+ Model)
timeFrame: This measure will be assessed before the trial begins and throughout the trial period, up to the final follow up (Follow up 3) at 47 weeks after post-counselling (53 weeks after baseline assessment).
measure: Process evaluation of SAATHI intervention (Augmented PM+ Model)
timeFrame: Process evaluation activities will be conducted throughout the intervention delivery period, and up to the final follow-up at 53 weeks after baseline assessment. Interim findings may be used to refine ongoing implementation.
measure: Evaluation of Competency-Based Training for Peer Providers of the SAATHI intervention (Augmented PM+ Model)
timeFrame: This evaluation will be conducted before and after the competency-based training of LGBTIQA+ peers, prior to the implementation of the SAATHI intervention in the field.
Locations:
Study officials:
References: