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

NCT06979193 | Active Not Recruiting DMC

• 1 other identifier: 398_2024
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Keywords

Problem Management Plus; LGBTIQA+; Mental Health Services; RCT; Nepal; Peer Counseling; Violence Prevention; Psychological Support; Participatory Research

Outcome Measures

Primary Outcomes (2)

• General Health Questionnaire (GHQ-12)

  The General Health Questionnaire (GHQ-12) will be used to assess psychological distress among study participants. The GHQ-12 consists of 12-items and, when scored using the Likert method, resulting in a total score ranging from 0 to 36, with higher scores indicate greater levels of psychological distress. Participants will be asked to reflect on their experiences over the past two weeks. The mean score will be used as a measure of mental distress.

  Baseline Assessment; Follow up at 47 weeks after SAATHI counselling completion (53 weeks after baseline assessment). Note: This variable will also be assessed as a secondary outcome at 7 weeks and 18 weeks after baseline.

• Experience of violence

  Experience of violence will be measured using a modified version of WHO multi-country questionnaire on women's health and domestic violence. The adapted tool assesses the prevalence and type of violence experienced by study participants at different time points. This will be measured as a binary variable with the value 1 if a participant has experienced any type of violence in the specified recall period, and 0 if they have not experienced any recent violence. The following categories are included in the definition of violence: controlling behaviors, psychological violence, physical violence, and sexual violence. The recall period for experience of violence at baseline will be the past 12 months. Changes in the experience of violence at follow-up assessments will be measured relative to baseline.

  Baseline Assessment; Follow up at 53 weeks after baseline assessment. Note: Experiences of violence (type-specific violence and severity/high-intensity violence) as a secondary outcome will be assessed at 18 weeks and at 12 months.

Secondary Outcomes (8)

• Post-Traumatic Stress Disorder Symptoms (PCL-5)

  Baseline Assessment; Follow up at one-week post-counselling (7 weeks after baseline); Follow up at 47 weeks post-counselling (53 weeks after baseline)

• Daily functioning (WHODAS 2.0- 12-item version)

  Baseline Assessment; Follow up at 12 weeks post-counselling (18 weeks after baseline); Follow up at 47 weeks post-counselling (53 weeks after baseline)

• Modified Collective Self-Esteem Scale

  Baseline Assessment; Follow up at 12 weeks post-counselling (18 weeks after baseline); Follow up at 47 weeks after PM+ counselling completion (53 weeks after baseline assessment).

• Neff's Self-Compassion Scale (Short- form)

  Baseline Assessment; Follow up at 12 weeks post-counselling (18 weeks after baseline); Follow up at 47 weeks after PM+ counselling completion (53 weeks after baseline assessment).

• MOS Modified Social Support Survey- Five Item Version (MSSS-5)

  Baseline Assessment; Follow up at 47 weeks post-counselling (53 weeks after baseline).

Other Outcomes (3)

• Perceived feasibility and acceptability of SAATHI intervention (Augmented PM+ Model)

  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).

• Process evaluation of SAATHI intervention (Augmented PM+ Model)

  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.

• Evaluation of Competency-Based Training for Peer Providers of the SAATHI intervention (Augmented PM+ Model)

  This evaluation will be conducted both before and after the competency-based training of LGBTIQA+ peers.

Study Arms (3)

Control Arm (Arm 1)- Usual Standard Care

NO INTERVENTION

Standard care includes all available mental health and violence prevention services in the study area. If participants are found to have severe psychological distress or are at risk of suicide at any time during the study, they will be referred to a mental health professional. The study team includes psychiatrists and psychosocial counselors who will be available to provide remote counseling or in-person consultations, if needed. If free services are not available, the study will arrange appointments, cover consultation fees, and support travel costs for up to five sessions. A leaflet with mental health information, practical tips, and contact details for support organizations (including 24-hour suicide prevention hotlines) will be provided. Participants will also be referred to One Stop Crisis Management Centers for counseling, medical treatment, and legal support for survivors of violence.

Arm 2- SAATHI intervention (Augmented PM+ counseling)

EXPERIMENTAL

In addition to standard care, participants in the SAATHI intervention (Arm 2) will receive peer-led augmented Problem Management Plus (PM+) counseling, along with safety planning.

Behavioral: SAATHI intervention (Augmented PM+ counseling)

Arm 3- SAATHI intervention with Peer-Led Group Meetings

EXPERIMENTAL

Participants in Intervention Arm 3 will receive the same counselling as those in Arm 2, consisting of six weekly peer-led sessions. In addition, they will take part in 11 monthly peer-led group support meetings.

Behavioral: SAATHI intervention with Peer-Led Group Meetings

Interventions

SAATHI intervention (Augmented PM+ counseling) BEHAVIORAL

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.

Arm 2- SAATHI intervention (Augmented PM+ counseling)

SAATHI intervention with Peer-Led Group Meetings BEHAVIORAL

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.

Arm 3- SAATHI intervention with Peer-Led Group Meetings

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Public Health and Environment Research Centre (PERC), Nepal: lead
• Department of Global Public Health and Primary Care, University of Bergen: collaborator
• Blue Diamond Society, Nepal: collaborator
• Sahayatri Samaj, Parsa: collaborator
• Friends Hetauda, Makwanpur: collaborator
• Pahichan Nepal, Sarlahi: collaborator
• Manab Sachet Samaj, Chitwan: collaborator
• Sunaulo Bihani Samaj, Dhanusha: collaborator
• CruiseAIDS Nepal, Kathmandu: collaborator
• Parichaya Samaj, Lalitpur: collaborator

Study Sites (6)

SAATHI Program Chitwan site

Chitwan, Bagmati, Nepal

Location

SAATHI Program Kathmandu and Lalitpur site

Kathmandu, Bagmati, Nepal

Location

SAATHI Program Makwanpur site

Makwanpur, Bagmati, Nepal

Location

SAATHI Program Dhanusha site

Dhanusha, Madhesh, Nepal

Location

SAATHI Program Parsa site

Parsa, Madhesh, Nepal

Location

SAATHI Program Sarlahi site

Sarlahi, Madhesh, Nepal

Location

MeSH Terms

Conditions

Psychological Well-Being; Coitus; Homosexuality

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Sexual Behavior; Sexuality

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 18, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: January 2031-December 2031
• Access Criteria: 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.

Locations

NE (6)