NCT06979193: SAATHI

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

Active, enrolled NA Last updated 18 February 2026

What this trial tests

NA trial testing SAATHI intervention (Augmented PM+ counseling) in Mental Health in 960 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

20 May 2025

Primary endpoint
31 December 2026

30 April 2027

Quick facts

Lead sponsor	Public Health and Environment Research Centre (PERC), Nepal
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	960
Start date	20 May 2025
Primary completion	31 December 2026
Estimated completion	30 April 2027
Sites	6 locations across Nepal

Drugs / interventions tested

• SAATHI intervention (Augmented PM+ counseling)
• SAATHI intervention with Peer-Led Group Meetings

Conditions studied

• Mental Health — all drugs for Mental Health →
• Psychological Distress — all drugs for Psychological Distress →
• Secondary Violence Reduction — all drugs for Secondary Violence Reduction →
• Discrimination — all drugs for Discrimination →

Sponsor

Public Health and Environment Research Centre (PERC), Nepal

Who can join

Adults 18 to 55, any sex, with Mental Health or Psychological Distress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.