# Protocol for an Exploratory RCT of the Traumatic Stress Relief Intervention With Persons With Lived Experience of Leprosy in Addis Ababa, Ethiopia

## TL;DR

This study will test a mental health intervention for people in Ethiopia who have experienced leprosy to reduce trauma, anxiety, and depression.

## Contribution

The study introduces a novel mental health intervention using the TSR program for individuals with leprosy in Ethiopia.

## Key findings

- The TSR intervention will be evaluated for its effectiveness in reducing PTSD symptoms.
- Interviews will assess the acceptability of the intervention among participants.
- Results will guide future large-scale mental health programs for NTD-affected populations.

## Abstract

Objectives: Neglected tropical diseases (NTDs), such as leprosy, significantly impact mental health and overall well-being. This study aims to evaluate the effectiveness and acceptability of a mental health intervention targeting individuals affected by leprosy in Ethiopia. The intervention utilizes the Traumatic Stress Relief (TSR) program to target symptoms of posttraumatic stress disorder (PTSD), anxiety, and depression, and to improve overall mental health.

Methods: This exploratory randomized controlled trial (RCT) will recruit participants with lived experiences of leprosy. Participants will receive four group sessions of a low-intensity TSR intervention. The intervention will be administered by a pair of trained facilitators, including one mental health practitioner and one community member with lived experience of leprosy. Data will be collected through self-report questionnaires to assess changes in PTSD symptoms, anxiety, and depression. In addition, interviews will provide further insights into participants' experiences and the acceptability of the intervention.

Discussion: This exploratory trial will provide insights into the feasibility of mental health interventions for individuals affected by leprosy. The findings will inform the design of future trials to evaluate the effectiveness of such programs on a larger scale and in more diverse contexts.

Trial Registration: The UK's Clinical Study Registry: ISRCTN868254411