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Addressing leprosy trauma using the traumatic stress relief programme: an exploratory trial with persons with lived experience in Addis Ababa, Ethiopia

An exploratory trial evaluating the traumatic stress relief programme in individuals with leprosy in Addis Ababa, Ethiopia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN86825441
Enrollment
100
Registered
2024-09-05
Start date
2024-11-01
Completion date
Unknown
Last updated
2025-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leprosy related trauma and mental health difficulties Mental and Behavioural Disorders

Interventions

The study employs a randomized controlled trial design to evaluate the effectiveness of the Traumatic Stress Relief (TSR) intervention for individuals affected by leprosy in Addis Ababa, Ethiopia. The

Sponsors

Leprosy Research Initiative
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. A lived experience of leprosy 2. Aged 18 years old and over 3. Able to provide informed consent, indicating they understand the study's purpose, procedures, and potential risks 4. Reside in or have access to the study site in Addis Ababa, Ethiopia, for the duration of the intervention 5. Able to understand and communicate in Amharic

Exclusion criteria

Exclusion criteria: 1. Individuals who do not have a lived experience of leprosy will be excluded from the study 2. Aged under 18 years old 3. Unable to provide informed consent due to cognitive or other impairments will be excluded. Informed consent must indicate an understanding of the study's purpose, procedures, and potential risks. 4. Do not reside in or have access to the study site in Addis Ababa, Ethiopia 5. Unable to understand and communicate in Amharic will be excluded, as this is necessary for effective participation in the study

Design outcomes

Primary

MeasureTime frame
Level of traumatic stress measured using the International Trauma Questionnaire (ITQ) before and after the sessions

Secondary

MeasureTime frame
1. The severity of depressive symptoms and overall mental health measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline and immediately post-intervention 2. The severity of anxiety symptoms measured using the Generalized Anxiety Disorder-7 (GAD-7) at baseline and immediately post-intervention 3. Quality of Life measured using the EQ-5D-5L (EuroQol Five-Dimensional Scale), including participants' mobility, self-care, usual activities, pain/discomfort, and anxiety/depression at baseline 4. The level of social support and the extent of participants' social networks measured using the Oslo Social Support Scale (OSSS-3) at baseline 5. Perceived stigma associated with having leprosy measured using the 5-Question Stigma Indicator - Affected People (5-QSI-AP) at baseline 6. Participants' perceptions of the acceptability and feasibility of the Traumatic Stress Relief Programme measured using the TFA Acceptability Questionnaire immediately post-intervention

Countries

Ethiopia

Contacts

Public ContactSafa Kemal Kaptan
safa.kaptan@bogazici.edu.tr+90 212 359 73 24

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026