Primary Care Intervention for PTSD in Ethiopia

PTSD Clinical Trial

Official title: Posttraumatic Stress Disorder Intervention for People With Severe Mental Illness in Low- and Middle-Income Country Primary Care Settings

Status Enrolling by invitation

Clinical Trial Summary

Mixed methods (qualitative and quantitative) cluster randomized pilot feasibility trial (n=40) to refine the the Brief Relaxation, Education and Trauma Healing (BREATHE) Ethiopia intervention and explore effectiveness and implementation. Fifty patients will be enrolled across the pre-pilot and the pilot to account for potential treatment dropout. Eight health care centers will be randomized to Treatment or Waitlist conditions.

1. Primary outcomes: Change in hypothesized treatment mechanisms: (1) increased knowledge about PTSD; reductions in (2) PTSD-related stigma; (3) trauma-related cognitions; and (4) self-reported arousal; (5) increased use of stress management strategies; and (6) reductions in physiological arousal as measured by increased heart rate variability.

2. Secondary outcomes: Change in symptoms and functional impairment. Reductions in (1) PTSD (2) depression and anxiety symptoms, and (3) functional impairment.

3. Process evaluation: Mixed methods multi-stakeholder process evaluation of the implementation of the intervention as measured by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). We will collect qualitative data on Adoption and Implementation (e.g. facilitators and barriers to intervention delivery) and quantitative assessment of patient and provider participation and retention (Reach), satisfaction (Adoption) and fidelity (Implementation).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• PTSD

• NCT number: NCT04385498
• Study type: Interventional
• Source: University of California, Los Angeles
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2022
• Completion date: December 2024