NCT04385498 2020.

Study name	Primary care intervention for PTSD in Ethiopia
Methods	Randomised controlled trial
Participants	Inclusion criteria 1. For all participants: 18 years of age or older 2. For all participants: able and willing to provide informed consent to participate in the study 3. For all participants: able to complete procedures in Amharic or English 4. For patients: treatment at a Sodo district primary care clinic for severe mental illness (SMI) 5. For patients: identified as having: a. Experienced a traumatic event, b. Associated PTSD symptoms defined as scores on the PTSD Checklist DSM‐5 (PCL‐5), AND c. Any associated functional impairment on the WHODAS‐2 6. For healthcare providers: providers working at target health centres who administer, provide care for, or supervise the care of patients with mental health concerns 7. For caregivers: identified by the patient as a close family member or friend whom the patient gives permission to be involved in the study Exclusion criteria 1. Current high risk of suicide as measured by the Composite International Diagnostic Interview (CIDI) Suicide module 2. Inability to participate in treatment, as determined by the psychiatric nurse
Interventions	Intervention BREATHE Intervention Five 20 to 30‐minute sessions focusing on breathing re‐training, psychoeducation, and positive coping, with additional sessions as needed Control Treatment as usual Typical primary care treatment including medication management and follow‐up
Outcomes	Primary outcomes 1. Change in PTSD Knowledge Test score [Time Frame: Day 0 baseline, 3 months] 2. Change in PTSD Related Stigma measured by the Internalized Stigma of Mental Illness Scale [Time Frame: Day 0 baseline, 3 months] 3. Change in trauma‐related cognitions assessed by the Post‐Traumatic Cognitions Inventory [Time Frame: Day 0 baseline, 3 months] 4. Change in self‐reported arousal measured with Self‐Assessment Manikin [Time Frame: Day 0 baseline, 3 months] 5. Change in stress management strategy use as measured by self‐ and caregiver reports [Time Frame: Day 0 baseline, 3 months] 6. Change in physiological arousal measured by heart rate variability (HRV) [Time Frame: Day 0 baseline, 3 months] Secondary outcomes 1. Change in PTSD symptoms measured by the PTSD Checklist for Diagnostic Statistical Manual‐5 [Time Frame: Day 0 baseline, 3 months] 2. Change in depression symptoms measured by the Patient Health Questionnaire [Time Frame: Day 0 baseline, 3 months] 3. Change in anxiety symptoms measured by the Generalized Anxiety Disorder‐7 [Time Frame: Day 0 baseline, 3 months] 4. Change in functional impairment assessed by the WHO Disability Assessment Schedule II [Time Frame: Day 0 baseline, 3 months]
Starting date	Estimated start date: December 2020
Contact information	laurenng@ucla.edu abebaw.fekadu@aau.edu.et
Notes