Primary Care Intervention for PTSD in Ethiopia

Not Applicable

Completed

• Conditions: PTSD

• Registration Number: NCT04385498
• Lead Sponsor: University of California, Los Angeles

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-13
• Study Start: 2023-06-01
• Primary Completion: 2023-10-20
• Study Completion: 2023-10-20
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-01
• Last Update Posted: 2025-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. For all participants: Being 18 years of age or older

2. For all participants: Being able and willing to provide informed consent to participate in the study

3. For all participants: Being 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:

   1. Experienced a traumatic event,
   2. Associated PTSD symptoms defined as scores on the PTSD Checklist DSM-5 (PCL-5), AND
   3. any associated functional impairment on the WHODAS-2.

6. For health care providers: Providers working at the target health centers who administer, provider care for, or supervise the care of patients with mental health concerns.

7. For caregivers: Being 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 the treatment, as determined by the psychiatric nurse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in PTSD Related Stigma	Day 0 baseline, 3 months	Changes in levels of PTSD Related Stigma measured by The Internalized Stigma of Mental Illness Scale (1 minimal stigma to 4 severe internalized stigma).
Change in Trauma-related cognitions	Day 0 baseline, 3 months	Changes in levels of trauma-related cognitions assessed by the Post-Traumatic Cognitions Inventory (36-252 higher scores indicating higher incidence of negative trauma related cognitions).
Change in Self-reported arousal	Day 0 baseline, 3 months	Changes in self-reported arousal levels measured with Self-Assessment Manikin (Self-Assessment Manikin measures arousal using 3 subscales: Valence, 1 unpleasant to 5 pleasant; Arousal rating, 1 calm to 5 excited; and Dominance, 1 independent to 5 dependent).
Change in Physiological arousal	Day 0 baseline, 3 months	Changes in physiological arousal levels measured by heart rate variability (HRV).
Change in PTSD Knowledge	Day 0 baseline, 3 months	Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge).
Change in Stress management strategy use	Day 0 baseline, 3 months	Changes in use of the breathing retraining techniques as measured by self- and caregiver-reports during in-session homework review.

Secondary Outcome Measures

Name	Time	Method
Change in PTSD Symptoms	Day 0 baseline, 3 months	Changes in PTSD symptoms measured by the PTSD Checklist for Diagnostic Statistical Manual-5 (DSM-5; 0-80 higher scores indicating more severe symptoms).
Change in Depression Symptoms	Day 0 baseline, 3 months	Changes in depression symptoms measured by the Patient Health Questionnaire (PHQ-9; 0-27 with higher scores indicating more severe depression).
Change in Anxiety Symptoms	Day 0 baseline, 3 months	Changes in anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7; 0-21 with higher scores indicating more severe anxiety).
Change in Functional impairment	Day 0 baseline, 3 months	Changes in functional impairment assessed by the WHO Disability Assessment Schedule II (WHODAS 2.0; 0-48 with high scores indicating more severe functional impairment).

Trial Locations

Locations (1)

Addis Ababa University; 🇪🇹 Addis Ababa, Ethiopia