Primary Care Intervention for PTSD in Ethiopia

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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: PTSD
• Intervention / Treatment: Behavioral: BREATHE Intervention; Behavioral: Waitlist Treatment as Usual

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia
    • Addis Ababa University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BREATHE Intervention; Five session program, with additional sessions provided based on the individual's learning style and needs. Sessions are designed to be 20 to 30 minutes long, to accommodate the needs of the primary health care centers. Sessions will ideally be conducted once per week, but may be conducted as infrequently as once per month.	Behavioral: BREATHE Intervention; 5 session program focusing on breathing retraining, psychoeducation, and positive coping.; Other Names: BREATHE Ethiopia
Active Comparator: Waitlist Treatment as Usual; Typical primary care treatment which will include medication management and follow-up at the health facilities, at at least the same frequency as treatment arm. At the End of the trial participants will be able to receive the BREATHE Ethiopia PTSD treatment	Behavioral: Waitlist Treatment as Usual; Typical primary care treatment which will include medication management and follow-up at the health facilities, at at least the same frequency as treatment arm. At the end of the trial Participants will be able to receive the BREATHE Ethiopia treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PTSD Knowledge	Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge).	Day 0 baseline, 3 months
Change in PTSD Related Stigma	Changes in levels of PTSD Related Stigma measured by The Internalized Stigma of Mental Illness Scale (1 minimal stigma to 4 severe internalized stigma).	Day 0 baseline, 3 months
Change in Trauma-related cognitions	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).	Day 0 baseline, 3 months
Change in Self-reported arousal	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).	Day 0 baseline, 3 months
Change in Stress management strategy use	Changes in use of the breathing retraining techniques as measured by self- and caregiver-reports during in-session homework review.	Day 0 baseline, 3 months
Change in Physiological arousal	Changes in physiological arousal levels measured by heart rate variability (HRV).	Day 0 baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PTSD Symptoms	Changes in PTSD symptoms measured by the PTSD Checklist for Diagnostic Statistical Manual-5 (DSM-5; 0-80 higher scores indicating more severe symptoms).	Day 0 baseline, 3 months
Change in Depression Symptoms	Changes in depression symptoms measured by the Patient Health Questionnaire (PHQ-9; 0-27 with higher scores indicating more severe depression).	Day 0 baseline, 3 months
Change in Anxiety Symptoms	Changes in anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7; 0-21 with higher scores indicating more severe anxiety).	Day 0 baseline, 3 months
Change in Functional impairment	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).	Day 0 baseline, 3 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Addis Ababa University

Publications and helpful links

General Publications

• Ng LC, Serba EG, Dubale BW, Fekadu A, Hanlon C. Posttraumatic stress disorder intervention for people with severe mental illness in a low-income country primary care setting: a randomized feasibility trial protocol. Pilot Feasibility Stud. 2021 Jul 30;7(1):149. doi: 10.1186/s40814-021-00883-3.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: psychotherapy; Ethiopia; Post Traumatic Stress Disorder; Severe Mental Illness; global mental health
• Other Study ID Numbers: 19-001993

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No