Primary Care Intervention for PTSD in Ethiopia

NCT04385498 | Completed

• 1 other identifier: 19-001993
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

PTSD

Keywords

Post Traumatic Stress Disorder; Severe Mental Illness; psychotherapy; global mental health; Ethiopia

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Change in PTSD Symptoms

  Day 0 baseline, 3 months

• Change in Depression Symptoms

  Day 0 baseline, 3 months

• Change in Anxiety Symptoms

  Day 0 baseline, 3 months

• Change in Functional impairment

  Day 0 baseline, 3 months

Study Arms (2)

BREATHE Intervention

EXPERIMENTAL

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

Waitlist Treatment as Usual

ACTIVE COMPARATOR

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

Interventions

BREATHE Intervention BEHAVIORAL

5 session program focusing on breathing retraining, psychoeducation, and positive coping.

Also known as: BREATHE Ethiopia

BREATHE Intervention

Waitlist Treatment as Usual BEHAVIORAL

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.

Waitlist Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all participants: Being 18 years of age or older
• For all participants: Being able and willing to provide informed consent to participate in the study
• For all participants: Being able to complete procedures in Amharic or English.
• For patients: Treatment at a Sodo district primary care clinic for Severe Mental Illness (SMI)
• For patients: Identified as having:
• Experienced a traumatic event,
• Associated PTSD symptoms defined as scores on the PTSD Checklist DSM-5 (PCL-5), AND
• any associated functional impairment on the WHODAS-2.
• 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.
• 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

You may not qualify if:

• Current high risk of suicide as measured by the Composite International Diagnostic Interview (CIDI) Suicide module
• Inability to participate in the treatment, as determined by the psychiatric nurse.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Addis Ababa University: collaborator

Study Sites (1)

Addis Ababa University

Addis Ababa, Ethiopia

Location

Related Publications (1)

• 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.

  PMID: 34330334 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Mental Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 13, 2020
• Study Start: June 1, 2023
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2023
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

ET (1)