Primary Care Intervention for PTSD in Ethiopia

NCT ID: NCT04385498

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-10-20

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).

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BREATHE Intervention

Intervention Type: BEHAVIORAL

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

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

Group Type: ACTIVE_COMPARATOR

Waitlist Treatment as Usual

Intervention Type: 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.

Interventions

BREATHE Intervention

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

BREATHE Ethiopia

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Addis Ababa University

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Lauren Ng, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Addis Ababa University

Addis Ababa, , Ethiopia

Countries

Ethiopia

References

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.

Reference Type: DERIVED

PMID: 34330334 (View on PubMed)

Other Identifiers

19-001993

Identifier Type: -

Identifier Source: org_study_id