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Completed

NCT Number: NCT04385498

Primary Care Intervention for PTSD in Ethiopia

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).

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Addis Ababa University

Addis Ababa, Ethiopia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

BREATHE Intervention

Behavioral

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

Other names: BREATHE Ethiopia

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.

Primary outcomes

  1. Change in PTSD Knowledge

    Time frame: 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).

  2. Change in PTSD Related Stigma

    Time frame: 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).

  3. Change in Trauma-related cognitions

    Time frame: 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).

  4. Change in Self-reported arousal

    Time frame: 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).

  5. Change in Stress management strategy use

    Time frame: 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.

  6. Change in Physiological arousal

    Time frame: Day 0 baseline, 3 months

    Changes in physiological arousal levels measured by heart rate variability (HRV).

Secondary outcomes

  1. Change in PTSD Symptoms

    Time frame: 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).

  2. Change in Depression Symptoms

    Time frame: 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).

  3. Change in Anxiety Symptoms

    Time frame: 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).

  4. Change in Functional impairment

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Addis Ababa University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 13, 2020
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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