Primary Care Intervention for PTSD in Ethiopia

Not Applicable

Active, not recruiting

Interventions: Behavioral: BREATHE Intervention
Behavioral: Waitlist Treatment as Usual

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).

Recruitment & Eligibility

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:
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.
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.

Arm && Interventions

Group	Intervention	Description
BREATHE Intervention	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.
Waitlist Treatment as Usual	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

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).