Primary Care Intervention for PTSD in Ethiopia

University of California, Los Angeles (UCLA)

Status: Active, not recruiting

Conditions: PTSD

Treatments: Behavioral: BREATHE Intervention; Behavioral: Waitlist Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT04385498

19-001993

Details and patient eligibility

About

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).

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

BREATHE Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: BREATHE Intervention

Waitlist Treatment as Usual

Active Comparator group

Description:

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

Treatment:

Behavioral: Waitlist Treatment as Usual