Summary

Eligibility
for people ages 18 years and up (full criteria)
Dates
study started
estimated completion
Principal Investigator
by Lauren Ng (ucla)

Description

Summary

Mixed methods (qualitative and quantitative) 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. 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).

Official Title

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

Keywords

PTSD Post Traumatic Stress Disorder Severe Mental Illness psychotherapy global mental health Ethiopia BREATHE Intervention

Eligibility

You can join if…

Open to people ages 18 years and up

  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:
  6. Experienced a traumatic event,
  7. Associated PTSD symptoms defined as scores on the PTSD Checklist DSM-5 (PCL-5), AND
  8. any associated functional impairment on the WHODAS-2.
  9. 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.
  10. 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 CAN'T join if...

  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.

Lead Scientist at University of California Health

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04385498
Study Type
Interventional
Last Updated