Clinical trial NCT04385498: Primary Care Intervention for PTSD in Ethiopia
Official title: Posttraumatic Stress Disorder Intervention for People With Severe Mental Illness in Low- and Middle-Income Country Primary Care Settings
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: PTSD
Keywords: Post Traumatic Stress Disorder
Severe Mental Illness
psychotherapy
global mental health
Ethiopia
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Addis Ababa University
First posted: 2020-05-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change in PTSD Knowledge
timeFrame: Day 0 baseline, 3 months
measure: Change in PTSD Related Stigma
timeFrame: Day 0 baseline, 3 months
measure: Change in Trauma-related cognitions
timeFrame: Day 0 baseline, 3 months
measure: Change in Self-reported arousal
timeFrame: Day 0 baseline, 3 months
measure: Change in Stress management strategy use
timeFrame: Day 0 baseline, 3 months
measure: Change in Physiological arousal
timeFrame: Day 0 baseline, 3 months
Secondary outcomes:
measure: Change in PTSD Symptoms
timeFrame: Day 0 baseline, 3 months
measure: Change in Depression Symptoms
timeFrame: Day 0 baseline, 3 months
measure: Change in Anxiety Symptoms
timeFrame: Day 0 baseline, 3 months
measure: Change in Functional impairment
timeFrame: Day 0 baseline, 3 months
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Addis Ababa University
Study officials:
References:
citation: 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.