Primary Care Intervention for PTSD in Ethiopia

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04385498
• Other study ID #: 19-001993
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: December 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: December 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• BREATHE Intervention
5 session program focusing on breathing retraining, psychoeducation, and positive coping.
• 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 treatment.

Locations

Country	Name	City	State
Ethiopia	Addis Ababa University	Addis Ababa

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Addis Ababa University

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD Knowledge	Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge).	Day 0 baseline, 3 months
Primary	Change in PTSD Related Stigma	Changes in levels of PTSD Related Stigma measured by The Internalized Stigma of Mental Illness Scale (1 minimal stigma to 4 severe internalized stigma).	Day 0 baseline, 3 months
Primary	Change in Trauma-related cognitions	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).	Day 0 baseline, 3 months
Primary	Change in Self-reported arousal	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).	Day 0 baseline, 3 months
Primary	Change in Stress management strategy use	Changes in use of the breathing retraining techniques as measured by self- and caregiver-reports during in-session homework review.	Day 0 baseline, 3 months
Primary	Change in Physiological arousal	Changes in physiological arousal levels measured by heart rate variability (HRV).	Day 0 baseline, 3 months
Secondary	Change in PTSD Symptoms	Changes in PTSD symptoms measured by the PTSD Checklist for Diagnostic Statistical Manual-5 (DSM-5; 0-80 higher scores indicating more severe symptoms).	Day 0 baseline, 3 months
Secondary	Change in Depression Symptoms	Changes in depression symptoms measured by the Patient Health Questionnaire (PHQ-9; 0-27 with higher scores indicating more severe depression).	Day 0 baseline, 3 months
Secondary	Change in Anxiety Symptoms	Changes in anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7; 0-21 with higher scores indicating more severe anxiety).	Day 0 baseline, 3 months
Secondary	Change in Functional impairment	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).	Day 0 baseline, 3 months