Primary Care Intervention for PTSD in Ethiopia

• ClinicalTrials.gov Identifier: NCT04385498
• Recruitment Status: Enrolling by invitation
• First Posted: May 13, 2020
• Last Update Posted: August 11, 2022
• Sponsor: University of California, Los Angeles
• Collaborator: Addis Ababa University
• Information provided by (Responsible Party): Lauren Ng, PhD, University of California, Los Angeles

Study Description

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).

Condition or disease	Intervention/treatment	Phase
PTSD	Behavioral: BREATHE Intervention; Behavioral: Waitlist Treatment as Usual	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Posttraumatic Stress Disorder Intervention for People With Severe Mental Illness in Low- and Middle-Income Country Primary Care Settings
• Actual Study Start Date: January 1, 2022
• Estimated Primary Completion Date: March 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: BREATHE Intervention; 5 session program focusing on breathing retraining, psychoeducation, and positive coping.; Other Name: BREATHE Ethiopia
Active Comparator: 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	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in PTSD Knowledge [ Time Frame: 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).
2. Change in PTSD Related Stigma [ Time Frame: 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).
3. Change in Trauma-related cognitions [ Time Frame: 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).
4. Change in Self-reported arousal [ Time Frame: 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).
5. Change in Stress management strategy use [ Time Frame: 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.
6. Change in Physiological arousal [ Time Frame: Day 0 baseline, 3 months ]
   Changes in physiological arousal levels measured by heart rate variability (HRV).

Secondary Outcome Measures :

1. Change in PTSD Symptoms [ Time Frame: 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).
2. Change in Depression Symptoms [ Time Frame: 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).
3. Change in Anxiety Symptoms [ Time Frame: 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).
4. Change in Functional impairment [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Ethiopia

Addis Ababa University

Addis Ababa, Ethiopia

Sponsors and Collaborators

University of California, Los Angeles

Addis Ababa University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Lauren Ng, PhD, Principal Investigator, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT04385498
• Other Study ID Numbers: 19-001993
• First Posted: May 13, 2020
• Last Update Posted: August 11, 2022
• Last Verified: August 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lauren Ng, PhD, University of California, Los Angeles:

Post Traumatic Stress Disorder; Severe Mental Illness; psychotherapy; global mental health; Ethiopia