PTSDNCT04385498
Primary Care Intervention for PTSD in Ethiopia
A study testing BREATHE Intervention and Waitlist Treatment as Usual in people with PTSD, run by University of California, Los Angeles at 1 site in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- BREATHE Intervention and Waitlist Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Jun 2023to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For all participants: Being 18 years of age or older
- For all participants: Being able and willing to provide informed consent to participate in the study
- For all participants: Being able to complete procedures in Amharic or English.
- For patients: Treatment at a Sodo district primary care clinic for Severe Mental Illness (SMI)
- For patients: Identified as having:
- Experienced a traumatic event,
Show all 10Show fewer
- Associated PTSD symptoms defined as scores on the PTSD Checklist DSM-5 (PCL-5), AND
- any associated functional impairment on the WHODAS-2.
- 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.
- 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
Who cannot join
- Current high risk of suicide as measured by the Composite International Diagnostic Interview (CIDI) Suicide module
- Inability to participate in the treatment, as determined by the psychiatric nurse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Posttraumatic Stress Disorder Intervention for People With Severe Mental Illness in Low- and Middle-Income Country Primary Care Settings
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.
- 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.
- Secondary outcomes: Change in symptoms and functional impairment. Reductions in (1) PTSD (2) depression and anxiety symptoms, and (3) functional impairment.
- 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).
- Conditions
- PTSD
- Being tested
- BREATHE Intervention, Waitlist Treatment as Usual
- Keywords
- Post Traumatic Stress Disorder, Severe Mental Illness, psychotherapy, global mental health, Ethiopia
- Medical subject headings
- Stress Disorders, Post-Traumatic, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREATHE InterventionBehavioural
Also called BREATHE Ethiopia
5 session program focusing on breathing retraining, psychoeducation, and positive coping.
Waitlist Treatment as UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BREATHE Intervention | Experimental | 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. Receives: Behavioral: BREATHE Intervention |
| Waitlist Treatment as Usual | Active comparator | 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 Receives: Behavioral: Waitlist Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Knowledge
Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge).
Measured: Day 0 baseline, 3 months
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).
Measured: Day 0 baseline, 3 months
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).
Measured: Day 0 baseline, 3 months
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).
Measured: Day 0 baseline, 3 months
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.
Measured: Day 0 baseline, 3 months
Change in Physiological arousal
Changes in physiological arousal levels measured by heart rate variability (HRV).
Measured: Day 0 baseline, 3 months
Secondary outcomes (4)
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).
Measured: Day 0 baseline, 3 months
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).
Measured: Day 0 baseline, 3 months
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).
Measured: Day 0 baseline, 3 months
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).
Measured: Day 0 baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Jun 2023
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Ababa University
- Responsible party
- Principal investigator, Lauren Ng, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385498
- Sponsor's protocol ID
- 19-001993
- Status last verified
- Aug 2025
- First submitted
- 28 Apr 2020
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34330334
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posttraumatic Stress Disorder Intervention for People With Severe Mental Illness in Low- and Middle-Income Country Primary Care Settings
- ClinicalTrials.gov ID
- NCT04385498
- Acronym / sponsor ID
- 19-001993
- Conditions
- PTSD
- Keywords
- Post Traumatic Stress Disorder, Severe Mental Illness, psychotherapy, global mental health, Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Addis Ababa University
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Secondary outcomes: Change in symptoms and functional impairment. Reductions in (1) PTSD (2) depression and anxiety symptoms, and (3) functional impairment.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BREATHE Intervention | Experimental | Behavioral: BREATHE InterventionFive 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. |
| Waitlist Treatment as Usual | Active comparator | Behavioral: Waitlist Treatment as UsualTypical 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- For all participants: Being 18 years of age or older
- For all participants: Being able and willing to provide informed consent to participate in the study
- For all participants: Being able to complete procedures in Amharic or English.
- For patients: Treatment at a Sodo district primary care clinic for Severe Mental Illness (SMI)
- For patients: Identified as having:
Key exclusion criteria (2 listed)
- Current high risk of suicide as measured by the Composite International Diagnostic Interview (CIDI) Suicide module
- Inability to participate in the treatment, as determined by the psychiatric nurse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BREATHE InterventionAlso: BREATHE Ethiopia5 session program focusing on breathing retraining, psychoeducation, and positive coping. | Behavioural | BREATHE Intervention |
| Waitlist Treatment as UsualTypical 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. | Behavioural | Waitlist Treatment as Usual |
Primary outcome
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).
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).
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).
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).
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.
Change in Physiological arousal
Time frame: Day 0 baseline, 3 months
Changes in physiological arousal levels measured by heart rate variability (HRV).
4 secondary outcomes
Change in PTSD Symptoms
Time frame: Day 0 baseline, 3 months
Change in Depression Symptoms
Time frame: Day 0 baseline, 3 months
Change in Anxiety Symptoms
Time frame: Day 0 baseline, 3 months
Change in Functional impairment
Time frame: Day 0 baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Derived from this study: PubMed 34330334Ng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BREATHE Intervention and Waitlist Treatment as Usual in people with PTSD, run by University of California, Los Angeles at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Knowledge (time frame: Day 0 baseline, 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04385498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025; AzTrials last refreshed its copy on 1 Nov 2026.