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| Name | Class |
|---|---|
| Addis Ababa University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BREATHE Intervention | Behavioral | 5 session program focusing on breathing retraining, psychoeducation, and positive coping. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change in Physiological arousal | Changes in physiological arousal levels measured by heart rate variability (HRV). | Day 0 baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Depression Symptoms |
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Inclusion Criteria:
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:
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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addis Ababa University | Addis Ababa | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34330334 | Derived | 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. |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| Waitlist Treatment as Usual | Behavioral | 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. |
|
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 |
| 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 |
| 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 |