Addressing Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Central Uganda

Study Overview
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Brief Summary
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Screen participants attending 11 healthcare facilities in Mubende District for psychological distress using the locally validated Luganda or English version of the WHO- Self Report Questionnaire (SRQ-20). Those individuals found to have significant psychological distress (a score of 6 and above) will be offered Ebola+D intervention [a stepped care collaborative delivery model to address the medium- to long-term EBOLA associated psychological Distress and psychosocial problems] . A cohort of Ebola Virus Disease (EVD) affected individuals accessing the Ebola +D mental health intervention will be recruited and followed up for 12 months with assessments at three time points; baseline, 3 months and 12 months.

Detailed Description
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Ebola Virus Disease (EVD) is associated with high mortality, physical morbidity among patients and survivors, plus being associated with significant mental health and psychosocial problems among patients/survivors, their family members, members of the affected communities, health workers and volunteers. To support the medical services of Mubende district cope with the Ebola associated mental health and psychosocial problems, the Ministry of Health of Uganda has partnered with the MRC/UVRI & LSHTM Uganda Research Unit to implement a health systems strengthening project in the district entitled, 'Addressing the medium to long-term EBOLA associated psychological Distress and psychosocial problems in Mubende District in central Uganda (Ebola+D Project)'. Methodology: The project will be undertaken in the 11 selected health care facilities in Mubende district. Members of the community attending these selected health care facilities will be screened for psychological distress using the locally validated Luganda or English version of the WHO- Self Report Questionnaire (SRQ-20). Those individuals found to have significant psychological distress (a score of 6 and above) will be offered Ebola+D intervention. A cohort of EVD affected individuals accessing the Ebola +D mental health intervention will be recruited and followed up for 12 months with assessments at three time points; baseline, 3 months and 12 months.

Official Title
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Proposal to Address the Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Mubende District in Central Uganda (Ebola+D Project)

Conditions
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Ebola Virus Disease

Intervention / Treatment
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* Behavioral: Ebola+D intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community member of Mubende district staying within the catchment area of the primary health care facility (PHCF); 18years and above, Able to communicate in either English or Luganda (local language spoken in the study region and the language into which the questionnaires will be translated), Has a WHO SRQ-20 score of 6 and above (except for Ebola survivors who are eligible even when their SRQ-20 score is either below or above 6). - Exclusion Criteria: Unable to engage with the research process for any reason that may include sensory impairment or cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Screen participants attending 11 healthcare facilities at Mubende for psychological distress using the locally validated Luganda or English version of the WHO- Self Report Questionnaire (SRQ-20). Those individuals found to have significant psychological distress (a score of 6 and above) will be offered Ebola+D intervention. The intervention will include psycho-education, Problem Solving Therapy, antidepressant medication and referral to a supervising specialist mental health worker. A cohort of EVD affected individuals accessing the Ebola +D mental health intervention will be recruited and followed up for 12 months with assessments at three time points; baseline, 3 months and 12 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ebola+D intervention<br>Ebola+D intervention will include psycho-education, Problem Solving Therapy, antidepressant medication and referral to a supervising specialist mental health worker. | Behavioral: Ebola+D intervention<br>* Ebola+D intervention will include psycho-education, Problem Solving Therapy, antidepressant medication and referral to a supervising specialist mental health worker.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Addressing the medium- to long-term EBOLA associated psychological Distress and psychosocial problems in Mubende District in central Uganda | Remission at ''3 months'' after completion of prescribed mental health treatment step(s) reduced psychological distress (SRQ-20 scores < 6) on two occasions ''4 weeks'' apart | Reduced psychological distress (SRQ-20 scores < 6) on two occasions ''4 weeks'' apart. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ebola associated psychological distress