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

NCT06093646 | Unknown

• 1 other identifier: RGEK230305
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ebola Virus Disease

Keywords

Ebola associated psychological distress

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Ebola+D intervention

EXPERIMENTAL

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

Interventions

Ebola+D intervention BEHAVIORAL

Ebola+D intervention will include psycho-education, Problem Solving Therapy, antidepressant medication and referral to a supervising specialist mental health worker.

Ebola+D intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community member of Mubende district staying within the catchment area of the primary health care facility (PHCF);
• years 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). -

You may not qualify if:

• Unable to engage with the research process for any reason that may include sensory impairment or cognitive impairment

Sponsors & Collaborators

• MRC/UVRI and LSHTM Uganda Research Unit: lead
• Ministry of Health, Uganda: collaborator

Study Sites (1)

Mubende Regional Referal Hospital

Kampala, Uganda

RECRUITING

Related Publications (1)

• Kyohangirwe L, Mpango RS, Tusiime C, Rutakumwa R, Ssebunnya J, Obuku A, Kiconco BE, Sekitoleko I, Sentongo H, Kalani K, Muhwezi W, Greco G, Baltra RA, Knizek BL, Kaleebu P, Mondelli V, Kyegombe N, Tenywa P, Amanyire P, Ssembajjwe W, Lund C, Kinyanda E. Protocol to develop and pilot a primary mental healthcare intervention model to address the medium- to long-term Ebola associated psychological distress and psychosocial problems in Mubende District in Central Uganda (the Ebola+D project). PLoS One. 2025 Aug 6;20(8):e0329591. doi: 10.1371/journal.pone.0329591. eCollection 2025.

  PMID: 40768507 DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Officials

• Eugene Kinyanda, PhD

  MRC/UVRI and LSHTM Uganda Research unit, Uganda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard S. Mpango, PhD

CONTACT

0772592504; Richard.Mpango@mrcuganda.org

Eugene Kinyanda, PhD

CONTACT

0788461950; Eugene.Kinyanda@mrcuganda.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Masking will not be applied; eligible participants (with psychological distress) who consent to participate in this study will be offered the Ebola+D intervention
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: October 23, 2023
• Study Start: September 22, 2023
• Primary Completion: June 15, 2024
• Study Completion: August 15, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: After the study (August 2024
• Access Criteria: Data sets

Locations

UG (1)