Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202408896160144 Date of Approval: 16/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Psychological Intervention for people with bipolar disorder in integrated care settings in rural Ethiopia
Official scientific title Feasibility and acceptability of a contextualized brief Psychological Intervention for people with bipolar disorder in rural Ethiopia (PSI-BE)
Brief summary describing the background and objectives of the trial There is a huge unmet need for appropriate psychological interventions (PSIs) for bipolar disorder for use in low-and middle-income countries. We developed a Psychological Intervention for BD in Ethiopia (PSI-BE) using the Medical Research Council’s (MRC) framework for the Development and Evaluation of Complex Interventions in a Primary Health Care (PHC) setting in Ethiopia. The aim of this study is to investigate the feasibility, acceptability and fidelity of this newly developed psychological intervention for BD in a PHC setting in south-central Ethiopia.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) PSIBE
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 01/05/2020
Actual trial start date 01/06/2021
Anticipated date of last follow up 30/06/2020
Actual Last follow-up date 31/08/2021
Anticipated target sample size (number of participants) 18
Actual target sample size (number of participants) 18
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group brief Psychological Intervention for people with bipolar disorder five sessions five weeks The developed psychological intervention (15) has five sessions which are (i) Initial engagement which focuses on needs assessment and goal setting; (ii) Psychoeducation about bipolar disorder symptoms, early warning signs of relapse, and the causes and influencing factors for bipolar disorder; (iii) Treatment and treatment adherence including treatment options, medication side effects, and treatment adherence; (iv) Promoting wellness through problem-solving techniques and sleep hygiene; and (v) Anxiety management and relapse prevention planning through use of muscle relaxation and breathing retraining and preparing and implementing an action plan to prevent relapse. 18
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For people with bipolar disorder • Age 18 or above • Diagnosed with BD and on treatment during the study period • Willing to attend five consecutive weekly sessions. • Psychiatric nurses conducted a clinical assessment to confirm the patients were euthymic and able to give informed consent and participate in the study. For caregivers • Age 18 or above • Immediate caregivers of patients with BD • Willing to attend five consecutive weekly sessions. none Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/10/2020 Institutional Review Board of the College of Health Sciences Addis Ababa University
Ethics Committee Address
Street address City Postal code Country
Zambia Addis Ababa 9086 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Feasibility and acceptability of the intervention post intervention after five weeks
Secondary Outcome Severity of mood symptoms pre-post
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Butajira primay hospital Butajira Butajira Ethiopia
Kela health center and Bui hospital Sodo district Bui Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
DELTAS Africa Initiative 215 Euston Rd UK United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Addis Ababa University Zambia Addis Ababa 9086 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mekdes Demissie mekdemissie@gmail.com +251913205130 Zambia
City Postal code Country Position/Affiliation
Addis Ababa 9086 Ethiopia researcher
Role Name Email Phone Street address
Public Enquiries Mekdes Demissie mekdemissie@gmail.com +251913205130 Zambia
City Postal code Country Position/Affiliation
Addis Ababa 9086 Ethiopia Researcher
Role Name Email Phone Street address
Scientific Enquiries Mekdes Demissie mekdemissie@gmail.com +251913205130 Zambia
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We are willing to share the de-identified “raw” data with researchers and other organisation Clinical Study Report 3 years We are willing to share the de-identified “raw” data with researchers and other organisation
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 29/07/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 29/07/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information