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.: PACTR202001530966598 Date of Approval: 27/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Group Interpersonal Therapy for Depression in Ethiopia
Official scientific title Adaptation and Feasibility Testing of Group Interpersonal Therapy for Depression in People with Tuberculosis in Primary Care Setting in Ethiopia
Brief summary describing the background and objectives of the trial We will adapt group interpersonal therapy for people with tuberculosis in Ethiopia and test the feasibility of the procedures of a clinical trail including recruitment, randomization, assessment, blinding, fidelity of intervention, dropout rates. Then acceptability to patients, providers, and facilities will be examined. preliminary analysis will be done on the effect of the intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 01/03/2020
Actual trial start date
Anticipated date of last follow up 31/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group interpersonal therapy 90 minutes therapy given every week eight weeks Group interpersonal therapy is a psychotherapy which was developed in the 1970s for the treatment of depression by mental health specialists. In 2016, the WHO recommended it to be used in primary care settings by non-mental health specialists. The basic idea of this intervention is that there is a connection between a person's mood and their interpersonal difficulties. The intervention solves the interpersonal problems to treat depression. 30
Control Group The traditional coffee ceremony of Ethiopia once a week eight weeks The traditional coffee ceremony of Ethiopia has three stages called abol, tona and bereka. It keeps people together and creates a sense of togetherness. This intervention is given to control for the effect of 'social group' in group therapy. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Participants should be 18 years or above • Must be attending TB care in the selected health facilities • People with pulmonary TB must be on anti-TB treatment for at least two weeks for the purpose of preventing transmission • Must score 5 or above on PHQ-9 (Kroenke et al., 2010) and report the presence of at least some disability. • Participants with a plan to be transferred out of the study area in the next three months • Patients with severe mental, neurological or substance use disorders • Actively suicidal patients • People with known MDR-TB • TB patients in the in-patient department • Participants who do not speak Amharic language 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 13/12/2019 Ethical review board
Ethics Committee Address
Street address City Postal code Country
Tikur Anbessa Addis Ababa 9086 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Depression score Before treatment and after treatment
Secondary Outcome Disability score Before intervention and after intervention
Secondary Outcome quality of life score before intervention and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Felegehiwot Hospital kebele 13, Bahir Dar Bahir Dar 1985 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust London NW1 2BE London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Addis Ababa University Tikur Anbessa 5657 Addis Ababa 9086 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fentie Ambaw ambaw.fentie@gmail.com 00251911817007 Bahir Dar Kebele 16
City Postal code Country Position/Affiliation
Bahir Dar 1985 Ethiopia Associate professor at the School of Public Health Bahir Dar University
Role Name Email Phone Street address
Public Enquiries Atalay Alem atalay.alem@gmail.com 00251912501446 Tikur Anbessa 5657
City Postal code Country Position/Affiliation
Addis Ababa 9086 Ethiopia Addis Ababa University
Role Name Email Phone Street address
Scientific Enquiries Charlotte Hanlon charlotte.hanlon@kcl.ac.uk 00251912803374 Tikur Anbessa 5657
City Postal code Country Position/Affiliation
Addis Ababa 9086 Ethiopia Addis Ababa University and Kings College London
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be available to researchers all over the world for strictly non-profit purposes. Study Protocol December 2020 to December 2021 Non-profit purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information