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.: PACTR202306771120632 Date of Approval: 13/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Interpersonal Psychotherapy for Groups adapted for the Ugandan Population: A randomized controlled trial of six sessions versus eight sessions of trigger concordant and trigger discordant therapy
Official scientific title Interpersonal Psychotherapy for Groups adapted for the Ugandan Population: A randomized controlled trial of six sessions versus eight sessions of trigger concordant and trigger discordant therapy
Brief summary describing the background and objectives of the trial Background: Interpersonal Psychotherapy for Groups (IPT-G) has been rigorously tested and widely used in Uganda to treat depression, the most common mental disorder. However, many practitioners have noted that IPT-G clients frequently attend the first four or five sessions of therapy, and do not attend subsequent sessions. This study aims to test the efficacy of an adapted short version of IPT-G (6 trigger-concordant sessions) compared to the current standard of care for IPT-G at StrongMinds (8 trigger-discordant weekly sessions) and a waiting list control group. Main objective: To compare the effectiveness of 6 trigger-concordant IPT-G to 8 trigger-discordant IPT-G sessions on reducing depressive symptomatology among individuals in Uganda. Both therapies will be compared to a control group (delayed treatment). Specific objectives: For participants who receive 6 trigger-concordant weekly IPT-G sessions versus 8 trigger-discordant weekly IPT-G sessions, to compare changes in (1) depressive symptoms, (2) functionality, and (3) quality of life.
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 This trial will test the effectiveness of a modification of Interpersonal Psychotherapy for Groups in which therapy is shortened from 6 to 8 weeks and participants are grouped by depression trigger
Anticipated trial start date 01/09/2022
Actual trial start date 05/09/2022
Anticipated date of last follow up 22/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
2022364 Makerere School of Health Sciences Research Ethics Committee
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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 6 SESSIONS trigger concordant weekly Interpersonal Therapy for Groups sessions ONE HOUR WEEKLY SESSION 21 weeks (6 weeks of treatment + 15 weeks of follow-up) The adapted Interpersonal Therapy for Groups (IPT-G) model will focus on one common IPT trigger for depression throughout treatment (six sessions). All groups will be comprised of participants with one common trigger for depression with a focus on treating their depressive symptomatology over six sessions. Session one constitutes an introductory phase in which participants meet each other for the first time, establish ground rules for respect and confidentiality, and learn about the therapy methods and schedule. Sessions two to five are known as the working phase, in which each participant (in a group setting) will work to improve their symptoms following the guidance of a facilitator using IPT strategies. Session six focuses on reflecting on each client’s goals, assessing symptoms, and reviewing how participants can use IPT strategies after the completion of therapy. 150
Control Group 8 trigger discordant weekly Interpersonal Therapy for Groups sessions ONE HOUR WEEKLY SESSION FOR 8 WEEKS (EIGHT SESSIONS) ALL TRIGGERS INCLUDED 23 weeks (8 weeks of treatment + 15 weeks of follow-up) The Treatment as Usual (TAU) arm will be 8-weekly sessions of Interpersonal Therapy for Groups (IPT-G), which is the current standard of care at StrongMinds. Session one constitutes an introductory phase in which participants meet each other for the first time, establish ground rules for respect and confidentiality, and learn about the therapy methods and schedule. Sessions two to seven are known as the working phase, in which participants are actively engaged and helping each other by making suggestions regarding one another’s problems. This is also the phase where members are educated about symptoms and common triggers of depression. Session eight focuses on reflecting on each client’s goals, assessing symptoms, and reviewing how participants can use IPT strategies after the completion of therapy. 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Persons aged 18 years and over screened using the PHQ-9 and reported to have depression (cut off score of 10 and above on the PHQ-9), with two or more triggers of depression. Participants with at least two similar triggers out of the four IPT triggers to depressions will be included in the study. Participants must be fluent in either English or Luganda and be able to consent to participation. Persons who state or carry reports indicating a previous diagnosis of intellectual disability, psychiatric disorder other than depression, or dementia, and those who are physically too unwell to participate in the interview will be excluded. Participants who meet the inclusion criteria but have impairments that hinder engagement with the research procedures for any reasons (is deaf or hard of hearing, speech, and visual impairment with no aids to see, unable to give consent will be excluded. Those who are not fluent in either spoken English or Luganda, Those under the age of 18, will also be excluded from the study. Study sites will be located in Luganda-speaking regions. Potential participants will receive a participant study information sheet or a verbal description of the study by any of the research assistants, according to their preference, and any of their questions will be answered. Written consent will be sought. Only those who give written informed consent will be recruited to the study. 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 22/09/2022 Makerere University School of Health Sciences Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P.O. Box 7072 Kampala N/A Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PHQ-9 score change between pre- and post-intervention 6 or 8 weeks after enrollment
Secondary Outcome WHOQOL-BREF score change between pre- and post-intervention 6 or 8 weeks after enrollment
Secondary Outcome WHODAS 2.0 score change between pre- and post-intervention 6 or 8 weeks after enrollment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
StrongMinds Uganda Plot 32 Luthuli Rise, Bugolobi, P.O.Box 35874 Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
StrongMinds Global Plot 32 Luthuli Rise, Bugolobi, P.O.Box 35874 Kampala Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor StrongMinds 515 Valley Street, Suite 200 Maplewood 07040 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Anna Bershteyn 227 East 30th Street, 6th Fl New York 10016 United States of America
Katia M Peterson 2101 L Street NW, Suite 800 Washington DC 20037 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rosco Kasujja rkasujja@mak.ac.ug +256752507050 P.O. Box 7062
City Postal code Country Position/Affiliation
Kampala Uganda Senior Lecturer at Makerere University School of Psychology
Role Name Email Phone Street address
Public Enquiries PETER BIRUNGI peter.birungi@strongminds.org +256701342849 DWONYI CLOSE
City Postal code Country Position/Affiliation
KAMPALA 9370 Uganda STRONGMINDS GLOBAL
Role Name Email Phone Street address
Scientific Enquiries ANNA BERSHTEYN Anna.Bershteyn@nyulangone.org +19175185775 227 East 30th Street, 6th Fl
City Postal code Country Position/Affiliation
NEW YORK 10016 United States of America Assistant Professor at NYU Grossman School of Medicine Department of Population Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified dataset will be shared upon request. Qualified researchers will be requested to submit a research proposal and Statistical Analysis Plan, and once approved, execute a Data Sharing Agreement prior to sharing data. Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 36 months. Access to the dataset can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement. For more information or to submit a request, please contact roscoe.kasujja@strongminds.org.
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