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.: PACTR201402000742370 Date of Approval: 14/01/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Group support psychotherapy for depressed HIV infected individuals in northern Uganda: A randomized controlled trial.
Official scientific title Group support psychotherapy for depressed HIV infected individuals in northern Uganda: A randomized controlled trial.
Brief summary describing the background and objectives of the trial Depression is common among HIV infected adults in sub-Saharan Africa, affecting between one in three to one in five patients in antiretroviral therapy (ART) programs. Newly diagnosed patients HIV patients are at high risk for depression.There is a lack of recent research on psycho-therapeutic interventions for depression in sub-Saharan Africa. Previous research in rich resource settings has repeatedly demonstrated that group psychotherapy is an efficient and effective form of intervention for depression. Adapted western psychotherapeutic interventions have also been shown to reduce depression symptoms among adults in Uganda. However, these interventions were not developed for the local populations in Uganda and their adapted versions were evaluated outside the existing government health structures; hence uptake of the interventions has been limited. Further, there has been no assessment of their impact on HIV treatment outcomes. Our experience within the Peter C Alderman Foundation (PCAF) trauma clinics suggests that patients with depression receiving medications and participating in group support counseling have greater improvement in functional status than those receiving medications and individual counseling. This observation led us to develop a culturally sensitive group support psychotherapy intervention for treating depression in HIV affected individuals. In this study, primarily, we test whether participating in group support psychotherapy sessions leads to reduction in depression symptoms and increase in functioning compared with participating in group HIV education sessions. Second, we test whether participating in group support psychotherapy sessions leads to improved adherence to antiretroviral therapy compared with participating in group HIV education sessions. Other secondary outcomes include coping skills, stigma, self-esteem and social support.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied depression,Infections and Infestations,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 20/01/2014
Actual trial start date
Anticipated date of last follow up 20/09/2014
Actual Last follow-up date 30/10/2014
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 109
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
HS 1398 Uganda National Council for Science and Technology
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 stratified random sampling will be done. The sample will be stratified according to gender (80 females and 40 males).40 pieces of paper labeled ¿control group¿ and 40 pieces of paper labeled ¿group intervention¿ were rolled into small paper balls and place in a box. On the day of randomization female participants were asked to pick a piece of paper from the box. Those who picked a paper with control group received group HIV education while those who received a paper with group intervention received group support psychotherapy. The same procedure was repeated for men. coding of papers was done by project staff situated off site. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group support psychotherapy One session per week 8 weeks The intervention consists of eight sessions in which participants receive psych education on the group process, precipitants of depression, share personal problems, learn positive coping skills especially how to cope with stigma, discuss negative coping skills, learn problem solving strategies and basic livelihood skills. The intervention is delivered in group format and groups are gender specific 60
Control Group Basic HIV education one session per week 8 weeks The intervention consists of eight sessions in which participants receive basic HIV education on topics such as the progression of HIV virus in the body, transmission and prevention, mother to child transmission and prevention and basic facts about anti-retroviral therapy. The intervention is delivered in group format and groups are gender specific. 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
able to provide informed consent 19-65 years of age Meets criteria for major depression assessed by Mini International Neuropsychiatric Interview Has HIV/AIDS Less than 19 years Does not have depression Does not have HIV/AIDS Has hearing or visual impairment 19 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 23/05/2013 Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera road, Ntinda. P.O.BOX 6884 Kampala 256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome depression symptoms baseline 2 months 6 months
Primary Outcome functioning level baseline 2 months 6 months
Secondary Outcome Adherence to ART baseline 2 months 6 months
Secondary Outcome CD4 counts baseline 2 months 6 months
Secondary Outcome coping skills,social support, self-esteem, stigma baseline 2 months 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Meeting point-Kitgum P.O.BOX 96 Kitgum 256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada at the Sandra Rotman Center MaRS Center, South Tower, 101 College Street, Suite 406, Toronto ,Ontario, Canada M5G1L7 Toronto 416 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Peter C. Alderman Foundation P.O. Box 278 Bedford, NY, 10506 Bedford United States of America Charities/Societies/Foundation
Primary Sponsor Grand Challenges Canada at the Sandra Rotman Center MaRS Center, South Tower, 101 College Street, Suite 406, Toronto ,Ontario, Canada M5G1L7 Toronto 416 Canada Funding Agency
Secondary Sponsor Makerere University College of Health Sciences, Department of Psychiatry P.O.BOX 7062 Kampala 256 Uganda University
COLLABORATORS
Name Street address City Postal code Country
Kizito Wamala African Centre for the Treatment and Rehabilitation of Torture Victims (ACTV)Block 39 Plot 113 Owen Road (off Tufnell Drive) Kamwokya P.O.Box 6108 Kampala 256 Uganda
James Okello Gulu University P.O.BOX 166 Gulu 256 Uganda
Stephen Alderman P.O. Box 278 Bedford, NY, 10506 Bedford United States of America
Seggane Musisi Makerere University College of Health Sciences Department of Psychiatry P.O.BOX 7072 Kampala 256 Uganda
Raymond Odokonyero Makerere University College of Health Sciences Department of Psychiatry P.O.BOX 7072 Kampala 256 Uganda
Ramin Mojtabai Johns Hopkins School of Public Health, Mental health Department, 624 N.Broadway Baltimore 410 United States of America
Edward J Mills fFaculty of Health Sciences, University of Ottawa Toronto 256 Canada
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Etheldreda Nakimuli-Mpungu enakimul@jhsph.edu +256715105276 1Makerere University, College of Health Sciences, Department of Psychiatry, P.O.BOX 7072
City Postal code Country Position/Affiliation
Kampala 256 Uganda Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Leah Nawegulo l.nawegulo@uncst.go.ug +256414705500 Plot 6 Kimera Road, Ntinda P.O.BOX 6884
City Postal code Country Position/Affiliation
Kampala 256 Uganda Executive Secretary/ UGANDA NATIONAL COUNCIL FOR SCIENCE AND TECHNOLOGY
Role Name Email Phone Street address
Scientific Enquiries James Tumwine kabaleimc@gmail.com +256414533541 1Makerere University, College of Health Sciences, School Of Medicine P.O.BOX 7072
City Postal code Country Position/Affiliation
Kampala 256 Uganda Professor
REPORTING
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