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.: PACTR201910542343192 Date of Approval: 17/10/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Cognitive Behavioral therapy on depression reduction and medication adherence among people living with HIV/AIDS
Official scientific title A Randomized Controlled Trial of Cognitive Behavioral Therapy Outcome for Adherence and Depression (CBT-AD) among people living with HIV/AIDS who have been on Anti Retro viral therapy (ART) follow up at Jimma University Medical Center (JUMC) 2017/018
Brief summary describing the background and objectives of the trial 6. Executive summary Background: In Ethiopia, HIV infected clients with depression symptoms reported worsening ART adherence, perceived stigma, sleep quality, stress coping skills problems which implies that testing non-pharmacological interventions such as Cognitive behavioural therapy (CBT) is highly recommended treatment option rather than relying on only drug treatment. However, there is no study done in Ethiopia and even in Africa on the effectiveness of Cognitive behavioural therapy on depression symptom reduction among ART clients. Objective: the aim of this mega research project is to evaluate Cognitive Behavioral Therapy Outcome for Adherence and Depression (CBT-AD) among people living with HIV/AIDS who have been in Anti Retro viral therapy (ART) follow up at Jimma University Medical Center (JUMC) Method: A two arm, randomized, controlled, cross-over trial comparing CBT-AD will be employed. The intervention group will also receive 13 sessions of CBT-AD. 128 HIV infected clients who have been on ART follow up JUMC will be selected from screened eligible ART patients by using simple random sampling technique. Data will be collected at baseline and three follow ups. 13 sessions of CBT-AD intervention will be given to experiment group. Data will be analyzed by SPSS version 20.0 software using ANCOVA, paired t-tests, repeated measures analyses of variance, multivariate analysis and exploratory analyses Variables with p-value less than ≤0.05 will be used as cutoff point for statistical significance
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Psychosocial
Anticipated trial start date 01/10/2017
Actual trial start date 01/01/2018
Anticipated date of last follow up 30/03/2019
Actual Last follow-up date 30/06/2019
Anticipated target sample size (number of participants) 283
Actual target sample size (number of participants) 273
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cognitive Behavioral Therapy and Drug Adherence 13 sessions; once weekly; a session for 60 minutes long six months intervention groups receive behavioral interventions mainly focused on reducing depression symptoms for 12 sessions, using Cognitive behavioral therapy, and ART drug adherence improvement therapy for one session. 143
Control Group Non cognitive Behavioral Therapy and drug adherence therapy group Beginning form randomization to follow up assessments no CBTAD intervention is given 143 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age 18 and above • People living with HIV/AIDS (PLWHA) who are on ART medication • Mild to moderate depression (BDI-II score of 14 to 28) • PLWHA on ART follow up for at least four months Age below 18 • People living with HIV/AIDS (PLWHA) who are not on ART medication • Severe depression (BDI-II score of 29 and above) • PLWHA on ART follow up for less than three months 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 30/01/2018 IRB of Institute of Health of Jimma University
Ethics Committee Address
Street address City Postal code Country
Jimma Jimma 251378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Depression symptom, ART drug adherence improvement Time2, Time3, Time 4
Secondary Outcome perceived stigma, Sleep quality Time2, Time3, Time4
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jimma University Medical center ART clinic Jimma Jimma 251378 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Research fund Jimma Jimma 251378 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma University Research and Community Service Office Jimma Jimma 251378 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hailemariam Hailesilassie hailemariamh2011@gmail.com +251920488557 Jimma
City Postal code Country Position/Affiliation
Jimma 251378 Ethiopia Lecturer at Jimm University
Role Name Email Phone Street address
Scientific Enquiries Abrham Tamrat abrishntamirat@gmail.com +251913241339 Jimma
City Postal code Country Position/Affiliation
Jimma 251378 Ethiopia Lecturer at Jimma University
Role Name Email Phone Street address
Public Enquiries Habtamu Kerebih habtishk@gmail.com +25124316221 Gonder
City Postal code Country Position/Affiliation
Gonder 251378 Ethiopia Assistant Professor at University of Gonder
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Now, we have finished the trial and we are at the time to start manuscript writing. We are just waiting trial registration code. Clinical Study Report Immediately after we get registration code, we will start manuscript preparation Cognitive behavioral therapy, depression, ART clients, ART adherence, sleep quality, perceived stigma
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Result: CBT-AD (N=134 pparticiapnts) had signfciant large effect size improvements in depression (f= 853.21, p < .001, partial eta squared=0.78), perceived stigma (f=125.54, p < 0.001, partial eta squared= 0.317), sleep quality (f=20.10, p<0.001, partial eta squared= 0.317) compared to control group (n=140 particiapnts) at post treatment (4 months). Over three follow-ups, CBT-AD groups (n==122 particiapnts) maintined lower depressive symptoms (f=507.97, p<0.001, partial eta squared= 0.808), lower perceieved stigma (f=1012.14, P<0.001, Partial Eta Squared= 0.893) regardless of soci-demographich caharcteristiic differences. Conclusion: Cognitive behavioural therapy is helpful to HIV/AIDS patients to reduce depression, pereceived stigma, and improve ART medication adherence and sleep quality. Recommendation: structured cognitive behavioural therapy shall be integrated in the managmenet of HIV/AIDS patients with depression and related adherence, sleep, and stigma reports. Key words: Cognitive behavioral therapy, depression, ART clients, ART adherence, sleep quality, perceived stigma 16/10/2019 16/10/2019
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks Not yet finished
Changes to trial information