- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06109610
Cognitive Behavioral Therapy on Adherence and Depression (CBT-AD) Among HIV/AIDS Patients
October 28, 2023 updated by: Zakir Abdu, Mattu University
A Randomized Control Trial of Cognitive Behavioral Therapy on Adherence and Depression (CBT-AD) Among HIV/AIDS Patients on Follow up at Mattu Karl and Bedele Hospital, 2019
Depression is highly comorbid with HIV/ AIDS and is associated with worse poor adherence to antiretroviral therapy (ART), and potentially to long-term immune functioning.
Cognitive behavioral therapy may solve these problem.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Depression is highly comorbid with HIV/ AIDS and is associated with worse poor adherence to antiretroviral therapy (ART), and potentially to long-term immune functioning.
Poor adherence decreases the benefits of ART as well as chances of prolonged survival.
An intervention that integrates CBT for depression with a cognitive behavioral approach to adherence counseling (cognitive behavioral therapy intervention for adherence and depression (CBT-AD)) has been found to be effective in improving adherence and reducing depression in PLWH.
Study Type
Interventional
Enrollment (Estimated)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zakir Abdu, MSc
- Phone Number: 0913845371
- Email: zakirabdu45@gmail.com
Study Locations
-
-
-
Addis Ababa, Ethiopia, 318
- Recruiting
- Mattu University
-
Contact:
- Yadeta Alemayehu, MSc
- Phone Number: 0984569410
- Email: yadoalex45@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- PLWHA who were 18 years old and above were included in the study
Exclusion Criteria:
- PLWHA who were previously took CBT and participants with acute physical or mental disturbances were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Taking Behavioral Therapy
|
The treatment will be offered to participants free of charge.
Cognitive Behavioral Therapy (CBT) sessions will be delivered in a group therapy format and the sessions will be offered in successive weeks.
The protocol will be then administered to the intervention group (in 8 groups over a period of six months, eight sessions, each of 30 minutes' length).
|
|
No Intervention: Control group
Do not taking Behavioral Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The mean score of Depression will change after intervention
Time Frame: Through study completion, an average of 1 yea
|
Depression is measured by Patient Health Questionnaire (PHQ-9) Depression Scale.
The minimum value is 0 and the maximum value is 27.
The higher score mean worse outcome
|
Through study completion, an average of 1 yea
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zakir Abdu, MSc, Mattu Universitry
- Study Chair: Mohammedamin Hajure, MSc, Mattu University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2021
Primary Completion (Estimated)
November 1, 2023
Study Completion (Estimated)
November 1, 2023
Study Registration Dates
First Submitted
October 17, 2023
First Submitted That Met QC Criteria
October 28, 2023
First Posted (Actual)
October 31, 2023
Study Record Updates
Last Update Posted (Actual)
October 31, 2023
Last Update Submitted That Met QC Criteria
October 28, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHS/19/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Any qualified researchers could get the data from principal investigator at any time
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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