Cognitive Behavioral Therapy on Adherence and Depression (CBT-AD) Among HIV/AIDS Patients

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109610
• Other study ID #: CHS/19/2019
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: October 2023
• Source: Mattu University
• Contact: Zakir Abdu, MSc
• Phone: 0913845371
• Email: zakirabdu45[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Medication Adherence

Intervention

Behavioral:
• Cognitive 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).

Locations

Country	Name	City	State
Ethiopia	Mattu University	Addis Ababa

Sponsors (1)

Lead Sponsor	Collaborator
Mattu University

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean score of Depression will change after intervention	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