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

Sponsor
Mattu University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06109610
Collaborator
(none)
128
Enrollment
1
Location
2
Arms
30
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavioral Therapy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Taking Behavioral Therapy

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).
No Intervention: Control group

Do not taking Behavioral Therapy

Outcome Measures

Primary Outcome Measures

  1. The mean score of Depression will change after intervention [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mattu University Addis Ababa Ethiopia 318

Sponsors and Collaborators

  • Mattu University

Investigators

  • Principal Investigator: Zakir Abdu, MSc, Mattu Universitry
  • Study Chair: Mohammedamin Hajure, MSc, Mattu University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zakir Abdu, Assistant Professor of Psychiatry, Mattu University
ClinicalTrials.gov Identifier:
NCT06109610
Other Study ID Numbers:
  • CHS/19/2019
First Posted:
Oct 31, 2023
Last Update Posted:
Oct 31, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Depression
Depressive Disorder

Study Results

No Results Posted as of Oct 31, 2023