NCT06109610

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started May 2021

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

2.5 years

First QC Date

October 17, 2023

Last Update Submit

October 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Intervention group

EXPERIMENTAL

Taking Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy

Control group

NO INTERVENTION

Do not taking Behavioral Therapy

Interventions

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).

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PLWHA who were 18 years old and above were included in the study

You may not qualify if:

  • PLWHA who were previously took CBT and participants with acute physical or mental disturbances were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mattu University

Addis Ababa, 318, Ethiopia

RECRUITING

MeSH Terms

Conditions

DepressionMedication Adherence

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Zakir Abdu, MSc

    Mattu Universitry

    PRINCIPAL INVESTIGATOR
  • Mohammedamin Hajure, MSc

    Mattu University

    STUDY CHAIR

Central Study Contacts

Zakir Abdu, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychiatry

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 31, 2023

Study Start

May 1, 2021

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Any qualified researchers could get the data from principal investigator at any time

Locations