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Effectiveness and Cost-Effectiveness of Depression Treatment for Individuals With TB in South Africa

NCT05091580 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1410

Last updated 2025-07-17

No results posted yet for this study

Summary

This hybrid type I effectiveness-implementation trial will increase understanding of the effectiveness and cost-effectiveness of integrating a brief evidence-based treatment for major depressive disorder (MDD) within the tuberculosis (TB) care platform to improve TB and MDD. Findings from this R01 are likely to inform policy and treatment guidelines for the integrated management of TB and MDD in low- and middle-income countries globally.

Conditions

Interventions

BEHAVIORAL

Interpersonal Counseling

Interpersonal Counseling is a brief (4-8 sessions) psychological intervention that was developed to treat depression in primary care. In IPC, counselors provide psychoeducation about the connection of depressive symptoms to social triggers and support patients in leveraging social networks to address these stressors and reduce depressive symptoms. Since depressive symptoms are often a transient reaction to life stress (e.g. TB diagnosis), many individuals are able to achieve significant alleviation of symptoms in as few as four sessions. IPC focuses on reducing interpersonal conflict and improving social cohesion in families, which may have the advantage of strengthening the ability of families to support TB patients in completing treatment to achieve cure. All individuals will be offered 4-5 sessions (weekly), with up to 3 optional booster sessions (monthly) until TB treatment is completed.

BEHAVIORAL

Enhanced treatment as usual

Depression screening and referral (as needed)

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER

  • Desmond Tutu HIV Foundation

    collaborator OTHER

  • University of Cape Town

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • New York State Psychiatric Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-24
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • South Africa

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05091580 on ClinicalTrials.gov