DepressionNCT05091580
Effectiveness and Cost-Effectiveness of Depression Treatment for Individuals With TB in South Africa
A study testing Interpersonal Counseling and Enhanced treatment as usual in people with Depression and Tuberculosis, run by New York State Psychiatric Institute at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Tuberculosis
- What is being tested?
- Interpersonal Counseling and Enhanced treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSouth Africa
- Study dates
- 24 Mar 2023to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or over
- initiating treatment for TB
- ability to provide informed consent
Who cannot join
- unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness and Cost-effectiveness of Implementing Evidence-based Depression Treatment Within the TB Care Platform in South Africa: A Hybrid Effectiveness-implementation Trial
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.
Read the detailed description
TB and depression are the leading infectious cause of death and the leading cause of disability, respectively. Furthermore, they are commonly co-occurring and negatively synergistic. TB and depression comorbidity is associated with a 2.85 greater chance of death and 8.70 higher risk for loss to follow up (LTFU) from treatment, which has a cascade of negative individual-, community-, societal-, and health system-level implications. As a treatable condition, depression is a remediable driver of the TB epidemic. The WHO has called for a global policy framework for TB and mental health integration, recommending brief psychological interventions to address mental disorders in primary care settings. Interpersonal counseling (IPC) is a brief version of one such evidence-based intervention that has demonstrated efficacy and effectiveness in treating depression when delivered by non-mental health specialists, including in South Africa. The purpose of this study is to assess the effectiveness and cost-effectiveness of integrating IPC (for depression) into the TB care platform to improve TB and depression outcomes, as well as mitigate TB-related catastrophic costs. As the country with the highest TB burden in the world, nearly 60% of whom are co-infected with HIV, South Africa is the ideal setting for this study. This 3-year hybrid type I effectiveness-implementation trial will be implemented in the Eastern and Western Capes of South Africa to integrate IPC to treat depression comorbidity within the TB care platform with the following aims: Aim 1) To evaluate the effectiveness and implementation outcomes of integrating IPC treatment for depression into the existing TB care platform to improve TB and depression outcomes; Aim 2) To determine the influence of theoretically based intervention mediators and moderators on TB treatment outcomes; Aim 3) To assess the cost-effectiveness of integrating depression treatment into the TB care platform from the patient and health system perspectives. This research will provide critical clinical, programmatic, and economic data to inform the WHO global policy framework for TB and mental health integration, and cost-effective clinical practice to improve TB outcomes, especially in low-resource settings.
Recruitment was temporarily paused on September 1, 2024 due to an interruption in funding. Anticipated restart: October 2026
- Conditions
- Depression, Tuberculosis
- Being tested
- Interpersonal Counseling, Enhanced treatment as usual
- Keywords
- effectiveness, cost-effectiveness, implementation science, Hybrid Type I Trial, South Africa, Depression, Tuberculosis
- Medical subject headings
- Depression, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal CounselingBehavioural
Interpersonal Counseling is a brief (4-5 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).
Enhanced treatment as usualBehavioural
Depression screening and referral (as needed)
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Interpersonal Counseling for Depression | Experimental | New adult TB patients with depressive symptoms (PHQ-9 > 10) will be offered 4-5 sessions of Interpersonal Counseling delivered by a trained lay counsellor. Receives: Behavioral: Interpersonal Counseling |
| Control: Enhanced Treatment as Usual | Other | New adult TB patients will be screened for depression and those with significant symptoms (PHQ-9 > 15 and/or suicidal ideation) will be referred to the clinic nurse for evaluation and referral to specialized mental health care as needed. Routine screening for depression is not a standard practice for TB patients; therefore assessment and referral is considered "enhanced" treatment as usual. Individuals will be interviewed at baseline and treatment completion. Receives: Behavioral: Enhanced treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
TB treatment success rate
Patient level TB treatment success (yes/no) will be extracted from clinic records and defined based on the South African National TB Control Guidelines as all smear-positive patients that were cured (negative smear in last month of treatment) and those that completed treatment but did not meet the criteria for cure or failure.
Measured: 6 months
Secondary outcomes (1)
Depression remission rate
Patient level depression remission (yes/no) will be assessed using the Patient Health Questionnaire (PHQ-9) and defined as a score less than 10.
Measured: 2 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start24 Mar 2023
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Why it stopped: Interruption in funding; Planned restart: October 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individually randomized hybrid type I effectiveness-implementation trial
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Desmond Tutu HIV Foundation, University of Cape Town, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Annika Sweetland, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091580
- Sponsor's protocol ID
- 8217
- Other IDs
- R01AI148461
- Status last verified
- Aug 2026
- First submitted
- 28 Sep 2021
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of scientific findings with the research and clinical communities will be executed through the centralized NIH data repository, publications in peer reviewed journals, and presentations at scientific meetings. If requested, we will share our statistical code (SAS, Stata, R) for use with other investigators. We will also post the methods and analysis plan of this proposal on the Open Science Framework hosted by the Center for Open Science. Data to be shared will include all of the individual participant data collected during the trial, after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Cost-effectiveness of Implementing Evidence-based Depression Treatment Within the TB Care Platform in South Africa: A Hybrid Effectiveness-implementation Trial
- ClinicalTrials.gov ID
- NCT05091580
- Acronym / sponsor ID
- 8217
- Conditions
- Depression, Tuberculosis
- Keywords
- effectiveness, cost-effectiveness, implementation science, Hybrid Type I Trial, South Africa, Depression, Tuberculosis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Interruption in funding; Planned restart: October 2026
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Columbia University, Desmond Tutu HIV Foundation, University of Cape Town, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
TB and depression are the leading infectious cause of death and the leading cause of disability, respectively. Furthermore, they are commonly co-occurring and negatively synergistic. TB and depression comorbidity is associated with a 2.85 greater chance of death and 8.70 higher risk for loss to follow up (LTFU) from treatment, which has a cascade of negative individual-, community-, societal-, and health system-level implications. As a treatable condition, depression is a remediable driver of the TB epidemic. The WHO has called for a global policy framework for TB and mental health integration, recommending brief psychological interventions to address mental disorders in primary care settings. Interpersonal counseling (IPC) is a brief version of one such evidence-based intervention that has demonstrated efficacy and effectiveness in treating depression when delivered by non-mental health specialists, including in South Africa. The purpose of this study is to assess the effectiveness and cost-effectiveness of integrating IPC (for depression) into the TB care platform to improve TB and depression outcomes, as well as mitigate TB-related catastrophic costs. As the country with the highest TB burden in the world, nearly 60% of whom are co-infected with HIV, South Africa is the ideal setting for this study. This 3-year hybrid type I effectiveness-implementation trial will be implemented in the Eastern and Western Capes of South Africa to integrate IPC to treat depression comorbidity within the TB care platform with the following aims: Aim 1) To evaluate the effectiveness and implementation outcomes of integrating IPC treatment for depression into the existing TB care platform to improve TB and depression outcomes; Aim 2) To determine the influence of theoretically based intervention mediators and moderators on TB treatment outcomes; Aim 3) To assess the cost-effectiveness of integrating depression treatment into the TB care platform from the patient and health system perspectives. This research will provide critical clinical, programmatic, and economic data to inform the WHO global policy framework for TB and mental health integration, and cost-effective clinical practice to improve TB outcomes, especially in low-resource settings.
Recruitment was temporarily paused on September 1, 2024 due to an interruption in funding. Anticipated restart: October 2026
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individually randomized hybrid type I effectiveness-implementation trial
| Arm | Type | Receives |
|---|---|---|
| Intervention: Interpersonal Counseling for Depression | Experimental | Behavioral: Interpersonal CounselingNew adult TB patients with depressive symptoms (PHQ-9 > 10) will be offered 4-5 sessions of Interpersonal Counseling delivered by a trained lay counsellor. |
| Control: Enhanced Treatment as Usual | Other | Behavioral: Enhanced treatment as usualNew adult TB patients will be screened for depression and those with significant symptoms (PHQ-9 > 15 and/or suicidal ideation) will be referred to the clinic nurse for evaluation and referral to specialized mental health care as needed. Routine screening for depression is not a standard practice for TB patients; therefore assessment and referral is considered "enhanced" treatment as usual. Individuals will be interviewed at baseline and treatment completion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or over
- initiating treatment for TB
- ability to provide informed consent
Key exclusion criteria (1 listed)
- unable or unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal CounselingInterpersonal Counseling is a brief (4-5 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). | Behavioural | Intervention: Interpersonal Counseling for Depression |
| Enhanced treatment as usualDepression screening and referral (as needed) | Behavioural | Control: Enhanced Treatment as Usual |
Primary outcome
TB treatment success rate
Time frame: 6 months
Patient level TB treatment success (yes/no) will be extracted from clinic records and defined based on the South African National TB Control Guidelines as all smear-positive patients that were cured (negative smear in last month of treatment) and those that completed treatment but did not meet the criteria for cure or failure.
1 secondary outcome
Depression remission rate
Time frame: 2 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Yes. Sharing of scientific findings with the research and clinical communities will be executed through the centralized NIH data repository, publications in peer reviewed journals, and presentations at scientific meetings. If requested, we will share our statistical code (SAS, Stata, R) for use with other investigators. We will also post the methods and analysis plan of this proposal on the Open Science Framework hosted by the Center for Open Science. Data to be shared will include all of the individual participant data collected during the trial, after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Counseling and Enhanced treatment as usual in people with Depression and Tuberculosis, run by New York State Psychiatric Institute at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TB treatment success rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.