Effectiveness and implementation of a transdiagnostic therapy for addressing mental and behavioral health problems and improving treatment outcomes for people with tuberculosis in India

About This Grant

Tuberculosis (TB) is the leading infectious cause of death, with recent rising incidence in the U.S. Depression and unhealthy alcohol use (UAU) increase nonadherence to TB medications and poor TB treatment outcomes. Yet, mental and behavioral health services have not been integrated into routine TB care in the U.S. or elsewhere. No high-quality randomized controlled trials (RCTs) have evaluated the impact of treating depression and UAU on TB outcomes. Critical barriers preventing integration of these services into TB care include lack of trained personnel and limited benefits of therapies focused on a single condition, such as depression or UAU alone, when people with TB often also have comorbid problems, such as anxiety or trauma. A transdiagnostic intervention, in which multiple mental and behavioral health problems can be addressed by a single provider, may be more clinically effective and efficient to implement. We previously demonstrated the effectiveness of a transdiagnostic cognitive behavioral therapy-based intervention, the Common Elements Treatment Approach (CETA), which trains lay health workers to address an array of potentially co-occurring mental and behavioral health problems. Despite evidence that CETA improves mental and behavioral health, it has not been implemented as part of TB care. Our hypothesis is that CETA can improve mental and behavioral health outcomes while decreasing unfavorable TB outcomes. In this R01, we will rapidly optimize CETA for delivery by trained TB survivors within TB care. We will then conduct a type 1 hybrid effectiveness-implementation RCT, in which we will randomize 494 people with TB who have depression, UAU, or both to receive CETA or enhanced usual care. Mental and behavioral health outcomes will be evaluated at three- and five-months post-baseline. Participants will be followed during TB treatment and for 12 months after treatment completion to assess unfavorable TB outcomes, defined as the composite of death, treatment failure, treatment non-completion, and TB recurrence. We will conduct a chained multiple mediation analysis to assess CETA’s effectiveness for reducing depression and UAU (primary mental and behavioral health outcomes), while assessing their mediating effects for reducing medication nonadherence and unfavorable TB outcomes (primary TB outcome). To inform future CETA scale-up within TB care, including for use in low-resource communities in the U.S., we will quantitatively assess CETA provider fidelity and CETA completion by people with TB, while qualitatively examining implementation barriers and facilitators with people with TB, CETA counselors, and TB program stakeholders, informed by the Consolidated Framework for Implementation Research. To ensure the feasibility of answering this critical scientific question, the field research will be conducted in India, which has the world’s highest TB incidence, to be able to provide vital evidence on an intervention that could improve outcomes for the >10,000 people with TB disease annually in the U.S., many of whom concurrently experience mental health and substance use challenges.