Assessing Psychological Distress among Tuberculosis Patients and Their Household Members

Post Date: 
Clinical Sites: 

This study was terminated effective 4/20/23

This is a C-TRIUMPH study conducted under the Regional Prospective Observational Research for Tuberculosis (RePORT) Network, an international TB consortium. 

Quantifying severity of psychological distress is of critical importance, as we anticipate seeing higher depression levels in patients with treatment-resistant TB. These patients may be non-adherent, leading to higher transmission rates. Due to depression, they may also be more sedentary, which could be linked to poor treatment outcomes in the setting of chronic disease/inflammation.  Ultimately, by assessing psychological distress in the RePORT India cohort, we can work towards understanding the correlation between depression scores and TB severity, as well as family contact depression scores. Depression scores may allow rapid triage of patients for potential community-based activation therapy provided by trained peers or lower level providers. 

Proposal Rationale and Primary Research Question 

We propose adding the PHQ-2 and PHQ-9 questions to the Common Protocol case report forms (CRFs), as they are the most commonly used screeners in a primary care setting to identify depressive symptoms (PHQ-2) and quickly quantify severity of depression (PHQ-9). 

The National Mental Health Survey in India also used these scales to determine point prevalence of depression (2.7%) and to identify the treatment gap, which is 85%. Congruity with the National Mental Health Survey is of importance for explaining forthcoming findings from the RePORT India Consortium. 

The PHQ-2 is quite brief at two questions, which would then trigger the PHQ-9 if positive. The PHQ-9 simply identifies each of the core DSM-4 and 5 symptoms of depression and assigns severity using a Likert scale.  There is a validated version available in Hindi that has been used in studies across Goa, Maharashtra, and Madhya Pradesh.

Our hope is to also assess cell surface receptors in the serotonin system and immune system that may guide treatment, as well as fibrinolytic proteins in the serum for biomarkers of depression in chronic disease.  We believe that medicines like ketamine, may have a more robust effect in chronic disease due to the anti-inflammatory mechanism of action, and that there may be a dosing strategy that preserves the adaptive immune response involved in fighting TB, while diminishing deleterious chronic systemic inflammation that damages certain areas of the brain. First and foremost, quantifying depression in the RePORT India cohort will be necessary prior to moving into more granular studies of biomarkers.

Intended/Potential Use of Study Findings: 

This study will allow us to know quantify the severity of psychological distress among TB patients and their household contacts and that would allow to develop intervention to help TB patients early detection of distress and provide treatment for favorable TB treatment outcome and adherence to TB medications.