Interventional Indirect Effects: A Novel Approach to Optimise Complex Psychological Therapies to Treat Depression for Scale-up in Goa, India
Abstract Introduction: Understanding how and under what circumstances complex psychological therapies work (or not) is important to bring evidence-informed intervention to scale, especially in resource poor settings. However, current methods do not apply methodology that account for the underlying complexity of these interventions including the interplay between implementation outcomes, implementation strategies and mechanisms. Here we apply a robust mediation analysis to address these issues to data from the Healthy Activity Program (HAP) trial –a psychological intervention for depression delivered using task-shifting with lay counsellors in Goa India.Methods: Interventional in(direct) effects were used to simultaneously decompose the total effect of the intervention on depression symptoms measured through the Patient Health Questionnaire (PHQ-9). The following indirect effects were considered: fidelity of receipt including number of sessions and homework completed; behavioural activation according to an adapted version of the Behavioural Activation for Depression Short Form (BADS-SF), and extra sessions offered to participants who did not respond to the intervention. Results: Of the total effect of the intervention measured through the difference in PHQ-9 scores between treatment arms (mean difference: -2.2, 95% bias-corrected CI: -3.2, -0.8), 45% was mediated through improved levels of behavioural activation (-1.0, -1.3, -0.6). There was little evidence to support the mediating role of characteristics of the sessions nor the extra sessions offered to participants who did not respond to the treatment. ConclusionsFindings from our analyses have demonstrated how interventional (in)direct effects can be applied to understand how implementation research programmes can be optimised for scale-up. Our results highlight the importance of sessions focusing on behavioural activation to improve symptoms of depression. Targeting non-responders with strategies other than extra therapy sessions has the potential to improve depression outcomes at a population level.