The HARMONIC trial: study protocol for a randomised controlled feasibility trial of Shaping Healthy Minds - a modular transdiagnostic intervention for mood, stress and anxiety disorders in adults

Abstract

Axiety, mood and trauma-related disorders are common, affecting up to 20% of adults. Many of these individuals will experience symptoms of more than one disorder as diagnostically defined. However, most psychological treatments focus on individual disorders and are less effective for those who experience comorbid disorders. The HARMONIC trial introduces a novel transdiagnostic intervention (Shaping Healthy Minds), which synthesises several evidence-based treatment techniques to address the gap in effective interventions for people with complex and comorbid difficulties. This early-phase trial aims to estimate the efficacy and feasibility of the transdiagnostic intervention in preparation for a later-phase randomised controlled trial, and to explore mechanisms of change