Affective disorders: eliminate WArning signs and REstore functioning—AWARE—a randomised controlled multimodule intervention study, presentation of design and intervention

INTRODUCTION: Affective disorders are associated with impaired overall functioning and quality of life (QoL). Despite different medical and psychological treatment options, the prognosis remains largely unchanged. Consequently, the field needs new intervention strategies especially targeting patient groups with impaired functioning. This study aims to improve functioning and QoL in patients with affective disorders using a comprehensive 360° intervention. METHODS AND ANALYSIS: Affective disorders: eliminate WArning signs And REstore (AWARE) functioning is a randomised, controlled, parallel-group design study. Participants will be 120 outpatients, men or women, aged 18–65 years, with a diagnosis of bipolar disorder or major depressive disorder. Inclusion requires an objectively rated impaired functioning defined as a score ≥11 according to the Functioning Assessment Short Test. Participants will be randomised to 6-month AWARE intervention or treatment as usual (TAU). The AWARE intervention is a 360° multimodal intervention based on the International Classification of Functioning Brief Core Set for bipolar and unipolar disorder targeting functioning. The primary outcome is improvement of observation-based activities of daily living (ADL) ability using Assessment of Motor and Process Skills. Secondary outcomes are changes from baseline to endpoint in functioning, QoL, stress, cognition and physical health. Our hypothesis is that the AWARE treatment in comparison with TAU will improve observed ability to perform ADL, patients self-perceived level of functioning and QoL. Status: currently recruiting patients. ETHICS AND DISSEMINATION: Ethical approval has been obtained from The Regional Ethics Committee in the Capital Region of Denmark. All patients will be provided oral and written information about the trial before informed consent is obtained. The study results will be disseminated by peer-review publications. If the present AWARE intervention shows beneficial effects, the goal is to use it as a template for future interventions addressing disability in patients with affective disorders as well as for patients within other diagnostic categories. TRIAL REGISTRATION NUMBER: NCT04701827; Clinicaltrials.gov.