Comparative Effects of Behavioral Analysis Therapy of Feelings and Brief Focal Psychotherapy: Protocol for a Randomized Controlled Assessor-Blinded Clinical Trial.

BACKGROUND: Brief psychotherapies have been shown to improve clinical symptoms within a limited number of sessions without compromising treatment quality. OBJECTIVES: This study aims to test the effects of the experimental Behavioral Analysis Therapy of Feelings (BATF) in a randomized controlled trial design. METHODS: This randomized, controlled, assessor-blinded clinical trial compares BATF with Brief Focal Psychotherapy in individuals presenting symptoms of anxiety and/or depression. Participants with substance use disorders, tobacco or alcohol use, pregnancy, or use of oral contraceptives will be excluded. Participants will be randomized in a 1:1 ratio with stratification by clinical condition. Outcomes will be assessed at baseline, Week 4, and Week 13 using the Hamilton Anxiety Rating Scale, the Montgomery-Åsberg Depression Rating Scale, the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7, and the Pittsburgh Sleep Quality Index. In addition to clinical outcomes, exploratory salivary and blood biomarkers associated with stress, inflammation, and neurobiological function will be evaluated. The trial is registered in the Brazilian Clinical Trials Registry (RBR-10p45rdg) and has Universal Trial Number U1111-1313-4499. CONCLUSIONS: This protocol describes a randomized controlled trial comparing BATF with Brief Focal Psychotherapy. The study is designed to generate preliminary evidence on the effects of the intervention in anxiety and depressive symptoms.