Efficacy of brief dynamic interpersonal therapy in patients with major depressive disorder: a prospective, multicenter randomized controlled trial protocol

Abstract Background In China, psychodynamic psychotherapies are widely used as a treatment for depression. However, very few efficacy studies of psychodynamic therapies have been conducted with the Chinese population. This paper describes a study protocol of a multicenter randomized controlled trial of dynamic interpersonal psychotherapy (DIT), a brief manualized depression-focused intervention, in Chinese adults with major depressive disorder (MDD). Methods Recruitment is planned in five hospitals. Two hundred forty patients with MDD will be randomly allocated on a 1:1:1 basis to either medication plus DIT, medication plus an active control psychotherapy, or medication alone. Patients will be assessed at baseline and at weeks 2, 4, 8, 12, and 16 during the acute treatment phase and 1, 3, 6, and 12 months posttreatment. The primary outcome is change from baseline in the 17-item Hamilton Depression Rating Scale, administered by independent raters who are blind to treatment allocation. The Hamilton Anxiety Rating Scale, Patient Health Questionnaire-9, Generalized Anxiety Disorder 7-item scale, response, remission and relapse rates, self-assessment of overall efficacy and satisfaction of patients, and side effect profiles are secondary measures. Discussion This will be the first multicentered RCT in China to assess the efficacy of a brief psychodynamic intervention for MDD. The study has the potential to inform clinical treatment guidelines for the treatment of depression in China. Trial registration ChiCTR, ChiCTR1800016970 . Registered on July 5, 2018