Protocol for a sequential, multiple assignment, randomised trial to test the effectiveness of message-based psychotherapy for depression compared with telepsychotherapy

INTRODUCTION: Digital mental health tools have become popular alternatives to traditional psychotherapy. One emerging form of digital mental health is message-based care, the use of text messages or asynchronous voice or video messaging to provide psychotherapy. There has been no research into whether this is an effective method of psychotherapy as a stand-alone treatment or in combination with traditional psychotherapy. METHODS AND ANALYSIS: This is a sequential, multiple assignment randomised trial to compare message-based care, videoconference-psychotherapy and a combination of the two treatments in 1000 depressed adults. Participants will be recruited through Talkspace, a digital mental health company, and randomised to receive 6 weeks of either message-based care only or videoconference-psychotherapy only. At 6 weeks, participants will be evaluated for their response to treatment. Those with a 50% or more response to treatment will continue with their assigned condition. Those who do not respond will be randomised to either monthly videoconference-psychotherapy or weekly videoconference-psychotherapy plus message-based care. Primary outcomes will be depression and social functioning. We will also explore moderators of treatment outcome. ETHICS AND DISSEMINATION: The study received ethics approval from the University of Washington Institutional Review Board. Results of this study will be presented in peer-reviewed journals and at professional conferences. TRIAL REGISTRATION NUMBER: NCT04513080; Pre-results.