REMOTION Blended Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting: Protocol for a Pilot Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Emotion regulation has been identified as an important transdiagnostic factor relevant to the treatment of mental disorders. A variety of empirically validated psychotherapeutic treatments aim to incorporate elements targeting emotion regulation. Most of these treatment approaches are conceptualized as standard face to face treatments, not as blended treatments that include an internet-based intervention. OBJECTIVE The aim of this study is to examine, for the first time, a new internet-based intervention, REMOTION, which will be provided transdiagnostically, as an add-on to psychotherapy in the form of a blended treatment. METHODS This article describes the protocol for a pilot randomized controlled study. A total of 70 participants will be assigned to either the intervention group, which will use REMOTION, an internet-based program an add-on to psychotherapy, or to a treatment as usual group (TAU) that receives psychotherapy alone. To maximize external validity, a typical outpatient treatment sample of patients diagnosed with a range of disorders such as depression, anxiety disorders, and adjustment disorder will be recruited from a university outpatient clinic. Patients with bipolar disorder, psychotic disorders or acute suicidality will be excluded from the study. The feasibility and potential effectiveness of the intervention will be examined by assessing data at baseline, after six weeks, and at follow-up after twelve weeks. The primary outcome is general symptom severity, assessed with the Brief Symptom Inventory after six weeks and after twelve weeks. Secondary outcomes are emotion regulation, depressive symptoms, anxiety symptoms, health related quality of life, well-being and a variety of feasibility parameters also assessed at six and twelve weeks. Data will be analyzed on an intention to treat (ITT) basis. RESULTS The study is currently recruiting participants, data collection started in February 2020. Results for the study are expected in 2022. CONCLUSIONS REMOTION is a novel intervention to transdiagnostically reduce symptom severity and improve emotion regulation of psychotherapy patients in a blended format. This pilot randomized controlled trial will inform larger, future studies using transdiagnostic, blended treatment. CLINICALTRIAL ClinicalTrials.gov, NCT04262726