Does an Internet-Based Emotion Regulation Intervention Provide Added Value for Acute Psychiatric Inpatient Care? Protocol for a Randomized Controlled Pilot Trial

Background: There is a lack of studies on internet-based interventions in inpatient settings. This is especially true for studies of internet-based interventions in acute psychiatric inpatient care. Internet-based interventions in this specific setting may provide benefits such as patient empowerment and overall improved treatment outcomes. However, there may also be specific barriers to their implementation that are unique due to the complexity of acute psychiatric inpatient care. Objective: The aim of this study is to examine the feasibility and preliminary evidence for effectiveness of a web-based emotion regulation intervention provided as an add-on to acute psychiatric inpatient care. Methods: The goal is to randomly allocate 60 patients with a range of different diagnoses in a 1:1 ratio to either treatment as usual (TAU), which consists of acute psychiatric inpatient treatment, or to the intervention group, which will receive TAU plus access to a web-based intervention that focuses on reduction of emotion regulation difficulties and improvement of emotion regulation skills. The primary outcome is symptom severity, assessed with the short form of the Brief Symptom Inventory at baseline, after 4 weeks, after 8 weeks, and at hospital discharge. Secondary outcomes include 2 emotion regulation parameters, intervention use, usability, patient satisfaction, and reasons for patient loss to follow-up. Results: Participant recruitment started in August 2021 and as of March 2023 was ongoing. First publication of study results is expected in 2024. Conclusions: This study protocol describes a study that intends to examine a web-based emotion regulation intervention in acute psychiatric inpatient care. The study will provide information on the feasibility of the intervention and possible effects on symptom severity and emotion regulation. The results will provide new insights on blended treatment, in this case the combination of a web-based intervention and face-to-face psychiatric treatment, in an understudied patient group and setting. Trial Registration: ClinicalTrials.gov NCT04990674; https://clinicaltrials.gov/ct2/show/NCT04990674 International Registered Report Identifier (IRRID): DERR1-10.2196/47656

Automated summary

This study aims to examine the feasibility and preliminary evidence for effectiveness of a web-based emotion regulation intervention provided as an add-on to acute psychiatric inpatient care. The study will randomly allocate 60 patients to either treatment as usual (TAU) or the intervention group, which will receive TAU plus access to a web-based intervention focusing on emotion regulation. The primary outcome is symptom severity, and secondary outcomes include emotion regulation parameters and patient satisfaction.