Evaluation of Two Web-Based Interventions (Res-Up! and REMOTION) in Routine Outpatient Psychotherapy (Therapy Online Plus—TOP): Protocol for a Randomized Controlled Trial

Abstract

Background Only 11%-40% of those with a mental disorder in Germany receive treatment. In many cases, face-to-face psychotherapy is not available because of limited resources, such as an insufficient number of therapists in the area. New approaches to improve the German health care system are needed to counter chronification. Web-based interventions have been shown to be effective as stand-alone and add-on treatments to routine practice. Interventions designed for a wide range of mental disorders such as transdiagnostic interventions are needed to make treatment for mental disorders more accessible and thus shorten waiting times and mitigate the chronification of mental health problems. In general, interventions can be differentiated as having either a capitalization (CAP) focus—thus drawing on already existing strengths—or a compensation (COMP) focus—trying to compensate for deficits. Up to now, the effectiveness of transdiagnostic web-based interventions with either a CAP or a COMP focus has not yet been evaluated. Objective This study is the first to examine the effectiveness of two transdiagnostic web-based interventions: (1) the activation of resilience and drawing on existing strengths (CAP: Res-Up!) and (2) the improvement of emotion regulation (COMP: REMOTION), compared with care as usual (CAU) in routine outpatient psychotherapy. Methods Adults with at least 1 mental health disorder will be recruited at 4 outpatient centers in Germany. Participants will then be randomized equally into 1 of the 2 intervention groups Res-Up! (CAP) and REMOTION (COMP) or into the control group (CAU). Assessments will be made at baseline (T0), at 6 weeks after treatment start (T1), and at 12 weeks after treatment start (T2). A primary outcome will be symptom severity (Brief Symptom Inventory-18). Secondary outcomes will focus on emotion regulation and resilience. Results Participant recruitment and data collection started in April 2020 and were ongoing as of July 2022. We expect participants to benefit more from the interventions than from the CAU control on the dimensions of symptom severity, resilience, and emotion regulation. Furthermore, we expect to find possible differences between CAP and COMP. The results of the study are expected in 2023. Conclusions This randomized controlled trial will compare CAU with the transdiagnostic web-based interventions Res-Up! and REMOTION, and will thus inform future studies concerning the effectiveness of transdiagnostic web-based interventions in routine outpatient psychotherapy. Trial Registration ClinicalTrials.gov NCT04352010; https://clinicaltrials.gov/ct2/show/NCT04352010 International Registered Report Identifier (IRRID) DERR1-10.2196/41413

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

“…It is structurally based on the extended process model (EPM) of emotion regulation [ 34 ]. It is currently also being examined as an add-on to outpatient psychotherapy in a different study [ 35 ] and is being examined in a large, randomized, controlled, 3-armed outpatient trial in Germany that focuses on effectiveness [ 36 ]. It has never been examined in an inpatient setting up to this point.…”

“…Such an intervention may be of particular interest for inpatient populations, where comorbidity is likely highly prevalent [ 37 ]. A full overview of the intervention content for each module can be found in Table 1 and has also been published in 2 previous publications [ 35 , 36 ]. REMOTION is only available in German.…”

“…REMOTION modules and content. Note that this entire textbox is adapted from tables already published in previous publications by Bielinski et al [35] and Trimpop et al [36], which are published under Creative Commons Attribution 4.0 International License [38].…”