Background Emotion regulation has been identified as an important transdiagnostic factor relevant to the treatment of mental health disorders. Many empirically validated psychotherapeutic treatments incorporate elements targeting emotion regulation. Most of these treatment approaches are conceptualized as standard face-to-face treatments not as blended treatments, which include an internet-based intervention. Objective The aim of this study is to examine, for the first time, a new internet-based intervention—REMOTION—that will be provided transdiagnostically, as an add-on to psychotherapy, to provide a blended treatment format. Methods A total of 70 participants will be assigned (1:1 allocation ratio) to either the intervention group (REMOTION + psychotherapy) or the treatment-as-usual group 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, 6 weeks (post), and 12 weeks (follow-up). The primary outcome is general symptom severity, assessed with the Brief Symptom Inventory. Secondary outcomes are emotion regulation, depressive symptoms, anxiety symptoms, health related quality of life, well-being, and a variety of feasibility parameters. Quantitative data will be analyzed on an intention-to-treat basis. Results Participant recruitment and data collection started in February 2020, and as of November 2020, are ongoing. Results for the study are expected in 2022. Conclusions This pilot randomized controlled trial will inform future studies using transdiagnostic blended treatment. Trial Registration ClinicalTrials.gov NCT04262726; http://clinicaltrials.gov/ct2/show/NCT04262726 International Registered Report Identifier (IRRID) DERR1-10.2196/20936
Zusammenfassung Hintergrund Über die letzten Jahrzehnte wurden verschiedene Ansätze zur Digitalisierung der Psychotherapie (PT) entwickelt. Eine Behandlungsform stellt die Kombination von „Face-to-face“-PT und Online-Interventionen, die „Blended-PT“, dar. Während das Forschungsinteresse zu Blended-PT in den letzten Jahren zugenommen hat, wurde die praktische Anwendung von Blended-PT im deutschsprachigen Raum bisher weniger stark umgesetzt. Auch bedingt durch die globale, durch die „coronavirus disease 2019“ (COVID-19) ausgelöste Pandemie gewinnen Blended-PT und andere Online-Ansätze zunehmend an Bedeutung. Ziel der Arbeit Ein Überblick zum Thema und zu verschiedenen Formen von Blended-PT wird gegeben. Im Weiteren wird auf die Wirksamkeit, die Sicht der Patient:innen und Therapeut:innen sowie auf das Thema der Implementierung eingegangen. Material und Methoden Narrative Übersicht der Literatur zum Thema Blended-PT; auf Basis einer umfassenden Suche werden wichtige Überlegungen und Befunde eingeordnet und beschrieben. Ergebnisse Der Begriff der Blended-PT wird bisher uneinheitlich verwendet. In Anlehnung an Blended-Learning-Ansätze können „blends“ auf verschiedenen Ebenen stattfinden. Es kann zwischen ergänzenden und transformierenden Blends unterschieden werden. In transformierenden Blends verändert das Format die Face-to-face-PT grundlegend. Zu einigen Blended-PT-Formen gibt es bereits Wirksamkeitsbelege, zu anderen besteht dringender Forschungsbedarf. Im Vergleich zu Face-to-face-PT und reiner Online-Therapie könnte die Blended-PT verschiedene Vorteile bieten. Schlussfolgerung Das Interesse an Blended-PT wächst aufseiten von Patient:innen und Therapeut:innen. Um evidenzbasierte Blended-PT erfolgreich anbieten zu können, bedarf es der engen Zusammenarbeit zwischen Wissenschaft, Institutionen, Therapeut:innen und Kostenträgern im Gesundheitssystem.
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
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
BACKGROUND Only 11-40% of those affected by a mental disorder in Germany receive treatment. New approaches to improve the German health care system are needed in order to counter chronification. Online-interventions have been shown to be effective as stand-alone as well as add-ons 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. In general, interventions can be differentiated as having either a capitalization focus - thus drawing on already existing strengths (CAP) - or a compensation focus - trying to compensate for deficits (COMP). Up to now, the effectiveness of transdiagnostic online-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 online-interventions focusing on (1) the activation of resilience and drawing on existing strengths (CAP: Res-Up!) and (2) the improvement of emotion regulation (COMP: REMOTION), compared to care as usual in routine outpatient psychotherapy. METHODS Adults with at least one mental health disorder will be recruited at four outpatient centers in Germany. Assessments will be made at baseline (T0), at 6-weeks-posttreatment (T1) and at 12-weeks follow-up (T2). Primary outcome will be symptom severity (BSI-18). Secondary outcomes will focus on emotion regulation and resilience. RESULTS Participant recruitment and data collection started in April 2020 and are ongoing as of July 2022. Results of the study are expected in 2023. CONCLUSIONS This randomized controlled trial will compare care as usual with the transdiagnostic internet-interventions Res-Up! and REMOTION and will thus inform future studies concerning the effectiveness of transdiagnostic online interventions in routine outpatient psychotherapy. CLINICALTRIAL ClinicalTrials.gov NCT04352010, International Registered Report Identifier (IRRID)
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