REMOTION: a Trial to Investigate the Feasibility and Potential Effectiveness of a Blended, Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting

Study Overview
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Brief Summary
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Emotion regulation has been identified as an important transdiagnostic factor in the treatment of mental health disorders. This study aims to examine, for the first time, REMOTION, a novel blended therapy intervention aimed at reducing symptom severity and improving emotion regulation of patients in an outpatient psychotherapy setting. REMOTION is an internet based intervention that is administered as an add-on to psychotherapy. This study aims to investigate feasibility and also potential effectiveness of REMOTION in an outpatient setting. Participants will be randomly assigned to the study conditions. Outcomes are assessed at baseline, after six weeks and after twelve weeks.

Official Title
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REMOTION: a Randomized Controlled Pilot Trial to Investigate the Feasibility and Potential Effectiveness of a Blended, Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting

Conditions
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Mental Disorders

Intervention / Treatment
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* Behavioral: REMOTION
* Behavioral: TAU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older In psychotherapeutic treatment at the outpatient clinic of the Department of Clinical Psychology at the University of Bern Mental disorder present Internet access available Written informed consent Exclusion Criteria: Current participation in another intervention, outside of the treatment at the outpatient clinic, that is geared specifically at emotion regulation Current or history of psychotic disorders or bipolar disorder Acute suicidality Insufficient mastery of German language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REMOTION + TAU<br>Participants in the REMOTION group receive REMOTION in addition to psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern. | Behavioral: REMOTION<br>* REMOTION is an internet-based intervention aimed at transdiagnostically reducing symptom severity and improving emotion regulation of psychotherapy patients. The structure of REMOTION is based on the idea of an extended process model of emotion regulation as postulated by J.J. Gross (2015). The program includes the following modules: introduction, psychoeducation, identification, selection, implementation and monitoring/modification. A variety of elements based on different psychotherapy approaches (Cognitive Behavioral Therapy, Emotion Focused Therapy, Dialectical Behavior Therapy etc.) are integrated in the program. Participants should work through one module per week. REMOTION is administered as an add-on to treatment as usual (TAU), which is psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern.<br>Behavioral: TAU<br>* Treatment as usual (TAU) refers to psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern. Psychotherapy at the outpatient clinic is based on Psychological Therapy (Grawe, 1998) principles, which are largely rooted in academic psychology and which mainly draw on interventions from Cognitive Behavior Therapy. Individual case conceptualization are key in Psychological Therapy, along with general therapeutic factors and a focus on the therapeutic relationship.<br>|
| Active Comparator: TAU<br>Participants in TAU receive psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern. | Behavioral: TAU<br>* Treatment as usual (TAU) refers to psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern. Psychotherapy at the outpatient clinic is based on Psychological Therapy (Grawe, 1998) principles, which are largely rooted in academic psychology and which mainly draw on interventions from Cognitive Behavior Therapy. Individual case conceptualization are key in Psychological Therapy, along with general therapeutic factors and a focus on the therapeutic relationship.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General symptom severity | Assessed with Brief Symptom Inventory (Franke, 2000, German version) | baseline | 
| General symptom severity | Assessed with Brief Symptom Inventory (Franke, 2000, German version) | 6 weeks | 
| General symptom severity | Assessed with Brief Symptom Inventory (Franke, 2000, German version) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulties in emotion regulation | Assessed with Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004, German version by Ehring et al., 2008). | baseline, 6 weeks,12 weeks | 
| Emotion competencies questionnaire | Assessed with Emotion Competencies Questionnaire (SEK-27, Berking & Znoj, 2008) | baseline, 6 weeks, 12 weeks | 
| Depressive Symptoms | Assessed with Patient Health Questionnaire-9 (PHQ-9, German version by Löwe & Spitzer, 2002). | baseline, 6 weeks, 12 weeks | 
| Anxiety symptoms | Assessed with Generalized Anxiety Disorder Scale-7 (GAD-7, German version by Löwe et al., 2008) | baseline, 6 weeks, 12 weeks | 
| Well-Being | Assessed with the World Health Organisation-Five Well-Being Index (German version, Brähler, et al., 2007). | baseline, 6 weeks, 12 weeks | 
| Health related quality of life | Assessed with the Short Form Health Survey (SF-12, German version by Gandek et al., 1998) | baseline, 6 weeks, 12 weeks | 
| Feasibility parameter: number of participants taking part in the study |  | at randomization | 
| Feasibility parameter: adherence | Adherence assessed by amount of modules completed | 6 weeks,12 weeks (REMOTION group only) | 
| Feasibility parameter: adherence | Adherence assessed by amount of pages visited in REMOTION | 6 weeks,12 weeks (REMOTION group only) | 
| Feasibility parameter: adherence | Adherence assessed by amount of exercises completed in REMOTION | 6 weeks, 12 weeks (REMOTION group only) | 
| Feasibility parameter: program usability | Assessed with the System Usability Scale (SUS, Brooke, 1996) | 6 weeks, 12 weeks (REMOTION group only) | 
| Feasibility parameter: user experience | Assessed with the meCUE questionnaire (Minge & Riedel, 2013) | 6 weeks, 12 weeks (REMOTION group only) | 
| Feasibility parameter: attitude toward psychological online interventions | Attitudes will be assessed with the Attitude toward Psychological Online Interventions Questionnaire (APOI, German version by Schröder, 2015). | baseline, 6 weeks, 12 weeks | 
| Feasibility parameter: satisfaction with the intervention | Assessed with the Client Satisfaction Questionnaire (CSQ-8, German version by Schmidt, 1989, and adapted for internet interventions). | 6 weeks, 12 weeks (REMOTION group only) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transdiagnostic, Blended therapy, Internet-based, Emotion regulation