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 (REMOTION)

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

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorders
• Intervention / Treatment: Behavioral: REMOTION; Behavioral: TAU

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3012
    • Psychotherapeutische Praxisstelle, Universität Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REMOTION + TAU; 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; 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.; Behavioral: TAU; 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.
Active Comparator: TAU; Participants in TAU receive psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern.	Behavioral: TAU; 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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic alliance	Alliance will be assessed with the Working Alliance Inventory (WAI-SR, German version by Wilmers et al., 2008)	6 weeks, twelve weeks
Self Compassion	Assessed with the Self Compassion Scale (German version by Hupfeld & Ruffieux, 2011)	baseline, six weeks, twelve weeks
Negative effects of REMOTION	Assessed with an adapted version of the Inventory to Assess Negative Effects of Psychotherapy (INEP; Ladwig et al., 2014)	six weeks, 12 weeks (REMOTION group only)
Therapist variables	Assessed with items created for the study (demographics, use of emotion regulation interventions in therapy, use of online interventions in therapy)	baseline, 6 weeks, 12 weeks
Therapist variables specific to REMOTION	Assessed with items created for the study (for example perceived effect of REMOTION etc.)	6 weeks, 12 weeks (REMOTION group only)
Patient emotion regulation difficulties as rated by the therapist	Assessed with the DERS-t (modified version of the German version by Ehring et al., 2008)	baseline, 6 weeks,12 weeks
Patient emotion regulation competencies as rated by the therapist	Assessed with the SEK-27-t (modified version of the German version by Bering & Znoj, 2008)	baseline, 6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Principal Investigator: Thomas Berger, Prof. Dr., Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Bern

Publications and helpful links

General Publications

• Bielinski LL, Krieger T, Moggi F, Trimpop L, Willutzki U, Nissen C, Berger T. REMOTION Blended Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2020 Nov 12;9(11):e20936. doi: 10.2196/20936.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Actual): November 27, 2022
• Study Completion (Actual): November 27, 2022

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Emotion regulation; Transdiagnostic; Blended therapy; Internet-based
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 2019-01929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No