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

Not Applicable

Completed

• Conditions: Mental Disorders
• Interventions: Behavioral: REMOTION; Behavioral: TAU

• Registration Number: NCT04262726
• Lead Sponsor: University of Bern

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-10
• Study Start: 2020-02-26
• Primary Completion: 2022-11-27
• Study Completion: 2022-11-27
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REMOTION + TAU	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.
TAU	TAU	Participants in TAU receive psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern.
REMOTION + TAU	REMOTION	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.

Primary Outcome Measures

Name	Time	Method
General symptom severity	12 weeks	Assessed with Brief Symptom Inventory (Franke, 2000, German version)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Psychotherapeutische Praxisstelle, Universität Bern; 🇨🇭 Bern, Switzerland