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

Mental Disorders Clinical Trial

— REMOTION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04262726
• Other study ID #: 2019-01929
• Status: Completed
• Phase: N/A
• Start date: February 26, 2020
• Est. completion date: November 27, 2022

Study information

• Verified date: January 2023
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 27, 2022
• Est. primary completion date: November 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Psychotherapeutische Praxisstelle, Universität Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Therapeutic alliance	Alliance will be assessed with the Working Alliance Inventory (WAI-SR, German version by Wilmers et al., 2008)	6 weeks, twelve weeks
Other	Self Compassion	Assessed with the Self Compassion Scale (German version by Hupfeld & Ruffieux, 2011)	baseline, six weeks, twelve weeks
Other	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)
Other	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
Other	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)
Other	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
Other	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
Primary	General symptom severity	Assessed with Brief Symptom Inventory (Franke, 2000, German version)	baseline
Primary	General symptom severity	Assessed with Brief Symptom Inventory (Franke, 2000, German version)	6 weeks
Primary	General symptom severity	Assessed with Brief Symptom Inventory (Franke, 2000, German version)	12 weeks
Secondary	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
Secondary	Emotion competencies questionnaire	Assessed with Emotion Competencies Questionnaire (SEK-27, Berking & Znoj, 2008)	baseline, 6 weeks, 12 weeks
Secondary	Depressive Symptoms	Assessed with Patient Health Questionnaire-9 (PHQ-9, German version by Löwe & Spitzer, 2002).	baseline, 6 weeks, 12 weeks
Secondary	Anxiety symptoms	Assessed with Generalized Anxiety Disorder Scale-7 (GAD-7, German version by Löwe et al., 2008)	baseline, 6 weeks, 12 weeks
Secondary	Well-Being	Assessed with the World Health Organisation-Five Well-Being Index (German version, Brähler, et al., 2007).	baseline, 6 weeks, 12 weeks
Secondary	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
Secondary	Feasibility parameter: number of participants taking part in the study		at randomization
Secondary	Feasibility parameter: adherence	Adherence assessed by amount of modules completed	6 weeks,12 weeks (REMOTION group only)
Secondary	Feasibility parameter: adherence	Adherence assessed by amount of pages visited in REMOTION	6 weeks,12 weeks (REMOTION group only)
Secondary	Feasibility parameter: adherence	Adherence assessed by amount of exercises completed in REMOTION	6 weeks, 12 weeks (REMOTION group only)
Secondary	Feasibility parameter: program usability	Assessed with the System Usability Scale (SUS, Brooke, 1996)	6 weeks, 12 weeks (REMOTION group only)
Secondary	Feasibility parameter: user experience	Assessed with the meCUE questionnaire (Minge & Riedel, 2013)	6 weeks, 12 weeks (REMOTION group only)
Secondary	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
Secondary	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)