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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: 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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04262726
Acronym
REMOTION
Enrollment
70
Registered
2020-02-10
Start date
2020-02-26
Completion date
2022-11-27
Last updated
2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorders

Keywords

Transdiagnostic, Blended therapy, Internet-based, Emotion regulation

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.

Interventions

BEHAVIORALREMOTION

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.

BEHAVIORALTAU

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.

Sponsors

University of Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
General symptom severitybaselineAssessed with Brief Symptom Inventory (Franke, 2000, German version)

Secondary

MeasureTime frameDescription
Anxiety symptomsbaseline, 6 weeks, 12 weeksAssessed with Generalized Anxiety Disorder Scale-7 (GAD-7, German version by Löwe et al., 2008)
Health related quality of lifebaseline, 6 weeks, 12 weeksAssessed with the Short Form Health Survey (SF-12, German version by Gandek et al., 1998)
Feasibility parameter: number of participants taking part in the studyat randomization
Feasibility parameter: adherence6 weeks,12 weeks (REMOTION group only)Adherence assessed by amount of modules completed
Feasibility parameter: program usability6 weeks, 12 weeks (REMOTION group only)Assessed with the System Usability Scale (SUS, Brooke, 1996)
Feasibility parameter: user experience6 weeks, 12 weeks (REMOTION group only)Assessed with the meCUE questionnaire (Minge & Riedel, 2013)
Feasibility parameter: attitude toward psychological online interventionsbaseline, 6 weeks, 12 weeksAttitudes will be assessed with the Attitude toward Psychological Online Interventions Questionnaire (APOI, German version by Schröder, 2015).
Feasibility parameter: satisfaction with the intervention6 weeks, 12 weeks (REMOTION group only)Assessed with the Client Satisfaction Questionnaire (CSQ-8, German version by Schmidt, 1989, and adapted for internet interventions).
Difficulties in emotion regulationbaseline, 6 weeks,12 weeksAssessed with Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004, German version by Ehring et al., 2008).
Emotion competencies questionnairebaseline, 6 weeks, 12 weeksAssessed with Emotion Competencies Questionnaire (SEK-27, Berking & Znoj, 2008)
Depressive Symptomsbaseline, 6 weeks, 12 weeksAssessed with Patient Health Questionnaire-9 (PHQ-9, German version by Löwe & Spitzer, 2002).
Well-Beingbaseline, 6 weeks, 12 weeksAssessed with the World Health Organisation-Five Well-Being Index (German version, Brähler, et al., 2007).

Other

MeasureTime frameDescription
Negative effects of REMOTIONsix weeks, 12 weeks (REMOTION group only)Assessed with an adapted version of the Inventory to Assess Negative Effects of Psychotherapy (INEP; Ladwig et al., 2014)
Therapist variablesbaseline, 6 weeks, 12 weeksAssessed with items created for the study (demographics, use of emotion regulation interventions in therapy, use of online interventions in therapy)
Therapist variables specific to REMOTION6 weeks, 12 weeks (REMOTION group only)Assessed with items created for the study (for example perceived effect of REMOTION etc.)
Patient emotion regulation difficulties as rated by the therapistbaseline, 6 weeks,12 weeksAssessed with the DERS-t (modified version of the German version by Ehring et al., 2008)
Patient emotion regulation competencies as rated by the therapistbaseline, 6 weeks, 12 weeksAssessed with the SEK-27-t (modified version of the German version by Bering & Znoj, 2008)
Self Compassionbaseline, six weeks, twelve weeksAssessed with the Self Compassion Scale (German version by Hupfeld & Ruffieux, 2011)
Therapeutic alliance6 weeks, twelve weeksAlliance will be assessed with the Working Alliance Inventory (WAI-SR, German version by Wilmers et al., 2008)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026