An interventional study of REMOTION and TAU in Mental Disorders, sponsored by University of Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-01-10.
Sponsored by University of Bern · Not applicable, Interventional, and Treatment
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.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's enrollment of 70 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →University of Bern is the lead sponsor of 207 studies on the registry; 47 are open to participants now.
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Exclusion Criteria:
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 · Behavioral: 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
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.
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.
General symptom severity
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
Time frame: baseline
General symptom severity
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
Time frame: 6 weeks
General symptom severity
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
Time frame: 12 weeks
Difficulties in emotion regulation
Assessed with Difficulties in Emotion Regulation Scale (DERS, Gratz \& Roemer, 2004, German version by Ehring et al., 2008).
Time frame: baseline, 6 weeks,12 weeks
Emotion competencies questionnaire
Assessed with Emotion Competencies Questionnaire (SEK-27, Berking \& Znoj, 2008)
Time frame: baseline, 6 weeks, 12 weeks
Depressive Symptoms
Assessed with Patient Health Questionnaire-9 (PHQ-9, German version by Löwe \& Spitzer, 2002).
Time frame: baseline, 6 weeks, 12 weeks
Anxiety symptoms
Assessed with Generalized Anxiety Disorder Scale-7 (GAD-7, German version by Löwe et al., 2008)
Time frame: baseline, 6 weeks, 12 weeks
Well-Being
Assessed with the World Health Organisation-Five Well-Being Index (German version, Brähler, et al., 2007).
Time frame: 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)
Time frame: baseline, 6 weeks, 12 weeks
Feasibility parameter: number of participants taking part in the study
Time frame: at randomization
Feasibility parameter: adherence
Adherence assessed by amount of modules completed
Time frame: 6 weeks,12 weeks (REMOTION group only)
Feasibility parameter: adherence
Adherence assessed by amount of pages visited in REMOTION
Time frame: 6 weeks,12 weeks (REMOTION group only)
Feasibility parameter: adherence
Adherence assessed by amount of exercises completed in REMOTION
Time frame: 6 weeks, 12 weeks (REMOTION group only)
Feasibility parameter: program usability
Assessed with the System Usability Scale (SUS, Brooke, 1996)
Time frame: 6 weeks, 12 weeks (REMOTION group only)
Feasibility parameter: user experience
Assessed with the meCUE questionnaire (Minge \& Riedel, 2013)
Time frame: 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).
Time frame: 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).
Time frame: 6 weeks, 12 weeks (REMOTION group only)
Therapeutic alliance
Alliance will be assessed with the Working Alliance Inventory (WAI-SR, German version by Wilmers et al., 2008)
Time frame: 6 weeks, twelve weeks
Self Compassion
Assessed with the Self Compassion Scale (German version by Hupfeld \& Ruffieux, 2011)
Time frame: 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)
Time frame: 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)
Time frame: baseline, 6 weeks, 12 weeks
Therapist variables specific to REMOTION
Assessed with items created for the study (for example perceived effect of REMOTION etc.)
Time frame: 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)
Time frame: 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)
Time frame: baseline, 6 weeks, 12 weeks
Plan to share: No
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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University of Bern