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Clinical Trials/NCT04262726
NCT04262726
Completed
Not Applicable

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

University of Bern1 site in 1 country70 target enrollmentFebruary 26, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Disorders
Sponsor
University of Bern
Enrollment
70
Locations
1
Primary Endpoint
General symptom severity
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 26, 2020
End Date
November 27, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

General symptom severity

Time Frame: 12 weeks

Assessed with Brief Symptom Inventory (Franke, 2000, German version)

Secondary Outcomes

  • Difficulties in emotion regulation(baseline, 6 weeks,12 weeks)
  • Depressive Symptoms(baseline, 6 weeks, 12 weeks)
  • Health related quality of life(baseline, 6 weeks, 12 weeks)
  • Feasibility parameter: adherence(6 weeks, 12 weeks (REMOTION group only))
  • Feasibility parameter: program usability(6 weeks, 12 weeks (REMOTION group only))
  • Feasibility parameter: attitude toward psychological online interventions(baseline, 6 weeks, 12 weeks)
  • Feasibility parameter: satisfaction with the intervention(6 weeks, 12 weeks (REMOTION group only))
  • Anxiety symptoms(baseline, 6 weeks, 12 weeks)
  • Feasibility parameter: number of participants taking part in the study(at randomization)
  • Well-Being(baseline, 6 weeks, 12 weeks)
  • Feasibility parameter: user experience(6 weeks, 12 weeks (REMOTION group only))
  • Emotion competencies questionnaire(baseline, 6 weeks, 12 weeks)

Study Sites (1)

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