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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Bern
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- General symptom severity
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
REMOTION + 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.
Intervention: 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.
Intervention: TAU (Behavioral)
REMOTION + 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.
Intervention: TAU (Behavioral)
Outcomes
Primary Outcomes
General symptom severity
Time Frame: 12 weeks
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
General symptom severity
Time Frame: baseline
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
General symptom severity
Time Frame: 6 weeks
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
Secondary Outcomes
- Well-Being(baseline, 6 weeks, 12 weeks)
- Feasibility parameter: number of participants taking part in the study(at randomization)
- Feasibility parameter: program usability(6 weeks, 12 weeks (REMOTION group only))
- 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: 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: user experience(6 weeks, 12 weeks (REMOTION group only))
- Emotion competencies questionnaire(baseline, 6 weeks, 12 weeks)
- Feasibility parameter: adherence(6 weeks,12 weeks (REMOTION group only))