Back to resultsAcute-REMOTION: REMOTION in Acute Psychiatric Care (Acute-REMOTION)
Primary Purpose
Mental Disorder
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
REMOTION
TAU
Sponsored by
About this trial
This is an interventional treatment trial for Mental Disorder
Eligibility Criteria
Inclusion Criteria:
- 18 or older
- In acute inpatient care
- With internet access
- Informed consent given
Exclusion Criteria:
- Current participation in another specific emotion regulation intervention group
- Current or history of psychotic disorders, bipolar disorder, mental retardation or organic mental disorders
- Acute suicidality
- Insufficient mastery of German language
Sites / Locations
- Universitäre Psychiatrische Dienste Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
REMOTION + TAU
TAU
Arm Description
Outcomes
Primary Outcome Measures
Change in general symptom severity
Assessed with the Brief Symptom Inventory 18 (BSI-18)
Change in general symptom severity
Assessed with the Brief Symptom Inventory 18 (BSI-18)
Change in general symptom severity
Assessed with the Brief Symptom Inventory 18 (BSI-18)
Change in general symptom severity
Assessed with the Brief Symptom Inventory 18 (BSI-18)
Secondary Outcome Measures
Difficulties in emotion regulation
Assessed with the Difficulties in Emotion Regulation Scale (DERS)
Emotion regulation skills
Assessed with the Self-Report Measure for the Assessment of Emotion Regulation Skills (SEK-27)
Usability of REMOTION
Assessed with the System Usability Scale (SUS)
Satisfaction with REMOTION
Assessed with the ZUF-8 (Fragebogen zur Messung der Patientenzufriedenheit) Questionnaire adapted for an internet-based program
REMOTION usage parameters
Amount of modules completed and amount of exercises completed
Qualitative interviews with healthcare workers
Recorded interviews on the topic of attitudes towards / barriers and facilitators / advantages and disadvantages of internet-based interventions in inpatient care
Qualitative interviews with patients lost to follow up
Individuals lost to follow up can take part in a telephone interview on a voluntary basis, this examines reasons for loss to follow up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04990674
Brief Title
Acute-REMOTION: REMOTION in Acute Psychiatric Care
Acronym
Acute-REMOTION
Official Title
Acute-REMOTION: a Randomized Controlled Pilot Trial to Investigate the Feasibility and Potential Effects of a Transdiagnostic Treatment to Reduce Symptom Severity and Improve Emotion Regulation in Acute Psychiatric Patient Care
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 9, 2021 (Actual)
Primary Completion Date
June 16, 2023 (Actual)
Study Completion Date
July 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to examine REMOTION, an internet-based intervention aimed at reducing symptom severity and improving emotion regulation in an acute psychiatric inpatient care setting. REMOTION is currently being studied in an outpatient psychotherapy setting. This study aims to investigate feasibility and first effects of this intervention in inpatient psychiatric care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
REMOTION + TAU
Arm Type
Experimental
Arm Title
TAU
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
REMOTION
Intervention Description
REMOTION is an internet-based program focusing on emotion regulation and aimed at reducing patient symptom severity and improving emotion regulation. It consists of six modules and the structure is based on the extended process model of emotion regulation by Gross (2015). The intervention is currently being studied in an outpatient psychotherapy setting (Bielinski et al., 2020).
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
Treatment as usual (TAU), refers to standard treatment in an acute inpatient care setting at the Universitäre Psychiatrische Dienste Bern. This treatment includes different standard inpatient psychiatric care components (integrative psychiatric care).
Primary Outcome Measure Information:
Title
Change in general symptom severity
Description
Assessed with the Brief Symptom Inventory 18 (BSI-18)
Time Frame
Assessed at Baseline
Title
Change in general symptom severity
Description
Assessed with the Brief Symptom Inventory 18 (BSI-18)
Time Frame
Assessed after 4 weeks
Title
Change in general symptom severity
Description
Assessed with the Brief Symptom Inventory 18 (BSI-18)
Time Frame
Assessed after inpatient discharge (on average 24 days after inpatient intake)
Title
Change in general symptom severity
Description
Assessed with the Brief Symptom Inventory 18 (BSI-18)
Time Frame
Assessed after 8 weeks
Secondary Outcome Measure Information:
Title
Difficulties in emotion regulation
Description
Assessed with the Difficulties in Emotion Regulation Scale (DERS)
Time Frame
Assessed at Baseline, then after 4 Weeks, after inpatient discharge (on average 24 days after inpatient intake), and after 8 Weeks
Title
Emotion regulation skills
Description
Assessed with the Self-Report Measure for the Assessment of Emotion Regulation Skills (SEK-27)
Time Frame
Assessed at Baseline, then after 4 Weeks, after inpatient discharge (on average 24 days after inpatient intake), and after 8 Weeks
Title
Usability of REMOTION
Description
Assessed with the System Usability Scale (SUS)
Time Frame
Assessed after 4 weeks, after inpatient discharge (on average 24 days after inpatient intake), and after 8 Weeks
Title
Satisfaction with REMOTION
Description
Assessed with the ZUF-8 (Fragebogen zur Messung der Patientenzufriedenheit) Questionnaire adapted for an internet-based program
Time Frame
Assessed after 4 Weeks, after inpatient discharge (on average 24 days after inpatient intake), and after 8 Weeks
Title
REMOTION usage parameters
Description
Amount of modules completed and amount of exercises completed
Time Frame
Assessed after 4 weeks, after inpatient discharge (on average 24 days after inpatient intake) and after 8 weeks
Title
Qualitative interviews with healthcare workers
Description
Recorded interviews on the topic of attitudes towards / barriers and facilitators / advantages and disadvantages of internet-based interventions in inpatient care
Time Frame
4 months after study start
Title
Qualitative interviews with patients lost to follow up
Description
Individuals lost to follow up can take part in a telephone interview on a voluntary basis, this examines reasons for loss to follow up
Time Frame
After a patient is lost to follow-up (after the 8 week timepoint when follow-up is assessed, has passed for the individual patient)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 or older
In acute inpatient care
With internet access
Informed consent given
Exclusion Criteria:
Current participation in another specific emotion regulation intervention group
Current or history of psychotic disorders, bipolar disorder, mental retardation or organic mental disorders
Acute suicidality
Insufficient mastery of German language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franz Moggi, Prof. Dr.
Organizational Affiliation
Universitäre Psychiatrische Dienste Bern, Universität Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäre Psychiatrische Dienste Bern
City
Bern
ZIP/Postal Code
3000 Bern 60
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acute-REMOTION: REMOTION in Acute Psychiatric Care
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