Acute-REMOTION: REMOTION in Acute Psychiatric Care (Acute-REMOTION)

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

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorder
• Intervention / Treatment: Behavioral: REMOTION; Behavioral: TAU

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3000 Bern 60
    • Universitäre Psychiatrische Dienste Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAU	Behavioral: TAU; 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).
Experimental: REMOTION + TAU	Behavioral: REMOTION; 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).; Behavioral: TAU; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in general symptom severity	Assessed with the Brief Symptom Inventory 18 (BSI-18)	Assessed at Baseline
Change in general symptom severity	Assessed with the Brief Symptom Inventory 18 (BSI-18)	Assessed after 4 weeks
Change in general symptom severity	Assessed with the Brief Symptom Inventory 18 (BSI-18)	Assessed after inpatient discharge (on average 24 days after inpatient intake)
Change in general symptom severity	Assessed with the Brief Symptom Inventory 18 (BSI-18)	Assessed after 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulties in emotion regulation	Assessed with the Difficulties in Emotion Regulation Scale (DERS)	Assessed at Baseline, then after 4 Weeks, after inpatient discharge (on average 24 days after inpatient intake), and after 8 Weeks
Emotion regulation skills	Assessed with the Self-Report Measure for the Assessment of Emotion Regulation Skills (SEK-27)	Assessed at Baseline, then after 4 Weeks, after inpatient discharge (on average 24 days after inpatient intake), and after 8 Weeks
Usability of REMOTION	Assessed with the System Usability Scale (SUS)	Assessed after 4 weeks, after inpatient discharge (on average 24 days after inpatient intake), and after 8 Weeks
Satisfaction with REMOTION	Assessed with the ZUF-8 (Fragebogen zur Messung der Patientenzufriedenheit) Questionnaire adapted for an internet-based program	Assessed after 4 Weeks, after inpatient discharge (on average 24 days after inpatient intake), and after 8 Weeks
REMOTION usage parameters	Amount of modules completed and amount of exercises completed	Assessed after 4 weeks, after inpatient discharge (on average 24 days after inpatient intake) and after 8 weeks
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	4 months after study start
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	After a patient is lost to follow-up (after the 8 week timepoint when follow-up is assessed, has passed for the individual patient)

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Principal Investigator: Franz Moggi, Prof. Dr., Universitäre Psychiatrische Dienste Bern, Universität Bern

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): July 18, 2023

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 2020-01139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No