Acute-REMOTION: REMOTION in Acute Psychiatric Care

Mental Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04990674
• Other study ID #: 2020-01139
• Status: Completed
• Phase: N/A
• Start date: August 9, 2021
• Est. completion date: July 18, 2023

Study information

• Verified date: July 2023
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 18, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorder
• Mental Disorders

Intervention

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).
• 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).

Locations

Country	Name	City	State
Switzerland	Universitäre Psychiatrische Dienste Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in general symptom severity	Assessed with the Brief Symptom Inventory 18 (BSI-18)	Assessed at Baseline
Primary	Change in general symptom severity	Assessed with the Brief Symptom Inventory 18 (BSI-18)	Assessed after 4 weeks
Primary	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)
Primary	Change in general symptom severity	Assessed with the Brief Symptom Inventory 18 (BSI-18)	Assessed after 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)