NCT04990674

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

August 9, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

July 15, 2021

Last Update Submit

July 24, 2023

Conditions

Mental Disorder

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • Difficulties in emotion regulation

    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 at Baseline, then after 4 Weeks, after inpatient discharge (on average 24 days after inpatient intake), and after 8 Weeks

  • Usability of REMOTION

    Assessed after 4 weeks, after inpatient discharge (on average 24 days after inpatient intake), and after 8 Weeks

  • Satisfaction with REMOTION

    Assessed after 4 Weeks, after inpatient discharge (on average 24 days after inpatient intake), and after 8 Weeks

  • REMOTION usage parameters

    Assessed after 4 weeks, after inpatient discharge (on average 24 days after inpatient intake) and after 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

REMOTION + TAU

EXPERIMENTAL
Behavioral: REMOTIONBehavioral: TAU

TAU

ACTIVE COMPARATOR
Behavioral: TAU

Interventions

REMOTIONBEHAVIORAL

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).

REMOTION + TAU
TAUBEHAVIORAL

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).

REMOTION + TAUTAU

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • or older
  • In acute inpatient care
  • With internet access
  • Informed consent given

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitäre Psychiatrische Dienste Bern

Bern, 3000 Bern 60, Switzerland

Location

Related Publications (2)

  • Bielinski LL, Walchli G, Lange A, von Kanel E, Demel LK, Nissen C, Moggi F, Berger T. A qualitative analysis of healthcare professionals' experiences with an internet-based emotion regulation intervention added to acute psychiatric inpatient care. BMC Psychiatry. 2024 Dec 27;24(1):955. doi: 10.1186/s12888-024-06365-z.

    PMID: 39731056DERIVED

  • Bielinski LL, Walchli G, Nissen C, Berger T, Moggi F. Does an Internet-Based Emotion Regulation Intervention Provide Added Value for Acute Psychiatric Inpatient Care? Protocol for a Randomized Controlled Pilot Trial. JMIR Res Protoc. 2023 Jul 11;12:e47656. doi: 10.2196/47656.

    PMID: 37432724DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Franz Moggi, Prof. Dr.

    Universitäre Psychiatrische Dienste Bern, Universität Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2021

First Posted

August 4, 2021

Study Start

August 9, 2021

Primary Completion

June 16, 2023

Study Completion

July 18, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)