Mental DisorderAcute-REMOTIONNCT04990674
Acute-REMOTION: REMOTION in Acute Psychiatric Care
A study testing REMOTION and TAU in people with Mental Disorder, run by University of Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mental Disorder
- What is being tested?
- REMOTION and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Aug 2021to 18 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or older
- In acute inpatient care
- With internet access
- Informed consent given
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitäre Psychiatrische Dienste Bern
Bern, 3000 Bern 60
About this study
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
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.
- Conditions
- Mental Disorder
- Being tested
- REMOTION, TAU
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMOTIONBehavioural
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).
TAUBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| REMOTION + TAU | Experimental | Not described Receives: Behavioral: REMOTION; Behavioral: TAU |
| TAU | Active comparator | Not described Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in general symptom severity
Assessed with the Brief Symptom Inventory 18 (BSI-18)
Measured: Assessed at Baseline
Change in general symptom severity
Assessed with the Brief Symptom Inventory 18 (BSI-18)
Measured: Assessed after 4 weeks
Change in general symptom severity
Assessed with the Brief Symptom Inventory 18 (BSI-18)
Measured: 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)
Measured: Assessed after 8 weeks
Secondary outcomes (7)
Difficulties in emotion regulation
Assessed with the Difficulties in Emotion Regulation Scale (DERS)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After a patient is lost to follow-up (after the 8 week timepoint when follow-up is assessed, has passed for the individual patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start9 Aug 2021
- Primary completion16 Jun 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franz Moggi, Prof. Dr., Principal investigator, Universitäre Psychiatrische Dienste Bern, Universität Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990674
- Sponsor's protocol ID
- 2020-01139
- Acronym
- Acute-REMOTION
- Status last verified
- Jul 2023
- First submitted
- 15 Jul 2021
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39731056Bielinski 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.
PubMed 37432724
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04990674
- Acronym / sponsor ID
- Acute-REMOTION / 2020-01139
- Conditions
- Mental Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REMOTION + TAU | Experimental | Behavioral: REMOTION, Behavioral: TAU |
| TAU | Active comparator | Behavioral: TAU |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 or older
- In acute inpatient care
- With internet access
- Informed consent given
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REMOTIONREMOTION 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). | Behavioural | REMOTION + TAU |
| TAUTreatment 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). | Behavioural | REMOTION + TAU, TAU |
Primary outcome
Change in general symptom severity
Time frame: Assessed at Baseline
Assessed with the Brief Symptom Inventory 18 (BSI-18)
Change in general symptom severity
Time frame: Assessed after 4 weeks
Assessed with the Brief Symptom Inventory 18 (BSI-18)
Change in general symptom severity
Time frame: Assessed after inpatient discharge (on average 24 days after inpatient intake)
Assessed with the Brief Symptom Inventory 18 (BSI-18)
Change in general symptom severity
Time frame: Assessed after 8 weeks
Assessed with the Brief Symptom Inventory 18 (BSI-18)
7 secondary outcomes
Difficulties in emotion regulation
Time frame: Assessed at Baseline, then after 4 Weeks, after inpatient discharge (on average 24 days after inpatient intake), and after 8 Weeks
Emotion regulation skills
Time frame: Assessed at Baseline, then after 4 Weeks, after inpatient discharge (on average 24 days after inpatient intake), and after 8 Weeks
Usability of REMOTION
Time frame: Assessed after 4 weeks, after inpatient discharge (on average 24 days after inpatient intake), and after 8 Weeks
Satisfaction with REMOTION
Time frame: Assessed after 4 Weeks, after inpatient discharge (on average 24 days after inpatient intake), and after 8 Weeks
REMOTION usage parameters
Time frame: Assessed after 4 weeks, after inpatient discharge (on average 24 days after inpatient intake) and after 8 weeks
Qualitative interviews with healthcare workers
Time frame: 4 months after study start
Qualitative interviews with patients lost 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Derived from this study: PubMed 39731056Bielinski 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.
- Derived from this study: PubMed 37432724Bielinski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franz Moggi, Prof. Dr. principal investigator
Universitäre Psychiatrische Dienste Bern, Universität Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REMOTION and TAU in people with Mental Disorder, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in general symptom severity (time frame: Assessed at Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04990674, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.