Acute-REMOTION: REMOTION in Acute Psychiatric Care

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Mental Disorder

Intervention / Treatment
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* Behavioral: REMOTION
* Behavioral: TAU


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REMOTION + TAU<br> | Behavioral: REMOTION<br>* 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).<br>Behavioral: TAU<br>* 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).<br>|
| Active Comparator: TAU<br> | Behavioral: TAU<br>* 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).<br>|

What is the study measuring?
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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) |