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Completed

NCT Number: NCT04990674

Acute-REMOTION: REMOTION in Acute Psychiatric 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.

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Key information

Conditions

Mental Disorder Mental Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitäre Psychiatrische Dienste Bern

Bern, 3000 Bern 60, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REMOTION

Behavioral

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

Behavioral

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).

Primary outcomes

  1. Change in general symptom severity

    Time frame: Assessed at Baseline

    Assessed with the Brief Symptom Inventory 18 (BSI-18)

  2. Change in general symptom severity

    Time frame: Assessed after 4 weeks

    Assessed with the Brief Symptom Inventory 18 (BSI-18)

  3. 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)

  4. Change in general symptom severity

    Time frame: Assessed after 8 weeks

    Assessed with the Brief Symptom Inventory 18 (BSI-18)

Secondary outcomes

  1. 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

    Assessed with the Difficulties in Emotion Regulation Scale (DERS)

  2. 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

    Assessed with the Self-Report Measure for the Assessment of Emotion Regulation Skills (SEK-27)

  3. Usability of REMOTION

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

    Assessed with the System Usability Scale (SUS)

  4. Satisfaction with REMOTION

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

    Assessed with the ZUF-8 (Fragebogen zur Messung der Patientenzufriedenheit) Questionnaire adapted for an internet-based program

  5. REMOTION usage parameters

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

    Amount of modules completed and amount of exercises completed

  6. Qualitative interviews with healthcare workers

    Time frame: 4 months after study start

    Recorded interviews on the topic of attitudes towards / barriers and facilitators / advantages and disadvantages of internet-based interventions in inpatient care

  7. 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)

    Individuals lost to follow up can take part in a telephone interview on a voluntary basis, this examines reasons for loss to follow up

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study 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

Acronym: Acute-REMOTION

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2021
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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