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REMOTION: a Trial to Investigate the Feasibility and Potential Effectiveness of a Blended, Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting (REMOTION)

Primary Purpose

Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
REMOTION
TAU
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorders focused on measuring Transdiagnostic, Blended therapy, Internet-based, Emotion regulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • In psychotherapeutic treatment at the outpatient clinic of the Department of Clinical Psychology at the University of Bern
  • Mental disorder present
  • Internet access available
  • Written informed consent

Exclusion Criteria:

  • Current participation in another intervention, outside of the treatment at the outpatient clinic, that is geared specifically at emotion regulation
  • Current or history of psychotic disorders or bipolar disorder
  • Acute suicidality
  • Insufficient mastery of German language

Sites / Locations

  • Psychotherapeutische Praxisstelle, Universität Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

REMOTION + TAU

TAU

Arm Description

Participants in the REMOTION group receive REMOTION in addition to psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern.

Participants in TAU receive psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern.

Outcomes

Primary Outcome Measures

General symptom severity
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
General symptom severity
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
General symptom severity
Assessed with Brief Symptom Inventory (Franke, 2000, German version)

Secondary Outcome Measures

Difficulties in emotion regulation
Assessed with Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004, German version by Ehring et al., 2008).
Emotion competencies questionnaire
Assessed with Emotion Competencies Questionnaire (SEK-27, Berking & Znoj, 2008)
Depressive Symptoms
Assessed with Patient Health Questionnaire-9 (PHQ-9, German version by Löwe & Spitzer, 2002).
Anxiety symptoms
Assessed with Generalized Anxiety Disorder Scale-7 (GAD-7, German version by Löwe et al., 2008)
Well-Being
Assessed with the World Health Organisation-Five Well-Being Index (German version, Brähler, et al., 2007).
Health related quality of life
Assessed with the Short Form Health Survey (SF-12, German version by Gandek et al., 1998)
Feasibility parameter: number of participants taking part in the study
Feasibility parameter: adherence
Adherence assessed by amount of modules completed
Feasibility parameter: adherence
Adherence assessed by amount of pages visited in REMOTION
Feasibility parameter: adherence
Adherence assessed by amount of exercises completed in REMOTION
Feasibility parameter: program usability
Assessed with the System Usability Scale (SUS, Brooke, 1996)
Feasibility parameter: user experience
Assessed with the meCUE questionnaire (Minge & Riedel, 2013)
Feasibility parameter: attitude toward psychological online interventions
Attitudes will be assessed with the Attitude toward Psychological Online Interventions Questionnaire (APOI, German version by Schröder, 2015).
Feasibility parameter: satisfaction with the intervention
Assessed with the Client Satisfaction Questionnaire (CSQ-8, German version by Schmidt, 1989, and adapted for internet interventions).

Full Information

First Posted
February 6, 2020
Last Updated
January 9, 2023
Sponsor
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT04262726
Brief Title
REMOTION: a Trial to Investigate the Feasibility and Potential Effectiveness of a Blended, Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting
Acronym
REMOTION
Official Title
REMOTION: a Randomized Controlled Pilot Trial to Investigate the Feasibility and Potential Effectiveness of a Blended, Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
November 27, 2022 (Actual)
Study Completion Date
November 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Emotion regulation has been identified as an important transdiagnostic factor in the treatment of mental health disorders. This study aims to examine, for the first time, REMOTION, a novel blended therapy intervention aimed at reducing symptom severity and improving emotion regulation of patients in an outpatient psychotherapy setting. REMOTION is an internet based intervention that is administered as an add-on to psychotherapy. This study aims to investigate feasibility and also potential effectiveness of REMOTION in an outpatient setting. Participants will be randomly assigned to the study conditions. Outcomes are assessed at baseline, after six weeks and after twelve weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
Transdiagnostic, Blended therapy, Internet-based, Emotion regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REMOTION + TAU
Arm Type
Experimental
Arm Description
Participants in the REMOTION group receive REMOTION in addition to psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern.
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
Participants in TAU receive psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern.
Intervention Type
Behavioral
Intervention Name(s)
REMOTION
Intervention Description
REMOTION is an internet-based intervention aimed at transdiagnostically reducing symptom severity and improving emotion regulation of psychotherapy patients. The structure of REMOTION is based on the idea of an extended process model of emotion regulation as postulated by J.J. Gross (2015). The program includes the following modules: introduction, psychoeducation, identification, selection, implementation and monitoring/modification. A variety of elements based on different psychotherapy approaches (Cognitive Behavioral Therapy, Emotion Focused Therapy, Dialectical Behavior Therapy etc.) are integrated in the program. Participants should work through one module per week. REMOTION is administered as an add-on to treatment as usual (TAU), which is psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern.
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
Treatment as usual (TAU) refers to psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern. Psychotherapy at the outpatient clinic is based on Psychological Therapy (Grawe, 1998) principles, which are largely rooted in academic psychology and which mainly draw on interventions from Cognitive Behavior Therapy. Individual case conceptualization are key in Psychological Therapy, along with general therapeutic factors and a focus on the therapeutic relationship.
Primary Outcome Measure Information:
Title
General symptom severity
Description
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
Time Frame
baseline
Title
General symptom severity
Description
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
Time Frame
6 weeks
Title
General symptom severity
Description
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Difficulties in emotion regulation
Description
Assessed with Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004, German version by Ehring et al., 2008).
Time Frame
baseline, 6 weeks,12 weeks
Title
Emotion competencies questionnaire
Description
Assessed with Emotion Competencies Questionnaire (SEK-27, Berking & Znoj, 2008)
Time Frame
baseline, 6 weeks, 12 weeks
Title
Depressive Symptoms
Description
Assessed with Patient Health Questionnaire-9 (PHQ-9, German version by Löwe & Spitzer, 2002).
Time Frame
baseline, 6 weeks, 12 weeks
Title
Anxiety symptoms
Description
Assessed with Generalized Anxiety Disorder Scale-7 (GAD-7, German version by Löwe et al., 2008)
Time Frame
baseline, 6 weeks, 12 weeks
Title
Well-Being
Description
Assessed with the World Health Organisation-Five Well-Being Index (German version, Brähler, et al., 2007).
Time Frame
baseline, 6 weeks, 12 weeks
Title
Health related quality of life
Description
Assessed with the Short Form Health Survey (SF-12, German version by Gandek et al., 1998)
Time Frame
baseline, 6 weeks, 12 weeks
Title
Feasibility parameter: number of participants taking part in the study
Time Frame
at randomization
Title
Feasibility parameter: adherence
Description
Adherence assessed by amount of modules completed
Time Frame
6 weeks,12 weeks (REMOTION group only)
Title
Feasibility parameter: adherence
Description
Adherence assessed by amount of pages visited in REMOTION
Time Frame
6 weeks,12 weeks (REMOTION group only)
Title
Feasibility parameter: adherence
Description
Adherence assessed by amount of exercises completed in REMOTION
Time Frame
6 weeks, 12 weeks (REMOTION group only)
Title
Feasibility parameter: program usability
Description
Assessed with the System Usability Scale (SUS, Brooke, 1996)
Time Frame
6 weeks, 12 weeks (REMOTION group only)
Title
Feasibility parameter: user experience
Description
Assessed with the meCUE questionnaire (Minge & Riedel, 2013)
Time Frame
6 weeks, 12 weeks (REMOTION group only)
Title
Feasibility parameter: attitude toward psychological online interventions
Description
Attitudes will be assessed with the Attitude toward Psychological Online Interventions Questionnaire (APOI, German version by Schröder, 2015).
Time Frame
baseline, 6 weeks, 12 weeks
Title
Feasibility parameter: satisfaction with the intervention
Description
Assessed with the Client Satisfaction Questionnaire (CSQ-8, German version by Schmidt, 1989, and adapted for internet interventions).
Time Frame
6 weeks, 12 weeks (REMOTION group only)
Other Pre-specified Outcome Measures:
Title
Therapeutic alliance
Description
Alliance will be assessed with the Working Alliance Inventory (WAI-SR, German version by Wilmers et al., 2008)
Time Frame
6 weeks, twelve weeks
Title
Self Compassion
Description
Assessed with the Self Compassion Scale (German version by Hupfeld & Ruffieux, 2011)
Time Frame
baseline, six weeks, twelve weeks
Title
Negative effects of REMOTION
Description
Assessed with an adapted version of the Inventory to Assess Negative Effects of Psychotherapy (INEP; Ladwig et al., 2014)
Time Frame
six weeks, 12 weeks (REMOTION group only)
Title
Therapist variables
Description
Assessed with items created for the study (demographics, use of emotion regulation interventions in therapy, use of online interventions in therapy)
Time Frame
baseline, 6 weeks, 12 weeks
Title
Therapist variables specific to REMOTION
Description
Assessed with items created for the study (for example perceived effect of REMOTION etc.)
Time Frame
6 weeks, 12 weeks (REMOTION group only)
Title
Patient emotion regulation difficulties as rated by the therapist
Description
Assessed with the DERS-t (modified version of the German version by Ehring et al., 2008)
Time Frame
baseline, 6 weeks,12 weeks
Title
Patient emotion regulation competencies as rated by the therapist
Description
Assessed with the SEK-27-t (modified version of the German version by Bering & Znoj, 2008)
Time Frame
baseline, 6 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older In psychotherapeutic treatment at the outpatient clinic of the Department of Clinical Psychology at the University of Bern Mental disorder present Internet access available Written informed consent Exclusion Criteria: Current participation in another intervention, outside of the treatment at the outpatient clinic, that is geared specifically at emotion regulation Current or history of psychotic disorders or bipolar disorder Acute suicidality Insufficient mastery of German language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Berger, Prof. Dr.
Organizational Affiliation
Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychotherapeutische Praxisstelle, Universität Bern
City
Bern
ZIP/Postal Code
3012
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33180026
Citation
Bielinski LL, Krieger T, Moggi F, Trimpop L, Willutzki U, Nissen C, Berger T. REMOTION Blended Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2020 Nov 12;9(11):e20936. doi: 10.2196/20936.
Results Reference
derived

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REMOTION: a Trial to Investigate the Feasibility and Potential Effectiveness of a Blended, Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting

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