Mental DisordersREMOTIONNCT04262726
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
A study testing REMOTION and TAU in people with Mental Disorders, run by University of Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mental Disorders
- 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
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Feb 2020to 27 Nov 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Psychotherapeutische Praxisstelle, Universität Bern
Bern, 3012
About this study
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
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.
- Conditions
- Mental Disorders
- Being tested
- REMOTION, TAU
- Keywords
- Transdiagnostic, Blended therapy, Internet-based, Emotion regulation
- Medical subject headings
- Mental Disorders, Emotional Regulation
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 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.
TAUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| REMOTION + TAU | Experimental | 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. Receives: Behavioral: REMOTION; Behavioral: TAU |
| TAU | Active comparator | Participants in TAU receive psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
General symptom severity
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
Measured: baseline
General symptom severity
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
Measured: 6 weeks
General symptom severity
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
Measured: 12 weeks
Secondary outcomes (14)
Difficulties in emotion regulation
Assessed with Difficulties in Emotion Regulation Scale (DERS, Gratz \& Roemer, 2004, German version by Ehring et al., 2008).
Measured: baseline, 6 weeks,12 weeks
Emotion competencies questionnaire
Assessed with Emotion Competencies Questionnaire (SEK-27, Berking \& Znoj, 2008)
Measured: baseline, 6 weeks, 12 weeks
Depressive Symptoms
Assessed with Patient Health Questionnaire-9 (PHQ-9, German version by Löwe \& Spitzer, 2002).
Measured: baseline, 6 weeks, 12 weeks
Anxiety symptoms
Assessed with Generalized Anxiety Disorder Scale-7 (GAD-7, German version by Löwe et al., 2008)
Measured: baseline, 6 weeks, 12 weeks
Well-Being
Assessed with the World Health Organisation-Five Well-Being Index (German version, Brähler, et al., 2007).
Measured: baseline, 6 weeks, 12 weeks
Health related quality of life
Assessed with the Short Form Health Survey (SF-12, German version by Gandek et al., 1998)
Measured: baseline, 6 weeks, 12 weeks
Feasibility parameter: number of participants taking part in the study
Measured: at randomization
Feasibility parameter: adherence
Adherence assessed by amount of modules completed
Measured: 6 weeks,12 weeks (REMOTION group only)
Feasibility parameter: adherence
Adherence assessed by amount of pages visited in REMOTION
Measured: 6 weeks,12 weeks (REMOTION group only)
Feasibility parameter: adherence
Adherence assessed by amount of exercises completed in REMOTION
Measured: 6 weeks, 12 weeks (REMOTION group only)
Feasibility parameter: program usability
Assessed with the System Usability Scale (SUS, Brooke, 1996)
Measured: 6 weeks, 12 weeks (REMOTION group only)
Feasibility parameter: user experience
Assessed with the meCUE questionnaire (Minge \& Riedel, 2013)
Measured: 6 weeks, 12 weeks (REMOTION group only)
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).
Measured: baseline, 6 weeks, 12 weeks
Feasibility parameter: satisfaction with the intervention
Assessed with the Client Satisfaction Questionnaire (CSQ-8, German version by Schmidt, 1989, and adapted for internet interventions).
Measured: 6 weeks, 12 weeks (REMOTION group only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start26 Feb 2020
- Primary completion27 Nov 2022
- Study completion27 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Berger, Prof. Dr., Principal investigator, Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262726
- Sponsor's protocol ID
- 2019-01929
- Other IDs
- 2019
- Acronym
- REMOTION
- Status last verified
- Jan 2023
- First submitted
- 6 Feb 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33180026
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04262726
- Acronym / sponsor ID
- REMOTION / 2019-01929
- Conditions
- Mental Disorders
- Keywords
- Transdiagnostic, Blended therapy, Internet-based, Emotion regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 27 Nov 2022 (actual)
- Study completion
- 27 Nov 2022 (actual)
- First posted
- 10 Feb 2020 (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.
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.
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: TAUParticipants 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. |
| TAU | Active comparator | Behavioral: TAUParticipants in TAU receive psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 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. | Behavioural | REMOTION + TAU |
| TAUTreatment 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. | Behavioural | REMOTION + TAU, TAU |
Primary outcome
General symptom severity
Time frame: baseline
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
General symptom severity
Time frame: 6 weeks
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
General symptom severity
Time frame: 12 weeks
Assessed with Brief Symptom Inventory (Franke, 2000, German version)
14 secondary outcomes
Difficulties in emotion regulation
Time frame: baseline, 6 weeks,12 weeks
Emotion competencies questionnaire
Time frame: baseline, 6 weeks, 12 weeks
Depressive Symptoms
Time frame: baseline, 6 weeks, 12 weeks
Anxiety symptoms
Time frame: baseline, 6 weeks, 12 weeks
Well-Being
Time frame: baseline, 6 weeks, 12 weeks
Health related quality of life
Time frame: baseline, 6 weeks, 12 weeks
Feasibility parameter: number of participants taking part in the study
Time frame: at randomization
Feasibility parameter: adherence
Time frame: 6 weeks,12 weeks (REMOTION group only)
Feasibility parameter: adherence
Time frame: 6 weeks,12 weeks (REMOTION group only)
Feasibility parameter: adherence
Time frame: 6 weeks, 12 weeks (REMOTION group only)
Feasibility parameter: program usability
Time frame: 6 weeks, 12 weeks (REMOTION group only)
Feasibility parameter: user experience
Time frame: 6 weeks, 12 weeks (REMOTION group only)
Feasibility parameter: attitude toward psychological online interventions
Time frame: baseline, 6 weeks, 12 weeks
Feasibility parameter: satisfaction with the intervention
Time frame: 6 weeks, 12 weeks (REMOTION group only)
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 10 Jan 2023.
- Derived from this study: PubMed 33180026Bielinski 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.
- Individual participant dataSharing planned: No
Related trials for Mental Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Thomas Berger, Prof. Dr. principal investigator
Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of 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 Disorders, 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 5 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 10 Jan 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?
General symptom severity (time frame: baseline). The study lists 3 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 NCT04262726, which also lists 1 linked publication.
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 10 Jan 2023.