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

NCT04262726 | Completed DMC

• 1 other identifier: 2019-01929
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorders

Keywords

Transdiagnostic; Blended therapy; Internet-based; Emotion regulation

Outcome Measures

Primary Outcomes (3)

• General symptom severity

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

  baseline

• General symptom severity

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

  6 weeks

• General symptom severity

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

  12 weeks

Secondary Outcomes (14)

• Difficulties in emotion regulation

  baseline, 6 weeks,12 weeks

• Emotion competencies questionnaire

  baseline, 6 weeks, 12 weeks

• Depressive Symptoms

  baseline, 6 weeks, 12 weeks

• Anxiety symptoms

  baseline, 6 weeks, 12 weeks

• Well-Being

  baseline, 6 weeks, 12 weeks

Other Outcomes (7)

• Therapeutic alliance

  6 weeks, twelve weeks

• Self Compassion

  baseline, six weeks, twelve weeks

• Negative effects of REMOTION

  six weeks, 12 weeks (REMOTION group only)

Study Arms (2)

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.

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.

Behavioral: TAU

Interventions

REMOTION BEHAVIORAL

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.

REMOTION + TAU

TAU BEHAVIORAL

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.

REMOTION + TAU; TAU

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Psychotherapeutische Praxisstelle, Universität Bern

Bern, 3012, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 33180026 DERIVED

MeSH Terms

Conditions

Mental Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Thomas Berger, Prof. Dr.

  Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: February 26, 2020
• Primary Completion: November 27, 2022
• Study Completion: November 27, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)