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NCT Number: NCT04262726

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

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.

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Key information

Conditions

Mental Disorders Behavior Emotional Regulation Self-Control Social Behavior

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychotherapeutische Praxisstelle, Universität Bern

Bern, 3012, Switzerland

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

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.

Primary outcomes

  1. General symptom severity

    Time frame: baseline

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

  2. General symptom severity

    Time frame: 6 weeks

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

  3. General symptom severity

    Time frame: 12 weeks

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

Secondary outcomes

  1. Difficulties in emotion regulation

    Time frame: baseline, 6 weeks,12 weeks

    Assessed with Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004, German version by Ehring et al., 2008).

  2. Emotion competencies questionnaire

    Time frame: baseline, 6 weeks, 12 weeks

    Assessed with Emotion Competencies Questionnaire (SEK-27, Berking & Znoj, 2008)

  3. Depressive Symptoms

    Time frame: baseline, 6 weeks, 12 weeks

    Assessed with Patient Health Questionnaire-9 (PHQ-9, German version by Löwe & Spitzer, 2002).

  4. Anxiety symptoms

    Time frame: baseline, 6 weeks, 12 weeks

    Assessed with Generalized Anxiety Disorder Scale-7 (GAD-7, German version by Löwe et al., 2008)

  5. Well-Being

    Time frame: baseline, 6 weeks, 12 weeks

    Assessed with the World Health Organisation-Five Well-Being Index (German version, Brähler, et al., 2007).

  6. Health related quality of life

    Time frame: baseline, 6 weeks, 12 weeks

    Assessed with the Short Form Health Survey (SF-12, German version by Gandek et al., 1998)

  7. Feasibility parameter: number of participants taking part in the study

    Time frame: at randomization

  8. Feasibility parameter: adherence

    Time frame: 6 weeks,12 weeks (REMOTION group only)

    Adherence assessed by amount of modules completed

  9. Feasibility parameter: adherence

    Time frame: 6 weeks,12 weeks (REMOTION group only)

    Adherence assessed by amount of pages visited in REMOTION

  10. Feasibility parameter: adherence

    Time frame: 6 weeks, 12 weeks (REMOTION group only)

    Adherence assessed by amount of exercises completed in REMOTION

  11. Feasibility parameter: program usability

    Time frame: 6 weeks, 12 weeks (REMOTION group only)

    Assessed with the System Usability Scale (SUS, Brooke, 1996)

  12. Feasibility parameter: user experience

    Time frame: 6 weeks, 12 weeks (REMOTION group only)

    Assessed with the meCUE questionnaire (Minge & Riedel, 2013)

  13. Feasibility parameter: attitude toward psychological online interventions

    Time frame: baseline, 6 weeks, 12 weeks

    Attitudes will be assessed with the Attitude toward Psychological Online Interventions Questionnaire (APOI, German version by Schröder, 2015).

  14. Feasibility parameter: satisfaction with the intervention

    Time frame: 6 weeks, 12 weeks (REMOTION group only)

    Assessed with the Client Satisfaction Questionnaire (CSQ-8, German version by Schmidt, 1989, and adapted for internet interventions).

Other outcomes

  1. Therapeutic alliance

    Time frame: 6 weeks, twelve weeks

    Alliance will be assessed with the Working Alliance Inventory (WAI-SR, German version by Wilmers et al., 2008)

  2. Self Compassion

    Time frame: baseline, six weeks, twelve weeks

    Assessed with the Self Compassion Scale (German version by Hupfeld & Ruffieux, 2011)

  3. Negative effects of REMOTION

    Time frame: six weeks, 12 weeks (REMOTION group only)

    Assessed with an adapted version of the Inventory to Assess Negative Effects of Psychotherapy (INEP; Ladwig et al., 2014)

  4. Therapist variables

    Time frame: baseline, 6 weeks, 12 weeks

    Assessed with items created for the study (demographics, use of emotion regulation interventions in therapy, use of online interventions in therapy)

  5. Therapist variables specific to REMOTION

    Time frame: 6 weeks, 12 weeks (REMOTION group only)

    Assessed with items created for the study (for example perceived effect of REMOTION etc.)

  6. Patient emotion regulation difficulties as rated by the therapist

    Time frame: baseline, 6 weeks,12 weeks

    Assessed with the DERS-t (modified version of the German version by Ehring et al., 2008)

  7. Patient emotion regulation competencies as rated by the therapist

    Time frame: baseline, 6 weeks, 12 weeks

    Assessed with the SEK-27-t (modified version of the German version by Bering & Znoj, 2008)

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study 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

Acronym: REMOTION

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2020
Registry last updated
Jan 10, 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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