Clinical trial 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
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
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Keywords: Transdiagnostic
Blended therapy
Internet-based
Emotion regulation
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: General symptom severity
timeFrame: baseline
measure: General symptom severity
timeFrame: 6 weeks
measure: General symptom severity
timeFrame: 12 weeks
Secondary outcomes:
measure: Difficulties in emotion regulation
timeFrame: baseline, 6 weeks,12 weeks
measure: Emotion competencies questionnaire
timeFrame: baseline, 6 weeks, 12 weeks
measure: Depressive Symptoms
timeFrame: baseline, 6 weeks, 12 weeks
measure: Anxiety symptoms
timeFrame: baseline, 6 weeks, 12 weeks
measure: Well-Being
timeFrame: baseline, 6 weeks, 12 weeks
measure: Health related quality of life
timeFrame: baseline, 6 weeks, 12 weeks
measure: Feasibility parameter: number of participants taking part in the study
timeFrame: at randomization
measure: Feasibility parameter: adherence
timeFrame: 6 weeks,12 weeks (REMOTION group only)
measure: Feasibility parameter: adherence
timeFrame: 6 weeks,12 weeks (REMOTION group only)
measure: Feasibility parameter: adherence
timeFrame: 6 weeks, 12 weeks (REMOTION group only)
measure: Feasibility parameter: program usability
timeFrame: 6 weeks, 12 weeks (REMOTION group only)
measure: Feasibility parameter: user experience
timeFrame: 6 weeks, 12 weeks (REMOTION group only)
measure: Feasibility parameter: attitude toward psychological online interventions
timeFrame: baseline, 6 weeks, 12 weeks
measure: Feasibility parameter: satisfaction with the intervention
timeFrame: 6 weeks, 12 weeks (REMOTION group only)
Other outcomes:
measure: Therapeutic alliance
timeFrame: 6 weeks, twelve weeks
measure: Self Compassion
timeFrame: baseline, six weeks, twelve weeks
measure: Negative effects of REMOTION
timeFrame: six weeks, 12 weeks (REMOTION group only)
measure: Therapist variables
timeFrame: baseline, 6 weeks, 12 weeks
measure: Therapist variables specific to REMOTION
timeFrame: 6 weeks, 12 weeks (REMOTION group only)
measure: Patient emotion regulation difficulties as rated by the therapist
timeFrame: baseline, 6 weeks,12 weeks
measure: Patient emotion regulation competencies as rated by the therapist
timeFrame: baseline, 6 weeks, 12 weeks
Locations:
city: Bern
country: Switzerland
facility: Psychotherapeutische Praxisstelle, Universität Bern
Study officials:
affiliation: Department of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Bern
name: Thomas Berger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.