Clinical trial NCT04352010: Therapy Online Plus (TOP+) - Comparing Two Online Interventions for Dealing With Challenging Life Circumstances
Official title: Therapy Online Plus (TOP+) - Comparing Two Online Interventions ("REMOTION" Resp. "Res-Up!") for Dealing With Challenging Life Circumstances
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Disorders
Online-Intervention
Keywords: Internet-based Therapy
Resilience
Emotion Regulation
Outcome Research
Strengths
Psychotherapy
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2020-04-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Psychotherapy interventions can roughly be grouped into compensation-oriented strategies (compensating for and and modifying personal deficits of patients) versus capitalization-oriented strategies (building on patients' personal strengths). Improvement of emotion regulation (compensation-oriented) as well as the activation of resilience (capitalisation-oriented) have been identified as important transdiagnostic factors in the treatment of mental disorders. The study aims to compare compensation vs. capitalization strategies by using two online programs, centered either on emotion-regulation ("REMOTION") or on activating resilience ("Res-Up!"). Res-Up! and REMOTION are administered as stand-alone intervention or as add-on treatment to standard psychotherapy.

Participants will be randomly assigned to three study conditions (Res-Up!, REMOTION, waiting control group). Outcomes are assessed at baseline, after six weeks and after twelve weeks.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of a mental disorder according to DSM-5
* Recruited at the training centers of the German Association for Behavior Therapy (Deutsche Gesellschaft für Verhaltenstherapie, DGVT) at Muenster, Bielefeld and Dortmund or at the Center of Mental Health and Psychotherapy, Witten/Herdecke University (all outpatients clinics

Exclusion Criteria:

* Insufficient German language skills
* Current severe episode of major depression
* Psychotic disorder

Primary outcomes:
measure: Change on Brief Symptom Inventory - short form (BSI-18) over multiple time points
timeFrame: Change from Baseline, then after six weeks and after twelve weeks
Secondary outcomes:
measure: Change on Patient Health Questionnaire-9 (PHQ-9) over multiple time points
timeFrame: Baseline, then after six weeks and after twelve weeks
measure: Change on Witten Resource Questionnaire (WIRF) over multiple time points
timeFrame: Change from Baseline, then after six weeks and after twelve weeks
measure: Change on Rosenberg-Self-Esteem Scale (RSES) over multiple time points
timeFrame: Change from Baseline, then after six weeks and after twelve weeks
measure: Change on Connor-Davidson Resilience Scale (CD-RISC-10) over multiple time points
timeFrame: Change from Baseline, then after six weeks and after twelve weeks
measure: Change on Self-assessment of Emotion Regulation Skills (Selbsteinschätzung emotionaler Kompetenzen; SEK-27) over multiple time points
timeFrame: Change from Baseline, then after six weeks and after twelve weeks
measure: Change on Self-Compassion Scale (SCS-D) over multiple time points
timeFrame: Change from Baseline, then after six weeks and after twelve weeks
measure: Change on Working Alliance Inventory (WAI) between two time points
timeFrame: Change from six weeks after treatment to twelve weeks after
measure: Change on Questionnaire Assessing the Acceptance of Unpleasant and Pleasant Emotions (Fragebogen zur Akzeptanz von Gefühlen; FrAGe) over multiple time points
timeFrame: Change from Baseline, then after six weeks and after twelve weeks
measure: Change on Positive and Negative Affect Schedule (PANAS) over multiple time points
timeFrame: At the beginning of every subpart of the intervention, every week up to 5 weeks
Other outcomes:
Locations:
city: Witten
country: Germany
facility: Witten/Herdecke University
state: North Rhine-Westphalia
Study officials:
affiliation: Witten/Herdecke University
name: Ulrike Willutzki, Prof. Dr.
role: STUDY_CHAIR
References: