Therapy Online Plus (TOP+) - Comparing Two Online Interventions for Dealing With Challenging Life Circumstances
TOP+
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2020
CompletedStudy Start
First participant enrolled
April 13, 2020
CompletedFirst Posted
Study publicly available on registry
April 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedJuly 6, 2022
July 1, 2022
2.2 years
March 25, 2020
July 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change on Brief Symptom Inventory - short form (BSI-18) over multiple time points
Franke, 2000; Internationally used self-report of symptom severity of patients \[18 items\] that includes three symptom scales, each including six items: Somatization, Depression, and Anxiety. Each measured on a 5-point scale according to how much one has been bothered by the symptom in the prior week.
Change from Baseline, then after six weeks and after twelve weeks
Secondary Outcomes (9)
Change on Patient Health Questionnaire-9 (PHQ-9) over multiple time points
Baseline, then after six weeks and after twelve weeks
Change on Witten Resource Questionnaire (WIRF) over multiple time points
Change from Baseline, then after six weeks and after twelve weeks
Change on Rosenberg-Self-Esteem Scale (RSES) over multiple time points
Change from Baseline, then after six weeks and after twelve weeks
Change on Connor-Davidson Resilience Scale (CD-RISC-10) over multiple time points
Change from Baseline, then after six weeks and after twelve weeks
Change on Self-assessment of Emotion Regulation Skills (Selbsteinschätzung emotionaler Kompetenzen; SEK-27) over multiple time points
Change from Baseline, then after six weeks and after twelve weeks
- +4 more secondary outcomes
Study Arms (3)
Online-Intervention "Res-Up!"
EXPERIMENTALParticipants in the Res-Up! group get access to Res-Up! while waiting for psychotherapy or in addition to psychotherapy. Participants will answer questionnaires after inclusion as well as six and twelve weeks later.
Online-Intervention "REMOTION"
EXPERIMENTALParticipants in the REMOTION group get access to REMOTION while waiting for psychotherapy or in addition to psychotherapy. Participants will answer questionnaires after inclusion as well as six and twelve weeks later.
Wait-control group
EXPERIMENTALParticipants in the wait-control group will not get access to the online-tools while waiting for psychotherapy or while in psychotherapy. Participants will answer questionnaires after inclusion, six weeks later and twelve weeks later.They get access to one of the online-tools after 12 weeks.
Interventions
Res-Up! is an internet-based intervention focusing on patients' strengths and positive experiences that have effects on distress, protective factors and quality of life. The intervention is based on the Personal Model of Resilience (PMR; Padesky and Mooney, 2012), which is a positive intervention that utilizes patients' strengths to overcome problems.The PMR activates resilient emotions, thoughts, metaphors, images and behaviors in four steps during five sessions about the aquisition of resilient strategies and their use in daily life. A variety of elements based on different psychotherapy approaches (Cognitive Behavioral Therapy, Emotion Focused Therapy, Positive Therapy etc.) are integrated in the program. Participants should work through one module per week. The intervention is conducted as I-CBT via the platform Minddistrict.Res-Up! is administered as a standalone or an add-on treatment to psychotherapy.
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 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 a standalone or an add-on treatment to psychotherapy.
In the waiting control group participants will answer questionnaires and they will gain access to either REMOTION or Res-Up! after twelve weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Insufficient German language skills
- Current severe episode of major depression
- Psychotic disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ulrike Willutzkilead
- University of Berncollaborator
Study Sites (1)
Witten/Herdecke University
Witten, North Rhine-Westphalia, 58455, Germany
Related Publications (1)
Trimpop LF, Bielinski LL, Berger T, Willutzki U. Evaluation of Two Web-Based Interventions (Res-Up! and REMOTION) in Routine Outpatient Psychotherapy (Therapy Online Plus-TOP): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Mar 15;12:e41413. doi: 10.2196/41413.
PMID: 36920449DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ulrike Willutzki, Prof. Dr.
Witten/Herdecke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Clinical Psychology and Psychotherapy
Study Record Dates
First Submitted
March 25, 2020
First Posted
April 17, 2020
Study Start
April 13, 2020
Primary Completion
July 1, 2022
Study Completion
April 1, 2023
Last Updated
July 6, 2022
Record last verified: 2022-07