Therapy Online Plus (TOP+) - Comparing Two Online Interventions for Dealing With Challenging Life Circumstances

Mental Disorders Clinical Trial

— TOP+  

Official title:

Therapy Online Plus (TOP+) - Comparing Two Online Interventions ("REMOTION" Resp. "Res-Up!") for Dealing With Challenging Life Circumstances

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04352010
• Other study ID #: 221/2019
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2020
• Est. completion date: April 2023

Study information

• Verified date: July 2022
• Source: University of Witten/Herdecke
• Contact: Leonie F Trimpop, M.Sc.
• Phone: +(0)49 2302 926 9704
• Email: leonie.trimpop[@]uni-wh.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2023
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Online-Intervention

Intervention

Behavioral:
• Res-Up!
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
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.

Other:
• Wait-Control Group
In the waiting control group participants will answer questionnaires and they will gain access to either REMOTION or Res-Up! after twelve weeks.

Locations

Country	Name	City	State
Germany	Witten/Herdecke University	Witten	North Rhine-Westphalia

Sponsors (2)

Lead Sponsor	Collaborator
Ulrike Willutzki	University of Bern

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change on Patient Health Questionnaire-9 (PHQ-9) over multiple time points	Kroenke, Spitzer, & Williams, 2001; Internationally used self-report for screening, diagnosing, monitoring and measuring the severity of depression [9 items, 4-point scale ("not at all" to "nearly every day")]. It is the major depressive disorder module of the full PHQ.	Baseline, then after six weeks and after twelve weeks
Secondary	Change on Witten Resource Questionnaire (WIRF) over multiple time points	Schürmann et al., 2019; Self-report of personal and external resources [37 items, 6-point Likert scale ("strongly disagree" to "strongly agree")]. Resources are measured in the three contexts: "everyday life", "crises well coped with" and "current problems" each including three subscales (action regulation, relaxation and social support).	Change from Baseline, then after six weeks and after twelve weeks
Secondary	Change on Rosenberg-Self-Esteem Scale (RSES) over multiple time points	Ferring & Filipp, 1996; Self-report of general self-esteem [10 items, 4-point scale ("strongly disagree" to "strongly agree")]. A total score will be computed with summed item scores (range: 0-30).	Change from Baseline, then after six weeks and after twelve weeks
Secondary	Change on Connor-Davidson Resilience Scale (CD-RISC-10) over multiple time points	Sarubin et al., 2015; Internationally used self-report of individual resilience [short version: 10 items, each rated on a 5-point scale (0-4), with higher scores reflecting stronger resilience]. A total score will be computed with averaged item scores.	Change from Baseline, then after six weeks and after twelve weeks
Secondary	Change on Self-assessment of Emotion Regulation Skills (Selbsteinschätzung emotionaler Kompetenzen; SEK-27) over multiple time points	Berking & Znoj, 2008; Self-Report Measure for the Assessment of Emotion Regulation Skills [27 items, 9 subscales, 5-point Likert scale ("not at all" to "always")].	Change from Baseline, then after six weeks and after twelve weeks
Secondary	Change on Self-Compassion Scale (SCS-D) over multiple time points	Neff, 2003; Internationally used self-report of of self-compassion [26 items, 6 subscales, 5-point scale ("almost never" to "almost always")]. Participants will be asked to rate the items according to how often they behave in the stated manner towards themselves in difficult times.	Change from Baseline, then after six weeks and after twelve weeks
Secondary	Change on Working Alliance Inventory (WAI) between two time points	Wilmers et al., 2008; Internationally used self-report of therapeutic alliance measuring bond, goals and tasks in psychotherapy based on feedback of patients concerning the current therapy session [online version: 12 items, 5-point Likert scale ("rarely or never" to "always")].	Change from six weeks after treatment to twelve weeks after
Secondary	Change on Questionnaire Assessing the Acceptance of Unpleasant and Pleasant Emotions (Fragebogen zur Akzeptanz von Gefühlen; FrAGe) over multiple time points	Beblo et al., 2011; Self-report of the acceptance and supression of unpleasant and unpleasant emotions [32 items, 2 subscales: Pleasant and Unpleasant emotions, 6-point scale ("strongly disagree" to "strongly agree")].	Change from Baseline, then after six weeks and after twelve weeks
Secondary	Change on Positive and Negative Affect Schedule (PANAS) over multiple time points	Watson, Clark, & Tellegen, 1988; Internationally used self-report of positive and negative affect [10 items, 5-point scale ("very slightly or not at all" to "extremely")]. Participants will be asked to rate the items according to how they feel "in the current moment". The PANAS includes two subscales of global positive affect (ten items, range: 1-5) and global negative affect (10 items, range: 1-5). Only the subscale of global positive affect will be used. Subscale scores are computed with averaged item scores.	At the beginning of every subpart of the intervention, every week up to 5 weeks