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

Primary Purpose

Mental Disorders, Online-Intervention

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Res-Up!
REMOTION
Wait-Control Group
Sponsored by
Ulrike Willutzki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorders focused on measuring Internet-based Therapy, Resilience, Emotion Regulation, Outcome Research, Strengths, Psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Witten/Herdecke UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Online-Intervention "Res-Up!"

Online-Intervention "REMOTION"

Wait-control group

Arm Description

Participants 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.

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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 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 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 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 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 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 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 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.

Full Information

First Posted
March 25, 2020
Last Updated
July 4, 2022
Sponsor
Ulrike Willutzki
Collaborators
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT04352010
Brief Title
Therapy Online Plus (TOP+) - Comparing Two Online Interventions for Dealing With Challenging Life Circumstances
Acronym
TOP+
Official Title
Therapy Online Plus (TOP+) - Comparing Two Online Interventions ("REMOTION" Resp. "Res-Up!") for Dealing With Challenging Life Circumstances
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ulrike Willutzki
Collaborators
University of Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders, Online-Intervention
Keywords
Internet-based Therapy, Resilience, Emotion Regulation, Outcome Research, Strengths, Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online-Intervention "Res-Up!"
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Online-Intervention "REMOTION"
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Wait-control group
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Behavioral
Intervention Name(s)
Res-Up!
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
REMOTION
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Wait-Control Group
Intervention Description
In the waiting control group participants will answer questionnaires and they will gain access to either REMOTION or Res-Up! after twelve weeks.
Primary Outcome Measure Information:
Title
Change on Brief Symptom Inventory - short form (BSI-18) over multiple time points
Description
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.
Time Frame
Change from Baseline, then after six weeks and after twelve weeks
Secondary Outcome Measure Information:
Title
Change on Patient Health Questionnaire-9 (PHQ-9) over multiple time points
Description
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.
Time Frame
Baseline, then after six weeks and after twelve weeks
Title
Change on Witten Resource Questionnaire (WIRF) over multiple time points
Description
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).
Time Frame
Change from Baseline, then after six weeks and after twelve weeks
Title
Change on Rosenberg-Self-Esteem Scale (RSES) over multiple time points
Description
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).
Time Frame
Change from Baseline, then after six weeks and after twelve weeks
Title
Change on Connor-Davidson Resilience Scale (CD-RISC-10) over multiple time points
Description
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.
Time Frame
Change from Baseline, then after six weeks and after twelve weeks
Title
Change on Self-assessment of Emotion Regulation Skills (Selbsteinschätzung emotionaler Kompetenzen; SEK-27) over multiple time points
Description
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")].
Time Frame
Change from Baseline, then after six weeks and after twelve weeks
Title
Change on Self-Compassion Scale (SCS-D) over multiple time points
Description
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.
Time Frame
Change from Baseline, then after six weeks and after twelve weeks
Title
Change on Working Alliance Inventory (WAI) between two time points
Description
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")].
Time Frame
Change from six weeks after treatment to twelve weeks after
Title
Change on Questionnaire Assessing the Acceptance of Unpleasant and Pleasant Emotions (Fragebogen zur Akzeptanz von Gefühlen; FrAGe) over multiple time points
Description
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")].
Time Frame
Change from Baseline, then after six weeks and after twelve weeks
Title
Change on Positive and Negative Affect Schedule (PANAS) over multiple time points
Description
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.
Time Frame
At the beginning of every subpart of the intervention, every week up to 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonie F Trimpop, M.Sc.
Phone
+(0)49 2302 926 9704
Email
leonie.trimpop@uni-wh.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Willutzki, Prof. Dr.
Organizational Affiliation
Witten/Herdecke University
Official's Role
Study Chair
Facility Information:
Facility Name
Witten/Herdecke University
City
Witten
State/Province
North Rhine-Westphalia
ZIP/Postal Code
58455
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonie F Trimpop, M.Sc.

12. IPD Sharing Statement

Learn more about this trial

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

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