Mental DisordersTOP+NCT04352010
Therapy Online Plus (TOP+) - Comparing Two Online Interventions for Dealing With Challenging Life Circumstances
A study testing Res-Up! and REMOTION in people with Mental Disorders and Online-Intervention, run by Ulrike Willutzki at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders, Online-Intervention
- What is being tested?
- Res-Up! and REMOTION
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 13 Apr 2020to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Insufficient German language skills
- Current severe episode of major depression
- Psychotic disorder
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Witten/Herdecke University
Witten, North Rhine-Westphalia, 58455
Leonie F Trimpop, M.Sc.
About this study
Official title: Therapy Online Plus (TOP+) - Comparing Two Online Interventions ("REMOTION" Resp. "Res-Up!") for Dealing With Challenging Life Circumstances
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.
- Conditions
- Mental Disorders, Online-Intervention
- Being tested
- Res-Up!, REMOTION, Wait-Control Group
- Keywords
- Internet-based Therapy, Resilience, Emotion Regulation, Outcome Research, Strengths, Psychotherapy
- Medical subject headings
- Mental Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Res-Up!Behavioural
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.
REMOTIONBehavioural
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.
Wait-Control GroupOther
In the waiting control group participants will answer questionnaires and they will gain access to either REMOTION or Res-Up! after twelve weeks.
| Study group | Role | What they receive |
|---|---|---|
| Online-Intervention "Res-Up!" | Experimental | 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. Receives: Behavioral: Res-Up! |
| Online-Intervention "REMOTION" | Experimental | 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. Receives: Behavioral: REMOTION |
| Wait-control group | Experimental | 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. Receives: Other: Wait-Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, then after six weeks and after twelve weeks
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).
Measured: Change from Baseline, then after six weeks and after twelve weeks
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).
Measured: Change from Baseline, then after six weeks and after twelve weeks
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.
Measured: 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
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")].
Measured: Change from Baseline, then after six weeks and after twelve weeks
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.
Measured: Change from Baseline, then after six weeks and after twelve weeks
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")].
Measured: Change from six weeks after treatment to twelve weeks after
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")].
Measured: Change from Baseline, then after six weeks and after twelve weeks
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.
Measured: At the beginning of every subpart of the intervention, every week up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start13 Apr 2020
- Primary completionJul 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulrike Willutzki
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor-investigator, Ulrike Willutzki, University of Witten/Herdecke
- Investigators
- Ulrike Willutzki, Prof. Dr., Study chair, Witten/Herdecke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352010
- Sponsor's protocol ID
- 221/2019
- Acronym
- TOP+
- Status last verified
- Jul 2022
- First submitted
- 25 Mar 2020
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36920449
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy Online Plus (TOP+) - Comparing Two Online Interventions ("REMOTION" Resp. "Res-Up!") for Dealing With Challenging Life Circumstances
- ClinicalTrials.gov ID
- NCT04352010
- Acronym / sponsor ID
- TOP+ / 221/2019
- Conditions
- Mental Disorders, Online-Intervention
- Keywords
- Internet-based Therapy, Resilience, Emotion Regulation, Outcome Research, Strengths, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ulrike WillutzkiUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Online-Intervention "Res-Up!" | Experimental | Behavioral: Res-Up!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. |
| Online-Intervention "REMOTION" | Experimental | Behavioral: REMOTIONParticipants 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 | Experimental | Other: Wait-Control GroupParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Insufficient German language skills
- Current severe episode of major depression
- Psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Online-Intervention "Res-Up!" |
| REMOTIONREMOTION 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. | Behavioural | Online-Intervention "REMOTION" |
| Wait-Control GroupIn the waiting control group participants will answer questionnaires and they will gain access to either REMOTION or Res-Up! after twelve weeks. | Other | Wait-control group |
Primary outcome
Change on Brief Symptom Inventory - short form (BSI-18) over multiple time points
Time frame: Change from Baseline, then after six weeks and after twelve weeks
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.
9 secondary outcomes
Change on Patient Health Questionnaire-9 (PHQ-9) over multiple time points
Time frame: Baseline, then after six weeks and after twelve weeks
Change on Witten Resource Questionnaire (WIRF) over multiple time points
Time frame: Change from Baseline, then after six weeks and after twelve weeks
Change on Rosenberg-Self-Esteem Scale (RSES) over multiple time points
Time frame: Change from Baseline, then after six weeks and after twelve weeks
Change on Connor-Davidson Resilience Scale (CD-RISC-10) over multiple time points
Time frame: 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
Time frame: Change from Baseline, then after six weeks and after twelve weeks
Change on Self-Compassion Scale (SCS-D) over multiple time points
Time frame: Change from Baseline, then after six weeks and after twelve weeks
Change on Working Alliance Inventory (WAI) between two time points
Time frame: Change from six weeks after treatment to twelve weeks after
Change on Questionnaire Assessing the Acceptance of Unpleasant and Pleasant Emotions (Fragebogen zur Akzeptanz von Gefühlen; FrAGe) over multiple time points
Time frame: Change from Baseline, then after six weeks and after twelve weeks
Change on Positive and Negative Affect Schedule (PANAS) over multiple time points
Time frame: At the beginning of every subpart of the intervention, every week up to 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Derived from this study: PubMed 36920449Trimpop 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Willutzki, Prof. Dr. study chair
Witten/Herdecke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Res-Up! and REMOTION in people with Mental Disorders and Online-Intervention, run by Ulrike Willutzki at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonie F Trimpop, M.Sc. (+(0)49 2302 926 9704, leonie.trimpop@uni-wh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on Brief Symptom Inventory - short form (BSI-18) over multiple time points (time frame: Change from Baseline, then after six weeks and after twelve weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04352010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.