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

Browse trials for

• Mental Disorders 2,107

Keywords

• Internet-based Therapy
• Resilience
• Emotion Regulation
• Outcome Research
• Strengths
• Psychotherapy

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's planned enrollment of 200 is above the median of 94 across 1,574 interventional studies indexed under Mental Disorders.

Lead sponsor

Ulrike Willutzki is the lead sponsor of 3 studies on the registry; none are open to participants now.

Study arms

• Experimental
  Online-Intervention "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.

  Behavioral: Res-Up!

• Experimental
  Online-Intervention "REMOTION"

  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.

  Behavioral: REMOTION

• Experimental
  Wait-control group

  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.

  Other: Wait-Control Group

Interventions

• BehavioralRes-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.

• BehavioralREMOTION

  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.

• OtherWait-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.

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.

   Time frame: Change from Baseline, then after six weeks and after twelve weeks

Secondary outcomes

1. 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.

   Time frame: Baseline, then after six weeks and after twelve weeks

2. 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).

   Time frame: Change from Baseline, then after six weeks and after twelve weeks

3. 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).

   Time frame: Change from Baseline, then after six weeks and after twelve weeks

4. 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.

   Time frame: Change from Baseline, then after six weeks and after twelve weeks

5. 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 \[27 items, 9 subscales, 5-point Likert scale ("not at all" to "always")\].

   Time frame: Change from Baseline, then after six weeks and after twelve weeks

6. 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.

   Time frame: Change from Baseline, then after six weeks and after twelve weeks

7. 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 \[online version: 12 items, 5-point Likert scale ("rarely or never" to "always")\].

   Time frame: Change from six weeks after treatment to twelve weeks after

8. 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 \[32 items, 2 subscales: Pleasant and Unpleasant emotions, 6-point scale ("strongly disagree" to "strongly agree")\].

   Time frame: Change from Baseline, then after six weeks and after twelve weeks

9. 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.

   Time frame: At the beginning of every subpart of the intervention, every week up to 5 weeks