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临床试验/NCT04352010
NCT04352010Unknown不适用

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

Ulrike Willutzki2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年4月13日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
2
主要终点
Change on Brief Symptom Inventory - short form (BSI-18) over multiple time points

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Insufficient German language skills
  • Current severe episode of major depression
  • Psychotic disorder

结局指标

主要结局

Change on Brief Symptom Inventory - short form (BSI-18) over multiple time points

时间窗: 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.

次要结局

  • 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 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)
  • Change on Working Alliance Inventory (WAI) between two time points(Change from six weeks after treatment to twelve weeks after)
  • Change on Self-Compassion Scale (SCS-D) over multiple time points(Change from Baseline, then after six weeks and after twelve weeks)
  • Change on Patient Health Questionnaire-9 (PHQ-9) over multiple time points(Baseline, then after six weeks and after twelve weeks)
  • Change on Questionnaire Assessing the Acceptance of Unpleasant and Pleasant Emotions (Fragebogen zur Akzeptanz von Gefühlen; FrAGe) 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 Positive and Negative Affect Schedule (PANAS) over multiple time points(At the beginning of every subpart of the intervention, every week up to 5 weeks)

研究者

发起方
Ulrike Willutzki
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ulrike Willutzki

Professor, Clinical Psychology and Psychotherapy

University of Witten/Herdecke

研究点 (2)

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