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临床试验/NCT05824182
NCT05824182已完成不适用

Fostering Resilience and Well-being in Young Adults With a History of Adverse Childhood Experiences - the FACE Self-help App

Jeannette Brodbeck2 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2023年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
167
试验地点
2
主要终点
Resilience

研究概览

简要总结

The FACE self-help app is an online intervention for young adults with Adverse Childhood Experiences (ACEs). It was developed based on well-established cognitive-behavioural therapy principles. The self-help app contains two components, one targeting emotion regulation (ER), the other social information processing (SIP).

详细描述

The FACE self-help app is an online intervention for young adults with Adverse Childhood Experiences (ACEs). It was developed based on well-established cognitive-behavioural therapy principles. The self-help app contains two components, one targeting emotion regulation (ER), the other social information processing (SIP).

The goal of the present study is to evaluate the efficacy of the FACE self-help app, which aims to foster resilience and improve well-being by enhancing emotion regulation, social skills and minimizing biases in social information processing.

The primary objective is to examine the efficacy of the FACE self-help app for improving resilience and well-being in young adults with a history of ACEs compared to a waiting list control group and to examine the stability of a possible effect.

Secondary objectives are to test

  1. the differential efficacy of the self- and emotion regulation and the social skills and social information processing component
  2. the effects of the FACE self-help app on real life data in affective states, social interactions, the use of coping strategies and state resilience.

研究设计

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

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Self-reported ACEs
  • An informed consent
  • The possession of a smartphone
  • Mastery of the German language.
  • Age between 18 and 25

排除标准

  • Inability to follow the procedures of the study, e.g., due to comprehension problems, visual impairment, lack of sufficient motor skills or severe psychological or somatic disorders which require immediate treatment which impedes the continuous work on the self-help programme. These points will be discussed with the participant in the screening telephone call.
  • Acute suicidality.

结局指标

主要结局

Resilience

时间窗: at week 13, t2 (post-measurement)

Resilience will be assessed with the German version (Sarubin et al., 2015) of the Connor-Davidson Resilience Scale (CD-RISC) (Connor \& Davidson, 2003). The scale contains 10 items that are rated on a 5-point scale from 0 - Not true at all to 4 - True nearly all the time. A higher score indicates more resilience.

次要结局

  • Well-being(at week 13, t2 (post-measurement))
  • Self-Esteem(at week 13, t2 (post-measurement))
  • Stability of decrease in fear of negative evaluation(at week 24, t4 (follow-up))
  • Stability of decrease in social avoidance(at week 24, t4 (follow-up))
  • Emotion Regulation(at week 13, t2 (post-measurement))
  • Fear of Negative Evaluation(at week 13, t2 (post-measurement))
  • Social Avoidance(at week 13, t2 (post-measurement))
  • Problem-Solving(at week 13, t2 (post-measurement))
  • Stability of improvement in emotion regulation(at week 24, t4 (follow-up))
  • Stability of improvement in problem-solving(at week 24, t4 (follow-up))
  • Stability of improvement in self-esteem(at week 24, t4 (follow-up))
  • Stability of improvement in resilience(at week 24, t4 (follow-up))
  • Stability of improvement in well-being(at week 24, t4 (follow-up))

研究者

发起方
Jeannette Brodbeck
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jeannette Brodbeck

Prof. Dr.

University of Applied Sciences and Arts Northwestern Switzerland

研究点 (2)

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