Randomised Controlled Trial to Test to What Extent the Adaptation of a Smartphone-based Self-help Programme to Albanian Immigrants' Cultural Concepts of Distress Enhances Its Acceptability and Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Treatment adherence
研究概览
简要总结
We aim to compare two different levels of cultural adaptation of an Internet- and mobile-based intervention for the treatment of depression called Hap-pas-Hapi among Albanian-speaking immigrants in Switzerland and Germany. One arm will include the generic (minimally adapted) version of Hap-pas Hapi. The other arm will include a version of Hap-pas-Hapi that was adapted to the target population's cultural concepts of distress. Both versions include five sessions and the same therapeutic techniques.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Electronic informed consent documented by time-stamped agreement to a set of consent questions
- •Albanian-speaking
- •Male and female participants aged above 18
- •Kessler Psychological Distress Scale (K10), Albanian version score >15
- •Access to Smartphone (iOS or Android) or web-browser
排除标准
- •People living outside Germany or Switzerland
- •Serious suicidal thoughts or plan (self-assessed with a corresponding question)
研究组 & 干预措施
Generic (surface adaptation)
The generic version of Hap-pas-Hapi includes only surface adaptations (i.e., adaptation of text and illustrations that are inacceptable or non-meaningful for the target group)
干预措施: Hap-pas-Hapi (Device)
Adapted (deep structure adaptation)
For the experimental intervention, Hap-pas-Hapi was adapted to Albanian immigrants' cultural concepts of distress (CCD). An ethnopsychological study was conducted for this purpose, since evidence on CCD in South Eastern Europe is scarce. Based on this study, three deep-structure adaptations were done: i) the symptom narrative provided by the narrator in the app was re-written to reflect Albanian immigrants' CCD; ii) a new explanatory model builder was implemented to address the target group's fatalistic beliefs; and iii) a goal-setting task was programmed to address the target group's socio-centric notion of the self.
干预措施: Hap-pas-Hapi (Device)
结局指标
主要结局
Treatment adherence
时间窗: Six weeks
Completing at least three (out of five) sessions of Hap-pas-Hapi;
Psychological distress
时间窗: Six weeks
Hopkins Symptom Checklist-25 (HSCL-25)
次要结局
- Functional impairment (health and disability)(Six weeks)
- Well-being(Six weeks)
- Post-traumatic stress disorder(Six weeks)
- Self-defined problems(Six weeks)