Cultural Adaptation of Hap-pas-Hapi (Step-by-Step) for Albanian-speaking Immigrants in Switzerland and Germany

Psychological Distress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04230135
• Other study ID #: Hap-pas-Hapi
• Status: Terminated
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: May 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 97
• Est. completion date: November 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• People living outside Germany or Switzerland
• Serious suicidal thoughts or plan (self-assessed with a corresponding question)

Related Conditions & MeSH terms

• Psychological Distress

Intervention

Device:
• Hap-pas-Hapi
Hap-pas-Hapi is a Smartphone-based intervention for the treatment of psychological distress. It includes five sessions and uses a narrative approach. Behavioural activation is the main active therapeutic agent in the intervention, along with stress management, positive self-talk, mood tracking, social support, and relapse prevention.

Locations

Country	Name	City	State
Germany	Freie Universität Berlin	Berlin
Switzerland	University of Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Freie Universität Berlin

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological distress	Hopkins Symptom Checklist-25 (HSCL-25)	Six weeks
Primary	Treatment adherence	Completing at least three (out of five) sessions of Hap-pas-Hapi;	Six weeks
Secondary	Functional impairment (health and disability)	WHO Disability Assessment Schedule (WHODAS 2.0)	Six weeks
Secondary	Well-being	The WHO Wellbeing Index (WHO-5)	Six weeks
Secondary	Post-traumatic stress disorder	The PTSD checklist, 8 items version (PCL-8)	Six weeks
Secondary	Self-defined problems	The Psychological Outcome Profiles (PSYCHLOPS)	Six weeks