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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04230135

Enrollment

Registered

2020-01-18

Start date

2020-06-15

Completion date

2021-11-30

Last updated

2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological Distress

Brief 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.

Interventions

DEVICEHap-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Psychological distress	Six weeks	Hopkins Symptom Checklist-25 (HSCL-25)
Treatment adherence	Six weeks	Completing at least three (out of five) sessions of Hap-pas-Hapi;

Secondary

Measure	Time frame	Description
Functional impairment (health and disability)	Six weeks	WHO Disability Assessment Schedule (WHODAS 2.0)
Well-being	Six weeks	The WHO Wellbeing Index (WHO-5)
Post-traumatic stress disorder	Six weeks	The PTSD checklist, 8 items version (PCL-8)
Self-defined problems	Six weeks	The Psychological Outcome Profiles (PSYCHLOPS)

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026