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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Psychological Distress

Intervention / Treatment
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* Device: Hap-pas-Hapi


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Generic (surface adaptation)<br>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) | Device: Hap-pas-Hapi<br>* 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.<br>|
| Experimental: Adapted (deep structure adaptation)<br>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. | Device: Hap-pas-Hapi<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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