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

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.

Study Overview

• Status: Terminated
• Conditions: Psychological Distress
• Intervention / Treatment: Device: Hap-pas-Hapi

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Freie Universität Berlin
• Switzerland
  • Zurich, Switzerland, 8050
    • University of Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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)	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.
EXPERIMENTAL: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Freie Universität Berlin

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2020
• Primary Completion (ACTUAL): August 31, 2021
• Study Completion (ACTUAL): November 30, 2021

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (ACTUAL): January 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Hap-pas-Hapi

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No