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

NCT04230135 | Terminated

• 1 other identifier: Hap-pas-Hapi
• Study Type: interventional
• Target: 97
• Locations: 2 countries
• Sites: 2

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.

Conditions

Psychological Distress

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Functional impairment (health and disability)

  Six weeks

• Well-being

  Six weeks

• Post-traumatic stress disorder

  Six weeks

• Self-defined problems

  Six weeks

Study Arms (2)

Generic (surface adaptation)

ACTIVE COMPARATOR

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

Adapted (deep structure adaptation)

EXPERIMENTAL

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

Interventions

Hap-pas-Hapi DEVICE

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.

Adapted (deep structure adaptation); Generic (surface adaptation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead
• Freie Universität Berlin: collaborator

Study Sites (2)

Freie Universität Berlin

Berlin, Germany

Location

University of Zurich

Zurich, 8050, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: June 15, 2020
• Primary Completion: August 31, 2021
• Study Completion: November 30, 2021
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

DE (1); CH (1)