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

Sponsor

University of Zurich (Other)

Overall Status

Terminated

CT.gov ID

NCT04230135

Collaborator

Freie Universität Berlin (Other)

Enrollment

Locations

Arms

17.5

Actual Duration (Months)

48.5

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychological Distress	Device: Hap-pas-Hapi	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

97 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 15, 2020

Actual Primary Completion Date :

Aug 31, 2021

Actual Study Completion Date :

Nov 30, 2021

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Freie Universität Berlin	Berlin		Germany
2	University of Zurich	Zurich		Switzerland	8050

Sponsors and Collaborators

University of Zurich
Freie Universität Berlin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Zurich

ClinicalTrials.gov Identifier:

NCT04230135

Other Study ID Numbers:

Hap-pas-Hapi

First Posted:

Jan 18, 2020

Last Update Posted:

May 25, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 25, 2022