Psychological DistressNCT04230135
Cultural Adaptation of Hap-pas-Hapi (Step-by-Step) for Albanian-speaking Immigrants in Switzerland and Germany
A study testing Hap-pas-Hapi in people with Psychological Distress, run by University of Zurich at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress
- What is being tested?
- Hap-pas-Hapi
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Jun 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- People living outside Germany or Switzerland
- Serious suicidal thoughts or plan (self-assessed with a corresponding question)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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
- Being tested
- Hap-pas-Hapi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hap-pas-HapiDevice
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Device: Hap-pas-Hapi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological distress
Hopkins Symptom Checklist-25 (HSCL-25)
Measured: Six weeks
Treatment adherence
Completing at least three (out of five) sessions of Hap-pas-Hapi;
Measured: Six weeks
Secondary outcomes (4)
Functional impairment (health and disability)
WHO Disability Assessment Schedule (WHODAS 2.0)
Measured: Six weeks
Well-being
The WHO Wellbeing Index (WHO-5)
Measured: Six weeks
Post-traumatic stress disorder
The PTSD checklist, 8 items version (PCL-8)
Measured: Six weeks
Self-defined problems
The Psychological Outcome Profiles (PSYCHLOPS)
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start15 Jun 2020
- Primary completion31 Aug 2021
- Study completion30 Nov 2021
Why it stopped: An insufficient number of participants could be recruited, and drop-out rates were very high (80%)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Freie Universität Berlin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230135
- Sponsor's protocol ID
- Hap-pas-Hapi
- Status last verified
- May 2022
- First submitted
- 13 Jan 2020
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04230135
- Acronym / sponsor ID
- Hap-pas-Hapi
- Conditions
- Psychological Distress
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: An insufficient number of participants could be recruited, and drop-out rates were very high (80%)
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Freie Universität Berlin
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generic (surface adaptation) | Active comparator | Device: Hap-pas-HapiThe 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) |
| Adapted (deep structure adaptation) | Experimental | Device: Hap-pas-HapiFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- People living outside Germany or Switzerland
- Serious suicidal thoughts or plan (self-assessed with a corresponding question)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hap-pas-HapiHap-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. | Device | Adapted (deep structure adaptation), Generic (surface adaptation) |
Primary outcome
Psychological distress
Time frame: Six weeks
Hopkins Symptom Checklist-25 (HSCL-25)
Treatment adherence
Time frame: Six weeks
Completing at least three (out of five) sessions of Hap-pas-Hapi;
4 secondary outcomes
Functional impairment (health and disability)
Time frame: Six weeks
Well-being
Time frame: Six weeks
Post-traumatic stress disorder
Time frame: Six weeks
Self-defined problems
Time frame: Six weeks
Results and safety
The study was stopped early (reason given: An insufficient number of participants could be recruited, and drop-out rates were very high (80%)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hap-pas-Hapi in people with Psychological Distress, run by University of Zurich at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: An insufficient number of participants could be recruited, and drop-out rates were very high (80%)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress (time frame: Six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.