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A randomised control study: evaluating the RECONNECTED digital mental health intervention in Kosovo

A complex system approach towards REsilient and CONNECTED low socioeconomic status people in times of change: a full factorial randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10501523
Enrollment
256
Registered
2026-02-09
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental wellbeing Mental and Behavioural Disorders

Interventions

This full factorial trial is part of the RECONNECTED project. The project will offer a digital support system with culturally adapted and personalized intervention tools to various vulnerable populati
with no or a maximum of two additional components (i.e., personalised micro-interventions and social activation). The full factorial design allows to assess the additional effect of each component, bo
conditions 3a and 4a) or micro-interventions supported by a machine learning algorithm (MI+ML
conditions 3b and 4b). All outcomes will be assessed online at four timepoints: baseline (t0), 6 weeks (primary endpoint, t1), 3 months (t2), and 6 months (t3) follow-up, with each assessment taking

Sponsors

Për Mendje Të Shëndoshë
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Mental wellbeing (languishing or moderately healthy) on the MHC-SF questionnaire scores 2. Informed consent (electronic and/or in person). 3. Can understand, write, and speak Albanian 4. Has a smartphone 5. Resides in Kosovo

Exclusion criteria

Exclusion criteria: 1. Severe mental illness 2. Mental health treatment 3. Inability to commit to engagement 4. Insufficient language comprehension

Countries

Kosovo

Contacts

Public ContactNaim Fanaj
dr.naim@pmsh-rks.com+383 (0)44192053

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026