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

ISRCTN	ISRCTN10501523
DOI	https://doi.org/10.1186/ISRCTN10501523
Sponsor	Për Mendje Të Shëndoshë
Funder	HORIZON EUROPE Framework Programme

Submission date: 07/02/2026
Registration date: 09/02/2026
Last edited: 09/02/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Naim Fanaj
Principal investigator, Public, Scientific

Str. Elbasani,pn
Prizren
20000
Kosovo

Phone	+383 (0)44192053
Email	dr.naim@pmsh-rks.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Factorial
Purpose	Prevention
Scientific title	A complex system approach towards REsilient and CONNECTED low socioeconomic status people in times of change: a full factorial randomized controlled trial
Study acronym	RECONNECTED
Study objectives
Ethics approval(s)	Approved 30/12/2025, Ethics Committee Alma Mater Europaea Campus College Rezonanca (Glloku te Shelgjet ”Veternik”, Prishtina, 10000, Kosovo; +383 (0)38 544 754; info@rezonanca-rks.com), ref: AD-6197/25
Health condition(s) or problem(s) studied	Mental wellbeing
Intervention	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 populations. The digital support system targets both individual and social factors simultaneously (i.e. mental health literacy, psychological resilience and social connectedness) to maximize health benefits. The main aim of this trial is to examine if personalised micro-interventions and social activation add wellbeing benefits to mental health literacy. The additional effects of personalised micro-interventions and social activation to mental health literacy will be tested through full factorial trial. The other objective is to conduct a process evaluation to assess the feasibility of the digital support system, including usability, perceived usefulness, overall satisfaction, potential unintended negative effects, and engagement. To study the first research aim, all participants will be randomised to receive the mental health literacy intervention; 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, both individually and in interaction. To study the second research aim, participants who receive the micro-interventions (conditions 3 and 4) are further randomized to receive either the standard micro-intervention (MI; 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 a maximum of 30-45 minutes to complete. After completion of the 6-month follow-up assessment, all participants are granted access to the full digital support system, including components not previously available due to randomization. This access remains available until trial completion. This study involves healthy individuals with an increased susceptibility to developing mental health problems in response to current global societal developments due to socioeconomic status. Adults aged 18 years or older also residing in low SES geographical areas in Kosovo. The selection of these populations ensures comprehensive coverage across different age groups.
Intervention type	Behavioural
Primary outcome measure(s)	Well-being measured using Mental Health Continuum – Short Form (MHC-SF) at baseline (t0), 6 weeks (primary endpoint, t1), 3 months (t2), and 6 months (t3) follow-up
Key secondary outcome measure(s)	Mental health literacy measured using Mental Health Literacy Questionnaire - Short version for adults (MHLQ-SVa) at baseline (t0), 6 weeks (primary endpoint, t1) Resilience measured using Connor-Davidson Resilience Scale - 10 (CDRS-10) at baseline (t0), 6 weeks (primary endpoint, t1), 3 months (t2), and 6 months (t3) follow-up Social connectedness measured using UCLA-9 Loneliness Scale; Lubben Social Network Scale (LSNS) and Initiating activities -Self-composed on social engagement at baseline (t0), 6 weeks (primary endpoint, t1), 3 months (t2), and 6 months (t3) follow-up
Completion date	30/06/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	256
Key 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
Key exclusion criteria	1. Severe mental illness 2. Mental health treatment 3. Inability to commit to engagement 4. Insufficient language comprehension
Date of first enrolment	01/04/2026
Date of final enrolment	01/12/2026

Locations

Countries of recruitment

Kosovo

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

09/02/2026: Study's existence confirmed by the Ethics Committee Alma Mater Europaea Campus College Rezonanca