A complex systems approach towards REsilient and CONNECTED vulnerable European communities in times of change: Finnish trial
| ISRCTN | ISRCTN18011789 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18011789 |
| Sponsor | HORIZON EUROPE Framework Programme |
| Funder | HORIZON EUROPE Framework Programme |
- Submission date
- 24/02/2026
- Registration date
- 25/02/2026
- Last edited
- 24/02/2026
- Recruitment status
- 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 Andre Sourander
Principal investigator, Public, Scientific
Principal investigator, Public, Scientific
Lemminkäisenkatu 3
Turku
20014
Finland
| Phone | +358 (0)29 450 5000 |
|---|---|
| andsou@utu.fi |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Factorial |
| Purpose | Supportive care |
| Scientific title | A complex systems approach towards REsilient and CONNECTED vulnerable European communities in times of change: Finnish trial |
| Study acronym | Reconnected Finland |
| Study objectives | 1. To examine if personalised micro-interventions and social prescribing add to the effects on wellbeing compared to mental health literacy alone. 2. To evaluate whether integrating a machine learning algorithm into personalised micro-interventions improves the effectiveness of these personalised micro-interventions compared to the standard version. 3. 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. |
| Ethics approval(s) |
Submitted 24/02/2026, Ethics Committee for Human Sciences at the University of Turku (Turun yliopisto, Turku, 20014, Finland; +358 (0)29 450 5000; eettinen@utu.fi), ref: TY/2005/2025 |
| Health condition(s) or problem(s) studied | Mental wellbeing |
| Intervention | A digital support system that addresses both individual and social factors (i.e., mental health literacy, social participation, and psychological resilience) Treatment duration is 6 weeks. All participants will be randomised to receive access to the digital support system, which includes the mental health literacy intervention, with no or a maximum of two additional components (i.e., personalised micro-interventions and social prescribing). The full factorial design allows us to assess the additional effect of each component, both individually and in interaction. Additionally, within the conditions that include micro-interventions (conditions 3 and 4), participants are further randomized: half receive the standard micro-intervention (MI; conditions 3a and 4a), while the other half receive micro-interventions accompanied by a machine learning algorithm (MI+ML; conditions 3b and 4b). All assessments will be conducted online at four timepoints: baseline (t0), 6 weeks (t1), 3 months (t2), and 6 months (t3) follow-up. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 256 |
| Key inclusion criteria | 1. Mental wellbeing status (languishing or moderately healthy) measured using the Mental Health Continuum-Short Form (MHC-SF). Include if a person is classified as: 1.1. “Languishing”: defined as scoring “never” or “once or twice” on ≥7 of the 14 items, including at least one item from the emotional well-being cluster, or 1.2. “Moderately mentally healthy”: defined as individuals who do not meet the criteria for either languishing or flourishing. Participants are classified as flourishing if they score “almost every day” or “every day” on ≥1 emotional well-being item and ≥6 psychological or social well-being items, or if their mean score across all 14 items is ≥ 4.0. 2. Informed consent: gives (electronic or in-person) consent. 3. 18 years old. |
| Key exclusion criteria | 1. Severe mental illness 2. Mental health treatment |
| Date of first enrolment | 01/04/2026 |
| Date of final enrolment | 01/04/2027 |
Locations
Countries of recruitment
- Finland
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
24/02/2026: Study's existence confirmed by the Ethics Committee for Human Sciences at the University of Turku.
