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Testing whether Moderated Online Social Therapy (MOST) helps reduce distress in young people, and whether it offers good value for health services, in Europe and Australia

Comparative effectiveness and public health impact of Moderated Online Social Therapy (MOST) in young people with heightened distress: a hybrid (cost-)effectiveness implementation study in Europe and Australia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11049965
Enrollment
448
Registered
2026-04-29
Start date
2026-05-04
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Psychological distress in help seeking young people Mental and Behavioural Disorders

Interventions

MOST intervention In this hybrid (cost-)effectiveness implementation study, a pragmatic, parallel-group, multi-country RCT will be conducted, in which participants will be randomly allocated using a

Sponsors

European Commission
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 25 Years

Inclusion criteria

Inclusion criteria: 1. Age 16-25 years 2. Help seeking (e.g., attending local mental health services or seeking help for psychological distress; health service; university student counselling etc.) 3. Able and willing to consent; parental consent when applicable (e.g., in Spain for YP aged 16 and 17) 4. A score of 10 or higher on the CORE-10 questionnaire 5. Have personal and private access to a computer, smartphone or tablet. 6. Ability and willingness to nominate an emergency contact person, such as a close family member

Exclusion criteria

Exclusion criteria: 1. Insufficient command of the local language at the study center (i.e. Dutch, English, or Spanish) 2. Present with acute suicidal behavior or imminent risk of harm to self 3. If their psychiatric symptoms are due to an organic cause 4. Prior exposure to MOST intervention (e.g. ENYOY)

Design outcomes

Primary

MeasureTime frame
Psychological distress measured using CORE-10 (Barkham et al., 2013) at 3-month follow-up

Secondary

MeasureTime frame
Functioning measured using Work and Social Adjustment Scale - youth version (WSAS-Y) (Jassi et al., 2020) at 3-month, 6-month, and 12-month follow-up;Quality of Life measured using My Life Tracker (MLT; Kwan et al., 2018) ; Co-created outcome measure (YAG, YOUTHreach consortium) at 3-month, 6-month, and 12-month follow-up;Depression measured using Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001) at 3-month, 6-month, and 12-month follow-up;Anxiety measured using Generalized Anxiety Disorder questionnaire-7 (GAD-7; Spitzer et al., 2006) at 3-month, 6-month, and 12-month follow-up;Self-esteem measured using Rosenberg Self-Esteem Scale questionnaire (RSES; Rosenberg, 1965) at 3-month, 6-month, and 12-month follow-up;Reach measured using Assessed by the number of individuals consenting to, participating in, initiating MOST, and dropping out during the intervention period. at 3-month, 6-month, and 12-month follow-up;Adoption measured using Asessed by the number and profile of sites and delivery agents trained and actively delivering MOST during the intervention period. at 3-month, 6-month, and 12-month follow-up;Implementation measured using Assessed by the extent to which MOST components are delivered and used as intended, using structured checklists and platform-derived usage data, the User Version of the Mobile Application Rating Scale (uMARS; Stoyanov et al., 2016), and a bespoke MOST satisfaction measure. at 3-month, 6-month, and 12-month follow-up;Maintenance measured using Assessed by continued use of MOST using platform-derived usage data and intended continuation of MOST use using self-report items. at 3-month, 6-month, and 12-month follow-up;Health economic measures measured using EQ-5D-5L (EuroQol Research Foundation, 2025; Herdman et al., 2011); Resource Use Measurement (RUM; YOUTHreach consortium)) at 3-month, 6-months, and 12-month follow-up;Social Media Use Measure measured using 8 items of the Compulsive internet use scale (Meerkerk et al. 200

Countries

Australia, Ireland, Netherlands, Spain

Contacts

Public ContactEsmée Otten
e.m.otten@amsterdamumc.nl+31616085813

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026