Effectiveness and public health impact of SELFIE, a blended ecological momentary intervention for improving self-esteem in young people

ISRCTN	ISRCTN61299413
DOI	https://doi.org/10.1186/ISRCTN61299413
Integrated Research Application System (IRAS)	364308
Grant number	101156514
Protocol serial number	2025-01-SELFIE
Sponsor	Central Institute of Mental Health
Funder	European Union

Submission date: 03/12/2025
Registration date: 10/12/2025
Last edited: 09/12/2025

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

Background and study aims
This study is about helping young people who have faced difficult experiences in childhood and now struggle with low self-esteem and mental health. The aim is to see if a program called SELFIE can boost self-esteem and improve mental well-being over time.

Who can participate?
Young people aged 14 to 25 who have a history of childhood adversity, are currently feeling distressed, and report low self-esteem can take part. Participants will be recruited from Germany, the UK, the Netherlands, Italy, Spain, and Estonia.

What does the study involve?
Participants will fill in questionnaires and keep a digital mood diary at four points over 12 months. Some participants will be randomly chosen to try the SELFIE training, which lasts six weeks. This includes activities on an app and three sessions with a mental health professional. Others will continue with their usual care. Random selection helps make sure results are fair.

What are the possible benefits and risks of participating?
Taking part may help improve mental health, self-esteem, and overall well-being. There are no known health risks linked to the study.

Where is the study run from?
The study is sponsored by the Central Institute of Mental Health in Germany.

When is the study starting and how long is it expected to run for?
Recruitment starts in January 2026 and ends in July 2027.

Who is funding the study?
The study is funded by the Central Institute of Mental Health in Germany.

Who is the main contact?
If you have questions, please contact Anita Schick at anita.schick@zi-mannheim.de.

Contact information

Prof Ulrich Reininghaus
Scientific

Central Institute of Mental Health
J5
68159 Mannheim
Mannheim
68159
Germany

ORCID ID	0000-0002-9227-5436
Phone	+4962117031930
Email	ulrich.reininghaus@zi-mannheim.de

Dr Anita Schick
Public, Scientific

Central Institute of Mental Health
J5
68159 Mannheim
Mannheim
68159
Germany

ORCID ID	0000-0002-2043-0353
Phone	+4962117031941
Email	anita.schick@zi-mannheim.de

Dr Frederike Schirmbeck
Principal investigator

Central Institute of Mental Health
J5
68159 Mannheim
Mannheim
68159
Germany

Phone	+062117037404
Email	frederike.schirmbeck@zi-mannheim.de

Study information

Primary study design	Interventional
Study design	Parallel-group assessor- and analyst-blind multi-country interventional randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Effectiveness and public health impact of SELFIE, a transdiagnostic, blended ecological momentary intervention for improving self-esteem in young people exposed to childhood adversity: a hybrid effectiveness-implementation study in 6 European countries
Study acronym	European SELFIE trial
Study objectives	The overarching aim of the hybrid effectiveness-implementation study is to assess the 1) effectiveness and 2) public health impact of SELFIE, a transdiagnostic, blended ecological momentary intervention for improving self-esteem, in young people exposed to childhood adversity in a hybrid effectiveness-implementation study in 6 European countries (Estonia, Germany, Italy, the Netherlands, Spain, and UK) and 7 clinical investigation sites. The trial has two objectives: 1. Translate, adapt and implement SELFIE in a participatory implementation study with stakeholder groups, namely clinicians and young people, in line with prevailing ethical and regulatory requirements in 6 European countries. 2. Examine a) Reach (i.e., user participation, feasibility, acceptability), b) clinical Effectiveness (defined as the interaction of efficacy × implementation in real-world care settings), c) Adoption (proportion of users and clinicians having used SELFIE in routine care settings), d) Implementation (defined as delivery of SELFIE as intended in routine care) and e) Maintenance (defined as intended continuation of intervention usage) in a multi-country RCT, which, consistent with the RE-AIM framework, will provide the basis for establishing the public health impact and sustainability of implementation of SELFIE.
Ethics approval(s)	Approved 27/11/2025, Ethics committee II of Heidelberg University (Theodor-Kutzer-Ufer 1-3, Mannheim, 68167, Germany; +49 621 383-71773; ethikkommission-II@medma.uni-heidelberg.de), ref: 2025-430 MF
Health condition(s) or problem(s) studied	Mental health problems
Intervention	SELFIE intervention In this hybrid effectiveness-implementation study, a parallel-group, assessor- and analyst-blind, multi-country RCT will be conducted, in which participants will be randomly allocated using a 1:1 ratio to one of two conditions: (a) the experimental condition, in which participants receive SELFIE in addition to Care-As-Usual (CAU) or (b) the control condition, in which participants are provided with CAU, with a nested process evaluation and an economic evaluation. Participants allocated to the experimental condition will have access to the SELFIE intervention, i.e. a guided self-help intervention and a medical device according to EU MDR 2017/745 consisting of three face-to-face sessions (on-site or online), delivered by trained mental health professionals, three e-mail contacts, and an Ecological Momentary Intervention (EMI) administered through a smartphone-based app for adaptive real-time and real-world transfer of the intervention components to daily life over a course of 6 weeks. We will assess outcomes at 4 points in time: at baseline, at 3-month follow-up, 6-month follow-up and 12-month follow-up. Thus, the duration of study participation for individual participants is 12 months. Randomization will be conducted using a concealed sequence generated by the trial statistician with stratification for study site and gender. The allocation list will be implemented in the electronic case report form.
Intervention type	Behavioural
Primary outcome measure(s)	General psychopathology at 6-month follow-up assessed by the revised Symptom Checklist (SCL-90-R; Derogatis (1977)). A total score will be calculated.
Key secondary outcome measure(s)	The following secondary outcomes will be assessed based on self-rated measures (to establish Effectiveness) at 3-month (t1), 6-month (t2), and 12-month follow-up (t3): 1. Well-being assessed with the Mylife tracker (Kwan et al., 2018) and the WEMWEBS (Tennant et al., 2007) 2. Self-esteem assessed with the Rosenberg Self-Esteem Scale (RSES; Schmitt and Allik, 2005) and the Self-Esteem Rating Scale (SERS; Lecomte et al., 2006) 3. Resilience assessed by the CD-RISC (Connor and Davidson, 2003) 4. Social functioning assessed with the WSAS (Jassi et al., 2020) 5. Quality of life assessed with the WHOQOL-BREF (Kwan and Rickwood, 2015; WHOQOL Group, 1998) 6. Psychological distress assessed with CORE-10 (Barkham et al., 2013) 7. Depression assessed by PHQ-9 (Kroenke et al., 2001) 8. Anxiety assessed using the GAD-7 (Spitzer et al., 2006) 9. Service attachment measured with the Service Attachment Questionnaire (SAQ; Goodwin et al., 2003) 10. User-led and co-created outcome measures developed by young people Secondary outcomes to assess Reach, Adoption, Implementation, and Maintenance: 11. Reach assessed by the number of individuals consenting to, participating in, and dropping out during the intervention period at 3-month follow-up 12. Adoption assessed using a checklist for usage of key components of the SELFIE intervention at 3-month follow-up 13. Implementation assessed by the extent to which SELFIE components are delivered as intended, using a checklist at 3-month follow-up 14. Maintenance assessed by the intended continuation of using the EMI components of SELFIE at 6-month and 12-month follow-up
Completion date	31/07/2028

Eligibility

Participant type(s)	Patient, Service user
Age group	Mixed
Lower age limit	14 Years
Upper age limit	25 Years
Sex	All
Target sample size at registration	448
Key inclusion criteria	1. Aged 14-25 years 2. Presence of clinically meaningful psychological distress opera-tionalized as a score of >10 on the CORE-10 or a GSI score > 0.52 on the SCL-90-R 3. Exposure to childhood adversity, broadly defined (physical, sex-ual or emotional abuse, emotional or physical neglect, peer bullying or parental conflict operationalized (Reininghaus et al. 2024)) 4. Self-esteem below average measured with the Rosenberg Self-Esteem Scale (RSES; (Schmitt and Allik 2005)) 5. Willingness to participate 6. Ability to give informed consent, and for minors: parental consent
Key exclusion criteria	1. Insufficient command of the principal country language: English, Estonian, German, Italian, Spanish or Dutch, 2. Mental health symptoms are due to an organic cause, 3. Meeting criteria for a clinical diagnosis of intellectual disability (ICD-10 F70-F79) or with a disorder of psychological development (ICD-10 F80-89) that are sufficiently severe to impair a person's ability to provide informed consent 4. Inability to use a smartphone 5. Individuals with acute risk to themselves or others.
Date of first enrolment	01/01/2026
Date of final enrolment	31/07/2027

Locations

Countries of recruitment

United Kingdom
England
Estonia
Germany
Italy
Netherlands
Spain

Study participating centres

Birmingham and Solihull Mental Health NHS Foundation Trust

Forward Thinking Birmingham, 5th Floor, 1 Printing House St
Birmingham
B4 6DF
England

Central Institute of Mental Health

J 5
Mannheim
68159
Germany

University Maastricht

MHeNS / FHML
Vijverdalseweg 1
Maastricht
6226
Netherlands

Amsterdam UMC

DE BOELELAAN 1117
Amsterdam
1081
Netherlands

Provincia Lombardo Veneta - Ordine Ospedaliero Di San Giovanni Di Dio- Fatebenefratelli

IRCCS Centro San Giovanni di Dio Fatebenefratelli
Via Pilastroni 4
Brescia
25121
Italy

Hospital General Universitario Gregorio Marañón

Instituto de Psiquiatría y Salud Mental Hospital Gregorio Marañón
Calle Ibiza 43
Madrid
28009
Spain

Mittetulundusuhing Peaasjad

Maneeži tn 3
Tallinn
10111
Estonia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Editorial Notes

03/12/2025: Trial's existence confirmed by Ethics committee II of Heidelberg University.