mental health problems
Conditions
Interventions
The SELFIE intervention is 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
Myin-Germeys et al. 2016
Reininghaus 2018
Reininghaus et al. 2016) and a guided self-help approach using principles of cognitive-behavioral therapy, aimed at modifying cognitive biases (selective perception and selective memory) inherent to n
Sponsors
Central Institute of Mental Health
Eligibility
Age
12 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1) aged 14-25 years, 2) presence of clinically meaningful psychological distress operationalized 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, sexual 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
Exclusion criteria
Exclusion criteria: 1) insufficient command of the principal country language (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 de-velopment (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 (assessed by BDI-2 (Beck Depression Inventory) item 9 with answer options 2 or 3).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint to establish Effectiveness will be general psy-chopathology at 6-month follow-up (t2) assessed by the revised Symptom Checklist (SCL-90-R; Derogatis (1977)) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints will be assessed based on self-rated measures (to establish Effectiveness) at3-month (t1), 6-month (t2), and 12-month follow-up (t3):• Social functioning (WSAS; Jassi et al., 2020) • Quality of life (assessed with the WHOqol-bref (Kwan and Rickwood 2015; Whoqol Group 1998)),• Wellbeing (assessed with the Mylife tracker (Kwan et al. 2018) and with the WEMWEBS (Tennant et al., 2007),• Self-esteem (Rosenberg Self-Esteem Scale (RSES; (Schmitt and Allik 2005) and the self-esteem rating scale (SERS; (Lecomte et al. 2006)),• Psychological distress assessed with CORE-10 (Barkham et al., 2013),• Mental health assessed by PHQ-9 (Kroenke et al., 2001), • Anxiety using the GAD-7 (Spitzer et al., 2006),• Resilience assessed by the CD-RISC (Connor and Da-vidson, 2003), • Service attachment measured with the Service Attachement Questionnaire (SAQ, Goodwin et al., 2003)• In addition, we will use user-led/co-created outcome measures generated by young people. Further, the following secondary outcomes will be assessed to es-tablish Reach, Adoption, Implementation, and Maintenance:• Reach will be assessed based on the number of individuals consenting to, participating in and dropping out from the clinical study during the intervention period at 3-month fol-low-up. • Adoption will be assessed | — |
Countries
Estonia, Germany, Italy, Netherlands, Spain, United Kingdom
Contacts
Public ContactS.M.J. Leijdesdorff
Universiteit Maastricht
Outcome results
None listed