An observational study in Mental Health and Neurodevelomental Disorders, sponsored by O-Kidia. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by O-Kidia · Observational
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Among 63 studies in Psychological Well-Being with a site in France — 38 open to participants now, 42 under way, 1 of them phase 3. Psychological Well-Being · France.
Among the 63 studies in Psychological Well-Being with a site in France, this one is the 3rd largest by planned enrollment of the 33 observational ones that give a count, is one of 11 that started in 2025, is one of 33 observational ones, reaches primary completion later than 29 of the 41 other live ones, and was the 58th registered.
2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
Browse Psychological Well-Being studies →38 of the 63 studies in Psychological Well-Being with a site in France are open now. Recruiting first, the newest first:
Hôpital le Vinatier · Sites in France
Ages 18–65
Etablissement Public de Santé Mentale de Metz-Jury · Sites in France
Ages 18+
Centre Hospitalier Annecy Genevois · Sites in France
Ages 18+
Assistance Publique Hopitaux De Marseille · Sites in France
Ages 18+ · Women only
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 401 Psychological Well-Being studies recruiting now, 218 (54%) set no upper age limit and 157 (39%) stop at 75 or younger; 120 take children under 18; 204 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
63 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 11 started in 2025.
This study's planned enrollment of 13,710 is above the median of 300 across 358 observational studies indexed under Psychological Well-Being.
Median enrollment 196 across the 30 interventional studies, 245 across the 33 observational. Of the 13 that completed or were terminated, 0 (0%) have results posted.
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5 of 63 have an industry lead sponsor. The 10 most frequent:
O-Kidia is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
O-Kidia has 1 study filed under Psychological Well-Being — fewer than ten, so there is no comparison to draw.
15 of the studies in Psychological Well-Being with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07161284Hospices Civils de LyonImpact of Mental Health First Aid-trained Peers on the Mental Well-being of First-year Medical Residents. | 2026-12 |
| NCT05770089University Hospital, CaenVideoconferencing Adapted Physical Activity in Anorexia Nervosa: a Pilot Study | 2026-12-01 |
| NCT06738784Centre Hospitalier Charles Perrens, BordeauxEvaluation of the Efficiency of the PRPP (Perceive, Recall, Plan and Perform) Task Analysis System on Support and Orientation Decisions for People With Aging Psychiatric Disorders (PATPV) Living in Independent Housing. | 2026-12-31 |
| NCT07667686Etablissement Public de Santé Mentale de Metz-JuryFrench Validation of the Recovery Assessment Scale (RAS-FR) | 2027-01 |
| NCT07804940Université Paris CitéImproving School Climate and Children's Well-being Through the Life Skills "Feel Good" Intervention in French Schools: A Controlled Before-and-After Study | 2027-01-01 |
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Among the 63 studies in Psychological Well-Being with a site in France, from their registry updates:
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To fully grasp mental health, it is essential to understand and assess it by considering all the factors that affect it: family environment, school environment, emotional relationships, living conditions, social networks, etc.
The symptom network approach takes into account a network of overlapping, multi-layered interactions. These networks evolve over time and are constantly mediated by other nodes, i.e., symptoms, which allows for the identification of markers (vulnerabilities or comorbidities) and the establishment of the dynamics of causal mechanisms. Mental health is thus a sum of stable states within a dynamic network structure of symptoms.
Beyond determining prevalence, the SMILE project therefore aims for an analytical, network-based approach to symptoms of mental health and the inherent vulnerabilities of students through a self-administered questionnaire designed to examine various cognitive, emotional, social, and behavioral functions, and to address this new approach. The SMILE study could also help advance public health and identify the impact of university actions on the mental health of their own students.
The main objective of the SMILE study is to conduct a survey on the mental health and inherent vulnerabilities of the student population in France over the three years of higher education. More specifically, it aims to examine their health status, behaviors, perceptions, and practices, thereby addressing key scientific and societal questions.
Participants will be assessed using a single self-administered questionnaire. The collected variables will be analyzed using a symptom network approach that combines recurrent neural network algorithms and autotransformers. In parallel, subgroup analyses and correlations will be sought between responses and/or scores from the study questionnaires.
Beyond determining the prevalence of student mental health and inherent vulnerabilities during higher education, the SMILE study could contribute to advancements in public health and identify the impact of institutional actions on the mental health of their own students.
Several secondary objectives were defined:
To describe subgroups of young people according to:
4,000 students across France during 3 years of their university studies (from 1 to 8 years post-baccalaureate)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adult ADHD Self-Report Scale (ASRS v1.1)
The Adult ADHD Self-Report Scale (ASRS v1.1) is an 18-item self-report questionnaire developed by Kessler and colleagues in collaboration with the World Health Organization to screen for ADHD symptoms in adults, based on DSM-IV/DSM-5 criteria. Each item is rated on a 5-point frequency scale from 0 ("Never") to 4 ("Very Often"). Part A (the first six items, most predictive of an ADHD diagnosis) ranges from 0 to 24, with a score of 14 or higher generally considered a positive screen; Part B (the remaining twelve items) ranges from 0 to 48; and the combined total score ranges from 0 to 72. Reference: Kessler, R. C., Adler, L., Ames, M., Demler, O., Faraone, S., Hiripi, E., Howes, M. J., Jin, R., Secnik, K., Spencer, T., Ustun, T. B., \& Walters, E. E. (2005). The World Health Organization Adult ADHD Self-Report Scale (ASRS): A short screening scale for use in the general population. Psychological Medicine, 35(2), 245-256.
Time frame: every year for 3 years
Social Provisions Scale (SPS-10)
The Social Provisions Scale (SPS-10) is a 10-item self-report instrument developed by Caron (2013) as a brief version of Cutrona and Russell's (1987) original 24-item Social Provisions Scale, designed to assess perceived social support across dimensions such as attachment, social integration, reassurance of worth, guidance, and reliable alliance. Each item is rated on a 4-point Likert scale from 1 ("Strongly Disagree") to 4 ("Strongly Agree"), producing (cite index="30-1"\>a total score ranging from 10 to 40, with higher scores indicating greater perceived social support\</cite\>. Reference: Cutrona, C. E., \& Russell, D. W. (1987). The provisions of social relationships and adaptation to stress. In Advances in Personal Relationships (Vol. 1, pp. 37-67). JAI Press; Caron, J. (2013). Un outil de mesure du soutien social: Le Questionnaire de Support Social - version abrégée (QSS-8) et l'Échelle de provisions sociales (EPS-10 items). Santé mentale au Québec.
Time frame: every year for 3 years
Physical health - sport activitites, health-service use
Derived from The Physical Activity Questionnaire for Adolescents (PAQ-A), developed by Kowalski, Crocker, and Donen (2004), is a self-administered 7-day recall instrument assessing general physical activity in adolescents aged 14-19. It contains 9 items rated on a 5-point scale, with the final score calculated as the mean of items, yielding a score from 1 (low activity) to 5 (high activity). The child version, PAQ-C, uses the same logic for ages 8-14. Reference: Kowalski, K. C., Crocker, P. R. E., \& Donen, R. M. (2004). Derived from The Health Care Utilization Questionnaire (HCUQ) is an interview-based tool assessing health care resource use over a recall period (often six months), covering items like physician visits, ER visits, hospital days, and medication use. Unlike psychometric scales, it has no fixed total score - each item is a raw count with no upper bound, and scoring varies by study. Reference: LIFE Study HCUQ v1.1, National Institute on Aging Aging Research Biobank.
Time frame: every year for 3 years
Academic experience -
The Academic experience measure used in this context is derived from Reynolds' (1988) Academic Self-Concept Scale but adapted with open-ended questions rather than the original 4-point Likert-scale items. As such, it does not yield a standardized numeric min/max score like the original 40-item version (1 to 4, averaged); responses are instead analyzed qualitatively (e.g., through thematic or content coding). Reference: adapted from Reynolds, W. M. (1988). Measurement of academic self-concept in college students. Journal of Personality Assessment, 52(2), 223-240.
Time frame: every year for 3 years
Mental Health Continuum-Short Form (MHC-SF)
The Mental Health Continuum-Short Form (MHC-SF) is a 14-item measure developed by Corey L. M. Keyes to assess positive mental health across three dimensions: emotional, social, and psychological well-being. Each item is rated on a 6-point frequency scale from 0 ("Never") to 5 ("Every day"), producing a total score ranging from 0 to 70, with higher scores reflecting greater well-being; respondents can additionally be classified as "flourishing," "languishing," or "moderately mentally healthy" based on their response pattern. Reference: Keyes, C. L. M. (2002). The mental health continuum: From languishing to flourishing in life. Journal of Health and Social Behavior, 43(2), 207-222.
Time frame: every year for 3 years
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a brief 7-item self-report questionnaire designed to screen for and assess the severity of generalized anxiety symptoms experienced over the past two weeks. Each item is rated on a 4-point scale from 0 ("Not at all") to 3 ("Nearly every day"), producing a total score ranging from 0 to 21, with commonly used severity thresholds at 5, 10, and 15 for mild, moderate, and severe anxiety, respectively. Reference: Spitzer, R. L., Kroenke, K., Williams, J. B. W., \& Löwe, B. (2006). A brief measure for assessing generalized anxiety disorder: The GAD-7. Archives of Internal Medicine, 166(10), 1092-1097.
Time frame: every year for 3 years
Center for Epidemiologic Studies Depression Scale (CES-D)
The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report instrument originally developed for use in general population studies to assess depressive symptomatology experienced over the past week, including depressed mood, feelings of guilt or worthlessness, sleep disturbance, and loss of appetite. Each item is rated on a 4-point scale from 0 to 3, yielding a total score ranging from 0 to 60, with a score of 16 or higher commonly used as a cutoff indicating clinically significant depressive symptoms. Reference: Radloff, L. S. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement, 1(3), 385-401.
Time frame: every year for 3 years
Kessler Psychological Distress Scale (K6)
The Kessler Psychological Distress Scale (K6) is a brief 6-item screener developed to assess nonspecific psychological distress, primarily symptoms of anxiety and depression, experienced over the past 30 days. Each item is rated on a 5-point scale from 0 ("None of the time") to 4 ("All of the time"), producing a total score ranging from 0 to 24, with higher scores indicating greater psychological distress; scores of 13 or above are often used to identify serious mental illness. Reference: Kessler, R. C., Andrews, G., Colpe, L. J., Hiripi, E., Mroczek, D. K., Normand, S.-L. T., Walters, E. E., \& Zaslavsky, A. M. (2002). Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychological Medicine, 32(6), 959-976.
Time frame: every year for 3 years
Short Grit Scale (Grit-S)
The Short Grit Scale (Grit-S) is an 8-item self-report measure developed by Duckworth and Quinn (2009) as a brief version of the original 12-item Grit Scale, assessing trait-level perseverance and passion for long-term goals across two facets: Consistency of Interest and Perseverance of Effort. Each item is rated on a 5-point scale, and (cite index="35-1"\>scores can vary from 1 point (low grit) to a maximum of 5 points (high grit), with the adult population average around 3.4\</cite\> (the score is typically expressed as a mean rather than a sum). Reference: Duckworth, A. L., \& Quinn, P. D. (2009). Development and validation of the Short Grit Scale (Grit-S). Journal of Personality Assessment, 91(2), 166-174.
Time frame: every year for 3 years
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-rated questionnaire developed by Buysse and colleagues to assess subjective sleep quality and disturbances over the preceding one-month period. The 19 items combine into seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction), (cite index="52-1"\>each ranging from 0 to 3, which are then summed to obtain a global PSQI score ranging from 0 to 21; higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties\</cite\>. Reference: Buysse, D. J., Reynolds, C. F., Monk, T. H., Berman, S. R., \& Kupfer, D. J. (1989). The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research. Psychiatry Research, 28(2), 193-213.
Time frame: every year for 3 years
School/Academic engagement
Derived from the School Engagement Measure (SEM), developed by Fredricks, Blumenfeld, Friedel, and Paris (2005) as part of the MacArthur Network research on school engagement, is a self-report instrument assessing three dimensions of student engagement: behavioral, emotional, and cognitive. The original version consists of 19 items rated on a 5-point Likert-type scale from 1 ("Never") to 5 ("Always"), so (cite index="63-1"\>each item can be scored from 1 to 5, with subscales for emotional engagement (6 items), behavioral engagement (5 items), and cognitive engagement (8 items)\</cite\>; a summed total score would therefore range from 19 to 95, though the measure is more commonly reported as subscale or item means rather than a single composite score. Reference: Fredricks, J. A., Blumenfeld, P. C., Friedel, J., \& Paris, A. (2005). School engagement. In K. A. Moore \& L. Lippman (Eds.) (pp. 305-321).
Time frame: every year for 3 years
Socio-demographic and educational
A derived form of The Hollingshead Four Factor Index of Socioeconomic Status, developed by Hollingshead (1975), estimates an individual's or household's socioeconomic status by combining education and occupation scores (weighted for the participant and spouse where applicable), (cite index="124-1"\>with total scores ranging from 8 to 66, reflecting social stratification in contemporary society\</cite\>. In this study, a derived version adapted into French was used, drawing on the same education and occupation weighting principles as the original but reformulated to fit the French educational and occupational classification system rather than the original American categories. Reference: Hollingshead, A. B. (1975). Four Factor Index of Social Status. Department of Sociology, Yale University, New Haven, CT.
Time frame: at baseline
Quality of life and well-being : The World Health Organization Quality of Life - Brief (WHOQOL-BREF)
The World Health Organization Quality of Life - Brief (WHOQOL-BREF) is a 26-item self-report instrument developed by the WHOQOL Group as an abbreviated version of the WHOQOL-100, assessing quality of life across four domains: physical health, psychological health, social relationships, and environment, plus two standalone items on overall quality of life and general health. Each item is rated on a 5-point scale from 1 to 5, and (cite index="133-1"\>domain raw scores range from 7 to 35 for Physical Health, 6 to 30 for Psychological, 3 to 15 for Social Relationships, and 8 to 40 for Environment, with a total raw score ranging from 26 to 130\</cite\>; domain scores are commonly transformed to a 0-100 scale for easier interpretation, with higher scores indicating better quality of life. Reference: The WHOQOL Group (1998). Development of the World Health Organization WHOQOL-BREF quality of life assessment. Psychological Medicine, 28(3), 551-558.
Time frame: every year for 3 years
Plan to share: Yes — Data sharing In accordance with the FAIR principles, data is anonymized before being shared with other researchers without ever having access to personal data.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Once the recuitment is finished
Started Jul 2025 (actual). Primary completion is estimated for Dec 2027, 28 months after the start.
Of 158 observational studies under Psychological Well-Being, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 155. This study's planned 28 months is close to that.
How these figures are worked out, and which studies are left out of them.
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