An interventional study of Henka program in Mental Health, Resilience, Psychological and Emotional Well-being, sponsored by Fundació Sant Joan de Déu. Active, not recruiting at 1 site in Spain. Open to participants aged 11 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Fundació Sant Joan de Déu · Not applicable, Interventional, and Prevention
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Among 107 studies in Psychological Well-Being with a site in Spain — 36 open to participants now, 47 under way, none of them phase 3. Psychological Well-Being · Spain.
Among the 107 studies in Psychological Well-Being with a site in Spain, this one is the 6th largest by planned enrollment of the 86 interventional ones that give a count, is one of 17 that started in 2024, is one of 85 with no phase, reaches primary completion later than 27 of the 46 other live ones, and was the 101st registered.
2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
Browse Psychological Well-Being studies →36 of the 107 studies in Psychological Well-Being with a site in Spain are open now. Recruiting first, the newest first:
Francisco Antonio Nieto Escámez · Sites in Spain
Ages 60+ · Healthy volunteers
Svenja Taubner · Sites in Spain, Germany, Lithuania and 1 more country
Ages 8+ · Healthy volunteers
Hospital Virgen del Puerto · Sites in Spain
Ages 18+
Universitat Autonoma de Barcelona · Sites in Spain
Ages 18+ · Healthy volunteers
Hospital Universitari Vall d'Hebron Research Institute · Sites in Spain
Ages 18+ · Women only
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
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: 11 Years and older · all sexes · healthy volunteers too.
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107 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 17 started in 2024.
This study's planned enrollment of 1,084 is above the median of 110 across 1,798 interventional studies indexed under Psychological Well-Being.
Median enrollment 127 across the 86 interventional studies, 200 across the 21 observational. Of the 51 that completed or were terminated, 1 (2%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 107 have an industry lead sponsor. The 10 most frequent:
Fundació Sant Joan de Déu is the lead sponsor of 70 studies on the registry; 19 are open to participants now.
Fundació Sant Joan de Déu has 7 studies filed under Psychological Well-Being — fewer than ten, so there is no comparison to draw.
17 of the studies in Psychological Well-Being with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07925736Universidad Miguel Hernandez de ElcheALAS PROPIAS: BMGIM for Professionals Working in Intimate Partner Machista Violence Services | 2026-11-30 |
| NCT07925723Universidad Miguel Hernandez de ElcheALAS PROPIAS: Music Therapy for Women Experiencing Machista Violence in Intimate Partner Relationships | 2026-11-30 |
| NCT07655063Hospital Clinic of BarcelonaThe Green Room: Virtual Nature for Mental Well-being in the Acute Psychiatry Ward | 2026-12 |
| NCT06796946University of HuelvaDeprescription of Antidepressants in Primary Care (DAPriCare) | 2026-12 |
| NCT06450730Maimónides Biomedical Research Institute of CórdobaEffectiveness of a Combined mHealth-CBT Psychological Intervention to Improve Psychological Well-Being in Young Patients With T1D | 2026-12 |
Add all 17 to your calendar (.ics) → With an account.
Among the 107 studies in Psychological Well-Being with a site in Spain, from their registry updates:
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HENKA is a universal, whole-community, school-based program that aims to promote emotional well-being and prevent mental health problems among adolescents enrolled in 1st to 3rd year of Secondary Education (ESO) in Catalonia, Spain (approximately 12 to 16 years old), through the development of resilience. The programme's name takes its origin from the Japanese term Henka, meaning a positive and transformative change, reflecting its focus on fostering sustainable improvements in adolescents' socioemotional functioning.The program targets adolescents, their families and school professionals. Its effectiveness is being evaluated through a non-randomized, two-arm, cluster-controlled quantitative phase (intervention schools compared to control schools), combined with a qualitative phase using focus groups. The study builds on the HENKA Pilot study (Ethics Committee code PIC-85-22), which assessed the feasibility of the evaluation process, including the validity of the assessment instruments and participants' viability and acceptability, before scaling up the program to a larger population.
The quantitative phase uses school-level cluster sampling: recruitment was coordinated with the Department of Education and the Department of Health of the Government of Catalonia, and schools voluntarily enrolled in either the HENKA intervention group (target at least 100 schools) or the control group (target at least 25 schools), depending on whether they formalized full participation in the program or chose to take part in the evaluation component only. The first-year secondary school cohort served as the sampling cluster, with additional cohorts progressively enrolled across successive academic years, starting in 2023-2024, until the target sample size was reached; each cohort was followed longitudinally until the third year of secondary school. The intervention comprises student training, consisting of eight approximately 55-minute classroom sessions covering self-efficacy/self-esteem, emotional self-regulation, assertiveness, interpersonal skills, and mindfulness. This training is delivered by teachers during school hours, and the teachers have previously received training from specialist staff (train-the-trainer program). In some sessions, teachers are accompanied by Community Emotional Well-being Representatives (RBEC), health professionals provided by the Department of Health who support classroom delivery and help identify and manage mental-health-related situations among students. Families attend parent workshops. Control schools continue with their usual mental health talks and resources and are offered the HENKA materials after the study ends. Results are assessed through validated online questionnaires (Research Electronic Data Capture, REDCap) at up to six time points over three academic years. A sample size calculation performed a priori with G*Power 3.1.9.7 (effect size 0.2, alpha 0.05, power 0.95) indicated a minimum of 1,084 participants (542 per control and intervention group). In addition, a qualitative phase is conducted through focus groups with each participant segment (adolescents, families, educational professionals, and key regional well-being stakeholders from the Wellbeing for Being Well Program (BxB), the Community Emotional Well-being Representatives program (RBEC), and the Health and School Program (PSiE), held during the second and third trimesters of the 2024-2025 and 2025-2026 academic years, to explore participants' experiences and perspectives on the HENKA program.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Schools that formalize participation in HENKA (\~100 schools). Students receive 8 classroom sessions (55 min each) on self-efficacy, emotional self-regulation, assertiveness, interpersonal skills and mindfulness; teachers receive HENKA training; families are offered a 90-minute workshop.
Behavioral: Henka program
Schools that agree to participate in the evaluation only (\~25 schools), continuing their usual mental-health-related talks and resources; they receive the HENKA materials to implement independently after the study ends.
A universal, whole-community, school-based program to promote resilience and prevent mental health problems among adolescents. The program comprises eight approximately 55-minute classroom sessions covering self-efficacy/self-esteem, emotional self-regulation, assertiveness, interpersonal skills and mindfulness, delivered by teachers previously trained through the HENKA train-the-trainer program. In some sessions, teachers are accompanied by Community Emotional Well-being Representatives (RBEC), health professionals provided by the Department of Health who support classroom delivery and help identify and manage mental-health-related situations among students. Families are offered a parent workshop.
Change in Resilience - adolescents
Resilience Scale for Adolescents (READ), 28 items, mean item score, theoretical range 1- 5. Higher scores indicate greater resilience.
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in Resilience - families
Resilience Scale for Adults (RSA-33), 33 items, mean item score, theoretical range 1- 5. Higher scores indicate greater resilience.
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in school resilience - educational professionals
School Resilience Scale (SRS), 20 items, mean item score, theoretical range 1- 5. Higher scores indicate greater school resilience.
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in coping strategies - adolescents
Coping Strategies Scale for Adolescents (EA-A), 13 items (3 subscales: positive thinking/problem-solving 7 items, family support-seeking 3 items, peer support-seeking 3 items), mean item score, theoretical range 1- 5. Higher scores indicate greater use of adaptive coping strategies.
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in assertiveness - adolescents
Assertive Interpersonal Schema Questionnaire (AISQ), 21 items, sum score, theoretical range 21- 115. Higher scores indicate greater assertiveness.
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in perceived self-efficacy - adolescents
General Self-Efficacy Scale (EAG), 10 items, mean item score, theoretical range 1- 5. Higher scores indicate greater perceived self-efficacy.
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in empathy - adolescents
Basic Empathy Scale, brief version (BES-B), 9 items, mean item score, theoretical range 1- 5. Higher scores indicate greater empathy.
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in emotional repair - adolescents
Trait Meta-Mood Scale, emotional repair subscale (TMMS-24), 8 items, mean item score, theoretical range 1- 5. Higher scores indicate better emotional repair.
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in psychological well-being/distress - adolescents
General Health Questionnaire (GHQ-12), 12 items, sum score (binary scoring method), theoretical range 0- 12. Higher scores indicate greater psychological distress (worse outcome).
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in generalized anxiety - adolescents
Generalized Anxiety Disorder scale (GAD-7), 7 items, sum score, theoretical range 0-21. Higher scores indicate greater severity of generalized anxiety symptoms (worse outcome).
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in depression - adolescents
Patient Health Questionnaire for adolescents (PHQ-9), 9 items, sum score, theoretical range 0- 27. Higher scores indicate greater severity of depressive symptoms (worse outcome).
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in school resilience - adolescents
School Resilience Scale (SRS), 20 items,mean item score, theoretical range 1- 5. Higher scores indicate greater school resilience.
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in positive parenting functioning - families
Parental Functioning Scale (EFP), 12 items, 3 subscales (communication-interaction, affective bond, co-parenting agreement), sum score, theoretical range 0- 6. Higher scores indicate better positive parenting functioning.
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in family climate - families
Family Environment Scale (FES), 27 items, 3 subscales (cohesion, expressiveness, conflict), sum score, theoretical range 0- 27. Higher scores indicate better family climate.
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in psychological well-being/distress - families
General Health Questionnaire (GHQ-12), 12 items, sum score (binary scoring method), theoretical range 0- 12. Higher scores indicate greater psychological distress (worse outcome).
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in perceived stress - families
Perceived Stress Scale (PSS-10), 10 items, sum score, theoretical range 0- 40. Higher scores indicate greater perceived stress (worse outcome).
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in perception of student adjustment - educational professionals
Teacher's Perception of Students Scale (PROF-A), 14 items, mean item score, theoretical range 1- 10. Higher scores indicate more positive teacher-perceived student adjustment.
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in psychological well-being/distress - educational professionals
General Health Questionnaire (GHQ-12), 12 items, sum score (binary scoring method), theoretical range 0-12. Higher scores indicate greater psychological distress (worse outcome).
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Change in perceived stress - educational professionals
Perceived Stress Scale (PSS-10), 10 items, sum score, theoretical range 0 - 40. Higher scores indicate greater perceived stress (worse outcome).
Time frame: From baseline (T0) to 3-month and 12-month follow-up
Adolescents' experiences and perspectives on the HENKA program
Themes identified from semi-structured focus group discussions with adolescents, analyzed using thematic analysis within a phenomenological framework.
Time frame: Second and third trimesters of the 2024-2025 and 2025-2026 academic years
Families' experiences and perspectives on the HENKA program
Themes identified from semi-structured focus group discussions with families, analyzed using thematic analysis within a phenomenological framework.
Time frame: Second and third trimesters of the 2024-2025 and 2025-2026 academic years
Educational professionals' experiences and perspectives on the HENKA program
Themes identified from semi-structured focus group discussions with educational professionals, analyzed using thematic analysis within a phenomenological framework.
Time frame: Second and third trimesters of the 2024-2025 and 2025-2026 academic years
Key regional well-being stakeholders' experiences and perspectives on the HENKA program
Themes identified from semi-structured focus group discussions with representatives of the Wellbeing for Being Well Program (BxB), the Community Emotional Well-being Representatives program (RBEC), and the Health and School Program (PSiE), analyzed using thematic analysis within a phenomenological framework.
Time frame: Second and third trimesters of the 2024-2025 and 2025-2026 academic years
Plan to share: No — Data sharing with external researchers has not been established as part of the current study protocol. Individual participant data include sensitive information on minors' mental health and are subject to strict confidentiality safeguards under Spanish data protection law (Ley Orgánica 3/2018). The research team may consider data sharing requests on a case-by-case basis in the future, subject to institutional and ethics committee approval.
Started Jan 2024 (actual). Primary completion is estimated for Dec 2026, 35 months after the start.
Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 35 months is above that.
Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Fundació Sant Joan de Déu