NCT06473155

Brief Summary

Recent data show a deterioration in the mental health of adolescents, with an increase in anxiety, depression, sleep disturbances, eating disorders, and a significant increase in suicides. Psychological distress may be related to the absence of a life project that provides motivation, satisfaction, and direction in their lives, and allows the formation of an integrated sense of personal identity, along with a projection of improvement in abilities. An intervention aimed at enhancing the life project of adolescents could increase their life satisfaction and, secondarily, improve their mental health. The goal of this clinical trial is to learn if a structured intervention oriented towards the discovery and development of personal talents can have a strong positive impact on the life satisfaction and mental health of adolescents. The Spanish versions of the Satisfaction with Life Scale and Young Person-Clinical Outcomes in Routine Evaluation scales will be used to evaluate life satisfaction and psychological distress of participants before and after the intervention. In addition, the Geniotype questionnaire will be used to explore and enhance the participants' personal talents. The full intervention comprises eight sessions based on Humanistic Integrative Psychotherapy (HIP). It includes one session with Explore Your Meanings (EYME), an immersive digital platform based on the repertory grid technique aimed to enhance the success of therapeutic work and improve personal capabilities. Researchers will compare the full intervention, with an intervention in which the Geniotype questionnaire is substituted by a somatic symptoms questionnaire (with no implications for the talents of the participant) to see if the Geniotype identification works to increase life satisfaction and reduce psychological distress. The control group will be a non-active waiting list. Participants will attend eight weekly, one-hour sessions of a psychological intervention including Geniotype or a somatic symptoms questionnaire or remain in a waiting list for 2 months.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2024

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

November 5, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

June 5, 2024

Last Update Submit

November 15, 2024

Conditions

Keywords

adolescentpersonal satisfaction

Outcome Measures

Primary Outcomes (1)

  • Satisfaction with Life Scale (SWLS)

    The SWLS is an instrument used in research on quality of life and psychological well-being. It is a brief 5-item instrument using a 7-point Likert scale designed to measure individuals' global cognitive judgments of satisfaction with their life. The higher the score, the higher the level of satisfaction.

    SWLS will be administered at baseline, and at the end of the last (8th.) session (2 months).

Secondary Outcomes (1)

  • Young Person-Clinical Outcomes in Routine Evaluation (YP-CORE)

    YP-CORE will be administered at baseline, and at the end of the last (8th.) session (2 months).

Study Arms (3)

Wait List Control (WLC)

NO INTERVENTION

Wait List Control

Humanistic Integrative Psychotherapy and Identity Exploration (HIP+EYME)

EXPERIMENTAL

Humanistic Integrative Psychotherapy and Identity Exploration with Virtual Reality using Explore Your Meanings (EYME)

Behavioral: Experimental: Humanistic Integrative Psychotherapy and Identity Exploration (HIP+EYME)

Humanistic Integrative Psychotherapy, Identity, and Geniotype Exploration (HIP+EYME+GENIOTYPE)

EXPERIMENTAL

Humanistic Integrative Psychotherapy, Identity Exploration with Virtual Reality using Explore Your Meanings, and Geniotype characterization

Behavioral: Experimental: Humanistic Integrative Psychotherapy, Identity, and Geniotype Exploration (HIP+EYME+GENIOTYPE)

Interventions

Eight weekly, one-hour sessions based on HIP (including techniques such as analyzing transactions, recognizing ego states, script analysis, letter to my future self --10 years from now, psychoeducation on emotional intelligence, chair work with subpersonalities, fearful scene work, imaginal work with the life project) and the immersive exploration of personal identity using EYME.

Humanistic Integrative Psychotherapy and Identity Exploration (HIP+EYME)

Eight weekly, one-hour sessions based on HIP (including techniques such as analyzing transactions, recognizing ego states, script analysis, letter to my future self --10 years from now, psychoeducation on emotional intelligence, chair work with subpersonalities, fearful scene work, imaginal work with the life project) and the immersive exploration of personal identity using EYME. Also, participants will answer the Geniotype questionnaire and the results will be worked with the adolescents.

Humanistic Integrative Psychotherapy, Identity, and Geniotype Exploration (HIP+EYME+GENIOTYPE)

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Be a teenager between the ages of 14 and 18 (both included) and be in school.

You may not qualify if:

  • Diagnosis of mental disorder in the last year.
  • Active psychological or psychiatric treatment at the time of the investigation or less than 6 months before.
  • Suicidal ideation and/or self-harm.
  • Recently experienced bullying or intimidation (within the last 6 months).
  • Habitual consumption of drugs of abuse (chemical substances of various origins consumed for non-therapeutic purposes).
  • Insufficient level of proficiency in Spanish or Catalan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Besai

Barcelona, Catalonia, 08007, Spain

RECRUITING

Related Publications (16)

  • Aguirre Velasco A, Cruz ISS, Billings J, Jimenez M, Rowe S. What are the barriers, facilitators and interventions targeting help-seeking behaviours for common mental health problems in adolescents? A systematic review. BMC Psychiatry. 2020 Jun 11;20(1):293. doi: 10.1186/s12888-020-02659-0.

    PMID: 32527236BACKGROUND
  • Also Fontanet, A., Kostov, B., Benavent Àreu, J., Pinyol Martínez, M., Sotoca Momblona, J. M., Benabarre Hernández, A., & Sisó-Almirall, A. (2022). Pilot psychotherapy program for the deprescription of benzodiazepines for anxiety disorders. Revista Ansiedad y Estrés, págs. 74-80.

    BACKGROUND
  • Atienza, F. L., Pons, D., Balaguer, I., & García-Merita, M. (2000). Propiedades Psicométricas de la Escala de Satisfacción con la Vida en Adolescentes. Psicothema, 12(2), 314-319.

    BACKGROUND
  • Benton TD, Muhrer E, Jones JD, Lewis J. Dysregulation and Suicide in Children and Adolescents. Child Adolesc Psychiatr Clin N Am. 2021 Apr;30(2):389-399. doi: 10.1016/j.chc.2020.10.008. Epub 2021 Feb 16.

    PMID: 33743946BACKGROUND
  • Calzada Espanyol, M. A. (s.f.). Ensayo clínico aleatorizado en pacientes con depresión y trastornos de personalidad: eficacia de una terapia integradora humanista. Proyecto AFRONTA. [Tesis doctoral, Universitat Autònoma de Barcelona]. http://hdl.handle.net/10803/668738

    BACKGROUND
  • Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.

    PMID: 16367493BACKGROUND
  • Feixas G, Badia E, Bados A, Medina JC, Grau A, Magallon E, Botella L, Evans C. Adaptation and psychometric properties of the spanish version of the yp-core (Young Person's Clinical Outcomes in Routine Evaluation). Actas Esp Psiquiatr. 2018 May;46(3):75-82. Epub 2018 May 1.

    PMID: 29892966BACKGROUND
  • Feixas, G. y Cornejo, J. M. (1996). Manual de la técnica de rejilla mediante el programa RECORD ver. 2.0. Barcelona: Paidós.

    BACKGROUND
  • Feixas, G., Geldschläger, H., Carmona, M. y Garzón, B. (2002). Sistema de categorías de contenido para codificar constructos personales. Revista de Psicología General y Aplicada, 55, 337-348.

    BACKGROUND
  • Fransella, F., Bell, R. y Bannister, D. (2004). A Manual for Repertory Grid Technique (2ª edición). Wiley.

    BACKGROUND
  • Garcia-Gutierrez, A. & Feixas, G. (2018). GRIDCOR: A Repertory Grid Analysis Tool (Version 6.0) [Web application]. Retrieved from http://www.repertorygrid.net/en

    BACKGROUND
  • González Gómez, A., Alfaro Latorre, M., & Muñoz Montalvo, J. F. (2020). Salud mental en datos: prevalencia de los problemas de salud y consumo de psicofármacos y fármacos relacionados a partir de registros clínicos de atención primaria. BDCAP-Series 2. Datos 2017 [Informe]. Secretaría General de Salud Digital, Información e Innovación del Sistema Nacional de Salud.

    BACKGROUND
  • Hatano K, Hihara S, Nakama R, Tsuzuki M, Mizokami S, Sugimura K. Trajectories in sense of identity and relationship with life satisfaction during adolescence and young adulthood. Dev Psychol. 2022 May;58(5):977-989. doi: 10.1037/dev0001326. Epub 2022 Mar 17.

    PMID: 35298194BACKGROUND
  • Martínez-Hernáez, Á., & Muñoz García, A. (2010). Un infinito que no acaba. Modelos explicativos sobre la depresión y el malestar emocional entre los adolescentes barceloneses (España). Primera parte. Salud Mental, 33, 145-152.

    BACKGROUND
  • Meherali S, Punjani N, Louie-Poon S, Abdul Rahim K, Das JK, Salam RA, Lassi ZS. Mental Health of Children and Adolescents Amidst COVID-19 and Past Pandemics: A Rapid Systematic Review. Int J Environ Res Public Health. 2021 Mar 26;18(7):3432. doi: 10.3390/ijerph18073432.

    PMID: 33810225BACKGROUND
  • Montesano A, Medina JC, Paz C, Garcia-Mieres H, Nino-Robles N, Garcia-Grau E, Crespillo JC, Garcia-Gutierrez A, Alabernia-Segura M, Feixas G. Does virtual reality increase the efficacy of psychotherapy for young adults with mild-to-moderate depression? A study protocol for a multicenter randomized clinical trial. Trials. 2021 Dec 13;22(1):916. doi: 10.1186/s13063-021-05809-1.

    PMID: 34903251BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Maria Beltrán, BS Psych

    Centre Besai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Beltrán, BS Psych

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a randomized clinical trial comparing two psychosocial interventions with a control group (waiting list).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 25, 2024

Study Start

November 5, 2024

Primary Completion

June 30, 2025

Study Completion

December 30, 2025

Last Updated

November 18, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations