NCT05004298

Brief Summary

Scientific literature reports that focusing interventions on people with mental health problems, from the threshold of Positive Mental Health, is effective and allows the person to promote positive mental health behaviors. The well-known Animal Assisted Therapy is a complementary intervention used for decades that has reported scientific evidence in the field of mental health in communication, socialization, anxiety and adherence to treatment of patients. This protocol aims to create and evaluate an Assisted Therapy program with dogs in relation to the development and promotion of Positive Mental Health behaviors in people with mental illness in a community rehabilitation service.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 18, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

November 18, 2025

Status Verified

September 1, 2024

Enrollment Period

1.7 years

First QC Date

July 18, 2021

Last Update Submit

November 14, 2025

Conditions

Keywords

Positive Mental HealthMental Illness,Animal Assisted Therapy

Outcome Measures

Primary Outcomes (1)

  • Positive Mental Health Questionnaire Lluch (39-156points)

    Evaluate the effectiveness of the Animal Assisted Therapy Program

    Data collection will be done using an ad hoc form and the Positive Mental Health Questionnaire Lluch (1999). There is an interval of ten weeks between the pretest and posttest collection.

Study Arms (2)

Animal assisted terapy

EXPERIMENTAL

The Experimental Group, in addition to receiving the usual activities of the rehabilitation device. You will receive the ten weekly sessions of the TAA Program.The program structure will aim to influence the 6 specific factors, described in the Multifactorial Model of Positive Mental Health of Dr. Lluch, which are: F1-Personal Satisfaction, F2-Prosocial Attitude, F3-Self-control, F4-Autonomy, F5- Problem Solving and Self-actualization and F6 Interpersonal Relationship Skills. For this reason, direct contact exercises with the dog will be designed and defined to work on them.

Other: Animal Assited therapy

Control Group

NO INTERVENTION

The Control Group will receive the usual activities of the rehabilitation device.

Interventions

The intervention will be structured in 10 group sessions, with a weekly frequency and one hour duration.

Animal assisted terapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People diagnosed with a mental disorder
  • Presence of social dysfunction
  • Over 18 years
  • Voluntary acceptance to the study

You may not qualify if:

  • Allergies to dogs
  • Phobia of dogs
  • History of animal abuse
  • People whose cognitive capacity does not allow them to follow the sessions of the intervention program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital De la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (26)

  • World Health Organization (WHO). World Health Organization, Calouste Gulbenkian Foundation. Social determinants of mental health. Geneva [Internet]. 2014; Available from: http://apps.who.int/iris/bitstream/10665/112828/1/9789241506809_eng.pdf?ua=1

    RESULT
  • World Health Organization (WHO). The European mental health action plan 2013-2020. Copenhagen [Internet]. 2015; Available from: http://www.euro.who.int/__data/assets/pdf_file/0020/280604/WHO-Europe-Mental-HealthAcion-Plan-2013-2020.pdf

    RESULT
  • Generalitat de Catalunya. Pla director de salut mental i addiccions 2017-2020.Barcelona: Departament de Salut. 2017; Available from: https://salutweb.gencat.cat/web/.content/_ambits-actuacio/Linies-dactuacio/Estrategies-de-salut/Salut-mental-addiccions/Linies-estrategiques/estrategies2017_2020.pdf

    RESULT
  • Lluch MT. Concepto de salud mental positiva: factores relacionados. En: Fornés-Vives J, Gómez-Salgado J, eds. Recursos y programas para la salud mental : enfermería psicosocial II. Madrid: Funden. 2008;37-69.

    RESULT
  • Mission Australia in association with Black Dog Institute. Youth Mental Health Report: Youth Survey 2012-16. 2016;5-21. Available from: https://www.missionaustralia.com.au/publications/...mental-health-youth-report/file

    RESULT
  • Fernandez Alonso MC, Buitrago Ramirez F, Ciurana Misol R, Chocron Bentata L, Garcia Campayo J, Monton Franco C, Tizon Garcia JL; Grupo de Salud Mental del PAPPS. [Prevention of mental health disorders]. Aten Primaria. 2012 Jun;44 Suppl 1(Suppl 1):52-6. doi: 10.1016/S0212-6567(12)70014-8. No abstract available. Spanish.

  • Lluch MT, Sequeira C, J R. La salud mental positiva desde una perspectiva multifactorial. In En V. Fragoso y M. Sotto Mayor (Coords.), Gerontologia e transdisciplinariedade I (pp. 114-129). Sâo Paulo (Brasil): Portal Ediçôes Envelhecimento; 2017.

    RESULT
  • Jahoda M. Current concepts of positive mental health. New York: Basic Books. 1958;

    RESULT
  • Lluch T. Evaluación empírica de un modelo conceptual de salud mental positiva. Salud Ment. 2002;25(4):42-55.

    RESULT
  • Lluch MT. Construcción y análisis psicométrico de un cuestionario para evaluar la salud mental positiva. Rev Int Psicol clínica y la salud. 2003;1:61-78.

    RESULT
  • Sánchez-Ortega MA, Puig-Llobet M, Lluch-Canut MT. Efectividad de un programa de intervención psicosocial enfermera para potenciar la agencia de autocuidado y la salud mental positiva en personas con problemas crónicos de salud. 2010;326. Available from: http://diposit.ub.edu/dspace/bitstream/2445/101363/1/MASO_TESIS.pdf

    RESULT
  • Sanromà Ortiz M. Evaluación de un programa de empoderamiento para potenciar y desarrollar conductas promotoras de salud y salud mental positiva en estudiantes de enfermería. "Dinamiza la Salud: Cuídate y Cuida ". TDX (Tesis Dr en Xarxa) [Internet]. 2016 Apr 26 [cited 2020 May 18]; Available from: http://www.tdx.cat/handle/10803/386481

    RESULT
  • Amar J, Palacio J, Norte U, Llinás H, Puerta L, Sierra E, et al. Calidad de vida y Salud Mental Positiva en Menores Trabajadores De Toluviejo. Suma Psicológica. 2008;15(2):385-403.

    RESULT
  • Fine AH. Handbook on Animal-Assisted Therapy: Theoretical Foundations and Guidelines for Practice. 3rd ed. Academic Press; 2010. 588 p.

    RESULT
  • Calvo P, Fortuny JR, Guzman S, Macias C, Bowen J, Garcia ML, Orejas O, Molins F, Tvarijonaviciute A, Ceron JJ, Bulbena A, Fatjo J. Animal Assisted Therapy (AAT) Program As a Useful Adjunct to Conventional Psychosocial Rehabilitation for Patients with Schizophrenia: Results of a Small-scale Randomized Controlled Trial. Front Psychol. 2016 May 6;7:631. doi: 10.3389/fpsyg.2016.00631. eCollection 2016.

  • Olarte MA, Díaz VM. Intervenciones asistidas por animales: Intervenciones con perros en adultos mayores a partir del enfoque multimodal. Rev científica Eur [Internet]. 2016;5(10):269-86. Available from: https://doi.org/10.19044/esj.2016.v12n10p%25p

    RESULT
  • Martínez R. La terapia asistida por animales: Una perspectiva y línea de investigación en la atención a la diversidad. Indivisa Bol Estud Investig. 2008;9:117-44

    RESULT
  • Morris SB. Estimating effect sizes from pretest-posttest-control group designs. Org Res Methods. 2007;11:364-386

    RESULT
  • Bert F, Gualano MR, Camussi E, Pieve G, Voglino G, Siliquini R. Animal assisted intervention: A systematic review of benefits and risks. Eur J Integr Med. 2016 Oct;8(5):695-706. doi: 10.1016/j.eujim.2016.05.005. Epub 2016 May 20.

  • Cabra C. Terapia asistida con animales. Efectos positivos en la salud humana. J Agric Anim Sci. 2012;1(2):32-45.

    RESULT
  • Vallejo R. Introducción a la psicopatología y a la Psiquiátria. Sexta edic. Barcelona, España: Elsevier; 2006. 344 p

    RESULT
  • Alonso Y. ¿Los animales fomentan la salud humana? Un análisis preliminar. Rev.de Psicol Gral y Aplic. 2000;53(4):693-700.

    RESULT
  • Oropesa, P., Wilson, I.G., Saní, M., Gaínza Y. Terapia asistida con animales como fuente de recurso en el tratamiento rehabilitador. Medisan [Internet]. 2009;0-0. Available from: http://www.redalyc.org/articulo.oa?id=368448456014%0A

    RESULT
  • Jones MG, Rice SM, Cotton SM. Incorporating animal-assisted therapy in mental health treatments for adolescents: A systematic review of canine assisted psychotherapy. PLoS One. 2019 Jan 17;14(1):e0210761. doi: 10.1371/journal.pone.0210761. eCollection 2019.

  • Stefanini MC, Martino A, Allori P, Galeotti F, Tani F. The use of Animal-Assisted Therapy in adolescents with acute mental disorders: A randomized controlled study. Complement Ther Clin Pract. 2015 Feb;21(1):42-6. doi: 10.1016/j.ctcp.2015.01.001. Epub 2015 Jan 29.

  • Stefanini MC, Martino A, Bacci B, Tani F. The effect of animal-assisted therapy on emotional and behavioral symptoms in children and adolescents hospitalized for acute mental disorders. Eur J Integr Med [Internet]. 2016;8(2):81-8. Available from: http://dx.doi.org/10.1016/j.eujim.2016.03.001

    RESULT

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Judith Balaguer

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2021

First Posted

August 13, 2021

Study Start

October 1, 2022

Primary Completion

June 15, 2024

Study Completion

September 1, 2024

Last Updated

November 18, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations