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Art Therapy in Museums in Mental Health Recovery

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ClinicalTrials.gov Identifier: NCT03985904
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
University of Alcala
Information provided by (Responsible Party):
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief Summary:

This clinical trial aims to evaluate the effects of an art therapy intervention carried out in museums to facilitate the process of recovery in mental health.

In total 127 adults in mental health follow-up will be recruited for this study. They will be assigned in to two parallel non randomized groups: to either receive usual care from primary or specialized services (control group) or to receive usual care plus access to art therapy (intervention group).

Participants in the trial will be assessed for a period of 3 months. After the baseline visit, all participants will have follow-up visits every 3 months. In the follow up visits, investigators will assess participants recovery, social support, global functioning and use of health and social services.


Condition or disease Intervention/treatment Phase
Psychosis Other: ART THERAPY Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 127 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Art Therapy in Museums in the Process of Mental Health Recovery and Spanish Validation of the Questionnaire About the Process of Recovery (QPR-15)
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Art Therapy
Participants will attend art therapy group sessions for three months in a designated museum.
Other: ART THERAPY
ART THERAPY: Nursing Interventions Classification = 4330 Weekly group intervention carried out by a mental health nurse specialist, a mental health peer support, a museum educator and a social monitor.

No Intervention: Control
Participants will NOT attend art therapy group sessions but will continue with usual care during the three months



Primary Outcome Measures :
  1. Change from baseline personal recovery in adults in mental health follow-up at 3, 6 and 12 months. [ Time Frame: At baseline then at 3, 6 and 12 months. ]
    Questionnaire about the Process of Recovery (QPR-15) is an instrument of 15 items to measure the recovery of people using mental health services. Each item is scored using a Likert-type scale of 0 (strongly disagree) to 4 (strongly agree) with a total score of 0 to 60.


Secondary Outcome Measures :
  1. Change from baseline personal resiliency in adults in mental health follow-up at 3, 6 and 12 months [ Time Frame: At baseline then at 3, 6 and 12 months. ]
    Personal resiliency (Nursing Outcomes Classification = 1309) defined as the "adaptation and positive function of an individual after a significant adversity or crisis". It is a nursing result that has indicators that are used to determine the achievement or changes produced in response to a nurse intervention in the person with respect to states, behaviors or perceptions measured along a continuum using a Likert scale of 0 (never shown) to 5 (always shown).

  2. Change from baseline social support in adults in mental health follow-up at 3, 6 and 12 months [ Time Frame: At baseline then at 3, 6 and 12 months. ]
    Duke-UNC Functional Social Support Questionnaire is a self-administered questionnaire of 11 items to measure perceived social support. Each item is scored using a Likert-type scale of 1 (much less than I would like) to 5 (as much as I would like) with a score ranging between 11 and 55 points. In the Spanish validation, a cut point was chosen in the 15th percentile, which corresponds to a score lower than 32 indicating a low perceived social support and a score equal to or greater than 32 indicating a normal support.

  3. Change from baseline global functioning in adults in mental health follow-up at 3, 6 and 12 months [ Time Frame: At baseline then at 3, 6 and 12 months. ]
    Global Assessment of Functioning (GAF) evaluates the overall performance on the current psychological, social and occupational status on a scale of 0 to 100 points (the higher the score the better the performance).

  4. Change from baseline healthcare costs at 3, 6 and 12 months [ Time Frame: At baseline then at 12 months. ]

    Client socio-demographic and service receipt inventory - European version (CSSRI-EU) collects information on the use of services to calculate the cost of the required care. The use of services of the mental health network in the last three months will be collected: Emergency, Primary Care, Community Mental Health Unit, Hospitalization Unit, Rehabilitation Unit, Therapeutic Community, private center and others. The services derived from pharmacological expenditure per person will be included.

    It´s adaptability ensures it is compatible with the research aims, context, participants' likely circumstances, and the quantity and precision of information required




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants are 18 years or older.
  • Participants have a diagnosis of ICD-10 F20-29 or F31.7 with a psychotic history.
  • Participants agree to be part of the study by giving signed written consent.

Exclusion Criteria:

  • Score in GAF <50 points.
  • Current participation in regulated artistic activity.
  • Current participation in another study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985904


Contacts
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Contact: Jessica M Goodman Casanova +34660901966 jmariangoodman@gmail.com

Locations
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Spain
Jessica Marian Goodman Casanova
Málaga, MA, Spain, 29010
Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
University of Alcala
Investigators
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Principal Investigator: Jessica M Goodman Casanova IBIMA - FIMABIS

Publications:
Moorhead S, Johnson M, Maas ML, Swanson E. Clasificación de Resultados de Enfermería (NOC). Elsevier España, S.L. 2013.
Servicio Andaluz de Salud. Escala de evaluación global de funcionamiento o Escala de evaluación de la actividad global (EEAG) Global Assessment of Functioning Scale (GAF). 2010; Disponible en: http://www.juntadeandalucia.es/servicioandaluzdesalud/contenidos/publicaciones/Datos/433/pdf/14-GAF.pdf

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Responsible Party: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT03985904     History of Changes
Other Study ID Numbers: 0385-N-19
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud:
mental health recovery
art therapy
museum