NCT03985904

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 100 users of mental health services will be recruited for this study. Participants in the trial will be assessed at baseline and at 3 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

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

Study Start

First participant enrolled

March 4, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2022

Completed
Last Updated

July 26, 2022

Status Verified

February 1, 2022

Enrollment Period

2.9 years

First QC Date

June 11, 2019

Last Update Submit

July 21, 2022

Conditions

Psychosis

Keywords

mental health recoveryart therapymuseum

Outcome Measures

Primary Outcomes (1)

  • Change from baseline personal recovery in adults in mental health follow-up at 3 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.

    At baseline then at 3 months.

Secondary Outcomes (1)

  • Change from baseline social support in adults in mental health follow-up at 3 months.

    At baseline then at 3 months.

Study Arms (1)

Art Therapy

EXPERIMENTAL

Participants will attend art therapy group sessions for three months in a designated museum.

Other: ART THERAPY

Interventions

ART THERAPYOTHER

ART THERAPY: Nursing Interventions Classification = 4330 Weekly 2 hour group carried out by a mental health nurse, a social monitor and a museum educator.

Art Therapy

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Score in GAF \<50 points.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessica Marian Goodman Casanova

Málaga, MA, 29010, Spain

Location

Related Publications (7)

  • Law H, Neil ST, Dunn G, Morrison AP. Psychometric properties of the questionnaire about the process of recovery (QPR). Schizophr Res. 2014 Jul;156(2-3):184-9. doi: 10.1016/j.schres.2014.04.011. Epub 2014 May 9.

    PMID: 24816049BACKGROUND

  • Moorhead S, Johnson M, Maas ML, Swanson E. Clasificación de Resultados de Enfermería (NOC). Elsevier España, S.L. 2013.

    BACKGROUND

  • Bellon Saameno JA, Delgado Sanchez A, Luna del Castillo JD, Lardelli Claret P. [Validity and reliability of the Duke-UNC-11 questionnaire of functional social support]. Aten Primaria. 1996 Sep 15;18(4):153-6, 158-63. Spanish.

    PMID: 8962994BACKGROUND

  • 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

    BACKGROUND

  • Chisholm D, Knapp MR, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B. Client Socio-Demographic and Service Receipt Inventory--European Version: development of an instrument for international research. EPSILON Study 5. European Psychiatric Services: Inputs Linked to Outcome Domains and Needs. Br J Psychiatry Suppl. 2000;(39):s28-33. doi: 10.1192/bjp.177.39.s28.

    PMID: 10945075BACKGROUND

  • Ruddy R, Milnes D. Art therapy for schizophrenia or schizophrenia-like illnesses. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD003728. doi: 10.1002/14651858.CD003728.pub2.

    PMID: 16235338BACKGROUND

  • Attard A, Larkin M. Art therapy for people with psychosis: a narrative review of the literature. Lancet Psychiatry. 2016 Nov;3(11):1067-1078. doi: 10.1016/S2215-0366(16)30146-8. Epub 2016 Aug 12.

    PMID: 27528095BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jessica M Goodman Casanova

    IBIMA - FIMABIS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2019

First Posted

June 14, 2019

Study Start

March 4, 2019

Primary Completion

January 28, 2022

Study Completion

January 28, 2022

Last Updated

July 26, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)