Museum-based Group Art Therapy in Mental Health Recovery

Museum-based Group Art Therapy in the Process of Mental Health Recovery and Spanish Cultural Adaptation and Validation of the Questionnaire About the Process of Recovery (QPR-15)

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.

Study Overview

• Status: Completed
• Conditions: Psychosis
• Intervention / Treatment: Other: ART THERAPY

Detailed Description

Art therapy

QUALITY ASSURANCE PLAN. The researchers will review and report the process during the trial covering participant enrolment, consent and eligibility to protect participants, including reporting of harm and completeness, accuracy and timeliness of data collection.

STANDARD OPERATING PROCEDURES. Participants will be recruited over a period of three months by mental health professionals (mental health nurses, psychologists, psychiatrists and occupational therapists). Participants will not receive financial reimbursement for taking part in this trial. Participants will be identified from outpatient services who meet all the study eligibility criteria (listed in section Eligibility). ICD-10 (International Classification of Diseases) and GAF (Global Assessment of Functioning) will be used to screen participants at recruitment.

DATA DICTIONARY. All variables collected in this study will be listed and described in a case report form, with associated guidelines, to ensure consistency in all gathered data. The following data will be collected in this trial:

Sociodemographical data Clinical history Global Assessment of Functioning Scale (GAF) Questionnaire about the Process of Recovery (QPR-15) Visual Analogue Recovery Scale Duke-UNC Functional Social Support Questionnaire

SAMPLE SIZE ASSESSMENT. The estimated sample size is n = 102, for a t test with two independent samples, with one tail, an effect size of 0.5, an α of 95% and a power of 80%.

For the validation of the QPR-15, taking into account the subject-item ratio of at least 5: 1 (15 items), and considering the minimum number of recommended subjects to perform an Exploratory Factor Analysis, The minimum number of participants must be 100.

Thus, estimating losses of 20%, the total number of participants estimated for the study is n = 127.

STATISTICS ANALYSIS PLAN. The change of means in the main outcome variable will be analyzed with the Student's t-test and if the criteria for its application with the nonparametric Mann-Whitney U test are not met. For the categorical secondary variables, the Chi square test will be used.For all comparisons, a confidence level of 95% will be used. The program R version 3.5.1 will be used. for all statistical analyzes.

PLAN FOR MISSING DATA. Each researcher is responsible for ensuring that any missing data will be reported as missing in the study database. Procedures can sometimes be considered when using statistical methods that fail in the presence of any missing values, or when in the case of multiple-predictor statistical models all the data for an individual would be omitted because of a missing value in one of the predictors. For analyzes involving multiple regression analysis, a multiple imputation approach will be considered and used if statistically sound, depending on the proportion and pattern of missing values.

METHODS TO ENSURE VALIDITY AND QUALITY OF DATA. Accurate and reliable data collection will be assured by verification and cross-check of the case report form (CRF) against the researcher´s records (source document verification). Source document verification will be conducted for 5% of data in subjects. Discrepancies and queries will be generated accordingly in the CRF for online resolution by the researcher at the site. In addition, the CRF data will be reviewed on an ongoing basis for medical and scientific plausibility.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • MA
    • Málaga, MA, Spain, 29010
      • Jessica Marian Goodman Casanova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 2 hour group carried out by a mental health nurse, a social monitor and a museum educator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline social support in adults in mental health follow-up at 3 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.	At baseline then at 3 months.

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Collaborators: University of Alcala
• Investigators: Principal Investigator: Jessica M Goodman Casanova, IBIMA - FIMABIS

Publications and helpful links

General Publications

• 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.
• Moorhead S, Johnson M, Maas ML, Swanson E. Clasificación de Resultados de Enfermería (NOC). Elsevier España, S.L. 2013.
• 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.
• 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
• 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.
• Ruddy R, Milnes D. Art therapy for schizophrenia or schizophrenia-like illnesses. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD003728. doi: 10.1002/14651858.CD003728.pub2.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2019
• Primary Completion (Actual): January 28, 2022
• Study Completion (Actual): January 28, 2022

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: mental health recovery; art therapy; museum
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders
• Other Study ID Numbers: 0385-N-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No