PsychosisNCT03985904
Museum-based Group Art Therapy in Mental Health Recovery
A study testing ART THERAPY in people with Psychosis, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis
- What is being tested?
- ART THERAPY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 4 Mar 2019to 28 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Score in GAF <50 points.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychosis
- Being tested
- ART THERAPY
- Keywords
- mental health recovery, art therapy, museum
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Art Therapy | Experimental | Participants will attend art therapy group sessions for three months in a designated museum. Receives: Other: ART THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline then at 3 months.
Secondary outcomes (1)
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.
Measured: At baseline then at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start4 Mar 2019
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alcala
- Responsible party
- Sponsor
- Investigators
- Jessica M Goodman Casanova, Principal investigator, IBIMA - FIMABIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985904
- Sponsor's protocol ID
- 0385-N-19
- Status last verified
- Feb 2022
- First submitted
- 11 Jun 2019
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24816049Moorhead 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.
PubMed 8962994Servicio 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.
PubMed 10945075Ruddy 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.
PubMed 16235338Attard 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.
PubMed 27528095
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03985904
- Acronym / sponsor ID
- 0385-N-19
- Conditions
- Psychosis
- Keywords
- mental health recovery, art therapy, museum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Collaborators
- University of Alcala
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Art Therapy | Experimental | Other: ART THERAPYParticipants will attend art therapy group sessions for three months in a designated museum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Score in GAF <50 points.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ART THERAPYART THERAPY: Nursing Interventions Classification = 4330 Weekly 2 hour group carried out by a mental health nurse, a social monitor and a museum educator. | Other | Art Therapy |
Primary outcome
Change from baseline personal recovery in adults in mental health follow-up at 3 months.
Time frame: At baseline then 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.
1 secondary outcome
Change from baseline social support in adults in mental health follow-up at 3 months.
Time frame: At baseline then at 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Background: PubMed 24816049Law 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.
- BackgroundMoorhead S, Johnson M, Maas ML, Swanson E. Clasificación de Resultados de Enfermería (NOC). Elsevier España, S.L. 2013.
- Background: PubMed 8962994Bellon 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.
- BackgroundServicio 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: PubMed 10945075Chisholm 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.
- Background: PubMed 16235338Ruddy 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.
- Background: PubMed 27528095Attard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica M Goodman Casanova principal investigator
IBIMA - FIMABIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ART THERAPY in people with Psychosis, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline personal recovery in adults in mental health follow-up at 3 months. (time frame: At baseline then at 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03985904, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.