SchizophreniaNCT03575442
"Art Therapy" in Acute Psychiatry
A study testing 3 session program of "art therapy" in people with Schizophrenia and Mood Disorders, run by Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
Trial summary
Background: Given the complexity of this problem, psychiatric in-patients in the acute stage of their disease need different types of therapeutic programs to recover they mental health state. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Schizophrenia, Mood Disorders, Mental Disorder
- What is being tested?
- 3 session program of "art therapy"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2017to Dec 2020
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men (older than 18), hospitalized in a psychiatric unit;
- capable of communicating and understanding communication;
- acceptance and commitment to participate in the study;
- signature of study informed consent.
Who cannot join
- individuals with active psychotic symptomology, in manic phase and/or refusing to participate.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Psiquiatria B - Centro Hospitalar e Universitário de Coimbra
Coimbra, 3001-301
About this study
Official title: "Art Therapy" in Acute Psychiatry: a Psychosocial Intervention
Background: Given the complexity of this problem, psychiatric in-patients in the acute stage of their disease need different types of therapeutic programs to recover they mental health state. Usually they're submitted to systematic biological programs (namely psychopharmaceuticals), often considered a priority when compared to psychosocial programs. Among the different therapies that have been introduced in this context "art therapy", also named creative therapy, can constitute a treatment that complements the allopathic treatments, providing improvements in self-esteem and self-efficiency, distraction and relief from concerns and negative thoughts. Scientific evidence on the effects of psychosocial programs in the context of hospitalization of acute cases is scarce.
Aims: a) evaluate the effectiveness of a 3 session program of "art therapy" in changing emotional indicators, namely depression, anxiety, stress, and psychological well-being, in individuals with mental illness; b) analyze the meanings a person attributes to his creative self-expression.
Read more
Method: This is a pre-experimental, prospective study, with a pre test-post test design without control group, with a mixed approach (quantitative and qualitative). The study was performed in the psychiatry unit (Psiquiatria B), in the Centro Hospitalar e Universitário de Coimbra - Portugal. The target population was composed by men (older than 18), hospitalized in this ward. The exclusion criteria were: individuals with active psychotic symptomology, in manic phase and/or refusing to participate. The instruments used to collect information were: Depression, Anxiety and Stress Scale [DASS-21]; Ryff Scales of Psychological Well-Being (SPWB - 18 item version) and a semi-structured interview.
Data collection and the development of this study occurred in the following manner:
- Initial evaluation to verify the sample selection criteria in the first 48 hours after patient hospitalization;
- Obtain informed consent for the application of instruments and participation in the "art therapy" intervention program;
- Application of instruments (DASS-21 and SPWB-18 item version) before intervention;
- Development of the program applied as a group, during three weeks, one session a week, each lasting approximately 90 minutes and assisted by a specialist in plastic expression. Each session was held in an occupational therapy room, including all the material deemed necessary for the execution of some of the techniques introduced by the technician. After each session, a semi-structured interview was conducted with each participant in order to analyze the meanings attributed.
- In the end of the program, the same instruments were reapplied.
- Being tested
- 3 session program of "art therapy"
- Medical subject headings
- Schizophrenia, Mood Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 session program of "art therapy"Behavioural
With this program, we expect to offer socio-emotional well-being in the psychiatric context, and creative self-expression through painting. In addition, we hope to provide contributions towards the creation of quality standards of the professional practice of nurses, within the context of implementing psychosocial programs in mental health.
| Study group | Role | What they receive |
|---|---|---|
| 3 session program of "art therapy" | Other | Development of the program applied as a group, during three weeks, one session a week, each lasting approximately 90 minutes and assisted by a specialist in plastic expression. Each session was held in an occupational therapy room, including all the material deemed necessary for the execution of some of the techniques introduced by the technician. After each session, a semi-structured interview was conducted with each participant in order to analyze the meanings attributed. Receives: Behavioral: 3 session program of "art therapy" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the participant's emotional states of depression, anxiety and stress
Outcome measure - Depression, Anxiety and Stress Scale [DASS-21] - (Lovibond et al.,1995 adapted by Apóstolo, Mendes \& Azeredo, 2006)
Measured: Post-intervention assessment (week 3)
Change from Baseline in the participant's psychological well-being
Outcome measure - Ryff Scales of Psychological Well-Being (SPWB - 18 item version) - (Ryff, 1989 adapted by Novo, Neto, Marcelino \& Santo, 2006)
Measured: Post-intervention assessment (week 3)
Semi-structured interview
Aim: explore in a psychiatric context [in the acute stage of the disease] the sick person's experiences related to expression by painting after each of three scheduled interviews, during hospitalization.
Measured: Post-intervention assessment (week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Apr 2017
- Primary completion1 Mar 2018
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clara A. Campos, RN, Principal investigator, Unidade Local de Saúde de Coimbra, EPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575442
- Sponsor's protocol ID
- CHUC-007-17
- Status last verified
- Mar 2019
- First submitted
- 24 May 2018
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stickley T, Hui A. Arts In-Reach: taking 'bricks off shoulders' in adult mental health inpatient care. J Psychiatr Ment Health Nurs. 2012 Jun;19(5):402-9. doi: 10.1111/j.1365-2850.2011.01811.x. Epub 2011 Sep 20.
PubMed 22070164Van Lith, T. Art therapy in mental health: A systematic review of approaches and practices. The Arts in Psychotherapy. 2016; 47: 9-22.
Stickley T, Hui A, Morgan J, Bertram G. Experiences and constructions of art: a narrative-discourse analysis. J Psychiatr Ment Health Nurs. 2007 Dec;14(8):783-90. doi: 10.1111/j.1365-2850.2007.01173.x.
PubMed 18039303Davidson, L., Sells, D., Sangster, S., O'Connell, M. Qualitative studies of recovery: What can we learn from the person? In R. Ralph, & P. Corrigan (Eds.), Recovery in Mental Illness - Broadening our understanding of wellness. Washington, 2005, DC: American Psychological Association.
Thyme, K., Sundin, E., Stahlberg, G., Lindstrom, B. Eklof, H., Wiberg, B. The outcome of short term psychodynamic art therapy compared to short term psychodynamic verbal therapy for depressed women. Psychodynamic Psychotherapy. 2007; (21): 251-264.
Teglbjaerg HS. Art therapy may reduce psychopathology in schizophrenia by strengthening the patients' sense of self: a qualitative extended case report. Psychopathology. 2011;44(5):314-8. doi: 10.1159/000325025. Epub 2011 Jun 9.
PubMed 21659793Blomdahl, C., Gunnarsson, B., Guregard, S., Bjorklund, A. A realist review of art therapy for clients with depression. The Arts in Psychotherapy. 2013; 40(3): 322-330.
Montag C, Haase L, Seidel D, Bayerl M, Gallinat J, Herrmann U, Dannecker K. A pilot RCT of psychodynamic group art therapy for patients in acute psychotic episodes: feasibility, impact on symptoms and mentalising capacity. PLoS One. 2014 Nov 13;9(11):e112348. doi: 10.1371/journal.pone.0112348. eCollection 2014.
PubMed 25393414Noiseux S, St-Cyr Tribble D, Leclerc C, Ricard N, Corin E, Morissette R, Lambert R. Developing a model of recovery in mental health. BMC Health Serv Res. 2009 May 1;9:73. doi: 10.1186/1472-6963-9-73.
PubMed 19409092Laranjeira C, Campos C, Bessa A, Neves G, Marques MI. Mental Health Recovery Through "Art Therapy": A Pilot Study in Portuguese Acute Inpatient Setting. Issues Ment Health Nurs. 2019 May;40(5):399-404. doi: 10.1080/01612840.2018.1563255. Epub 2019 Apr 3.
PubMed 30943062
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Art Therapy" in Acute Psychiatry: a Psychosocial Intervention
- ClinicalTrials.gov ID
- NCT03575442
- Acronym / sponsor ID
- CHUC-007-17
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPEUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Jul 2018 (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.
Background: Given the complexity of this problem, psychiatric in-patients in the acute stage of their disease need different types of therapeutic programs to recover they mental health state. Usually they're submitted to systematic biological programs (namely psychopharmaceuticals), often considered a priority when compared to psychosocial programs. Among the different therapies that have been introduced in this context "art therapy", also named creative therapy, can constitute a treatment that complements the allopathic treatments, providing improvements in self-esteem and self-efficiency, distraction and relief from concerns and negative thoughts. Scientific evidence on the effects of psychosocial programs in the context of hospitalization of acute cases is scarce.
Aims: a) evaluate the effectiveness of a 3 session program of "art therapy" in changing emotional indicators, namely depression, anxiety, stress, and psychological well-being, in individuals with mental illness; b) analyze the meanings a person attributes to his creative self-expression.
Method: This is a pre-experimental, prospective study, with a pre test-post test design without control group, with a mixed approach (quantitative and qualitative). The study was performed in the psychiatry unit (Psiquiatria B), in the Centro Hospitalar e Universitário de Coimbra - Portugal. The target population was composed by men (older than 18), hospitalized in this ward. The exclusion criteria were: individuals with active psychotic symptomology, in manic phase and/or refusing to participate. The instruments used to collect information were: Depression, Anxiety and Stress Scale [DASS-21]; Ryff Scales of Psychological Well-Being (SPWB - 18 item version) and a semi-structured interview.
Data collection and the development of this study occurred in the following manner:
- Initial evaluation to verify the sample selection criteria in the first 48 hours after patient hospitalization;
- Obtain informed consent for the application of instruments and participation in the "art therapy" intervention program;
- Application of instruments (DASS-21 and SPWB-18 item version) before intervention;
- Development of the program applied as a group, during three weeks, one session a week, each lasting approximately 90 minutes and assisted by a specialist in plastic expression. Each session was held in an occupational therapy room, including all the material deemed necessary for the execution of some of the techniques introduced by the technician. After each session, a semi-structured interview was conducted with each participant in order to analyze the meanings attributed.
- In the end of the program, the same instruments were reapplied.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 session program of "art therapy" | Other | Behavioral: 3 session program of "art therapy"Development of the program applied as a group, during three weeks, one session a week, each lasting approximately 90 minutes and assisted by a specialist in plastic expression. Each session was held in an occupational therapy room, including all the material deemed necessary for the execution of some of the techniques introduced by the technician. After each session, a semi-structured interview was conducted with each participant in order to analyze the meanings attributed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men (older than 18), hospitalized in a psychiatric unit;
- capable of communicating and understanding communication;
- acceptance and commitment to participate in the study;
- signature of study informed consent.
Key exclusion criteria (1 listed)
- individuals with active psychotic symptomology, in manic phase and/or refusing to participate.
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 |
|---|---|---|
| 3 session program of "art therapy"With this program, we expect to offer socio-emotional well-being in the psychiatric context, and creative self-expression through painting. In addition, we hope to provide contributions towards the creation of quality standards of the professional practice of nurses, within the context of implementing psychosocial programs in mental health. | Behavioural | 3 session program of "art therapy" |
Primary outcome
Change from Baseline in the participant's emotional states of depression, anxiety and stress
Time frame: Post-intervention assessment (week 3)
Outcome measure - Depression, Anxiety and Stress Scale [DASS-21] - (Lovibond et al.,1995 adapted by Apóstolo, Mendes \& Azeredo, 2006)
Change from Baseline in the participant's psychological well-being
Time frame: Post-intervention assessment (week 3)
Outcome measure - Ryff Scales of Psychological Well-Being (SPWB - 18 item version) - (Ryff, 1989 adapted by Novo, Neto, Marcelino \& Santo, 2006)
Semi-structured interview
Time frame: Post-intervention assessment (week 3)
Aim: explore in a psychiatric context [in the acute stage of the disease] the sick person's experiences related to expression by painting after each of three scheduled interviews, during hospitalization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Background: PubMed 22070164Stickley T, Hui A. Arts In-Reach: taking 'bricks off shoulders' in adult mental health inpatient care. J Psychiatr Ment Health Nurs. 2012 Jun;19(5):402-9. doi: 10.1111/j.1365-2850.2011.01811.x. Epub 2011 Sep 20.
- BackgroundVan Lith, T. Art therapy in mental health: A systematic review of approaches and practices. The Arts in Psychotherapy. 2016; 47: 9-22.
- Background: PubMed 18039303Stickley T, Hui A, Morgan J, Bertram G. Experiences and constructions of art: a narrative-discourse analysis. J Psychiatr Ment Health Nurs. 2007 Dec;14(8):783-90. doi: 10.1111/j.1365-2850.2007.01173.x.
- BackgroundDavidson, L., Sells, D., Sangster, S., O'Connell, M. Qualitative studies of recovery: What can we learn from the person? In R. Ralph, & P. Corrigan (Eds.), Recovery in Mental Illness - Broadening our understanding of wellness. Washington, 2005, DC: American Psychological Association.
- BackgroundThyme, K., Sundin, E., Stahlberg, G., Lindstrom, B. Eklof, H., Wiberg, B. The outcome of short term psychodynamic art therapy compared to short term psychodynamic verbal therapy for depressed women. Psychodynamic Psychotherapy. 2007; (21): 251-264.
- Background: PubMed 21659793Teglbjaerg HS. Art therapy may reduce psychopathology in schizophrenia by strengthening the patients' sense of self: a qualitative extended case report. Psychopathology. 2011;44(5):314-8. doi: 10.1159/000325025. Epub 2011 Jun 9.
- BackgroundBlomdahl, C., Gunnarsson, B., Guregard, S., Bjorklund, A. A realist review of art therapy for clients with depression. The Arts in Psychotherapy. 2013; 40(3): 322-330.
- Background: PubMed 25393414Montag C, Haase L, Seidel D, Bayerl M, Gallinat J, Herrmann U, Dannecker K. A pilot RCT of psychodynamic group art therapy for patients in acute psychotic episodes: feasibility, impact on symptoms and mentalising capacity. PLoS One. 2014 Nov 13;9(11):e112348. doi: 10.1371/journal.pone.0112348. eCollection 2014.
- Background: PubMed 19409092Noiseux S, St-Cyr Tribble D, Leclerc C, Ricard N, Corin E, Morissette R, Lambert R. Developing a model of recovery in mental health. BMC Health Serv Res. 2009 May 1;9:73. doi: 10.1186/1472-6963-9-73.
- Results publication: PubMed 30943062Laranjeira C, Campos C, Bessa A, Neves G, Marques MI. Mental Health Recovery Through "Art Therapy": A Pilot Study in Portuguese Acute Inpatient Setting. Issues Ment Health Nurs. 2019 May;40(5):399-404. doi: 10.1080/01612840.2018.1563255. Epub 2019 Apr 3.
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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.
Clara A. Campos, RN principal investigator
Unidade Local de Saúde de Coimbra, EPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 session program of "art therapy" in people with Schizophrenia and Mood Disorders, run by Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
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 4 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: status not confirmed, as of the sponsor's last update on 10 Oct 2019. 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 Portugal. 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?
Results are not available in the source record.
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 in the participant's emotional states of depression, anxiety and stress (time frame: Post-intervention assessment (week 3)). The study lists 3 primary outcomes in all. 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 NCT03575442, which also lists 10 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 10 Oct 2019.