Art Therapy Effectiveness in the Level of Anxiety and Depression of Cancer Patients

Cancer Clinical Trial

— ATANDEC  

Official title:

Effectiveness of Art Therapy in the Level of Anxiety and Depression of Cancer Patients. Multicentric Random Clinical Trial (ATANDEC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04936139
• Other study ID #: CEI 20/69
• Status: Completed
• Phase: N/A
• Start date: February 21, 2021
• Est. completion date: November 3, 2023

Study information

• Verified date: February 2024
• Source: Althaia Xarxa Assistencial Universitària de Manresa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Having a diagnosis of cancer leaves a great emotional impact when it comes to strategies for coping with illness and life after illness. Participation in an art therapy program to forge and improve the emotional well-being is considered. Art therapy can be an effective intervention to help cancer patients lower their levels of anxiety and depression and in return improve their quality of life and their ability to cope with the disease.

Description:

Introduction: The passage of a cancer through a person leaves a great emotional impact when it comes to strategies for coping with illness and life after illness. Participation in an art therapy program to forge and improve your emotional well-being is considered. Research Project Hypothesis: Art therapy can be an effective intervention to help cancer patients lower their levels of anxiety and depression and in return improve their quality of life and their ability to cope with the disease. Objectives: To evaluate the effectiveness of art therapy in reducing the levels of anxiety and depression in cancer patients, as well as in improving the quality of life and coping strategies. Methodology: Randomized, controlled, parallel and multi-centric non-pharmacological clinical trial. Eight centers will participate in the study with an N of 423 patients. Patients older than 18 years of age who are diagnosed with cancer at any stage of treatment with the intention of radical treatment or palliative treatment with a life expectancy of more than 12 months will be included. If it is carried out in an online format, the person must have access to the internet. Patients who suffer from a current or previous serious psychological / psychiatric illness or those who have participated in an art therapy program structured in the context of oncological process will be excluded. Patients will be assigned to the control group (they will receive the usual follow-up from the center) or to the intervention group (art therapy program). Patients assigned to the intervention group will participate in an art therapy workshop once a week for 12 weeks, which will be done in person / online depending on the epidemiological situation of covid-19 and the needs of each center, The group will maintain the format (online / face-to-face) with which it has started throughout all the sessions. Art therapy is a discipline that offers a space to meet with oneself, where one can dialogue with different artistic languages, with the aim of promoting emotional integration and looking for new ways to integrate difficult experiences through creative language. Assessing anxiety and depression with the HAD scale, coping strategies with the Mini-MAC scale, and WHOQOL-BREF for quality of life will be used. Statistical analysis will be for treatment purposes. IBM SPSS Statistics v.24 and STATA v.14 will be used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: November 3, 2023
• Est. primary completion date: November 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years of age
• Intention for radical treatment or palliative treatment with a life expectancy of more than 12 months
• Have internet access in case the intervention is done online
• Agree to participate and sign informed consent

Exclusion Criteria:

• Patient with active diagnosis or personal history of severe psychological / psychiatric illness
• Patient who has participated in an art therapy program structured in the context of the oncological process

Related Conditions & MeSH terms

• Cancer
• Depression

Intervention

Behavioral:
• Art Therapy
During the 12 planned sessions, different artistic disciplines will be used: visual arts, music, play, narrative, dramatization, movement and body expression. Each session is structured in 3 phases: i. A first part of encounter and contextualization, to make contact with oneself, with the art therapist and with the group through a relaxation or meditation activity (35 minutes). ii. A second part, where the session continues with the work of artistic elaboration and production with the different materials and the different artistic languages (50 minutes). iii. A third part where the participants will be invited to make a closing, a moment to welcome and share whoever wishes, the experiences that have been experienced. A dialogue is created between Work-Patient-Art Therapist (35 minutes).

Locations

Country	Name	City	State
Spain	Althaia Xarxa Assistencial Universitària de Manresa	Manresa	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Elisenda Campreciós Suñol	Althaia Xarxa Assistencial Universitària de Manresa, Fundació privada Nous Cims

Country where clinical trial is conducted

Spain, 

References & Publications (11)

Andreu Vaillo Y, Murgui Perez S, Martinez Lopez P, Romero Retes R. Mini-Mental Adjustment to Cancer Scale: Construct validation in Spanish breast cancer patients. J Psychosom Res. 2018 Nov;114:38-44. doi: 10.1016/j.jpsychores.2018.09.004. Epub 2018 Sep 15 — View Citation

Archer S, Buxton S, Sheffield D. The effect of creative psychological interventions on psychological outcomes for adult cancer patients: a systematic review of randomised controlled trials. Psychooncology. 2015 Jan;24(1):1-10. doi: 10.1002/pon.3607. Epub — View Citation

Krikorian A, Limonero JT, Mate J. Suffering and distress at the end-of-life. Psychooncology. 2012 Aug;21(8):799-808. doi: 10.1002/pon.2087. Epub 2011 Oct 11. — View Citation

Monti DA, Peterson C, Kunkel EJ, Hauck WW, Pequignot E, Rhodes L, Brainard GC. A randomized, controlled trial of mindfulness-based art therapy (MBAT) for women with cancer. Psychooncology. 2006 May;15(5):363-73. doi: 10.1002/pon.988. — View Citation

Oster I, Svensk AC, Magnusson E, Thyme KE, Sjodin M, Astrom S, Lindh J. Art therapy improves coping resources: a randomized, controlled study among women with breast cancer. Palliat Support Care. 2006 Mar;4(1):57-64. doi: 10.1017/s147895150606007x. — View Citation

Puetz TW, Morley CA, Herring MP. Effects of creative arts therapies on psychological symptoms and quality of life in patients with cancer. JAMA Intern Med. 2013 Jun 10;173(11):960-9. doi: 10.1001/jamainternmed.2013.836. — View Citation

Svensk AC, Oster I, Thyme KE, Magnusson E, Sjodin M, Eisemann M, Astrom S, Lindh J. Art therapy improves experienced quality of life among women undergoing treatment for breast cancer: a randomized controlled study. Eur J Cancer Care (Engl). 2009 Jan;18(1 — View Citation

Thyme KE, Sundin EC, Wiberg B, Oster I, Astrom S, Lindh J. Individual brief art therapy can be helpful for women with breast cancer: a randomized controlled clinical study. Palliat Support Care. 2009 Mar;7(1):87-95. doi: 10.1017/S147895150900011X. — View Citation

Xu L, Cheng P, Wu Y, Zhang J, Zhu J, Cui J, Yu R. The effects of art therapy on anxiety and depression in breast cancer patients: An updated meta-analysis. Eur J Cancer Care (Engl). 2020 Sep;29(5):e13266. doi: 10.1111/ecc.13266. Epub 2020 May 25. — View Citation

Zhang MF, Wen YS, Liu WY, Peng LF, Wu XD, Liu QW. Effectiveness of Mindfulness-based Therapy for Reducing Anxiety and Depression in Patients With Cancer: A Meta-analysis. Medicine (Baltimore). 2015 Nov;94(45):e0897-0. doi: 10.1097/MD.0000000000000897. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression Scale (HAD scale)	The scale consists of 14 items that assess symptoms of anxiety and depression on a Likert scale of 4 response options. Scores between 0 and 7 are considered normal; between 8 and 10 doubtful, and scores above 11 for clinical problem of depression or anxiety.	3 months
Primary	Hospital Anxiety and Depression Scale (HAD scale)	The scale consists of 14 items that assess symptoms of anxiety and depression on a Likert scale of 4 response options. Scores between 0 and 7 are considered normal; between 8 and 10 doubtful, and scores above 11 for clinical problem of depression or anxiety.	6 months
Secondary	World Health Organization Quality of Life (WHOQOL-BREF scale)	The questionnaire contains a total of 26 questions, two global quality of life and general health questions, and one question from each of the 24 facets contained in the WHOQOL-100. It also consists of 4 areas or dimensions: physical health, psychological, social relationships and environment. Each item has 5 ordinary Likert-type response options and the time it takes is two weeks. Higher scores indicate better quality of life	3 months
Secondary	World Health Organization Quality of Life (WHOQOL-BREF scale)	The questionnaire contains a total of 26 questions, two global quality of life and general health questions, and one question from each of the 24 facets contained in the WHOQOL-100. It also consists of 4 areas or dimensions: physical health, psychological, social relationships and environment. Each item has 5 ordinary Likert-type response options and the time it takes is two weeks. Higher scores indicate better quality of life	6 months
Secondary	Mini-Mental Adjustment to Cancer Scale (MINI-MAC)	MINI-MAC is a 29-item instrument on a 4-choice Likert scale that assesses cognitive and behavioral responses to cancer. Differentiate 5 modes of coping: helplessness / hopelessness (ID), anxious worry (PA), cognitive avoidance (EN), fighting spirit (EL), and fatalism (FAE). Results are calculated for each of the examined strategies. Each strategy includes seven relevant statements. Every analysed subscale result range may be from 7 to 28. The higher the score, the stronger the behaviour typical for a given strategy of coping with càncer.	3 months
Secondary	Mini-Mental Adjustment to Cancer Scale (MINI-MAC)	MINI-MAC is a 29-item instrument on a 4-choice Likert scale that assesses cognitive and behavioral responses to cancer. Differentiate 5 modes of coping: helplessness / hopelessness (ID), anxious worry (PA), cognitive avoidance (EN), fighting spirit (EL), and fatalism (FAE). Results are calculated for each of the examined strategies. Each strategy includes seven relevant statements. Every analysed subscale result range may be from 7 to 28. The higher the score, the stronger the behaviour typical for a given strategy of coping with càncer.	6 months