Clinical Trials Directory

Trials / Completed

CompletedNCT03377816

The Role of Emotional Processing in Improving the Quality of Life of Breast Cancer Patients

The Role of Emotional Processing in Improving the Quality of Life of Breast Cancer Patients: a Mechanistic Study of Art Therapy in Reducing Depression, Fatigue and Pain.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
318 (actual)
Sponsor
University of Haifa · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to examine two mechanistic changes: emotion processing (awareness, expression and acceptance) and cholinergic anti-inflammatory processes (HRV and cytokine expression) through which an Art Therapy (AT) intervention reduces depression, pain and fatigue.

Detailed description

The study is a randomized controlled study with careful controls. Our study population is comprised of 240 BC patients in palliative and curative care (comprised of 50% Jewish and 50% Arab). This population will be randomized to receive a standard art therapy intervention or a comparison group. The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist The comparison group will engage in the coloring of prefabricated shapes (mandalas) and will receive Psychoeducation on topics related to coping with BC, identical to the topics of the AT group. This design will allow the study to test the mechanism of AT that is beyond the effects of time with a group, focus on a task and engagement with art materials.

Conditions

Interventions

TypeNameDescription
BEHAVIORALArt TherapyIn a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
BEHAVIORALSham Art TherapyIn a group setting participants will engage in Mandala coloring

Timeline

Start date
2019-06-11
Primary completion
2022-06-10
Completion
2022-06-10
First posted
2017-12-19
Last updated
2023-10-19
Results posted
2023-10-19

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT03377816. Inclusion in this directory is not an endorsement.