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The effectiveness of mindfulness based on art therapy using watercolor painting on emotion regulation, mindfulness and obsessive-compulsive symptoms

Protocol summary

Study aim
Determining the effect of mindfulness-based art therapy using watercolor painting on improving emotion regulation, mindfulness, and obsessive compulsive symptoms
Design
A randomized clinical trial with control group, parallel-groups, without blinding, on 40 participants with obsessive compulsive disorder.
Settings and conduct
Sampling and implementation of the intervention was performed at the Tamasha Counseling Center in Isfahan City. The experimental group revived 8 sessions of mindfulness training via watercolor painting techniques. The control group did not receive any treatment intervention.The pre-test, post-test and follow-up test was conducted immediately before, immediately after and two months after the intervention in both groups, respectively. The Persian version of the standardized questionnaires of emotion regulation, mindfulness and obsessive symptoms were used to collect data.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosing obsessive compulsive disorder by a psychiatrist and using the cut point of obsessive, compulsive symptom scale, Physical ability to do homework, Age range from 20 to 60 years. Exclusion criteria: Physical disability, Suffering from other psychological disorders, Participating in other psychotherapy interventions.
Intervention groups
Intervention group: Mindfulness training was done through art therapy and watercolor painting in 8 two-hour sessions. Two intervention sessions were conducted every week with an interval of 3 days; The tools used include brushes, cardboard, and watercolors, and the content of the sessions includes painting techniques that increase focus on feelings and thoughts in the present and reduce anxiety. Control group: included 3 weekly 45-minutes sessions of explanation about the characteristics of obsessive people.
Main outcome variables
Emotion regulation, Mindfulness, Obsessive-compulsive symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220911055937N1
Registration date: 2023-01-15, 1401/10/25
Registration timing: retrospective

Last update: 2023-01-15, 1401/10/25
Update count: 0
Registration date
2023-01-15, 1401/10/25
Registrant information
Name
Saghar Ahmadi
Name of organization / entity
The University of Ardakan
Country
Iran (Islamic Republic of)
Phone
+98 31 3236 5457
Email address
sagharahmadi30@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-11, 1401/05/20
Expected recruitment end date
2022-08-15, 1401/05/24
Actual recruitment start date
2022-08-29, 1401/06/07
Actual recruitment end date
2022-08-31, 1401/06/09
Trial completion date
empty
Scientific title
The effectiveness of mindfulness based on art therapy using watercolor painting on emotion regulation, mindfulness and obsessive-compulsive symptoms
Public title
Effect of art therapy based on mindfulness in obsessive-compulsive disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosing obsessive-compulsive disorder by a psychiatrist and using the cut-off point of the obsessive-compulsive symptoms scale Physical ability to do homework Age range 20 to 60 years
Exclusion criteria:
Suffering from other psychological disorders Participatiing in other psychotherapy interventions Physical disability
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method was used to assign the participants to the study groups; The individual was considered as randomization unit. The table of random numbers was used for randomization; First, numbers 01 to 40 were randomly assigned to participants. The direction of reading the numbers was determined from the top of the table. The first 20 numbers were considered for the experimental group and the second 20 numbers were considered for the control group. Also, random assignment concealment was used so that the assigned group is not known before assigning the individuals.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yazd University
Street address
University Blvd, Safaeiyeh.
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۱۸۴۱۱
Approval date
2022-08-28, 1401/06/06
Ethics committee reference number
IR.YAZD.REC.1401.043

Health conditions studied

1

Description of health condition studied
Obsessive compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder

Primary outcomes

1

Description
level of difficulty in emotion regulation score
Timepoint
The level of emotion regulation score was measured at three time points: Immediately before the intervention, Immediately after the intervention, Two months after the intervention.
Method of measurement
The measuring of emotion regulation was performed using a standardized questionnaire of "the Difficulty in Emotion Regulation Questionnaire" which developed by Gertz and Roemer.

2

Description
Level of mindfulness score
Timepoint
The level of mindfulness score was measured at three time points. Immediately before the intervention, immediately after the intervention, two months after the intervention.
Method of measurement
The measuring of mindfulness was performed using a standardized questionnaire of "Five-Factor Mindfulness Questionnaire".

3

Description
Level of obsession symptoms
Timepoint
The level of obsessive symptoms was measured at three time points. Immediately before the intervention, Immediately after the intervention, Two months after the intervention.
Method of measurement
The measuring of obsessive symptoms was performed using a standardized questionnaire of "Vancouver Algebraic Obsession Questionnaire".

Secondary outcomes

empty

Intervention groups

1

Description
Interventional group: Mindfulness is a method that can conducted using various techniques, including watercolor painting. The components of each session include techniques such as practicing attention and consciously focusing on drawing tools (pencil, brush, cardboard, paint, and water container) using different feelings; Drawing the emotions, physical sensations and inner feelings at the moment, with a pencil with closed eyes and the next time with open eyes (once with the right hand and once with the left hand). meditation, practicing attention and awareness of mind-body connection, awareness of the movement of the brush in the water and the resulting sound, mindfulness of color diffusion in the water inside the glass and focusing on changes in breathing rhythm were other components of the sessions. Drawing the inner feeling in the moment and drawing body sensations such as heat, cold, pain, itching, and burning were also practiced.. The content of mindfulness intervention sessions was taken from previous studies, however, painting techniques were used to implement the goals of each session. The tools used include all the necessary tools for watercolors painting, and the equipment used did not belong to any particular brand. In total, mindfulness intervention was conducted in 8 2-hour sessions. Two sessions were held every week and the interval between each session was three days.
Category
Rehabilitation

2

Description
Control group: The control group was on the waiting list but received three placebo sessions including general descriptions of the characteristics of obsessive compulsive disorder. The content of the sessions included the introduction of the guidelines of diagnostic and statistical manual of mental disorders (DSM) on the symptoms of obsessive-compulsive disorder. Each session lasted 45 minutes. The sessions were held weekly and the interval between each meeting was one week.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tamasha Counseling Center
Full name of responsible person
Dr Mohammadreza Abedi
Street address
Tamasha Center, Foroghi St.
City
Isfahan
Province
Isfehan
Postal code
۸۱۳۸۶۶۳۱۴۱
Phone
+98 31 3335 1577
Email
zarein40@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardakan University
Full name of responsible person
Behzad Kafash
Street address
PO box 184, Ayatollah Khatami Blv, Azadi Sq.
City
Ardakan
Province
Yazd
Postal code
8951895491
Phone
+98 35 3390 3000
Fax
+98 35 3390 1020
Email
bkafash@ardakan.ac.ir
Web page address
https://ardakan.ac.ir/page-Educational/fa/9/form/pId1624
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardakan University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ardakan University
Full name of responsible person
Saghar Ahmadi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 217, Safir Complex, Next to Nilfroshzadeh Alley, Azar st. Motahari, st
City
Isfahan
Province
Isfehan
Postal code
8133817639
Phone
+98 31 3236 5457
Email
sagharahmadi30@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardakan University
Full name of responsible person
Saghar Ahmadi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 217, Safir Complex, Next to Nilfroshzadeh Alley, Azar st. Motahari, st
City
Isfahan
Province
Isfehan
Postal code
8133817639
Phone
+98 31 3236 5457
Email
sagharahmadi30@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ardakan University
Full name of responsible person
Saghar Ahmadi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 217, Safir Complex, Next to Nilfroshzadeh Alley, Azar st. Motahari, st
City
Esfahan
Province
Isfehan
Postal code
8133817639
Phone
+98 31 3236 5457
Email
sagharahmadi30@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The output of statistical software can be shared after de-identifying participants
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The researchers
Under which criteria data/document could be used
Reasonable request
From where data/document is obtainable
Corresponding Author (Saghar Ahmadi)
What processes are involved for a request to access data/document
Send email to correspondening author
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