Determining the effectiveness of mindfulness-based group art therapy (MBAT) on depression, anxiety, intrusive thoughts and shame in sexual assault victims
Design
A clinical trial with a control group and randomization
Settings and conduct
Eight sessions of Monti's Mindfulness based art therapy for 2 hours each week in a psychology clinic in Hamedan
Participants/Inclusion and exclusion criteria
Being a female; having been sexually assaulted with the slight intensity (having a score of 24-32 on Weiss and Marmar's Impact of Event Scale—Revised; having the doctor's permission to take drugs (if taken any) with a fixed dosage; at least 18 years old; having informed consent and having been educated for at least 8 years.
Intervention groups
Experimental group: receive 8 sessions of psychotherapy. Control group: receive no kind of treatment
Main outcome variables
Depression and anxiety scores on short form of Depression Anxiety Stress Scales; intrusive thoughts score on the Impact of Event Scale—Revised; shame score on Personal Feelings Questionnaire
General information
Reason for update
Acronym
MBAT
IRCT registration information
IRCT registration number:IRCT20120619010063N8
Registration date:2019-07-16, 1398/04/25
Registration timing:prospective
Last update:2019-07-16, 1398/04/25
Update count:0
Registration date
2019-07-16, 1398/04/25
Registrant information
Name
Kheirollah Sadeghi
Name of organization / entity
Kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 1826 0700
Email address
khsadeghi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness-based group art therapy (MBAT) on depression, anxiety, intrusive thoughts and shame in sexual assault victims
Public title
The effectiveness of mindfulness-based group art therapy (MBAT) on improving psychological symptoms in sexual assault victims
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being a female
Having been sexually assaulted
Experiencing the trauma with a slight intensity (having a score between 24-32 on Weiss and Marmar's Impact of Event Scale—Revised
Having the doctor's permission for taking drugs (if taken any) in a fixed dosage during the treatment sessions
Age range from 18 to 65
Signing the informed consent
Having been educated for at least 8 years
Exclusion criteria:
Diagnose of schizophrenia,bipolar type I, being delusional, having active suicidal thoughts, substance abuse
Possibility of getting uncontrollably anxious or aggressive or having uncontrollable impulses
The existence of potential harm for patients
Being diagnosed with full criteria of personality disorders
Being diagnosed with panic disorder
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the samples based on entry criteria, the list of the sample information, will be kept in a sealed envelope. In the end, these people will be assigned to the control and test group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Sexual assault victim ( post-traumatic stress disorder subtype)
ICD-10 code
F43.10
ICD-10 code description
Posttraumatic stress disorder
Primary outcomes
1
Description
Depression score
Timepoint
At the beginning and end of the study and 2 months after the end of study
Method of measurement
Depression Anxiety Stress Scales - DASS
2
Description
Anxiety score
Timepoint
At the beginning and end of the study and 2 months after the end of study
Method of measurement
Depression Anxiety Stress Scales - DASS
3
Description
Intrusive thoughts
Timepoint
At the beginning and end of the study and 2 months after the end of study
Method of measurement
The Impact of Event Scale—Revised
4
Description
Shame
Timepoint
At the beginning and end of the study and 2 months after the end of study
Method of measurement
Personal Feelings Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: first, pre-tests will be taken. then this group receives 8 sessions of mindfulness-based art therapy. At the end of the intervention, post tests will be taken and follow-up tests will be done 2 months later
Category
Rehabilitation
2
Description
Control group: this group will be in waiting list and wont receive any interventions. The measurements for this group, will be done at the same time with test group. the intervention.follow-up measurements will be done two months later. at the end of all measurements, this group can receive 8 sessions pf mindfulness-based art therapy.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Alvand clinic
Full name of responsible person
Kheirollah Sadeghi
Street address
Alvand clinic- Parvin Etesami alley, Pastor street, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6515985575
Phone
+98 81 3828 2212
Email
golfamgoodarzi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Opposite Imam Ali hospital, Naft square
City
Kermanshah
Province
Kermanshah
Postal code
4562388887
Phone
+98 83 3838 4180
Email
golfamgoodarzi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kermanshah university of medical sciences
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
Kermanshah University of Medical Sciences
Full name of responsible person
Golfam Goodarzi
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Medical Sciences, Sorkhe Lizhe Ave, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
8614733481
Phone
+98 51 3606 5322
Email
golfamgoodarzi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Kheirollah Sadeghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kermanshah University of Medical Sciences, Faculty of Medical Sciences, Sorkhe lizhe Ave, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
671451568
Phone
+98 83 3887 4371
Email
khsadeghi@kums.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Golfam Goodarzi
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kermanshah University of Medical Sciences, Sorkhe lizhe Ave., Parastar Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
8614733491
Phone
+98 51 3606 5322
Email
golfamgoodarzi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available