Comparing the severity of symptoms of borderline personality disorder before and after music therapy in patients with borderline personality disorder referred to Iran Psychiatric Hospital.
Comparing the severity of symptoms of borderline personality disorder before and after music therapy in patients with borderline personality disorder referred to Iran Psychiatric Hospital.
Design
A clinical trial with a control group with parallel groups, without blinding, randomized on 40 patients.
Settings and conduct
In this study, for the case group, routine drug therapy plus music therapy is continued, and in the control group, only the routine drug treatments that they received previously are continued. During the treatment period, 4 active 2-hour face-to-face sessions once a week and 4 passive 1.5-hour virtual sessions of music therapy are considered for the intervals between face-to-face sessions.
Participants/Inclusion and exclusion criteria
Conditions for entering the study: patients with borderline personality disorder identified by a psychiatrist
Conditions for not entering the study: substance abuse؛ Mental retardation
Intervention groups
In this study, for the case group, routine drug therapy plus music therapy is continued, and in the control group, only the routine drug treatments that they received previously are continued.
Main outcome variables
severity of symptoms of borderline personality disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230824059249N1
Registration date:2024-07-22, 1403/05/01
Registration timing:registered_while_recruiting
Last update:2024-07-22, 1403/05/01
Update count:0
Registration date
2024-07-22, 1403/05/01
Registrant information
Name
mandana bostani marvi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 086 2815
Email address
info@mohandesannovin.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the severity of symptoms of borderline personality disorder before and after music therapy in patients with borderline personality disorder referred to Iran Psychiatric Hospital.
Public title
Investigating the effect of music therapy on the severity of symptoms of borderline personality disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with borderline personality disorder identified by a psychiatrist
Exclusion criteria:
Drug abuse
Mental retardation
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using permutation blocks of size 4 (AABB). In this way, blocks of 4 consist of random combinations. Patients will be randomly assigned to two groups of 20 using 10 blocks of size 4 and 1:1 ratio. Creating a random sequence in the blocks will be done by a statistician.
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
Iran university of medical science
Street address
No11,plq 11,17Avenue, naft town, poonak, tehran
City
Tehran
Province
Tehran
Postal code
1469873535
Approval date
2022-09-20, 1401/06/29
Ethics committee reference number
IR.IUMS.FMD.REC.1401.342
Health conditions studied
1
Description of health condition studied
Borderline personality disorder
ICD-10 code
F60.3
ICD-10 code description
Borderline personality disorder
Primary outcomes
1
Description
Severity of symptoms of borderline personality disorder
Timepoint
before the start of the intervention (at the beginning of the study) and after the intervention and the completion of the sessions
Method of measurement
The Best questionnaire for assessing the severity of symptoms of borderline personality disorder
Secondary outcomes
1
Description
General health
Timepoint
Before the start of the intervention (at the beginning of the study) and after the intervention and the completion of the sessions
Method of measurement
General Health Questionnaire (GHQ)
Intervention groups
1
Description
Intervention group: Routine drug therapy plus music therapy (during the treatment period, 4 active 2-hour face-to-face sessions once a week and 4 passive 1.5-hour virtual sessions of music therapy are considered for the intervals between face-to-face sessions).
Category
Treatment - Other
2
Description
Control group: Routine drug therapy
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Psychiatric Hospital
Full name of responsible person
Mandana Bostani marvi
Street address
Iran Psychiatry Center, Behind Tandgovian parking lot, next to Azadegan North Highway entrance, km 7 Lashkari Highway (Karaj Special Road),Tehran
City
Tehran
Province
Tehran
Postal code
1478748184
Phone
+98 21 4450 3395
Fax
Email
iph@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Kazem Mousazadeh
Street address
No11;plq 11;17 Avenue, Naft town, Poonak, Tehran
City
Tehran
Province
Tehran
Postal code
1469873535
Phone
+98 21 4483 5296
Email
info@mohandesannovin.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mandana Bostani marvi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No11,plq 11,17 Avenue, Naft town, Poonak, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۶۹۸۷۳۵۳۵info@m۳۵
Phone
+98 912 086 2815
Email
info@mohandesannovin.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mandaba Bostani marvi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
na11,plq11,17Aven, Naft town, Poonak, Tehran
City
Tehran
Province
Tehran
Postal code
1469873535
Phone
+98 21 4483 5296
Email
info@mohandesannovin.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mandana Bostani marvi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No11,plq 11,Naft town, Poonak, Tehran
City
Tehran
Province
Tehran
Postal code
1469873535
Phone
+98 912 086 2815
Fax
Email
info@mohandesannovin.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is still no plan for its publish
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