Efficacy Of Integration Of Biofeedback And Stand-Alone DBT Skills In Borderline Personality Disorder
Design
two groups will be divided randomly in 2group.
A casestudy with 4 subjects.
baseline measured twice a week. . DBT combination therapy will be taught to the experimental group and DBT treatment to the control group. During the intervention and during 24 sessions, repeated assessments are performed in the same way for both groups once every two weeks. Measurements performed at the baseline stage are repeated at the end of treatment and one month after the end of treatment. It is worth noting that the experimental group will receive both treatments in all 12 sessions of intervention.
Settings and conduct
Interventions related to the control group will be performed in Asma Clinic belonging to the University of Social Welfare and Rehabilitation Sciences and the experimental group in the Brain and Cognition Clinic.
Participants/Inclusion and exclusion criteria
Minimum age 21 years ;main diagnosis of borderline personality disorder.
At least a diploma Informed consent;
Exit criteria:
No psychotic disorders;
No substance abuse;
Do not take benzodiazepines;
Failure to receive current psychological therapies;
Intensification of active suicidal ideation;
Existence of acute phase of bipolar disorder;
Intervention groups
intervention group will receive mindfulness and emotion regulation skills in addition to biofeedback control group solely will receive mindfulness and emotion regulation skills
efficacy Of Integration Of Biofeedback And Stand-Alone DBT Skills In Borderline Personality Disorder
Public title
efficacy of psychotherapy in personality disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
personality disorder manifestation
Exclusion criteria:
Psychotic symptom
Bipolar disorder
Addiction
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
4
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, people referred by a psychiatrist, and diagnosed with borderline personality disorder, are interviewed by the therapist and clinic staff. If the conditions of the fifth handbook of mental disorders based on personality disorder and the conditions for entering treatment are met, these people are randomly divided into two groups of intervention and control by random allocation software, each of group has a capacity of 2 people.
The intervention group and the control group enter psychotherapy in two different centers
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 committtee of university of social welfare and rehabilitation science
Street address
NUMBER19,NESHAT2,MANOOCHERI,WESTERN FERDOS
City
Tehran
Province
Tehran
Postal code
5467891234
Approval date
2021-03-03, 1399/12/13
Ethics committee reference number
IR.USWR.REC.1399.251
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
EMOTION regulation
Timepoint
four time two weekly
Method of measurement
emotion regulation ders
Secondary outcomes
1
Description
alexithymia
Timepoint
every 2 week
Method of measurement
toronto quastionare
Intervention groups
1
Description
Control group: Behavior therapy techniques 12 sessions. The first 6 sessions of mindfulness techniques based on the latest handbook of Dr. Marsha Linhan and the second 6 sessions of emotion regulation techniques based on the mentioned book. Each session lasts 45 minutes and two sessions per week. Equipment needed: treatment room with two chairs
Category
Treatment - Other
2
Description
Intervention group: Behavior therapy techniques plus alpha neurofeedback protocol 12 sessions. 6 introductory sessions of mindfulness techniques based on Dr. Linhan's book for 30 minutes. And 15 minutes of mindfulness exercises with the help of pz point neurofeedback device. a8-12. Feedback is audio and the feedback process is blindfolded. Equipment: Neurofeedback device and conductive adhesive and alcohol for cleaning. The second 6 sessions of emotion regulation exercises according to Dr. Linhan's book for 45 minutes During the sessions, the skin conductance sensor will be used to give feedback to the patient on the activity of the autonomic system. Sodium chloride serum equipment for cleaning the index finger and skin conductance sensor.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Psychiatric Hospital
Full name of responsible person
Omid Rezayi
Street address
Amin Abad, Tehran
City
Tehran
Province
Tehran
Postal code
5469871236
Phone
+98 21 4411 3758
Fax
Email
mmmt01@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Pegah Abbasi
Street address
Kodakyar, Velenjak
City
Tehran
Province
Tehran
Postal code
5486325414
Phone
+98 21 2547 8963
Email
uswr@uc.ua.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal-fund
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohammad Mahdi Mehrabi Tavana
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Nehst2. Manoochehri, Ferdos
City
Tehran
Province
Tehran
Postal code
7896541235
Phone
+98 21 4411 3443
Email
mehdimehrabi22222@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohammad Mahdi Mehrabi Tavana
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Neshat2, Ferdos, Western Ferdos, Tehran
City
tehran
Province
Tehran
Postal code
5454598765
Phone
+98 21 5566 3254
Email
mehdimehrabi22222@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohammad mahdi Mehrabi tavana
Position
STUDENT
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No19, nehst 2, western fersos
City
Tehran
Province
Tehran
Postal code
5454545454
Phone
+98 21 4417 8138
Fax
Email
mmh.mehrabitavana@uswr.ac.ir
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
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
information will be distroyed
When the data will become available and for how long
until dissertation submited
To whom data/document is available
university department
Under which criteria data/document could be used
department checl
From where data/document is obtainable
to researcher
What processes are involved for a request to access data/document