The Effectiveness of Dialectical Behavior Therapy and repetitive Transcranial Magnetic Stimulation of the Dorsolateral Prefrontal Cortex on Symptoms of Borderline Personality Disorder: A Single blind randomized controlled clinical trial
The Effectiveness of Dialectical Behavior Therapy and repetitive Transcranial Magnetic Stimulation of the Dorsolateral Prefrontal Cortex on Symptoms of Borderline Personality Disorder: A Single blind randomized controlled clinical trial
Design
Limited randomization, block randomization (quadruple random blocks) with sealedenvelop.com online system;
Assignment concealment; Sample size: 50
Settings and conduct
Project location: Imam Hossein Hospital and 505 Hospital
Blinding: Single blind
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of an experienced psychiatrist based on DSM-5 and SCID-5-PD; Minimum diploma education; Age range between 18 and 45 years; Not receiving psychological treatment in the past; At least five times of self-harm (self-injury) in the past. Exclusion criteria: Having prominent psychotic symptoms and uncontrollable suicidal thoughts; Having delusional disorders; Patients who have been undergoing psychotherapy at the time of selection.
Intervention groups
1) The first group (positive control) includes healthy people who do not have any psychological or neurological problems.
2) The second group (negative control or waiting list) includes people with BPD who do not receive any intervention but all questionnaires are run on them (waiting list).
3) The third group (DBT group) includes people with BPD who receive only DBT.
4) The fourth group (rTMS group) includes people with BPD who receive only rTMS.
5) The fifth group (DBT + rTMS group) includes people with BPD who enter DBT treatment immediately after receiving and completing rTMS sessions.
Main outcome variables
Borderline Personality Disorder Severity Index (BPDSI), Distress Tolerance Scale (DTS), Barratt Impulsiveness Scale, Difficulties in Emotion Regulation Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170417033485N1
Registration date:2021-07-20, 1400/04/29
Registration timing:registered_while_recruiting
Last update:2021-07-20, 1400/04/29
Update count:0
Registration date
2021-07-20, 1400/04/29
Registrant information
Name
Dr. Alireza Mohammadi
Name of organization / entity
Neuroscience Research Center, Baqiyatallah University of Medical Science, Tehran, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 21 2612 7281
Email address
ar.mohammadi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-26, 1400/03/05
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Dialectical Behavior Therapy and repetitive Transcranial Magnetic Stimulation of the Dorsolateral Prefrontal Cortex on Symptoms of Borderline Personality Disorder: A Single blind randomized controlled clinical trial
Public title
The Effectiveness of Dialectical Behavior Therapy and repetitive Transcranial Magnetic Stimulation of the Dorsolateral Prefrontal Cortex on Symptoms of Borderline Personality Disorder: A Single blind randomized controlled clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of an experienced psychiatrist and possession of diagnostic properties of borderline personality disorder based on DSM-5 and SCID-5-PD
Minimum diploma education
Age range between 18 and 45 years
Failure to receive psychological treatment in the past with the aim of treating borderline personality disorder
At least five times self injury (self-harm) in the past
Exclusion criteria:
Having prominent psychotic symptoms and uncontrollable suicidal thoughts
Having delusional disorders
Patients undergoing psychotherapy at the time of selection
Age
From 18 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the restricted randomization method of the type of permuted block randomization (Random quadruple blocks) will be used and for this purpose, the online system sealedenvelop.com will be used, which randomly divides the four main intervention groups (D, C, B, E, …). Then the first patient enters group D, the second patient in group C, etc. until the groups are completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Once the relevant groups have been identified, the study is designed in such a way that, except for the lead researcher, none of the subjects and all those who come into contact with them unaware of the assignment of the study groups. For this purpose, first of all, all patients have the idea that each of them receives the intervention and are also unaware of the type of intervention. Second, other colleagues who are in contact with patients along the study path do not know the study group and its type.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Biomedical Research Ethics Committee of Baqiyatallah Hospital
The score of Borderline Personality Disorder Severity Index (BPDSI)
Timepoint
Before the intervention (Pre-test), after the intervention (Post-test) and one month after the intervention (Following)
Method of measurement
Borderline Personality Disorder Severity Index (BPDSI)
Secondary outcomes
1
Description
Distress Tolerance Scale (DTS)
Timepoint
Before the intervention (Pre-test), after the intervention (Post-test) and one month after the intervention (Following)
Method of measurement
Distress Tolerance Scale (DTS) Questionnaire
2
Description
Barratt Impulsiveness Scale
Timepoint
Before the intervention (Pre-test), after the intervention (Post-test) and one month after the intervention (Following)
Method of measurement
Barratt Impulsiveness Scale Questionnaire
3
Description
Difficulties in Emotion Regulation Scale
Timepoint
Before the intervention (Pre-test), after the intervention (Post-test) and one month after the intervention (Following)
Method of measurement
Difficulties in Emotion Regulation Scale Questionnaire
Intervention groups
1
Description
Dialectical Behavior Therapy: Dialectical behavioral therapy is a special type of cognitive behavioral therapy which developed in the late of 1980s by Marsha Linhan to help better treatment of borderline personality disorder; But it is currently used to treat a variety of psychological disorders. In this study, two groups will receive dialectical behavior therapy (DBT). The first is the group that receives DBT alone, and the group that receives it after receiving repetitive Transcranial Magnetic Stimulation (rTMS) sessions. DBT will be performed as group psychotherapy for 8 to 12 sessions (Linhan, 1993). After the intervention, questionnaires and Flanker test will be taken immediately after and one month later.
Category
Treatment - Other
2
Description
repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. In this study, a group will receive real rTMS and a placebo group received it artificially. In the rTMS group, rTMS will be performed with the device of Magstim Company under the supervision of a psychiatrist and a physiologist of the psychiatry center located in Imam Hossein (AS) Hospital. As mentioned, according to previous studies, the target area for this purpose will be right dorsolateral prefrontal cortex (right DLPFC) with a frequency of 10 Hz for 8 to 10 sessions of 20 minutes per day for two weeks. The placebo group will lie on the device but will not recieve any stimuluatin. After the intervention, questionnaires and Flanker test will be taken immediately after and one month later.
Category
Treatment - Devices
3
Description
Dialectical Behavior Therapy + repetitive Transcranial Magnetic Stimulation: This group receives two interventions and after performing and completing rTMS sessions (10 Hz for 8 to 10 sessions for 20 minutes per day for two weeks on DLPFC right hemisphere), 8 to 12 DBT sessions (Linhan, 1993) will be done. After the intervention, questionnaires and Flanker test will be taken immediately after and one month later.
Category
Treatment - Other
4
Description
Negative control group (waiting list) with sham brain stimulation: This group includes borderline patients who do not receive any intervention and whose brain stimulation is artificial. Sham rTMS stimulation was delivered using the same stimulation parameters and at the same site; however, a sham coil was used.
Category
Placebo
5
Description
Positive control group includes healthy people: Healthy people who do not receive any intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
505 Psychiatric Hospital
Full name of responsible person
Dr. Alireza Mohammadi
Street address
Arteh Highway - End of Shahid Mozhdi Boulevard (Oshan) - 505 Hospital