comparing the effectiveness of Unified Protocol (UP) versus Dialectical Behavioral Therapy (DBT) in severity of borderline personality disorder and Post-traumatic stress disorder in individuals with both disorders
evaluate the effectiveness of unified protocol and dialectic behavior therapy among individuals with borderline personality disorder and Post-traumatic stress disorder i
Design
clinical trial among participants in two intervention groups and two blinded designs in which psychotherapists and assessors will be blind in 3 phases: baseline- -intervention and 36-month follow-ups. Participants will randomly assign to each treatment condition by using https://www.sealedenvelope
Settings and conduct
This study will be conducted at the clinical psychology office in Taleghani Hospital. Participants will be allocated randomly to two intervention groups. therapists, assessors, and data analyst will not be aware of the treatment conditions.
Participants/Inclusion and exclusion criteria
Inclusion:(1) met Diagnostic statistic mental disorder -5 diagnostic criteria for both borderline personality disorder and Post-traumatic stress disorder, and 2) were at least 18-years old.
Excluded if they: 1) intellectual disability, 2) change in dosage and type of psychiatric medicine 3 months before the study, 3) met criteria for a psychotic disorder, bipolar disorder and brain diseases,4) required specialized treatment for high risk of suicide, 5) received 8 or more sessions of cognitive behavior therapy within last 5 years
Intervention groups
intervention group 1: The unified protocol consisted of a maximum of 36 sessions, 60-minute individual treatment sessions.
intervention group 2: Dialectic behavior therapy maximum of 52 sessions that applied in individual and group skills training (1 hours/week)
Main outcome variables
severity of BPD and PTSD symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231106059970N2
Registration date:2024-12-07, 1403/09/17
Registration timing:registered_while_recruiting
Last update:2024-12-07, 1403/09/17
Update count:0
Registration date
2024-12-07, 1403/09/17
Registrant information
Name
Banafsheh Mohajerin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 578 6918
Email address
bmohajerin@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the effectiveness of Unified Protocol (UP) versus Dialectical Behavioral Therapy (DBT) in severity of borderline personality disorder and Post-traumatic stress disorder in individuals with both disorders
Public title
evaluation of comparing the effectiveness of Unified Protocol and Dialectical Behavioral Therapy among individuals with borderline personality disorder and Post-traumatic stress disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Meet at least 5 out 9 Borderline personality disorder criteria of DSM-5-TR
Meet Post-traumatic stress disorder criteria of DSM-5-TR
at least 18 years old
Be able to speak and read Farsi
Exclusion criteria:
intellectual disability
change in dosage and type of psychiatric medicine 3-months prior to the study
met criteria for a psychotic disorder, bipolar disorder, or organic mental disorder that assessed by SCID-5 (SCID-5)
Required specialized treatment for high risk of suicide
received 8 or more sessions of psychotherapies within last 5 years
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
68
More than 1 sample in each individual
Number of samples in each individual:
34
34
Randomization (investigator's opinion)
Randomized
Randomization description
G*Power software will be used for calculating sample size by indicating the margin of error of 0.05 and power of 0.95 total sample size will be 60. participants will be randomly allocated in two groups by using https://www.dcode.fr/random-selection and after that each group will receive one of the treatments randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
At first, all participants will receive information about both interventions and their effectiveness based on previous studies. After they sign an informed consent form, a master-level clinical psychologist (blind to the study hypotheses) will give a code to each participant to register them for this study. By using https://www.dcode.fr/random-selection, participants will be randomly allocated to each intervention group. Psychotherapists will not be aware of other treatment conditions, and assessors will assess participants by using the code. Only the researcher will know about each participant and their treatment conditions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethics committees of Vice-chancellor in research Affairs- shahid Behehshti University of Me
Street address
Arabi St.Yaman St. Velenjak.Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2024-10-27, 1403/08/06
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.436
Health conditions studied
1
Description of health condition studied
Borderline personality disorder
ICD-10 code
F60.3
ICD-10 code description
Borderline personality disorder
2
Description of health condition studied
Post-traumatic Stress Disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
Primary outcomes
1
Description
borderline personality symptoms severity
Timepoint
before intervention start, after intervention, 6,12,18,24, and 36 months after intervention as a follow-up phase
Method of measurement
using questionnaire Borderline symptoms checklist
2
Description
Post-traumatic stress symptoms severity
Timepoint
before intervention start, after intervention, 6,12,18,24, and 36 months after intervention as a follow-up phase
Method of measurement
by using Post-traumatic stress disorder checklist questionnaire
Secondary outcomes
1
Description
anger severity
Timepoint
before intervention start, after intervention, 6,12,18,24, and 36 months after intervention as a follow-up phase
Method of measurement
by using self-report the State–Trait Anger Expression Inventory–2 questionnaire
2
Description
dissociative symptoms severity
Timepoint
before intervention start, after intervention, 6,12,18,24, and 36 months after intervention as a follow-up phase
Method of measurement
by using self-report the dissociative Experiences Scale questionnaire
3
Description
emotion dysregulation severity
Timepoint
before intervention start, after intervention, 6,12,18,24, and 36 months after intervention as a follow-up phase
Method of measurement
by using the Difficulties in Emotion Regulation Scale questionnaire
4
Description
self-harm severity
Timepoint
before intervention start, after intervention, 6,12,18,24, and 36 months after intervention as a follow-up phase
Method of measurement
by using self-report the deliberate Self-Harm Inventory questionnaire
5
Description
emptiness severity
Timepoint
before intervention start, after intervention, 6,12,18,24, and 36 months after intervention as a follow-up phase
Method of measurement
by using self-report the subjective Emptiness Scale questionnaire
Intervention groups
1
Description
Intervention group 1: The Unified Protocol (UP), is emotion-focused cognitive-behavioral therapy. It consists 5 core treatment modules: (1) mindful emotion awareness, (2) cognitive flexibility, (3) identifying and preventing patterns of emotion avoidance, (4) increasing awareness and tolerance of emotion-related physical sensations, and (5) interoceptive and situational emotion-focused exposures. Its 5 core modules are preceded by a module focused on enhancing motivation and an introductory module on the adaptive nature of emotions that provides a framework for understanding emotional experiences. Participants will receive at least 36 individual sessions weekly (1 hour ).
Category
Treatment - Other
2
Description
Intervention group 2: Dialectical behavioral treatment (DBT) is a comprehensive cognitive behavioral therapy. DBT combines change-based interventions from behavior therapy (such as skills training, exposure, cognitive modification) with acceptance-based interventions. The first stage of treatment focuses on reducing high-risk behaviors and increasing behavioral skills in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness. Post-traumatic stress disorder is targeted as needed in the second stage of treatment. Standard DBT is typically delivered at least 52 sessions of outpatient treatment consisting of four modes: (i) individual therapy (1 hour/week), (ii) group skills training (2.5 hours/week), (iii) therapist consultation team (1 hour/week), and (iv) between-session telephone consultation (as needed)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Banafsheh Mohajerin
Street address
Talegani Hospital-Arabi St. Yaman St. Velenjak
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۱۱۵۱
Phone
+98 912 578 6918
Email
banafshehmohajerin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
َShahid beheshti university of emdical science, Arabi St. Yaman St. Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9788
Email
urm@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Banafsheh Mohajerin
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Psychology department- Taleqani hospital- Arabi St- Yaman St- Velenjak- Tehran