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IRCT20231106059970N2 IRCT 2024-12-07 Shahid Beheshti University of Medical Sciences evaluation of comparing the effectiveness of Unified Protocol and Dialectical Behavioral Therapy among individuals with borderline personality disorder and Post-traumatic stress disorder 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 2024-11-21 anticipated 68 Complete https://irct.ir/trial/80092 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Condition 1: Borderline personality disorder. Condition 2: Post-traumatic Stress Disorder. Intervention 1: 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 ). Intervention 2: 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). Yes - There is a plan to make this available What will be shared: Data and analysis will be available at a reasonable request. When: after Publication data will be available To whom: Data will be available for psychologists and psychiatrists Conditions: upon reasonable request Where to obtain: Data will be available after the publication of the results upon reasonable request by sending an email to the corresponding author How to obtain: Data will be available after the publication of the results upon reasonable request by sending an email to the corresponding author Comments:
public Banafsheh Mohajerin
Psychology department- Taleqani hospital- Arabi St- Yaman St- Velenjak- Tehran
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۱۱۵۱ +98 912 578 6918 banafshehmohajerin@gmail.com Shahid Beheshti University of Medical Sciences scientific Banafsheh Mohajerin
Psychology department- Taleqani Hospital- Velenjak,Tehran
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۱۱۵۱ +98 912 578 6918 banafshehmohajerin@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both 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 F60.3 F43.1 Borderline personality disorder Post-traumatic stress disorder (PTSD) Treatment - Other Treatment - Other 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 ). 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) 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. 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. 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. 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. 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. 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. 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. Shahid Beheshti University of Medical Sciences Approved 2024-10-27 research ethics committees of Vice-chancellor in research Affairs- shahid Behehshti University of Me Arabi St.Yaman St. Velenjak.Tehran Tehran Tehran Iran (Islamic Republic of)